For Use in 2010 Federal and State Pharmacy Law Study Guide

Transcription

For Use in 2010
Federal and State
Pharmacy Law Study Guide
For the Standardized
Pharmacy Law Exam
Note: In this study guide, italics denotes language quoted verbatim from the law. The source of the
cited law has been provided when appropriate. A series of dots (. . .) within an italicized quote signifies that language has been editorially deleted because it is deemed not sufficiently relevant to the
objectives of this study guide. Because the language of the law as quoted in this study guide is taken out of context, and has been edited for purposes of educational clarity, the study guide should
not be used as a reference by one who is seeking a complete understanding of all laws. For specific
legal advice, pharmacists and pharmacy students should refer to the complete law at a library, or
seek competent legal counsel.
The materials provided in this study guide are updated annually. This study guide utilizes various
resources, including federal and state websites, which may only update materials periodically.
Changes in the law may occur prior to the next updated version. Purchasers are advised to review
the online federal and state resources listed in the Study Guide for the most up-to-date changes.
The laws reviewed in this study guide are not a complete listing of all federal and state laws and only
provide a review. For a complete listing of all state laws, refer to the website(s) provided in the
state materials of this study guide. For a complete listing of all federal laws, refer to the FDA website at http://www.fda.gov/opacom/laws/, and to the DEA website at
http://www.deadiversion.usdoj.gov/21cfr/index.html.
Disclaimer: The materials in this document are intended for general information purposes
only, and are not intended to provide, and do not constitute, legal advice. Persons who
need legal advice should contact an attorney.
Copyright 2010, RxLaw.org, Inc.
All Rights Reserved.
Index
Chapter 1: The Food & Drug Administration...............................3
Chapter 2: Federal Drug Control Law.........................................16
Chapter 3: The Drug Enforcement Administration......................85
Chapter 4: Federal Controlled Substance Law...........................108
Chapter 5: Florida Statutes.........................................................149
Chapter 6: Florida Administrative Rules....................................198
Chapter 7: Sample Pharmacy Law Exam...................................272
Federal Pharmacy Law Review
Chapter 1 : The Food and Drug Administration
The Federal Food and Drug Administration (FDA) is one of the most highly regarded federal agencies. The FDA is
an agency within the Department of Health and Human Services and consists of seven centers, including:
1. Center for Biologics Evaluation and Research (CBER). CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal
Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products
are safe and effective and available to those who need them. CBER also provides the public with information to
promote the safe and appropriate use of biological products. CBER's mission is to protect and enhance the public
health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and
cellular and gene therapies.
2. Center for Devices and Radiological Health (CDRH). CDRH is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment,
microwave ovens and color televisions.
3. Center for Drug Evaluation and Research (CDER). CDER performs an essential public health task by making
sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. The Center is a
consumer watchdog in America's healthcare system. CDER's best-known job is to evaluate new drugs before they
can be sold. The Center's review of new drug applications not only prevents quackery, but it provides doctors and
patients with the information they need to use medicines wisely.
4. Center for Food Safety and Applied Nutrition (CFSAN). CFSAN, in conjunction with FDA field staff, is responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled. CFSAN provides
services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency
administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to
food and cosmetics.
5. The Center for Tobacco Products (CTP). CTP oversees the implementation of the Family Smoking Prevention
and Tobacco Control Act. Some of the Agency’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels,
and establishing and enforcing advertising and promotion restrictions.
6. The Center for Veterinary Medicine (CVM). CVM regulates the manufacture and distribution of food additives
and drugs that will be given to animals. These include animals from which human foods are derived, as well as
food additives and drugs for pet (or companion) animals. CVM is responsible for regulating drugs, devices, and
food additives given to, or used on, over one hundred million companion animals, plus millions of poultry, cattle,
swine, and minor animal species. (Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats.)
7. The National Center for Toxicological Research (NCTR). NCTR is the FDA's internationally recognized research center. NCTR, in partnership with researchers from elsewhere in the FDA, other government agencies, academia, and industry, provides innovative technology, methods development, vital scientific training, and technical
expertise. The unique scientific expertise of NCTR is critical in supporting FDA product centers and their regulatory roles.
Copyright 2010, RxLaw.org, Inc. All Rights Reserved
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In addition to being trusted with safeguarding the safety, effectiveness and integrity of the nation’s drug supply, the
agency has had authority since 1948 to regulate the act of dispensing by a pharmacist. Although technically limited to the
regulation of “interstate commerce,” the courts have consistently held that the dispensing of a drug by a pharmacist to a patient, even though the act occurs entirely within a state, is an act that is in interstate commerce. Since the FDA has an important role in the regulation and implementation of federal laws, pharmacy practitioners should have a basic understanding of
the role of the FDA. The following provides information, including excerpts from FDA publications, describing the functioning of the agency. For additional information about the FDA, visit www.fda.gov.
A. CDER: The Consumer Watchdog for Safe and Effective Drugs
American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. CDER
ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.
This responsibility includes products that many consumers usually do not associate as drugs, such as fluoride toothpaste, dandruff shampoos and sunscreens. CDER carefully evaluates the benefits and risks of drugs and ensures that consumers have
access, as quickly as possible, to promising new treatments. The center oversees the research, development, manufacture and
marketing of drugs. CDER ensures truth in advertising for prescription drugs and monitors the use of marketed drugs for unexpected health risks. If unexpected risks are detected after approval, CDER takes action to inform the public, change a drug's
label, or--if necessary--remove a product from the market.
CDER has multiple Offices and Divisions, including: Office of New Drugs; Office of Nonprescription Products; Office of
Oncology Drug Products; Office of Pharmaceutical Science; Office of Biotechnology Products; Office of Generic Drugs; Office of New Drug Quality Assessment; Office of Testing and Research; Office of Surveillance and Epidemiology (formerly
Office of Drug Safety); and Division of Drug Information.
Prescription Drugs
Prescription medicines must be administered under a doctor's supervision or require a doctor's authorization for purchase.
There are several reasons that medicines are required to be sold by prescription. The disease or condition may be serious and
require a doctor's management. The same symptoms can be caused by different diseases that only a doctor can diagnose. The
different causes may require different medicines. Some medicines can be dangerous when used to treat the wrong diseases,
and some drugs are abused.
OTC Drugs
Over-the-counter (OTC) drugs play an increasingly vital role in America's health care system. OTC drug products are those
drugs that are available to consumers without a prescription. There are more than 80 therapeutic categories of OTC drugs,
ranging from acne drug products to weight control drug products. As with prescription drugs, CDER oversees OTC drugs to
ensure that they are properly labeled and that their benefits outweigh their risks. OTC drugs generally have these characteristics:
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their benefits outweigh their risks
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the potential for misuse and abuse is low
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consumer can use them for self-diagnosed conditions
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they can be adequately labeled
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health practitioners are not needed for the safe and effective use of the product
Generic Drugs
A generic drug is a chemical clone of a drug sold under a brand name. There are generic versions of both prescription and
OTC medicines. For example, ibuprofen is the generic name of the anti-inflammatory drug sold under the brand names
Motrin or Advil. The biggest difference between a generic drug and a brand-name drug is usually price. A generic drug often
costs about 30 percent less than the brand-name drug. Widespread use of generics helps control medical costs and insurance
premiums.
The FDA works with pharmaceutical companies to assure that all drugs marketed in the United States meet specifications for
identity, strength, quality, purity, and potency. Before approving a generic drug product, CDER requires many rigorous tests
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and procedures to assure that the generic drug can be substituted for the brand name drug. CDER bases evaluations of substitutability or "therapeutic equivalence" for generic drugs on scientific evaluations. By law, generic drug products must contain
the identical amounts of the same active drug ingredient as the brand name product. Drug products evaluated as
"therapeutically equivalent" can be expected to have equal effect and no difference when substituted for the brand name product. FDA considers drug products to be substitutable if they meet the criteria of therapeutic equivalence, even though the generic drug may differ in certain other characteristics (e.g., shape, flavor, or preservatives).
B. The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective
The path a drug travels from a lab to your medicine cabinet is usually long, and every drug takes a unique route. Often, a drug
is developed to treat a specific disease. An important use of a drug may also be discovered by accident. For example, Retrovir
(zidovudine, also known as AZT) was first studied as an anti-cancer drug in the 1960s with disappointing results. It wasn't
until the 1980s that researchers discovered the drug could treat AIDS, and the Food and Drug Administration approved the
drug, manufactured by GlaxoSmithKline, for that purpose in 1987. Most drugs that undergo preclinical (animal) testing never
even make it to human testing and review by the FDA. The drugs that do must undergo the agency's rigorous evaluation process, which scrutinizes everything about the drug--from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured.
Investigational New Drug Application
In many ways, the investigational new drug (IND) application is the result of a successful preclinical development program.
The IND is also the vehicle through which a sponsor advances to the next stage of drug development known as clinical trials
(human trials). During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is
reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting
the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in
limited, early-stage clinical studies.
The IND is not an application for marketing approval. Rather, it is a request for an exemption from the Federal statute that
prohibits an unapproved drug from being shipped in interstate commerce. Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will
probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that
legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA; however, its main purpose is to detail the data that provide documentation that it is indeed reasonable to proceed with certain human trials with the drug.
Treatment Investigational New Drug
Treatment Investigational New Drugs are used to make promising new drugs available to desperately ill patients as early in
the drug development process as possible. FDA will permit an investigational drug to be used under a treatment IND if there
is preliminary evidence of drug efficacy and the drug is intended to treat a serious or life-threatening disease, or if there is no
comparable alternative drug or therapy available to treat that stage of the disease in the intended patient population. In addition, these patients are not eligible to be in the definitive clinical trials, which must be well underway, if not almost finished.
An immediately life-threatening disease means a stage of a disease in which there is a reasonable likelihood that death will
occur within a matter of months or in which premature death is likely without early treatment. For example, advanced cases
of AIDS, herpes simplex encephalitis, and subarachnoid hemorrhage are all considered to be immediately life-threatening diseases. Treatment INDs are made available to patients before general marketing begins, typically during Phase 3 studies.
Treatment INDs also allow FDA to obtain additional data on the drug's safety and effectiveness.
New Drug Application
This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United
States. A new drug application (NDA) includes all animal and human data and analyses of the data, as well as information
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about how the drug behaves in the body and how it is manufactured. When an NDA comes in, the FDA has 60 days to decide
whether to file it so that it can be reviewed. The FDA can refuse to file an application that is incomplete. For example, some
required studies may be missing. In accordance with the Prescription Drug User Fee Act (PDUFA), the FDA's Center for
Drug Evaluation and Research (CDER) expects to review and act on at least 90 percent of NDAs for standard drugs no later
than 10 months after the applications are received. The review goal is six months for priority drugs. There is also continuous
interaction throughout the review process. For example, over roughly six years, the sponsor, Merck Research Laboratories of
West Point, Pa., and the FDA had several face-to-face meetings and about 28 teleconferences regarding the asthma drug Singulair (montelukast sodium).
Reviewing Applications
Though FDA reviewers are involved with a drug's development throughout the IND stage, the official review time is the
length of time it takes to review a new drug application and issue an action letter, an official statement informing a drug sponsor of the agency's decision. Once a new drug application is filed, an FDA review team--medical doctors, chemists, statisticians, microbiologists, pharmacologists, and other experts--evaluates whether the studies the sponsor submitted show that the
drug is safe and effective for its proposed use. No drug is absolutely safe; all drugs have side effects. "Safe" in this sense
means that the benefits of the drug appear to outweigh the risks.
The review team analyzes study results and looks for possible issues with the application, such as weaknesses of the study
design or analyses. Reviewers determine whether they agree with the sponsor's results and conclusions, or whether they need
any additional information to make a decision.
Each reviewer prepares a written evaluation containing conclusions and recommendations about the application. These evaluations are then considered by team leaders, division directors, and office directors, depending on the type of application.
Reviewers receive training that fosters consistency in drug reviews, and good review practices remain a high priority for the
agency. Sometimes, the FDA calls on advisory committees made up of outside experts, who help the agency decide on drug
applications. Whether an advisory committee is needed depends on many things. Considerations would be if it's a drug that
has significant questions, if it's the first in its class, or the first for a given indication. Generally, the FDA takes the advice of
advisory committees, but not always.
FDA Process for Responding to Drug Applications
As of August, 2008, CDER no longer issued "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER now issues a "complete response" letter at the end of the review period to let a drug company know of
the agency's decision on the application. This approach will help the FDA adopt a more consistent and neutral way of conveying information to a company when the FDA cannot approve a drug application in its present form. Taking the place of
"approvable" and "not approvable" letters, a "complete response" letter will be issued to let a company know that the review
period for a drug is complete and that the application is not yet ready for approval. The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval.
Drug Review Steps
Ÿ Preclinical (animal) testing.
Ÿ An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in
clinical trials.
Ÿ Phase 1 studies (typically involve 20 to 80 people).
Ÿ Phase 2 studies (typically involve a few dozen to about 300 people).
Ÿ Phase 3 studies (typically involve several hundred to about 3,000 people).
Ÿ The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug
sponsors to meet.
Ÿ Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
Ÿ After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
Ÿ If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.
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Ÿ The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug).
Ÿ The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
Ÿ FDA reviewers will issue a response letter to let a drug company know the agency’s decision on the application.
The Role of User Fees
Since the Prescription Drug User Fee Act (PDUFA) was passed in 1992, thousands of drugs and biologics have come to the
market, including new medicines to treat cancer, AIDS, cardiovascular disease, and life-threatening infections. PDUFA has
allowed the Food and Drug Administration to bring access to new drugs as fast or faster than anywhere in the world, all while
maintaining the same thorough review process. Under PDUFA, drug companies agree to pay fees that boost FDA resources,
and the FDA agrees to time goals for its review of new drug applications. Along with supporting increased staff, drug user
fees help the FDA upgrade resources in information technology. The agency has moved toward an electronic submission and
review environment, now accepting more electronic applications and archiving review documents electronically.
The goals set by PDUFA apply to the review of original new human drug and biological applications, resubmissions of original applications, and supplements to approved applications. The second phase of PDUFA, known as PDUFA II, was reauthorized in 1997 and extended the user fee program through September 2002. PDUFA III, which extended to Sept. 30, 2007, was
reauthorized in June 2002. PDUFA IV was reauthorized in September 2007 and extends an additional 5 years. PDUFA allows the FDA to spend some user fees to increase surveillance of the safety of medicines during their first two years on the
market, or three years for potentially dangerous medications. It is during this initial period, when new medicines enter into
wide use, that the agency is best able to identify and counter adverse side effects that did not appear during the clinical trials.
In addition to setting time frames for review of applications, PDUFA sets goals to improve communication and sets goals for
specific kinds of meetings between the FDA and drug sponsors. It also outlines how fast the FDA must respond to requests
from sponsors. Throughout a drug's development, the FDA advises sponsors on how to study certain classes of drugs, how to
submit data, what kind of data are needed, and how clinical trials should be designed.
C. Inside Clinical Trials: Testing Medical Products in People
What Is a Clinical Trial?
Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine,
blood product, or gene therapy. Potential treatments, however, must be studied in laboratory animals first to determine potential toxicity before they can be tried in people. Treatments having acceptable safety profiles and showing the most promise
are then moved into clinical trials.
Although "new" may imply "better," it is not known whether the potential medical treatment offers benefit to patients until
clinical research on that treatment is complete. Clinical trials are an integral part of new product discovery and development
and are required by the Food and Drug Administration before a new product can be brought to the market.
The FDA is committed to protecting the participants of clinical trials, as well as providing reliable information to those interested in participating. Recently, unethical behavior on the part of some researchers has shaken the public trust and prompted
the federal government to establish regulations and guidelines for clinical research to protect participants from unreasonable
risks.
Although efforts are made to control risks to clinical trial participants, some risk may be unavoidable because of the uncertainty inherent in clinical research involving new medical products. It's important, therefore, that people make their decision
to participate in a clinical trial only after they have a full understanding of the entire process and the risks that may be involved.
Why Participate in a Clinical Trial?
People volunteer to participate in clinical trials for different reasons. Some volunteer because they want to help advance medical knowledge. Others have tried all available treatments for their condition without success. In a 2000 Harris Poll of cancer
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clinical trial participants, 76 percent of the respondents said they participated because they believed that the trial offered the
best quality of care for their disease. Helping other people and receiving more and better attention for their own specific disease were other reasons cited. People should not, however, be tempted to enroll in a clinical trial simply because a potential
treatment is being offered free during a study, or because of the promise of money. This could lead to people overlooking
known risks.
Who Can Participate?
It's important to test medical products in the people they are meant to help. In the past, most new drug testing had been done
on white men. Groups such as women, blacks, and Hispanics often were not adequately represented. It's important to test
medical products in a wide variety of people because drugs can work differently in people of various ages, races, ethnicity,
and gender. The FDA seeks to ensure that people from many different groups are included in clinical trials.
Trial guidelines, or eligibility requirements, are developed by the researchers and usually include criteria for age, sex, type
and stage of disease, previous treatment history, and other medical conditions. Some trials involve people with a particular
illness or condition to be studied, while others seek healthy volunteers. Inclusion or exclusion criteria--medical or social standards used to determine whether a person may or may not be allowed to enter a clinical trial--help identify appropriate participants and help to exclude those who may be put at risk by participating in a trial. Volunteering for a clinical trial is no
guarantee of acceptance. Similarly, there's no guarantee that an individual in a clinical trial will receive the drug or medical
product being studied.
What Happens in a Clinical Trial?
Every clinical trial is carefully designed to answer certain research questions. A trial plan called a protocol maps out what
study procedures will be done, by whom, and why. Products are often tested to see how they compare to standard treatments
or to no treatment. The FDA often provides extensive technical assistance to researchers conducting clinical trials, helping
them design better trials that can characterize effects of a new product more efficiently, while reducing risks to those participating in the trials. The clinical trial team includes doctors and nurses, as well as other health care professionals. This team
checks the health of the participant at the beginning of the trial and assesses whether that person is eligible to participate.
Those found to be eligible--and who agree to participate--are given specific instructions, and then monitored and carefully
assessed during the trial and after it is completed.
Done at hospitals and research centers around the country, clinical trials are conducted in phases. Phase 1 trials try to determine dosing, document how a drug is metabolized and excreted, and identify acute side effects. Usually, a small number of
healthy volunteers (between 20 and 80) are used in Phase 1 trials. Phase 2 trials include more participants (about 100-300)
who have the disease or condition that the product potentially could treat. In Phase 2 trials, researchers seek to gather further
safety data and preliminary evidence of the drug's beneficial effects (efficacy), and they develop and refine research methods
for future trials with this drug. If the Phase 2 trials indicate that the drug may be effective--and the risks are considered acceptable, given the observed efficacy and the severity of the disease--the drug moves to Phase 3. In Phase 3 trials, the drug is
studied in a larger number of people with the disease (approximately 1,000-3,000). This phase further tests the product's effectiveness, monitors side effects and, in some cases, compares the product's effects to a standard treatment, if one is already
available. As more and more participants are tested over longer periods of time, the less common side effects are more likely
to be revealed. Sometimes, Phase 4 trials are conducted after a product is already approved and on the market to find out
more about the treatment's long-term risks, benefits, and optimal use, or to test the product in different populations of people,
such as children. Phase 2 and Phase 3 clinical trials generally involve a "control" standard. In many studies, one group of volunteers will be given an experimental or "test" drug or treatment, while the control group is given either a standard treatment
for the illness or an inactive pill, liquid, or powder that has no treatment value (placebo). This control group provides a basis
for comparison for assessing effects of the test treatment. In some studies, the control group will receive a placebo instead of
an active drug or treatment. In other cases, it is considered unethical to use placebos, particularly if an effective treatment is
available. Withholding treatment (even for a short time) would subject research participants to unreasonable risks.
The treatment each trial participant receives is often decided by a process called randomization. This process can be compared to a coin toss that is done by computer. During clinical trials, no one likely knows which therapy is better, and random-
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ization assures that treatment selection will be free of any preference a physician may have. Randomization increases the
likelihood that the groups of people receiving the test drug or control are comparable at the start of the trial, enabling comparisons in health status between groups of patients who participated in the trial. In conjunction with randomization, a feature
known as blinding helps ensure that bias doesn't distort the conduct of a trial or the interpretation of its results. Single-blinding means the participant does not know whether he or she is receiving the experimental drug, an established treatment for
that disease, or a placebo. In a single-blinded trial, the research team does know what the participant is receiving. A doubleblinded trial means that neither the participant nor the research team knows during the trial which participants receive the experimental drug. The patient will usually find out what he or she received at a pre-specified time in the trial.
What Are the Risks?
Some treatments being studied can have unpleasant, or even serious, side effects. Often these are temporary and end when the
treatment is stopped. Others, however, can be permanent. Some side effects appear during treatment, and others may not
show up until after the study is over. The risks depend on the treatment being studied and the health of the people participating in the trial. All known risks must be fully explained by the researchers before the trial begins. If new risk information becomes available during the trial, participants must be informed.
How Are People Protected?
Most clinical trials are federally regulated with built-in safeguards to protect participants. Today, the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) leads the department's programs for the
protection of human research participants and oversees human protection in HHS-funded research. The FDA has authority
over clinical trials for drug, biologic, and medical device products regulated by the agency. This authority includes studies
that are HHS-funded (with joint oversight by the FDA and the OHRP), as well as studies that are solely funded by industry or
by private parties. Many clinical trials are not subject to FDA regulation but are monitored by the institution sponsoring the
trial, such as a hospital. To help protect the rights and welfare of volunteers and verify the quality and integrity of data submitted for review, the FDA performs inspections of clinical trial study sites and anyone involved in the research. The quality
of clinical trials has improved markedly since the agency started inspecting in 1977. Between the FDA, other government
agencies, the review by institutional review boards, the required monitoring of studies by industry or private sponsors, and
the required oversight and reporting by investigators and their staff, a lot of people are looking out for the research subject's
safety.
What Is Informed Consent?
The FDA requires that potential participants be given complete information about the study. This process is known as
"informed consent," and it must be in writing. The informed consent process provides an opportunity for the researcher and
patient to exchange information and ask questions. Patients invited to enter a trial are not obligated to join, but can consent to
participate if they find the potential risks and benefits acceptable. A consent form must be signed by the participant prior to
enrollment and before any study procedures can be performed. Participants also have the right to leave a study at any time. At
the same time, people need to know that circumstances may arise under which their participation may be terminated by the
researcher, without their consent. For example, sometimes it becomes evident early on that a trial is not working and researchers know they are not going to get enough meaningful information to make continuation worthwhile. In addition, if an
unexpected change occurs in the health status of a participant, such as toxic effects or sudden kidney problems that may have
developed, it would not be in the best interest of the patient to continue, and certainly not consistent with what the investigator is trying to study. In any case, the circumstances must be described in the consent document.
Where to Get Information on Clinical Trials
It is often difficult for patients to learn about opportunities to participate in clinical trials. Doctors and patient advocacy
groups can be valuable resources for patients in search of clinical trial information. Newspapers, particularly in large cities,
often carry clinical trial recruitment advertisements. A call to the relevant department at nearby university medical centers can
lead to information about clinical trials currently recruiting patients.
The web site ClinicalTrials.gov also provides patients, family members, health care professionals, and members of the public
easy access to information on clinical trials for a wide range of diseases and conditions. The National Institutes of Health
(NIH), through its National Library of Medicine, has developed this site in collaboration with all NIH institutes and the FDA.
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The site contains information on thousands of clinical studies sponsored by the NIH, other federal agencies, and the pharmaceutical industry in about 100,000 locations worldwide. Studies listed in the database are conducted primarily in the United
States and Canada, but include locations in about 90 countries. ClinicalTrials.gov gives information about a trial's purpose,
who may participate, locations, and phone numbers for more details. In addition, a glossary is available that will help people
become familiar with the most common clinical trial terms.
Information Required for Informed Consent
The FDA requires that people be told that the study involves research of an unproven drug, biologic(such as a vaccine, blood
product, or gene therapy), or medical device; the purpose of the research; how long the participant will be expected to participate in the study; what will happen in the study and which parts of the study are experimental; possible risks or discomforts to
the participant; possible benefits to the participant; other procedures or treatments that might be advantageous to the participant instead of the treatment being studied; that the FDA may look at study records, but the records will be kept confidential;
whether any compensation and medical treatments, if any, are available if the participant is injured, what those treatments are,
where they can be found, and who will pay for the treatment; the person to contact with questions about the study, participants' rights, or if the participant gets hurt; that participation is voluntary and that participants can quit the study at any time
without penalty or loss of benefits to which they are otherwise entitled.
Institutional Review Boards
Clinical trial procedures are reviewed by institutional review boards (IRBs). These boards are composed of at least five members that include scientists, doctors, and lay people, and they must approve every clinical trial taking place within their jurisdiction--usually a hospital. The purpose of an IRB review is to ensure that appropriate steps are taken to protect the rights and
welfare of participants as subjects of research. If the risks to participants are found to be too great, the IRB will not approve
the research, or it will specify changes that must be made before the research can be done.
IRBs also review participant inclusion and exclusion requirements to be sure that appropriate people have been identified as
eligible for the trial. They often look at how and where recruitment for clinical trials will occur. IRBs review the adequacy of
the informed consent document to ensure that it includes all the elements required by law, and that it is at an appropriate reading level and understandable to study participants.
D. Protecting Drug Quality
CDER also promotes public health by regulating the manufacture of drugs and by setting standards for drug quality. CDER
works closely with FDA field inspectors to make sure that manufacturers comply with current good manufacturing practices.
Before a drug is approved, investigators determine whether the manufacturing data in the application are accurate. Once a
drug is approved, another inspection is required to show the firm can consistently make a drug in large quantities. Periodic
inspections check a firm's overall operation.
Current Good Manufacturing Practices (cGMPs)
Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every American. Consumers expect that
each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however,
are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. FDA inspects
pharmaceutical manufacturing facilities worldwide using scientifically and cGMP- trained individuals whose job it is to evaluate whether the company is following the cGMP regulations. FDA also relies upon reports of potentially defective drug
products from the public and the industry. FDA will often use these reports to identify sites for which an inspection or investigation is needed. Most companies that are inspected are found to be fully compliant with the cGMP regulations. If a company is not complying with cGMP regulations, any drug it makes is considered “adulterated” under the law. This kind of
adulteration means that the drug was not manufactured under conditions that comply with cGMP. It does not mean that there
is necessarily something wrong with the drug.
For consumers currently taking medicines from a company that was not following cGMPs, FDA usually advises these consumers not to interrupt their drug therapy, which could have serious implications for their health. Consumers should seek advice from their health care professionals before stopping or changing medications. Regulatory actions against companies with
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poor cGMPs are taken as a preventive measure because the manufacturing processes do not meet FDA’s regulatory standards.
By focusing on the procedures and processes used to make these drugs, FDA is working to ensure that drugs meet their quality standards and are safe and effective. The impact of cGMP violations depends on the nature of those violations and on the
specific drugs involved. A drug manufactured in violation of cGMP may still meet its labeled specifications, and the risk that
the drug is unsafe or ineffective could be minimal. Thus, FDA’s advice will be specific to the circumstances, and health care
professionals are best able to balance risks and benefits and make the right decision for their patients.
If the failure to meet cGMPs results in the distribution of a defective drug, the company may subsequently recall that product.
This protects the public by removing these drugs from the market. While FDA cannot force a company to recall a drug, companies will usually recall voluntarily or at FDA’s request. If a company refuses to recall a drug, FDA can warn the public and
could seize the drugs that are on the market. Even if the drugs are not defective, FDA can bring a seizure or injunction case in
court to address cGMP violations. When FDA brings a seizure case, the agency asks the court for an order that allows federal
officials to take possession of “adulterated” drugs and destroy them. This enables FDA to immediately prevent a company
from distributing those drugs to consumers. When FDA brings an injunction case, FDA asks the court to order a company to
stop violating cGMPs. Both seizure and injunction cases often lead to court orders that require companies to take many steps
to correct cGMP violations, such as hiring outside experts, writing new procedures, and conducting extensive training of their
employees. FDA can also bring criminal cases because of cGMP violations, seeking fines and jail time.
E. Now Available Without a Prescription
Over-the-counter (OTC) drug products are those drugs that are available to consumers without a prescription. There are more
than 80 classes (therapeutic categories) of OTC drugs, ranging from acne drug products to weight control drug products. As
with prescription drugs, CDER oversees OTC drugs to ensure that they are properly labeled and that their benefits outweigh
their risks.
OTC drugs play an increasingly vital role in America's health care system by providing easy access to certain drugs that can
be used safely without the help of a health care practitioner. This enables consumers to take control of their own health care
in many situations. There are more than 100,000 OTC drug products marketed, encompassing about 800 significant active
ingredients. The FDA has given OTC approval to drugs with such household names as Children's Advil and Children's
Motrin (ibuprofen), Orudis KT and Actron (ketoprofen), and Aleve (naproxen sodium) for pain relief and fever reduction;
Femstat 3 (butoconazole nitrate) for vaginal yeast infection; Pepcid AC (famotidine), Tagamet HB (cimetidine), Zantac 75
(ranitidine hydrochloride), Axid AR (nizatidine), and Prilosec OTC (omeprazole magnesium) for heartburn; Rogaine
(minoxidil) for hair growth; and Claritin (loratadine), the first non-sedating antihistamine.
The FDA believes that there is an important trend toward consumer participation in their own health care. It's part of the
agency's mission to keep up with the consumers' wish to be more involved. Switches have a huge impact on the health care
economy. The greater availability of medicines over the counter saves approximately $20 billion each year, according to a
1997 study. The $20 billion takes into account prescription costs, doctor visits, lost time from work, insurance costs, and
travel.
The Switch Process
The original Federal Food, Drug, and Cosmetic Act of 1938 made no clear-cut distinction between prescription and OTC
drugs. The 1951 Durham-Humphrey amendment to the act set up specific standards for classification. The amendment requires that drugs that cannot be used safely without professional supervision be dispensed only by prescription. Such drugs
may be deemed unsafe for nonprescription use because they are habit-forming or toxic, have too great a potential for harmful
effects, or are for medical conditions that can't be readily self-diagnosed. All other drugs can be sold OTC. A drug must be
made available without a prescription if, by following the labeling, consumers can use it safely and effectively without professional guidance.
The process of reclassifying drugs from prescription to OTC status is referred to as an "Rx to OTC switch." Drugs are commonly switched one of two ways: under the "OTC drug review," or by a manufacturer's submission of additional information
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to the original new drug application. The OTC drug review, which began in 1972, is an ongoing assessment of the safety and
effectiveness of all nonprescription drugs. In the first phase of the OTC drug review, panels of nongovernment experts review
active ingredients in marketed OTC drug products to determine whether they can be classified as safe and effective. The panels also review prescription ingredients to determine whether some are appropriate for OTC marketing.
The second common path to OTC approval is under the new drug application process. Under this process, manufacturers submit data to the FDA showing the drug is appropriate for self-administration. Data are submitted in a new drug application or a
supplement to an already approved drug application. Often the submission includes studies showing that the product's labeling can be read, understood, and followed by the consumer without the guidance of a health care provider. The FDA reviews
the new data, along with any information known about the drug from its prescription use. Under the new drug application
process, some drugs are approved initially as OTC drugs, but most are first approved for prescription use and later switched
to OTC.
In almost every case for the first drug switched in a drug category, the agency has sought the recommendation of a joint advisory committee made up of members of the agency's Nonprescription Drugs Advisory Committee and another advisory committee with expertise in the type of drug being considered. For example, because Rogaine is for conditions of the hair and
scalp, representatives of the Dermatologic and Ophthalmic Drugs Advisory Committee participated. While not bound by the
advisory committee's counsel, the FDA almost always follows its recommendation.
Benefit-Risk Comparison
When considering an Rx-to-OTC switch, the key question for the FDA is whether patients alone can achieve the desired medical result without endangering their safety. No drug is absolutely safe. There are risks associated with every medication, so
the FDA does a benefit-to-risk comparison to determine whether it is appropriate for consumers to self-medicate with a drug
for a certain use. On the safety side, the agency looks at the drug's toxicity--its potential for poisonous effects--when the drug
is used according to its labeled directions, and also from foreseeable misuse of the drug.
The FDA weighs a drug's safety against its benefit to patients. The agency considers whether consumers will be able to understand and follow label directions, whether patients can diagnose the condition themselves--or at least recognize the symptoms they want to treat--and whether routine medical examinations or laboratory tests are required for continued safe use of a
drug. No easy risk-benefit formula exists. The FDA does a case-by-case review of each drug because each drug raises unique
issues. Concerns about side effects can sometimes be managed by approving OTC drugs at lower doses than their prescription counterparts. The drugs must still be effective for the short-term symptoms for which they're intended. The issue of
whether a condition can be self-diagnosed was a central one for the advisory committee reviewing Rogaine. Most OTC drugs
are intended for treatment of symptoms that can be easily recognized, like headache or upset stomach. Others, though, are
intended to treat diseases like asthma or vaginal fungal infections, which cannot be consumer-diagnosed.
Consumer-Friendly Labeling
Labeling is an influential element in the OTC risk-benefit comparison. The decision about a drug's safety for OTC use can't
be made in a vacuum, by looking only at the drug ingredients. Every drug, used improperly, can cause adverse reactions.
Even appropriate use can lead to side effects (antihistamine use may cause drowsiness, for example). And some drugs can be
dangerously unsafe or ineffective if taken while using certain other drugs. Labeling can alert consumers to such potential
problems. Labeling of all drugs must be clear and truthful. For OTC drugs, the intended uses, directions, and warnings have
to be written so consumers, including individuals with low reading comprehension, can understand them.
In March 1999, the FDA finalized regulations to increase the readability of OTC labels by making the language more consumer-friendly and standardizing the format, including where important information is placed. The FDA believes that, in
some cases, consumers can get more information in the OTC labeling than they would get from their doctors. An example of
the consumer-friendly OTC label, available from the FDA website, is shown below.
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A Popular Alternative
Under the law, OTC drugs may be advertised directly to consumers without the many restrictions placed on prescription
products. OTC status provides a greater opportunity for direct communication with the consumer, not only by advertising in
magazines and on television, but also with packaging, brochures, and retail displays. Today's emphasis on self-care fuels the
popularity of nonprescription drugs. But OTC products are intended to supplement the medical options of the consumer, not
substitute for a prescriber's medical knowledge. If a health problem persists or worsens while using an OTC drug, consult a
health care provider. People must be in a partnership with their health care providers for optimal health. Many situations
aren't appropriate for self-treatment, and others may require professional guidance for self-treatment.
F. Postmarketing Surveillance Programs
Despite CDER's vigilant premarket review, active postmarketing surveillance of drug adverse effects is also essential. Because all possible side effects of a drug can't be anticipated based on preapproval studies involving only several hundred to
several thousand patients, FDA maintains a system of postmarketing surveillance and risk assessment programs to identify
adverse events that did not appear during the drug approval process. FDA monitors adverse events such as adverse reactions
and poisonings. The Agency uses this information to update drug labeling, and, on rare occasions, to reevaluate the approval
or marketing decision.
The following describes how CDER works to assure the ongoing safety and effectiveness of drug products currently marketed in the United States.
The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The ultimate goal of AERS is
to improve the public health by providing the best available tools for storing and analyzing safety reports. The reports in
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AERS are evaluated by a multidisciplinary staff safety evaluators, epidemiologists and other scientists in CDER’s Office of
Surveillance and Epidemiology to detect safety signals and to monitor drug safety. As a result, the FDA may take regulatory
actions to improve product safety and protect the public health, such as updating a product's labeling information, sending out
a "Dear Health Care Professional" letter, or re-evaluating an approval decision.
The MedWatch program is for health professionals and the public to voluntarily report serious reactions and problems with
medical products, such as drugs and medical devices. It also ensures that new safety information is rapidly communicated to
the medical community thereby improving patient care. All data contained on the MedWatch form will be entered into the
AERS database. After the FDA evaluates reports, the result may be safety alerts, letters to health care professionals, labeling
changes, product withdrawals, or further postmarketing research. When the FDA receives a MedWatch report, it is entered
into a database that allows a safety evaluator to compare it to similar reports. As few as a handful of reports may trigger a
careful investigation by the FDA and a manufacturer. To report to MedWatch, log onto the MedWatch site at
www.fda.gov/medwatch/. Reports can be made online, by phone (1-800-FDA-1088), or by downloading a form to fax (1800-FDA-0178) or mail (MedWatch, FDA,5600 Fishers Lane, Rockville, MD 20852-9787).
The Division of Drug Marketing, Advertising and Communications page also contains other useful drug advertising and surveillance information.
After a drug is approved and marketed, the FDA uses different mechanisms to assure that firms 1) adhere to the terms and
conditions of approval described in the application and 2) that the drug is manufactured in a consistent and controlled manner. This is done by periodic, unannounced inspections of drug production and control facilities by FDA's field investigators
and analysts.
Manufacturers of prescription medical products are required by regulation to submit adverse event reports to the FDA. The
MedWatch site provides information on mandatory reporting by manufacturers. In addition, drug manufacturers must submit
either error and accident reports or drug quality reports when deviation from current good manufacturing practice regulations
occur.
G. Strategies to Reduce Medication Errors: Working to Improve Medication Safety
FDA receives medication error reports on marketed human drugs (including prescription drugs, generic drugs, and over-thecounter drugs) and nonvaccine biological products and devices. The National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such
events may be related to professional practice, health care products, procedures, and systems, including prescribing; order
communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use." CDER medication errors program staff review medication error reports sent to the Institute of
Safe Medication Practices (ISMP) and MedWatch, evaluate causality, and analyze the data to provide feedback to others at
FDA.
A Regulatory Approach
The public took notice in 1999 when the Institute of Medicine (IOM) released a report, "To Err is Human: Building a Safer
Health System." According to the report, between 44,000 and 98,000 deaths may result each year from medical errors in hospitals alone, with more than 7,000 deaths each year related to medications. In response to the IOM's report, all parts of the
U.S. health system put error reduction strategies into high gear by re-evaluating and strengthening checks and balances to
prevent errors.
The FDA enhanced its efforts to reduce medication errors by dedicating more resources to drug safety, which included forming a new division on medication errors at the agency in 2002. Some important ways the FDA has worked to reduce medication errors includes: issuing a bar code label rule; reviewing drug names to minimize confusion between look or sound alike
drug names; improving OTC and prescription labels; publishing information for consumers and health professionals regarding new drug warnings and other safety information; and launching several medication risk reduction projects.
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H.
Direct-to-Consumer Advertising
When it comes to advertising prescription drugs on radio and television and in magazines, doctors say that, for the most part,
the ads have both positive and negative effects on their patients and practices. Results of a FDA survey, released in 2004, also
indicate that most physicians view direct-to-consumer (DTC) ads as one of many factors that affect their medical practices
and their interactions with patients.
For decades, prescription drug makers promoted their products exclusively to health care professionals, who were expected to
interpret drug information for their patients. Beginning in the early 1990s, some drug manufacturers began targeting consumers due, in part, to the aging baby boomers and to an increase in the number of patients participating in their own health care
decisions. Since then, DTC advertising has become a popular promotional tool.
The FDA oversees the advertising of prescription drug products under the Federal Food, Drug, and Cosmetic Act and related
regulations. The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) helps protect the public
health by assuring prescription drug information is truthful, balanced and accurately communicated. This is accomplished
through a comprehensive surveillance, enforcement and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers.
DDMAC reviewers have responsibility for reviewing prescription drug advertising and promotional labeling to ensure that
the information contained in these promotional materials is not false or misleading. They engage in a variety of tasks to perform this responsibility, including: providing written comments to pharmaceutical sponsors on proposed promotional materials to ensure clear and unambiguous communication of the laws and regulations relating to prescription drug promotion;
reviewing complaints about alleged promotional violations; initiating enforcement actions on promotional materials that are
false or misleading; comparing the product labeling and promotional materials of various closely related products to ensure
that the regulatory requirements are consistently and equitably applied; traveling to major medical meetings and pharmaceutical conventions to monitor promotional exhibits and activities; and acting as a liaison between DDMAC and other divisions
within the FDA on promotional issues.
DDMAC also reminds all companies who are engaging in DTC advertising of prescription drugs that the requirements of section 906 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) went into effect on March 25, 2008. Section 906 of FDAAA mandates that published direct-to-consumer advertisements for prescription drugs include the following
statement printed in conspicuous text: "You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088."
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Chapter 2: Federal Drug Control Law
I.
The Federal Food, Drug & Cosmetic Act (FDCA)
Passed by the United States Congress in 1938, and amended many times since then, the FDCA serves as the basis for
drug regulation in the United States. The FDCA is both simple and complex at the same time. The simplicity is that it specifies only three basic illegal acts; adulteration, misbranding, and the placing into interstate commerce of an unapproved new
drug. The complexity is that many activities are included under the umbrella of these three basic illegal acts. If you are ever
challenged to explain why something you know to be illegal is illegal under the FDCA, a safe explanation would be to assert
that the activity is either adulteration, misbranding, or the placing into interstate commerce of an unapproved new drug.
The passage of the FDCA in 1938 had a catalyst: the sulfanilamide tragedy of 1937. This miracle anti-infective sulfa
drug was made into an elixir that contained diethylene glycol. With no toxicity tests completed, the elixir led to 107 deaths,
mostly children. Unfortunately, the Pure Food and Drug Act (which was passed in 1906 and active in 1937) did not allow the
FDA to ban unsafe drugs. Since 1938, there have been a number of amendments to the FDCA that are important to be familiar with. These include:
Durham-Humphrey Amendment of 1951. This amendment distinguished at the federal level those drugs requiring a prescription from nonprescription drugs. Prescription drugs were defined as drugs that could not be used safely without medical
supervision, and restricted the sale of such drugs to prescription by a licensed practitioner. In addition to requiring a prescription for specific drugs, the Durham Humphrey Amendment also provided statutory provisions for the receipt of oral
prescriptions as well as allowing for the refilling of prescriptions. Prescription drugs required the legend “Caution: Federal law prohibits dispensing without a prescription”.
Kefauver-Harris Amendment of 1962. This amendment, also known as the Drug Efficacy Amendment, was enacted due to
the worldwide Thalidomide disaster, and required drugs (RX and OTC) to be proven safe AND effective by the FDA.
The efficacy requirement was retroactive to 1938 (DESI Project).
Orphan Drug Act of 1983. This amendment provided for tax and exclusive licensing incentives for manufactures to develop
and market drugs that were too expensive to develop and market for diseases that affect fewer than 200,000 Americans.
Drug Price Competition and Patent-Term Restoration Act of 1984. Also known as the Waxman-Hatch Amendment, it
streamlined the generic drug approval process and made generic drugs more readily available to the public, while providing incentives for manufacturers to develop new drugs through possible extension of patent life.
Prescription Drug Marketing Act of 1987. This amendment, enacted in response to threats of public health by secondary distribution systems, restricted sales and established record keeping requirements for prescription samples. It also prohibited health care entities from reselling their purchases to other businesses, and required state licensing of drug wholesalers.
Dietary Supplement Health and Education Act (DSHEA) of 1994. This amendment permitted manufacturers to make certain
claims not allowed under the FDCA for dietary supplements. Under DSHEA, the FDA was to treat dietary supplements
more like foods than drugs.
Food and Drug Administration Modernization Act of 1997. This amendment streamlined the regulatory procedures to ensure
the expedited availability of safe and effective drugs and devices. In addition, it increased the FDA’s public accountability, allowed for a fast tract approval process for drugs to treat serious/life threatening diseases, and established a databank
of information on clinical trials.
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A.
Definitions
Important to a thorough understanding of the FDCA is a knowledge of how the FDCA defines the terms to which it frequently refers. Whether an activity falls outside or inside a definition under the act may well determine whether the activity is lawful or unlawful. Some of the most important definitions follow. The language is quoted directly from the FDCA.
Numerations refer to subsections of Section 321, Title 21, of the United States Code.
(g) (1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other
animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food
or dietary supplement for which a claim is made... is not a drug solely because the label or the labeling contains such
a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is
made... is not a drug under clause (C) solely because the label or the labeling contains such a statement.
Note that the definition of “drug” is dependent on the intended use of the article, not on the actual use of it. And the relevant
intent is that of the provider of the article, not the user of the article. A single article may be a drug in one context, and not be
a drug in another context, because the intent of the provider changes between the two contexts. Note also that subsections
(B) and (C) differ significantly, because in (B) an article can be a drug due to its intended use in therapeutics, while in (C) an
article can be a drug merely due to its intended use in affecting the structure or function of the body.
(h) The term "device" . . . means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is-(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve
its primary intended purposes through chemical action within or on the body of man or other animals and which is
not dependent upon being metabolized for the achievement of its primary intended purposes.
Note that the principle distinction between drugs and devices is that drugs achieve their intended purpose through chemical
action while devices do not. Sometimes the distinction between drugs and devices is blurry, and it is important to ask in what
way the article achieves its intended purpose. The terms “drug” and “device” are mutually exclusive. A single article cannot
be both.
(i) The term "cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into,
or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or
altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term
shall not include soap.
The FDCA definition of “cosmetic” is relatively consistent with the lay usage of that term. The terms “cosmetic” and “drug”
are not mutually exclusive. A single article can be both.
(j) The term "official compendium" means the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them.
Official Compendia set standards with which those who are responsible for drug formulation and distribution must comply.
Many of the requirements for drugs are not explicitly stated within the FDCA because the act defers to an official compendium and merely requires compliance with compendial standards. This does not mean that there are no legally mandated standards; only that the standards are contained within a compendium that is adopted by reference within the act.
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(k) The term "label" means a display of written, printed, or graphic matter upon the immediate container of any article.
(m) The term "labeling" means all labels and other written, printed, or graphic matters (1) upon any article or any of
its containers or wrappers, or (2) accompanying such article.
Note that “labeling” includes the “label.” It is to the labeling that attention usually turns when decisions are made about the
intent of a provider of an article. It is the labeling that will frequently make the difference between an act being legal or illegal. Because the FDCA is oriented toward the product, rather than the prescibers and dispensers of the product, the labeling
is considered part of the product.
(p) The term "new drug" means-(1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and
experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the condition prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be
deemed to be a "new drug" if at any time prior to the enactment of this Act [enacted June 25, 1938] it was subject to
the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or (2) Any drug (except a new animal drug or an animal feed bearing or
containing a new animal drug) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
Note that whether a drug is “new” or “not new” (most people who are familiar with pharmacy law use the phrase “not new”
drug rather than “old” drug), depends on its general recognition as safe and effective under the conditions suggested in the
labeling. As the labeling changes, perceptions of newness may change. Only new drugs must be shown to be safe and effective prior to their being placed into interstate commerce. “Not new” drugs must meet all other relevant requirements for
drugs (i.e., adulteration and misbranding provisions), but not those applicable to new drugs, because they are not new.
B.
Adulteration
A drug may be adulterated either because it is actually adulterated or because it is deemed to be adulterated due to some requirement for proper storage or handling not having been met. The FDCA adopts a take-no-chances approach. It also recognizes the practical difficulties of proving that an article actually is adulterated. Thus, the act creates circumstances under
which the assumption is made that an article must be adulterated. These assumptions are virtually impossible to rebut. Selected language of the act follows. Numerations refer to subsections of Section 351, Title 21, of the United States Code.
A drug or device shall be deemed to be adulterated-(a)(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it
may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls
used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in
conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as
to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is
represented to possess; . . .
(b) If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its
strength differs from, or its quality or purity falls below, the standard set forth in such compendium. . .
(c) If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or its purity or
quality falls below, that which it purports or is represented to possess.
(d) If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or
(2) substituted wholly or in part therefor.
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Note that a drug may be adulterated either because it is actually adulterated in some way (contamination by a foreign substance, for example), or because it has been deemed to be adulterated due to the possibility of its being adulterated (by being
held under unsanitary conditions, for example).
C.
Misbranding
The FDCA requires that any information a manufacturer places on the label of a drug be truthful and not misleading. In addition, the act imposes certain mandatory disclosure requirements. So a provider of drugs cannot get cute and omit information
that is mandated, else the provider will violate the disclosure requirement. And the provider cannot disclose in a misleading
way or the provider will violate the basic requirement of truth. This is essentially a “Catch 22" situation, in which the only
way out is full and truthful (not misleading) disclosure. Selected language of the act follows. Numerations refer to subsections of Section 352, Title 21, of the United States Code.
A drug or device shall be deemed to be misbranded-(a) If its labeling is false or misleading in any particular...
(b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer,
packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or
numerical count: Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and
exemptions as to small packages shall be established, by regulations prescribed by the Secretary.
(c) If any word, statement, or other information required by or under authority of this Act to appear on the label or
labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements,
designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use.
(e)(1)(A) If it is a drug, unless its label bears... (i) the established name... of the drug, if there is such a name; ii) the
established name and quantity or... the proportion of each active ingredient, including the quantity, kind, and proportion of any alcohol,... (iii) the established name of each inactive ingredient listed in alphabetical order on the outside container of the retail package and, if determined to be appropriate... on the immediate container... except that
nothing in this subclause shall be deemed to require that any trade secret be divulged, and except that the requirements of this subclause with respect to alphabetical order shall apply only to nonprescription drugs that are not also
cosmetics and that this subclause shall not apply to nonprescription drugs not intended for human use. (B) For any
prescription drug the established name of such drug or ingredient, as the case may be, on such label (and on any labeling on which a name for such drug or ingredient is used) shall be printed prominently and in type at least half as
large as that used thereon for any proprietary name or designation for such drug or ingredient, except that to the extent that compliance with the requirements of subclause (ii) or (iii) of clause (A) or this clause is impracticable, exemptions shall be established by regulations promulgated by the Secretary. (2) If it is a device and it has an
established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name...
prominently printed in type at least half as large as that used thereon for any proprietary name or designation for
such device, except that to the extent compliance with the requirements of this subparagraph is impracticable, exemptions shall be established by regulations promulgated by the Secretary. (3) As used in subparagraph (1), the
term "established name," with respect to a drug or ingredient thereof, means (A) the applicable official name designated... or (B) if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium, or (C) if neither clause (A) nor clause (B) of this
subparagraph applies, then the common or usual name...
(f) Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those
pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users, except that where any requirement of clause (1) of this paragraph, as applied to any drug or device, is not
necessary for the protection of the public health, the Secretary shall promulgate regulations exempting such
drug/device from such requirement.
(g) If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and
labeled as prescribed therein. . . .
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(h) If it has been found ... to be a drug liable to deterioration, unless it is packaged in such form and manner, and its
label bears a statement of such precautions, ...as necessary for the protection of the public health. . . .
(i) If it is a drug and its container is so made, formed, or filled as to be misleading, or (2) if it is an imitation of another drug; or (3) if it is offered for sale under the name of another drug.
(j) If it is dangerous to health when used in the dosage, or manner or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.
(m) If it is a color additive the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive...
(n) In the case of any prescription drug distributed or offered for sale in any State, unless the manufacturer, packer,
or distributor thereof includes in all advertisements and other descriptive printed matter issued ... a true statement of
(1) the established name... printed prominently and in type at least half as large as that used for any trade or brand
name thereof, (2) the formula showing quantitatively each ingredient of such drug... and (3) such other information
in brief summary relating to side effects, contraindications, and effectiveness as shall be required in regulations
which shall be issued by the Secretary...
(p) If it is a drug and its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3
or 4 of the Poison Prevention Packaging Act of 1970 [15 USCS § 1472 or 1473].
Note that the general purpose of the misbranding provisions is to assure that accurate and complete information accompanies
every drug product, which applies to advertisements as well as to other product-related materials. Furthermore, a drug will be
considered misbranded if it does not comply with the Poison Prevention Packaging Act.
D.
New Drug Approval
One of the most controversial aspects of the FDCA is the restrictive provision regarding the approval of new drugs. The
Food and Drug Administration (FDA) is criticized by some because it is too lenient in its interpretation of the FDCA and permits new drugs to be marketed without adequate studies for safety and efficacy, while others criticize the agency for being
too strict and preventing the use of perfectly safe and effective remedies that are needed by people who are ill and near death.
In response to these criticisms, the agency has attempted to speed up approval of those new drugs that represent a significant
advance in therapy, while continuing to maintain a healthy skepticism regarding new drugs that are not as likely to advance
therapy and have the potential to cause significant harm. The language of the act follows. Numerations refer to subsections
of Section 355, Title 21, of the United States Code.
(a) No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval
of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.
(b) (1) Any person may file with the Secretary an application with respect to any drug subject to the provisions of
subsection (a). Such person shall submit to the Secretary as a part of the application (A) full reports of investigations
which have been made to show whether or not such drug is safe for use and whether such drug is effective in use; (B)
a full list of the articles used as components of such drug; (C) a full statement of the composition of such drug; (D) a
full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and
packing of such drug; (E) such samples of such drug and of the articles used as components thereof as the Secretary
may require; and (F) specimens of the labeling proposed to be used for such drug.
The information that must be included in an NDA is quite specific, and the brief list cited above is misleading in its simplicity. In fact, an NDA includes massive amounts of information beyond what is described here, because often FDA reviewers
require additional information to maintain a “comfort zone” regarding product safety and efficacy. In addition to safety and
efficacy information, product sponsors must include information about the patent status of the product they sponsor.
E.
Prescription Exemption
Some medications are so potentially hazardous to health that the law recognizes they are not capable of being labeled for safe
and effective use without medical supervision. For these drugs, a prescription is required before a pharmacist may dispense
them to a patient. These drugs must bear the “federal legend” on the label affixed to each stock bottle provided to pharmacists. When dispensed to patients, these drugs must be labeled with specific information required by the FDCA, but under
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such circumstances the drug is exempt from most requirements of the misbranding provisions. Other drugs are of such a
character that they can be labeled for safe and effective use without medical supervision, thus they are available without a
prescription. The FDCA specifies the conditions and characteristics that will cause a drug to be classified as Rx or OTC.
The language of the act follows. Numerations refer to subsections of Section 353, Title 21, of the United States Code.
(b)(1) A drug intended for use by man which-(A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or
(B) is limited by an approved application under section 505 [21 USCS § 355] to use under the professional supervision of a practitioner licensed by law to administer such drug, shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such
practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or
oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order
which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.
Note the two ways for a product to be classified as prescription-only: (1) lack of safety if used without medical supervision,
and (2) the sponsor’s request for prescription-only classification in the products NDA. Note also the three ways in which a
prescription may be authorized by a prescriber; (1) in writing, (2) verbal authorization, and (3) refilling a written or verbal
order. Finally, the dispensing of a prescription drug without a prescription is a misbranding violation, because the law says
so; regardless of the truthfulness and non-misleading nature of the drug labeling.
(2) Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of section 502 [21 USCS § 352], except paragraphs (a),
(i)(2) and (3), (k), and (l) [21 USCS § 352(a), (i)(2), (3), (k), (l)], and the packaging requirements of paragraphs (g),
(h) and (p) [21 USCS § 352(g), (h), (p)], if the drug bears a label containing the name and address of the dispenser,
the serial number and date of the prescription or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription. This exemption shall not apply to any drug dispensed in the course of the conduct of a business of
dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of paragraph (1) of this subsection.
Note the information that is required to appear on the label of a drug prescribed for a patient, when the drug is dispensed to
the patient. Some pieces of information are mandatory for every prescription, other pieces of information need be included
on the label only when they are contained in the prescription. The very important effect of this section is to exempt from
most important misbranding provisions those drugs that are dispensed pursuant to a prescription and are properly labeled.
This is the reason why requirements such as the “adequate directions for use” requirement need not be met by pharmacists
dispensing properly labeled drugs pursuant to a prescription; the drug is exempt from that requirement.
(3) The Secretary may by regulation remove drugs subject to section 505 [21 USCS § 355] from the requirements
of paragraph (1) of this subsection when such requirements are not necessary for the protection of the public health.
(4) (A) A drug that is subject to paragraph (1) shall be deemed to be misbranded if at any time prior to dispensing
the label of the drug fails to bear, at a minimum, the symbol "Rx only".
(B) A drug to which paragraph (1) does not apply shall be deemed to be misbranded if at any time prior to dispensing the label of the drug bears the symbol described in subparagraph (A).
Note that drugs may be switched from prescription to non-prescription status. They must contain the federal legend, which is
now “Rx Only,” but used to be “Caution: Federal law prohibits dispensing without a prescription.” If the label of a non-prescription drug contains this federal legend, then the drug is misbranded.
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F.
Prohibited Acts
It would be nice to think that all parties involved in drug development, marketing, and distribution could be trusted to voluntarily comply with requirements of the FDCA, and that there would be no need to actually enforce the law through penalties.
Actually, voluntary compliance with the act is quite prevalent, but occasionally there are those who “test the waters” by going
out on a limb and conducting themselves in ways that the law simply cannot allow. Very rarely there are others who simply
have no respect for the law or for the public health, and they conduct themselves in ways that cannot be tolerated. In either
event, the FDCA contains within it provisions to penalize those who fail to voluntarily comply with the law. These penalties
vary in severity, and can be used as necessary to protect the public health. The language of the act follows. Numerations refer to subsections of Section 331, Title 21, of the United States Code.
The following acts and the causing thereof are hereby prohibited:
(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that
is adulterated or misbranded.
(b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce.
(c) The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and
the delivery or proffered delivery thereof for pay or otherwise.
(d) The introduction or delivery for introduction into interstate commerce of any article in violation of section 404 or
505 [21 USCS § 344 or 355].
Note that the bad stuff that cannot be done relates primarily to adulteration, misbranding, and the placing into interstate commerce of an unapproved new drug. When these violations occur, the FDA may initiate injunction proceedings to prevent further distribution of a drug, it may seize the drug, and it may criminally prosecute those responsible for the violation. The act
also allows the FDA to issue a warning letter to alert violators of possible problems and to permit voluntary compliance. The
product recalls that are often publicized are theoretically voluntary, because there is no statutory authority to require them.
However, the FDA can enforce the statute strongly against those who do not “voluntarily” withdraw their product when
asked to do so. FDA does classify voluntary recalls. A Class I recall applies when there is a reasonable probability that the
product will cause serious adverse health consequences or death. A Class II recall applies when the product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse consequences is remote. A
Class III recall applies when a product is not likely to cause adverse health consequences.
II.
Application of the FDCA to Dispensing
Most of the provisions of the federal FDCA are applicable primarily to manufacturers of pharmaceuticals, although
they also have significant implications for dispensers. As a general rule, the FDCA applies only to interstate commerce, but
that phrase has been interpreted expansively within the rather narrow language of the FDCA. Pharmaceutical manufacturers
are frequently involved in transactions between states, while pharmacists usually are not (with the notable exception of pharmacists who work for pharmacies that deliver their products through the mail). Technically, the definition of “interstate commerce” is “(1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District
of Columbia or within any other Territory not organized with a legislative body.” (21 U.S.C. § 321). However, this definition
that would seem to encompass only transactions between states, has been held by case law to also incorporate transactions
within a state. In 1948, the Supreme Court of the United States held in United States v. Sullivan that the act of dispensing a
medication to a patient is an act that is within interstate commerce and to which the misbranding provisions of the FDCA apply. This means that pharmacists must concern themselves with possible violations of the FDCA when they dispense medications to patients.
III.
New Drugs
Any drug that is not generally recognized as safe (GRAS) or not generally recognized as effective (GRAE) is a new
drug. It is illegal to place a new drug into interstate commerce without first having a New Drug Application (NDA) approved
by the FDA. Many pharmacists assume that if a new drug is on the market then it must have been approved by the FDA or
the agency would swoop down unmercifully and punish those who have broken the law. Nothing could be farther from the
truth. The FDA cannot be in all places at all times. It is up to pharmacists to work with the agency to detect new drugs that
are being marketed without approval, and to report such violations to the agency.
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A.
The NDA Process
There are specific steps that must be followed by one who submits a NDA to the FDA, and by the FDA in reviewing the submission. These steps are explicitly outlined in the FDCA. The language of the act follows. Numerations refer to subsections
of Section 355, Title 21, of the United States Code.
(c)(1) Within one hundred and eighty days after the filing of an application under subsection (b), or such additional
period as may be agreed upon by the Secretary and the applicant, the Secretary shall either-(A) approve the application if he then finds that none of the grounds for denying approval specified in subsection
(d) applies, or
(B) give the applicant notice of an opportunity for a hearing before the Secretary under subsection (d) on the
question whether such application is approvable.
Note that the statute indicates there will be a firm resolution to a request for approval under an NDA within 180 days. This is
a laugh. It takes much longer. If the FDA were held to the 180 day period, then there would be no approvals, because the
level of certainty required for approval is impossible in 180 days, under all but the most unusual circumstances. The basis of
the approval decision follows:
(d) If the Secretary finds, after due notice to the applicant in accordance with subsection (c) and giving him an opportunity for a hearing, in accordance with said subsection, that (1) the investigations, reports of which are required
to be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably
applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such
conditions or do not show that such drug is safe for use under such conditions; (3) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its
identity, strength, quality, and purity; (4) upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information
to determine whether such drug is safe for use under such conditions; or (5) evaluated on the basis of the information
submitted to him as part of the application and any other information before him with respect to such drug, there is a
lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or (6) the application failed to
contain the patent information prescribed by subsection (b); or (7) based on a fair evaluation of all material facts,
such labeling is false or misleading in any particular; he shall issue an order refusing to approve the application. If,
after such notice and opportunity for hearing, the Secretary finds that clauses (1) through (6) do not apply, he shall
issue an order approving application. As used in this subsection and subsection (e), the term "substantial evidence"
means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of
which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is
represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed
labeling thereof. If the Secretary determines, based on relevant science, that data from one adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation) are sufficient
to establish effectiveness, the Secretary may consider such data and evidence to constitute substantial evidence for
purposes of the preceding sentence.
Note the seven criteria for NDA evaluation described above. Note also, the definition of “substantial evidence” which usually requires more than one randomized, controlled clinical trial (the word investigations is a plural word), but may be based on
a single study with confirmatory evidence.
What the agency grants, the agency can also take away. Should new information surface following the approval of an NDA,
indicating that the original approval was based on incomplete or erroneous information, the agency can withdraw approval of
the new drug. When this withdrawal occurs, the distribution of the drug must cease.
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(e) The Secretary shall, after due notice and opportunity for hearing to the applicant, withdraw approval of an application with respect to any drug under this section if the Secretary finds (1) that clinical or other experience, tests, or
other scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved; (2) that new evidence of clinical experience, not contained in such application or not available to the Secretary until after such application was approved, or tests by new methods, or tests by methods not
deemed reasonably applicable when such application was approved, evaluated together with the evidence available
to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the
conditions of use upon the basis of which the application was approved; or (3) on the basis of new information before him with respect to such drug, evaluated together with the evidence available to him when the application was
approved, that there is a lack of substantial evidence that the drug will have the effect it purports or is represented to
have under the conditions of use prescribed, recommended, or suggested in the labeling thereof; or (4) the patent information prescribed by subsection (c) was not filed within thirty days after the receipt of written notice from the Secretary specifying the failure to file such information; or (5) that the application contains any untrue statement of a
material fact: Provided, That if the Secretary (or in his absence the officer acting as Secretary) finds that there is an
imminent hazard to the public health, he may suspend the approval of such application immediately, and give the applicant prompt notice of this action and afford the applicant the opportunity for an expedited hearing under this subsection; but the authority conferred by this proviso to suspend the approval of an application shall not be delegated.
Note that in the absence of an imminent hazard to the public health, the holder of an NDA has the right to due process (notice
and an opportunity to be heard) before the NDA approval can be withdrawn. However, if the agency believes that there is an
imminent hazard to public health, an NDA can be withdrawn without due process.
The FDA views all drugs that have not been approved specifically for use within the United States as unapproved new drugs
when they are brought into the United States. It is illegal to import drugs into the United States without approval from the
FDA. This position of the agency has caused consternation among those who wish to save money by purchasing drugs outside the United States for use within the United States. While there is no legal way to bring drugs into the United States without FDA approval, the agency does exercise its discretion and will allow the personal importation of drugs that are necessary
for patient care, as long as the amount brought into the country is limited to that necessary to treat the patient for 90 days.
This is a matter of discretion offered to patients and not to their health care providers. It is not permitted for a health care
provider to import drugs to use in the treatment of patients, under the discretionary policy. Excerpts from the policy reads as
follows:
BACKGROUND
Because the amount of merchandise imported into the United States in personal shipments is normally small, both in
size and value, comprehensive coverage of these imports is normally not justified. This guidance clarifies how FDA
may best protect consumers with a reasonable expenditure of resources.
There has always been a market in the United States for some foreign made products that are not available domestically. For example, individuals of differing ethnic backgrounds sometimes prefer products from their homeland or
products labeled in their native language to products available in the United States. Other individuals seek medical
treatments that are not available in this country. Drugs are sometimes mailed to this country in response to a prescription-like order to allow continuation of a therapy initiated abroad. With increasing international travel and
world trade, we can anticipate that more people will purchase products abroad that may not be approved, may be
health frauds or may be otherwise not legal for sale in the United States.
In addition, FDA must be alert to foreign and domestic businesses that promote or ship unapproved, fraudulent or
otherwise illegal medical treatments into the United States or who encourage persons to order these products. Such
treatments may be promoted to individuals who believe that treatments available abroad will be effective in the treatment of serious conditions such as AIDS or cancer. Because some countries do not regulate or restrict the exportation of products, people who mail order from these businesses may not be afforded the protection of either foreign or
U.S. laws. In view of the potential scale of such operations, FDA has focused its enforcement resources more on
products that are shipped commercially, including small shipments solicited by mail-order promotions, and less on
24
those products that are personally carried, shipped by a personal non-commercial representative of a consignee, or
shipped from foreign medical facility where a person has undergone treatment.
PERSONAL BAGGAGE
FDA personnel are not to examine personal baggage. This responsibility rests with the U.S. Customs Service. It is
expected that a Customs officer will notify their local FDA district office when he or she has detected a shipment of
an FDA-regulated article intended for commercial distribution an article that FDA has specifically requested be detained, or an FDA regulated article that appears to represent a health fraud or an unknown risk to health.
MAIL SHIPMENTS
FDA personnel are responsible for monitoring mail importations. It is expected that a Customs officer from the Customs Mail Division will examine a parcel and will set it aside if it appears to contain a drug, biologic, or device, an
article that FDA has specifically requested be held, or an FDA-regulated article that appears to represent a health
fraud or unknown risk to health...
Importations detained in accordance with this guidance should be held by Customs until they are either released or
refused entry...
GENERAL GUIDANCE
The statements in this chapter are intended only to provide operating guidance for FDA personnel and are not intended to create or confer any rights, privileges, or benefits on or for any private person.
FDA personnel may use their discretion to allow entry of shipments of violative FDA regulated products when the
quantity and purpose are clearly for personal use, and the product does not present an unreasonable risk to the user.
Even though all products that appear to be in violation of statutes administered by FDA are subject to refusal, FDA
personnel may use their discretion to examine the background, risk, and purpose of the product before making a final
decision. Although FDA may use discretion to allow admission of certain violative items, this should not be interpreted as a license to individuals to bring in such shipments.
Commercial or Promotional Shipments
Commercial and promotional shipments are not subject to this guidance. Whether or not a shipment is commercial or
promotional may be determined by a number of factors including, for example, the type of product, accompanying
literature, size, value, and/or destination of the shipment. FDA personnel may also consider whether an importation
of drugs or medical devices is a commercial shipment by evaluating whether the article appears to have been purchased for personal use or whether the quantity suggests commercial distribution (i.e., the supply exceeds what one
person might take in approximately three months). Commercial shipments generally include shipments other than
those products that are personally carried, shipped by a personal non-commercial representative of a consignee, or
shipped from a foreign medical facility where a person has undergone treatment.
Drugs, Biologics, and Devices
When personal shipments of drugs and devices that appear violative are brought to FDA's attention by Customs,
FDA personnel will use their discretion to decide on a case by case basis whether to detain, refuse, or allow entry of
the product. Generally, drugs and devices subject to Import Alerts are not amenable to this guidance. Devices to be
used by practitioners for treating patients should not be viewed as personal importations subject to this chapter.
Drugs subject to Drug Enforcement Agency (DEA) jurisdiction should be returned to Customs for handling.
In deciding whether to exercise discretion to allow personal shipments of drugs or devices, FDA personnel may consider a more permissive policy in the following situations:
1. when the intended use is appropriately identified, such use is not for treatment of a serious condition, and
the product is not known to represent a significant health risk; or
2. when a) the intended use is unapproved and for a serious condition for which effective treatment may not
be available domestically either through commercial or clinical means; b) there is no known commercializa-
25
tion or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue;
c) the product is considered not to represent an unreasonable risk; and d) the individual seeking to import
the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply)and
provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the
product, or provides evidence that the product is for the continuation of a treatment begun in a foreign country.
B.
The 505(b)(2) Approval (Formerly Paper NDA)
Under the FDCA, there is a mechanism for approval of a new drug that does not require extensive and expensive clinical trials, and is not the traditional generic approval route. Once known as a “Paper NDA,” but now known by the section number
that authorizes it, the 505(b)(2) approval permits the sponsor of a new drug to obtain approval if safety and efficacy can be
shown through published studies or other evidence not created by the sponsor. As a practical matter, of course, this route will
not be available for patented completely new molecular entities, because there will have been no reported studies of them due
to their newness. But for slight modifications of existing drugs (a different salt or ester, for example), this is an approval that
may be permitted. The language of the act follows. Numerations refer to subsections of Section 355, Title 21, of the United
States Code.
(2) An application submitted under paragraph (1) for a drug for which the investigations described in clause (A) of
such paragraph and relied upon by the applicant for approval of the application were not conducted by or for the
applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom
the investigations were conducted shall also include—(A) a certification, in the opinion of the applicant and to the
best of his knowledge, with respect to each patent which claims the drug for which such investigations were conducted or which claims a use for such drug for which the applicant is seeking approval under this subsection and for
which information is required to be filed under paragraph (1) or subsection (c)—(i) that such patent information has
not been filed, (ii) that such patent has expired, (iii) of the date on which such patent will expire, or (iv) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is
submitted; and (B) if with respect to the drug for which investigations described in paragraph (1)(A) were conducted
information was filed under paragraph (1) or subsection (c) for a method of use patent which does not claim a use
for which the applicant is seeking approval under this subsection, a statement that the method of use patent does not
claim such a use.
.
C.
The IND Exemption
Before a drug can be shown to be safe and effective, it is necessary to study the drug in clinical trials. These trials occur
throughout the country, thus it is necessary to place the as yet unapproved new drug into interstate commerce so that the drug
can be provided to those who will use it for clinical trials. If there were no exemption from the FDCA provisions that prevent
the introduction into interstate commerce of an unapproved new drug, then clinical trials could not occur. Thus, an exemption has been provided through the IND (Investigational New Drug) provisions of the act. The language of the act follows.
Numerations refer to subsections of Section 355, Title 21, of the United States Code.
(i)(1) The Secretary shall promulgate regulations for exempting from the operation of the foregoing subsections of
this section drugs intended solely for investigational use by experts qualified by scientific training and experience to
investigate the safety and effectiveness of drugs.
Te basis for permitting an unapproved new drug to enter interstate commerce under an IND exemption is promising evidence
of safety and efficacy from preclinical studies with animals, and a summary of the literature for a drug. To be approved a request for an IND exemption must also describe how the drug will be used in clinical trials. Note particularly that an IND is
an exemption and not an approval. Nothing is being approved. This is simply a very narrow exemption from the requirement
for approval.
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D.
Postmarket Drug Safety
In accordance with Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA has a
website containing links to postmarket drug safety information to improve transparency and communication to patients and
healthcare providers (http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/).
Links available on this FDA site include: agency databases, including studies and clinical trials; latest safety information; regulation and guidance documents; information about FDA’s Drug Safety Oversight Board; information on how to use medicines safely; consumer articles on drug safety; general health information; FDA’s response to IOM reports; drug labeling
information; and Risk Evaluation and Mitigation Strategies (REMS).
In regards to REMS, the FDAAA created new section 505–1 of the Federal Food, Drug, and Cosmetic Act . Section 505–
1(a) of the act authorizes the FDA to require REMS:
Ÿ Before approval: if FDA determines REMS is necessary to ensure that the benefits of the drug outweigh the risks
Ÿ Post-approval: If FDA becomes aware of new safety information and determines REMS is necessary to ensure that
the benefits of the drug outweigh the risks
The goal of REMS is to ensure the safe use of medications that have risks if used improperly. These safety plans allow patients to have continued access to certain medicines for which there are safety concerns that can be managed through appropriate use.
The original list of products requiring REMS included the multiple myeloma medication thalidomide (Thalomide), the antipsychotic medication clozapine (Clozaril), and the abortifacient drug mifepristone (Mifeprex). More recently, on February 6,
2009, the FDA sent letters to manufacturers of long-acting opioid drug products, indicating that these drugs will be required
to have a REMS to ensure that the benefits of the drugs continue to outweigh the risks. The affected opioid drugs include
brand name and generic products and are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone.
To allow safe access to drugs with known serious risks, the FDA may require REMS for a drug include such elements as are
necessary to assure safe use of the drug.
Elements to assure safe use include:
• Clinician prescribers need specific training or experience or are specially certified.
• Pharmacies, practitioners, or healthcare settings dispenses the drug are specially certified.
• The drug is dispensed to patients only in certain healthcare settings, such as hospitals.
• The drug is dispensed to patients with evidence or other documentation of safe use conditions, such as laboratory
test results.
• Patients using the drug are subject to certain monitoring or are enrolled in a registry.
Examples of possible additional REMS elements could include Medication Guides (MedGuides) and/or Patient Package Inserts (PPIs), and a communication plan. Prior to REMS, and since 2005, these elements typically appeared in approved risk
minimization action plans (RiskMAPs) (see the guidance for industry entitled ‘‘Development and Use of Risk Minimization
Action Plans’’ (70 FR 15866, March 29, 2005)).
This influencing of actual drug usage is a change from the FDA’s traditional role as that of monitor, or gatekeeper, for new
drugs and medical products. Until the REMS program, the FDA developed the labels that detail how drugs are meant to be
used, but it left the final prescribing decisions to doctors, who are not bound by federal guidelines and can prescribe medications for off-label—uses other than what is FDA approved—uses. The language of the FDCA regarding REMS follows. Numerations refer to subsections of Section 355-1, Title 21, of the United States Code.
(a) Submission of proposed strategy.
(1) Initial approval. If the Secretary, in consultation with the office responsible for reviewing the drug and the office
responsible for postapproval safety with respect to the drug, determines that a risk evaluation and mitigation strategy
is necessary to ensure that the benefits of the drug outweigh the risks of the drug, and informs the person who sub-
27
mits such application of such determination, then such person shall submit to the Secretary as part of such application a proposed risk evaluation and mitigation strategy. In making such a determination, the Secretary shall consider
the following factors:
(A) The estimated size of the population likely to use the drug involved.
(B) The seriousness of the disease or condition that is to be treated with the drug.
(C) The expected benefit of the drug with respect to such disease or condition.
(D) The expected or actual duration of treatment with the drug.
(E) The seriousness of any known or potential adverse events that may be related to the drug and the background incidence of such events in the population likely to use the drug.
(F) Whether the drug is a new molecular entity.
(2) Postapproval requirement.
(A) In general. If the Secretary has approved a covered application (including an application approved before the effective date of this section) and did not when approving the application require a risk evaluation
and mitigation strategy under paragraph (1), the Secretary, in consultation with the offices described in
paragraph (1), may subsequently require such a strategy for the drug involved (including when acting on a
supplemental application seeking approval of a new indication for use of the drug) if the Secretary becomes
aware of new safety information and makes a determination that such a strategy is necessary to ensure that
the benefits of the drug outweigh the risks of the drug.
(B) Submission of proposed strategy. Not later than 120 days after the Secretary notifies the holder of an approved covered application that the Secretary has made a determination under subparagraph (A) with respect to the drug involved, or within such other reasonable time as the Secretary requires to protect the
public health, the holder shall submit to the Secretary a proposed risk evaluation and mitigation strategy...
(b) Definitions. For purposes of this section:
(1) Adverse drug experience. The term "adverse drug experience" means any adverse event associated with the use of
a drug in humans, whether or not considered drug related, including-(A) an adverse event occurring in the course of the use of the drug in professional practice;
(B) an adverse event occurring from an overdose of the drug, whether accidental or intentional;
(C) an adverse event occurring from abuse of the drug;
(D) an adverse event occurring from withdrawal of the drug; and
(E) any failure of expected pharmacological action of the drug.
(3) New safety information. The term "new safety information", with respect to a drug, means information derived
from a clinical trial, an adverse event report, a postapproval study... , or peer-reviewed biomedical literature; data
derived from the postmarket risk identification and analysis system...; or other scientific data deemed appropriate by
the Secretary about-(A) a serious risk or an unexpected serious risk associated with use of the drug that the Secretary has become
aware of (that may be based on a new analysis of existing information) since the drug was approved, since
the risk evaluation and mitigation strategy was required, or since the last assessment of the approved risk
evaluation and mitigation strategy for the drug; or
(B) the effectiveness of the approved risk evaluation and mitigation strategy for the drug obtained since the
last assessment of such strategy.
(4) Serious adverse drug experience. The term "serious adverse drug experience" is an adverse drug experience that(A) results in-(i) death;
(ii) an adverse drug experience that places the patient at immediate risk of death from the adverse drug experience as it occurred (not including an adverse drug experience that might have caused death had it occurred in a more severe form);
(iii) inpatient hospitalization or prolongation of existing hospitalization;
(iv) a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; or
(v) a congenital anomaly or birth defect; or
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(B) based on appropriate medical judgment, may jeopardize the patient and may require a medical or surgical intervention to prevent an outcome described under subparagraph (A).
(5) Serious risk. The term "serious risk" means a risk of a serious adverse drug experience.
(6) Signal of a serious risk. The term "signal of a serious risk" means information related to a serious adverse drug
experience associated with use of a drug and derived from-(A) a clinical trial;
(B) adverse event reports;
(C) a postapproval study, including a study under section 505(o)(3);
(D) peer-reviewed biomedical literature;
(E) data derived from the postmarket risk identification and analysis system under section 505(k)(4); or
(F) other scientific data deemed appropriate by the Secretary.
(8) Unexpected serious risk. The term "unexpected serious risk" means a serious adverse drug experience that is not
listed in the labeling of a drug, or that may be symptomatically and pathophysiologically related to an adverse drug
experience identified in the labeling, but differs from such adverse drug experience because of greater severity, specificity, or prevalence.
(c) Contents. A proposed risk evaluation and mitigation strategy under subsection (a) shall-(1) include the timetable required under subsection (d); and
(2) ...include additional elements described in subsections (e) and (f).
(d) Minimal strategy. For purposes of subsection (c)(1), the risk evaluation and mitigation strategy for a drug shall
require a timetable for submission of assessments of the strategy that-(1) includes an assessment, by the date that is 18 months after the strategy is initially approved;
(2) includes an assessment by the date that is 3 years after the strategy is initially approved;
(3) includes an assessment in the seventh year after the strategy is so approved; and
(4) subject to paragraphs (1), (2), and (3)-(A) is at a frequency specified in the strategy;
(B) is increased or reduced in frequency as necessary as provided for in subsection (g)(4)(A); and
(C) is eliminated after the 3-year period described in paragraph (1) if the Secretary determines that serious
risks of the drug have been adequately identified and assessed and are being adequately managed.
(e) Additional potential elements of strategy.
(1) In general. The Secretary, in consultation with the offices described in subsection (c)(2), may under such subsection require that the risk evaluation and mitigation strategy for a drug include 1 or more of the additional elements
described in this subsection if the Secretary makes the determination required with respect to each element involved.
(2) Medication guide; patient package insert. The risk evaluation and mitigation strategy for a drug may require
that, as applicable, the responsible person develop for distribution to each patient when the drug is dispensed-(A) a Medication Guide, as provided for under part 208 of title 21, Code of Federal Regulations (or any successor regulations); and
(B) a patient package insert, if the Secretary determines that such insert may help mitigate a serious risk of
the drug.
(3) Communication plan. The risk evaluation and mitigation strategy for a drug may require that the responsible person conduct a communication plan to health care providers, if, with respect to such drug, the Secretary determines
that such plan may support implementation of an element of the strategy (including under this paragraph). Such plan
may include-(A) sending letters to health care providers;
(B) disseminating information about the elements of the risk evaluation and mitigation strategy to encourage
implementation by health care providers of components that apply to such health care providers, or to explain certain safety protocols (such as medical monitoring by periodic laboratory tests); or
(C) disseminating information to health care providers through professional societies about any serious risks
of the drug and any protocol to assure safe use.
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(f) Providing safe access for patients to drugs with known serious risks that would otherwise be unavailable.
(1) Allowing safe access to drugs with known serious risks. The Secretary, in consultation with the offices described
in subsection (c)(2), may require that the risk evaluation and mitigation strategy for a drug include such elements as
are necessary to assure safe use of the drug, because of its inherent toxicity or potential harmfulness, if the Secretary
determines that-(A) the drug, which has been shown to be effective, but is associated with a serious adverse drug experience, can be approved only if, or would be withdrawn unless, such elements are required as part
of such strategy to mitigate a specific serious risk listed in the labeling of the drug; and
(B) for a drug initially approved without elements to assure safe use, other elements under subsections (c), (d), and (e) are not sufficient to mitigate such serious risk.
(2) Assuring access and minimizing burden. Such elements to assure safe use under paragraph (1) shall-(A) be commensurate with the specific serious risk listed in the labeling of the drug;
(B) within 30 days of the date on which any element under paragraph (1) is imposed, be posted publicly by
the Secretary with an explanation of how such elements will mitigate the observed safety risk;
(C) considering such risk, not be unduly burdensome on patient access to the drug, considering in particular(i) patients with serious or life-threatening diseases or conditions; and
(ii) patients who have difficulty accessing health care (such as patients in rural or medically underserved
areas); and
(D) to the extent practicable, so as to minimize the burden on the health care delivery system-(i) conform with elements to assure safe use for other drugs with similar, serious risks; and
(ii) be designed to be compatible with established distribution, procurement, and dispensing systems for
drugs.
(3) Elements to assure safe use. The elements to assure safe use under paragraph (1) shall include 1 or more goals to
mitigate a specific serious risk listed in the labeling of the drug and, to mitigate such risk, may require that-(A) health care providers who prescribe the drug have particular training or experience, or are specially
certified (the opportunity to obtain such training or certification with respect to the drug shall be available to
any willing provider from a frontier area in a widely available training or certification method (including an
on-line course or via mail) as approved by the Secretary at reasonable cost to the provider);
(B) pharmacies, practitioners, or health care settings that dispense the drug are specially certified (the opportunity to obtain such certification shall be available to any willing provider from a frontier area);
(C) the drug be dispensed to patients only in certain health care settings, such as hospitals;
(D) the drug be dispensed to patients with evidence or other documentation of safe-use conditions, such as
laboratory test results;
(E) each patient using the drug be subject to certain monitoring; or
(F) each patient using the drug be enrolled in a registry.
(4) Implementation system. The elements to assure safe use under paragraph (1) that are described in subparagraphs
(B), (C), and (D) of paragraph (3) may include a system through which the applicant is able to take reasonable steps
to-(A) monitor and evaluate implementation of such elements by health care providers, pharmacists, and other
parties in the health care system who are responsible for implementing such elements; and
(B) work to improve implementation of such elements by such persons.
(5) Evaluation of elements to assure safe use. The Secretary, through the Drug Safety and Risk Management Advisory Committee (or successor committee) of the Food and Drug Administration, shall-(A) seek input from patients, physicians, pharmacists, and other health care providers about how elements to
assure safe use under this subsection for 1 or more drugs may be standardized so as not to be-(i) unduly burdensome on patient access to the drug; and
(ii) to the extent practicable, minimize the burden on the health care delivery system;
(B) at least annually, evaluate, for 1 or more drugs, the elements to assure safe use of such drug to assess
whether the elements-(i) assure safe use of the drug;
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(ii) are not unduly burdensome on patient access to the drug; and
(iii) to the extent practicable, minimize the burden on the health care delivery system; and
(C) considering such input and evaluations-(i) issue or modify agency guidance about how to implement the requirements of this subsection; and
(ii) modify elements under this subsection for 1 or more drugs as appropriate.
(6) Additional mechanisms to assure access. The mechanisms under section 561 to provide for expanded access for
patients with serious or life-threatening diseases or conditions may be used to provide access for patients with a serious or life-threatening disease or condition, the treatment of which is not an approved use for the drug, to a drug that
is subject to elements to assure safe use under this subsection. The Secretary shall promulgate regulations for how a
physician may provide the drug under the mechanisms of section 561.
(7) Waiver in public health emergencies. The Secretary may waive any requirement of this subsection during the period described in section 319(a) of the Public Health Service Act [42 USC § 247d(a)] with respect to a qualified
countermeasure described under section 319F-1(a)(2) of such Act [42 USC § 247d-6a(a)(2)], to which a requirement
under this subsection has been applied, if the Secretary has-(A) declared a public health emergency under such section 319 [42 USC § 247d]; and
(B) determined that such waiver is required to mitigate the effects of, or reduce the severity of, such public
health emergency.
(g) Assessment and modification of approved strategy...
(h) Review of proposed strategies; review of assessments of approved strategies...
(7) Process for addressing drug class effects.
(A) In general. When a concern about a serious risk of a drug may be related to the pharmacological class of
the drug, the Secretary, in consultation with the offices described in subsection (c)(2), may defer assessments
of the approved risk evaluation and mitigation strategies for such drugs until the Secretary has convened 1
or more public meetings to consider possible responses to such concern...
(D) Action. After considering the discussions from any meetings under subparagraph (A), the Secretary may(i) announce in the Federal Register a planned regulatory action, including a modification to each risk evaluation and mitigation strategy, for drugs in the pharmacological class;
(ii) seek public comment about such action; and
(iii) after seeking such comment, issue an order addressing such regulatory action.
(i) Abbreviated new drug applications.
(1) In general. A drug that is the subject of an abbreviated new drug application under section 505(j) is subject to
only the following elements of the risk evaluation and mitigation strategy required under subsection (a) for the applicable listed drug:
(A) A Medication Guide or patient package insert, if required under subsection (e) for the applicable listed
drug.
(B) Elements to assure safe use, if required under subsection (f) for the listed drug. A drug that is the subject
of an abbreviated new drug application and the listed drug shall use a single, shared system under subsection (f). The Secretary may waive the requirement under the preceding sentence for a drug that is the subject
of an abbreviated new drug application...
(j) Drug Safety Oversight Board.
(1) In general. There is established a Drug Safety Oversight Board.
(2) Composition; meetings. The Drug Safety Oversight Board shall-(A) be composed of scientists and health care practitioners appointed by the Secretary, each of whom is an
employee of the Federal Government;
(B) include representatives from offices throughout the Food and Drug Administration, including the offices
responsible for postapproval safety of drugs;
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(C) include at least 1 representative each from the National Institutes of Health and the Department of
Health and Human Services (other than the Food and Drug Administration);
(D) include such representatives as the Secretary shall designate from other appropriate agencies that wish
to provide representatives; and
(E) meet at least monthly to provide oversight and advice to the Secretary on the management of important
drug safety issues.
E.
Dietary Supplements
Public demand for access to products that are believed to be useful in the treatment of physical and emotional ailments, but
that do not fall within the traditional boundaries of scientific medicine, has led to changes in the law that permit the marketing
of dietary supplements even if the supplements do not meet the stringent requirements applicable to drugs. A dietary supplement, that meets the requirements of the FDCA is not a new drug, and thus it does not require premarketing approval.
The FDCA contains a very specific definition of “dietary supplement.” The following language is quoted directly from the
FDCA. Numerations refer to subsections of Section 321, Title 21, of the United States Code.
ff) The term "dietary supplement"-(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the
following dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in (A) through (E).
This is only part of the very complex definition of the phrase “dietary supplement.” Note that it is the source of the article
that determines to a large extent whether the article is classified as a dietary supplement, or instead is classified as a drug.
The labeling on dietary supplements may make structure/function claims, but may not make therapeutic claims. The following language is quoted directly from the FDCA. Numerations refer to subsections of Section 343, Title 21, of the United
States Code.
(6) For purposes of paragraph (r)(1)(B), a statement for a dietary supplement may be made if-(A) the statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of
such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure
or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to
maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient,
(B) the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading, and
(C) the statement contains, prominently displayed and in boldface type, the following: "This statement has not
been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.".
A statement under this subparagraph may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease
or class of diseases. If the manufacturer of a dietary supplement proposes to make a statement described in the first
sentence of this subparagraph in the labeling of the dietary supplement, the manufacturer shall notify the Secretary
no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is
being made.
Note that when a manufacturer of a dietary supplement makes a structure or function claim and can substantiate that the claim
is truthful and not misleading, the dietary supplement is not a drug under the act, and therefore does not require premarket
approval.
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IV.
Generic Drug Products
A new chemical entity that is developed by a sponsor and is approved as a new drug under an NDA is granted a period of exclusive marketing, and during that time no other manufacturer may market the chemical entity. Patent laws protect
the new drug’s exclusivity for a period of time, and under some circumstances, the FDCA provides additional non-patent exclusivity. After all applicable periods of exclusivity have expired, it is possible for another manufacturer to formulate the
chemical entity into a product and market the product as a generic equivalent of the innovator product. The most frequent
way of getting to market as a generic equivalent is through an Abbreviated New Drug Application (ANDA). An ANDA relies on the safety and efficacy studies of the innovator product’s NDA. Through an ANDA, a sponsor of a generic equivalent
is required only to show bioequivalence with the innovator product. If such bioequivalence is shown, then the assumption is
made that the bioequivalent product must be as safe and effective as the innovator product.
A.
Bioequivalence Standards
Approval as bioequivalent under and ANDA requires that there be data from bioequivalence studies showing that the innovator product and the generic product are essentially identical. Studies do not need to show that the two products are exactly
the same. Although the two products must contain the same amount of active ingredient, and be in the same dosage form,
variables in formulation may cause there to be differences in rate and extent of absorption. Different diluents, binders, lubricants and other excipients may cause disintegration and dissolution to differ between two apparently identical products. The
FDCA requires that studies be done to demonstrate that any differences between the innovator and generic products do not
produce significant differences in rate and extent of absorption. The language of the act follows. Numerations refer to subsections of Section 355, Title 21, of the United States Code.
(j)(1) Any person may file with the Secretary an abbreviated application for the approval of a new drug.
(2) (A) An abbreviated application for a new drug shall contain-(i) information to show that the conditions of use prescribed, recommended, or suggested in the labeling proposed
for the new drug have been previously approved for a drug listed under paragraph (7) (hereinafter in this subsection
referred to as a "listed drug");
(iv) information to show that the new drug is bioequivalent to the listed drug referred to in clause (i), except that if
the application is filed pursuant to the approval of a petition filed under subparagraph (C), information to show that
the active ingredients of the new drug are of the same pharmacological or therapeutic class as those of the listed
drug referred to in clause (i) and the new drug can be expected to have the same therapeutic effect as the listed drug
when administered to patients for a condition of use referred to in clause (i);
(v) information to show that the labeling proposed for the new drug is the same as the labeling approved for the listed drug referred to in clause (i) except for changes required because of differences approved under a petition filed
under subparagraph (C) or because the new drug and the listed drug are produced or distributed by different manufacturers.
Note that the standards for approval of a generically equivalent product under an ANDA require a showing of generic equivalence (same chemical entity, same strength, same dosage form) and bioequivalence.
B.
The “Orange Book”
The FDCA mandates that the FDA publish an alphabetical list of approved drug products. The FDA does this by publishing
a book titled “Approved Drug Products With Therapeutic Equivalence Evaluations.” The cover of the book is the color orange, thus its unofficial name. Because the book is a public document, it is republished by commercial enterprises on a regular basis, and these reprintings may not retain the original orange cover color, thus leading to confusion as to why the odd
unofficial name is being used for a book that clearly does not warrant such a label. The “Orange Book” lists all products of a
drug, along with their sponsor and other information relating to the approval date and patent term. Most importantly for pharmacists, the “Orange Book” lists bioequivalence evaluations for drugs of which there is more than one product. A reference
standard is noted (usually the innovator product, but not always), and each generic product is compared with that reference
standard. Each product for which an evaluation has been made is given a two letter code, with the first letter of the two letters being either “A” or “B.” The second letter of the two letter code explains how the first letter came to be what it is. Only
the first letters are significant for making comparisons. If two products both have a code beginning with “A,” then the two
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products are considered to be bioequivalent. No other combination has meaning. In other words, an “A” rated product cannot be compared with a “B” rated product, and two “B” rated products cannot be compared with each other. Simply because
products are not both “A” rated does not mean they are bad products, it means only that they are not shown to be equivalent.
Perhaps they really are equivalent, but just have not been shown to be. So, just to be perfectly clear, a “B” rated product is
not a bad product, it is a product with which no other product has been shown to be bioequivalent.
V.
Labeling
It is probably obvious by now that the FDCA is a law that is very much oriented toward drug products, rather than drug use
systems, and that the labeling of a product is part of the product from a regulatory perspective. Remember that the label is
what is affixed to the container of a drug, and labeling is that plus whatever else accompanies the drug. Labeling must be
written, printed, or graphic matter to meet the requisites of the statutory definition. Thus, the spoken word would not qualify
as labeling.
A.
The Package Insert
The official labeling for a product includes a package insert that must be approved by the FDA. There are many good sources of information about drugs, but the character of the package insert causes it to be only a fair source of information due to
its inclusiveness of some matters with little relevance and omission of some matters of great relevance. However, the package insert, as the official labeling of a pharmaceutical product, has tremendous significance beyond that of some drug information references that may be more useful but less official. The package insert is written in technical language, and is
intended for use by health care professionals. There is no rule that forbids the conveyance of a package insert to a patient
who requests it, or for whom a health care professional believes it would be beneficial information. However, it is prudent to
offer patients assistance in understanding the technical language of the package insert, else the inclusive nature of the insert
may cause patients to be more fearful of adverse effects than the facts would warrant. The package insert must be developed
in accord with specific FDA standards. The language of the FDA regulation follows. This language represents a new approach to official labeling, with a new sequence of sections and a more user-friendly approach to language. Numerations refer to subsections of Section 201.57, Title 21, of the Code of Federal Regulations.
§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1).
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be
implemented according to the schedule specified in § 201.56(c), except for the requirement in paragraph (c)(18) of
this section to reprint any FDA-approved patient labeling at the end of prescription drug labeling or accompany the
prescription drug labeling, which must be implemented no later than June 30, 2007.
(a) Highlights of prescribing information. The following information must appear in all prescription drug labeling:
(1) Highlights limitation statement. The verbatim statement "These highlights do not include all the information
needed to use (insert name of drug product) safely and effectively. See full prescribing information for (insert name
of drug product)."
(2) Drug names, dosage form, route of administration, and controlled substance symbol. The proprietary name and
the established name of the drug, if any, as defined in section 502(e)(3) of the Federal Food, Drug, and Cosmetic Act
(the act) or, for biological products, the proper name (as defined in § 600.3 of this chapter) including any appropriate descriptors. This information must be followed by the drug's dosage form and route of administration. For controlled substances, the controlled substance symbol designating the schedule in which the controlled substance is
listed must be included as required by § 1302.04 of this chapter.
(3) Initial U.S. approval. The verbatim statement "Initial U.S. Approval" followed by the four-digit year in which
FDA initially approved a new molecular entity, new biological product, or new combination of active ingredients.
The statement must be placed on the line immediately beneath the established name or, for biological products, proper name of the product.
Note below that the “boxed warning” that has become prevalent in so many package inserts now has specific criteria for the
inclusion of information that must be prominently placed at the front of the package insert.
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(4) Boxed warning. A concise summary of any boxed warning required by paragraph (c)(1) of this section, not to exceed a length of 20 lines. The summary must be preceded by a heading, in upper-case letters, containing the word
"WARNING" and other words that are appropriate to identify the subject of the warning. The heading and the summary must be contained within a box and bolded. The following verbatim statement must be placed immediately following the heading of the boxed warning: "See full prescribing information for complete boxed warning."
(5) Recent major changes. A list of the section(s) of the full prescribing information, limited to the labeling sections
described in paragraphs (c)(1), (c)(2), (c)(3), (c)(5), and (c)(6) of this section, that contain(s) substantive labeling
changes that have been approved by FDA or authorized under § 314.70(c)(6) or (d)(2), or § 601.12(f)(1) through
(f)(3) of this chapter. The heading(s) and, if appropriate, the subheading(s) of the labeling section(s) affected by the
change must be listed together with each section's identifying number and the date (month/year) on which the change
was incorporated in labeling. These labeling sections must be listed in the order in which they appear in the full prescribing information. A changed section must be listed under this heading in Highlights for at least 1 year after the
date of the labeling change and must be removed at the first printing subsequent to the 1 year period.
(6) Indications and usage. A concise statement of each of the product's indications, as required under paragraph
(c)(2) of this section, with any appropriate subheadings. Major limitations of use (e.g., lack of effect in particular
subsets of the population, or second line therapy status) must be briefly noted. If the product is a member of an established pharmacologic class, the concise statement under this heading in Highlights must identify the class in the following manner: "(Drug) is a (name of class) indicated for (indication(s))."
(7) Dosage and administration. A concise summary of the information required under paragraph (c)(3) of this section, with any appropriate subheadings, including the recommended dosage regimen, starting dose, dose range, critical differences among population subsets, monitoring recommendations, and other clinically significant clinical
pharmacologic information.
(8) Dosage forms and strengths. A concise summary of the information required under paragraph (c)(4) of this section, with any appropriate subheadings (e.g., tablets, capsules, injectable, suspension), including the strength or potency of the dosage form in metric system (e.g., 10-milligram tablets) and whether the product is scored.
(9) Contraindications. A concise statement of each of the product's contraindications, as required under paragraph
(c)(5) of this section, with any appropriate subheadings.
(10) Warnings and precautions. A concise summary of the most clinically significant information required under
paragraph (c)(6) of this section, with any appropriate subheadings, including information that would affect decisions
about whether to prescribe a drug, recommendations for patient monitoring that are critical to safe use of the drug,
and measures that can be taken to prevent or mitigate harm.
(11) Adverse reactions. (i) A list of the most frequently occurring adverse reactions, as described in paragraph (c)(7)
of this section, along with the criteria used to determine inclusion (e.g., incidence rate). Adverse reactions important
for other reasons (e.g., because they are serious or frequently lead to discontinuation or dosage adjustment) must not
be repeated under this heading in Highlights if they are included elsewhere in Highlights (e.g., Warnings and Precautions, Contraindications).
(ii) For drug products other than vaccines, the verbatim statement "To report SUSPECTED ADVERSE REACTIONS,
contact (insert name of manufacturer) at (insert manufacturer's phone number) or FDA at (insert current FDA phone
number and Web address for voluntary reporting of adverse reactions)."
(iii) For vaccines, the verbatim statement "To report SUSPECTED ADVERSE REACTIONS, contact (insert name of
manufacturer) at (insert manufacturer's phone number) or VAERS at (insert the current VAERS phone number and
Web address for voluntary reporting of adverse reactions)."
(iv) For manufacturers with a Web site for voluntary reporting of adverse reactions, the Web address of the direct
link to the site.
(12) Drug interactions. A concise summary of the information required under paragraph (c)(8) of this section, with
any appropriate subheadings.
(13) Use in specific populations. A concise summary of the information required under paragraph (c)(9) of this section, with any appropriate subheadings.
(14) Patient counseling information statement. The verbatim statement "See 17 for Patient Counseling Information"
or, if the product has FDA-approved patient labeling, the verbatim statement "See 17 for Patient Counseling Infor-
35
mation and (insert either FDA-approved patient labeling or Medication Guide)."
(15) Revision date. The date of the most recent revision of the labeling, identified as such, placed at the end of Highlights.
(b) Full prescribing information: Contents. Contents must contain a list of each heading and subheading required in
the full prescribing information under § 201.56(d)(1), if not omitted under § 201.56(d)(4), preceded by the identifying number required under § 201.56(d)(1). Contents must also contain any additional subheading(s) included in the
full prescribing information preceded by the identifying number assigned in accordance with § 201.56(d)(2).
(c) Full prescribing information. The full prescribing information must contain the information in the order required
under paragraphs (c)(1) through (c)(18) of this section, together with the headings, subheadings, and identifying
numbers required under § 201.56(d)(1), unless omitted under § 201.56(d)(4). If additional subheadings are used
within a labeling section, they must be preceded by the identifying number assigned in accordance with §
201.56(d)(2).
Note below the content of the “boxed warning” as required by the new FDA criteria.
(1) Boxed warning. Certain contraindications or serious warnings, particularly those that may lead to death or serious injury, may be required by the FDA to be presented in a box. The boxed warning ordinarily must be based on
clinical data, but serious animal toxicity may also be the basis of a boxed warning in the absence of clinical data.
The box must contain, in uppercase letters, a heading inside the box that includes the word "WARNING" and conveys
the general focus of the information in the box. The box must briefly explain the risk and refer to more detailed information in the "Contraindications" or "Warnings and Precautions" section, accompanied by the identifying number
for the section or subsection containing the detailed information.
(2) 1 Indications and usage. This section must state that the drug is indicated for the treatment, prevention, mitigation, cure, or diagnosis of a recognized disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition.
(i) This section must include the following information when the conditions listed are applicable:
(A) If the drug is used for an indication only in conjunction with a primary mode of therapy (e.g., diet, surgery, behavior changes, or some other drug), a statement that the drug is indicated as an adjunct to that mode of therapy.
(B) If evidence is available to support the safety and effectiveness of the drug or biological product only in selected
subgroups of the larger population (e.g., patients with mild disease or patients in a special age group), or if the indication is approved based on a surrogate endpoint under § 314.510 or § 601.41 of this chapter, a succinct description
of the limitations of usefulness of the drug and any uncertainty about anticipated clinical benefits, with reference to
the "Clinical Studies" section for a discussion of the available evidence.
(C) If specific tests are necessary for selection or monitoring of the patients who need the drug (e.g., microbe susceptibility tests), the identity of such tests.
(D) If information on limitations of use or uncertainty about anticipated clinical benefits is relevant to the recommended intervals between doses, to the appropriate duration of treatment when such treatment should be limited, or
to any modification of dosage, a concise description of the information with reference to the more detailed information in the "Dosage and Administration" section.
(E) If safety considerations are such that the drug should be reserved for specific situations (e.g., cases refractory to
other drugs), a statement of the information.
(F) If there are specific conditions that should be met before the drug is used on a long term basis (e.g., demonstration of responsiveness to the drug in a short term trial in a given patient), a statement of the conditions; or, if the indications for long term use are different from those for short term use, a statement of the specific indications for each
use.
Note below that if a manufacturer is aware a drug is being used off-label, but there is evidence that the drug is unacceptably
risk when used off-label in which way, the FDA may require the manufacturer to instruction in the indications section that
there is a lack of evidence supporting the use of the drug in that way.
(ii) If there is a common belief that the drug may be effective for a certain use or if there is a common use of the drug
36
for a condition, but the preponderance of evidence related to the use or condition shows that the drug is ineffective or
that the therapeutic benefits of the product do not generally outweigh its risks, FDA may require that this section
state that there is a lack of evidence that the drug is effective or safe for that use or condition.
(iii) Any statements comparing the safety or effectiveness of the drug with other agents for the same indication must,
except for biological products, be supported by substantial evidence derived from adequate and well-controlled studies as defined in § 314.126(b) of this chapter unless this requirement is waived under § 201.58 or § 314.126(c) of this
chapter. For biological products, such statements must be supported by substantial evidence.
(iv) For drug products other than biological products, all indications listed in this section must be supported by substantial evidence of effectiveness based on adequate and well-controlled studies as defined in § 314.126(b) of this
chapter unless the requirement is waived under § 201.58 or § 314.126(c) of this chapter. Indications or uses must not
be implied or suggested in other sections of the labeling if not included in this section.
(v) For biological products, all indications listed in this section must be supported by substantial evidence of effectiveness. Indications or uses must not be implied or suggested in other sections of the labeling if not included in this
section.
(3) 2 Dosage and administration. (i) This section must state the recommended dose and, as appropriate:
(A) The dosage range,
(B) An upper limit beyond which safety and effectiveness have not been established, or beyond which increasing the
dose does not result in increasing effectiveness,
(C) Dosages for each indication and subpopulation,
(D) The intervals recommended between doses,
(E) The optimal method of titrating dosage,
(F) The usual duration of treatment when treatment duration should be limited,
(G) Dosing recommendations based on clinical pharmacologic data (e.g., clinically significant food effects),
(H) Modification of dosage needed because of drug interactions or in special patient populations (e.g., in children, in
geriatric age groups, in groups defined by genetic characteristics, or in patients with renal or hepatic disease),
(I) Important considerations concerning compliance with the dosage regimen,
(J) Efficacious or toxic concentration ranges and therapeutic concentration windows of the drug or its metabolites, if
established and clinically significant. Information on therapeutic drug concentration monitoring (TDM) must also be
included in this section when TDM is necessary.
(ii) Dosing regimens must not be implied or suggested in other sections of the labeling if not included in this section.
(iii) Radiation dosimetry information must be stated for both the patient receiving a radioactive drug and the person
administering it.
(iv) This section must also contain specific direction on dilution, preparation (including the strength of the final dosage solution, when prepared according to instructions, in terms of milligrams of active ingredient per milliliter of
reconstituted solution, unless another measure of the strength is more appropriate), and administration of the dosage
form, if needed (e.g., the rate of administration of parenteral drug in milligrams per minute; storage conditions for
stability of the reconstituted drug, when important; essential information on drug incompatibilities if the drug is
mixed in vitro with other drugs or diluents; and the following verbatim statement for parenterals: "Parenteral drug
products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.")
(4) 3 Dosage forms and strengths. This section must contain information on the available dosage forms to which the
labeling applies and for which the manufacturer or distributor is responsible, including:
(i) The strength or potency of the dosage form in metric system (e.g., 10 milligram tablets), and, if the apothecary
system is used, a statement of the strength in parentheses after the metric designation; and
(ii) A description of the identifying characteristics of the dosage forms, including shape, color, coating, scoring, and
imprinting, when applicable. The National Drug Code number(s) for the drug product must not be included in this
section.
Note the distinction between “contraindications” which describe situations in which the risk of use of a drug outweighs any
possible benefit, and “warnings and precautions” that describe how a drug is to be used to minimize risks.
37
(5) 4 Contraindications. This section must describe any situations in which the drug should not be used because the
risk of use (e.g., certain potentially fatal adverse reactions) clearly outweighs any possible therapeutic benefit. Those
situations include use of the drug in patients who, because of their particular age, sex, concomitant therapy, disease
state, or other condition, have a substantial risk of being harmed by the drug and for whom no potential benefit
makes the risk acceptable. Known hazards and not theoretical possibilities must be listed (e.g., if severe hypersensitivity to the drug has not been demonstrated, it should not be listed as a contraindication). If no contraindications are
known, this section must state "None."
(6) 5 Warnings and precautions. (i) General. This section must describe clinically significant adverse reactions
(including any that are potentially fatal, are serious even if infrequent, or can be prevented or mitigated through appropriate use of the drug), other potential safety hazards (including those that are expected for the pharmacological
class or those resulting from drug/drug interactions), limitations in use imposed by them (e.g., avoiding certain concomitant therapy), and steps that should be taken if they occur (e.g., dosage modification). The frequency of all clinically significant adverse reactions and the approximate mortality and morbidity rates for patients experiencing the
reaction, if known and necessary for the safe and effective use of the drug, must be expressed as provided under
paragraph (c)(7) of this section. In accordance with §§ 314.70 and 601.12 of this chapter, the labeling must be revised to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal
association with a drug; a causal relationship need not have been definitely established. A specific warning relating
to a use not provided for under the "Indications and Usage" section may be required by FDA in accordance with sections 201(n) and 502(a) of the act if the drug is commonly prescribed for a disease or condition and such usage is
associated with a clinically significant risk or hazard.
(ii) Other special care precautions. This section must contain information regarding any special care to be exercised
by the practitioner for safe and effective use of the drug (e.g., precautions not required under any other specific section or subsection).
(iii) Monitoring: Laboratory tests. This section must identify any laboratory tests helpful in following the patient's
response or in identifying possible adverse reactions. If appropriate, information must be provided on such factors as
the range of normal and abnormal values expected in the particular situation and the recommended frequency with
which tests should be performed before, during, and after therapy.
(iv) Interference with laboratory tests. This section must briefly note information on any known interference by the
product with laboratory tests and reference the section where the detailed information is presented (e.g., "Drug Interactions" section).
(7) 6 Adverse reactions. This section must describe the overall adverse reaction profile of the drug based on the entire safety database. For purposes of prescription drug labeling, an adverse reaction is an undesirable effect, reasonably associated with use of a drug, that may occur as part of the pharmacological action of the drug or may be
unpredictable in its occurrence. This definition does not include all adverse events observed during use of a drug,
only those adverse events for which there is some basis to believe there is a causal relationship between the drug and
the occurrence of the adverse event.
(i) Listing of adverse reactions. This section must list the adverse reactions that occur with the drug and with drugs
in the same pharmacologically active and chemically related class, if applicable. The list or lists must be preceded by
the information necessary to interpret the adverse reactions (e.g., for clinical trials, total number exposed, extent and
nature of exposure).
Note below that the listing of adverse reactions must be rank ordered according either to frequency or severity, and must be
categorized by body system affected.
(ii) Categorization of adverse reactions. Within a listing, adverse reactions must be categorized by body system, by
severity of the reaction, or in order of decreasing frequency, or by a combination of these, as appropriate. Within a
category, adverse reactions must be listed in decreasing order of frequency. If frequency information cannot be reliably determined, adverse reactions must be listed in decreasing order of severity.
(A) Clinical trials experience. This section must list the adverse reactions identified in clinical trials that occurred at
or above a specified rate appropriate to the safety database. The rate of occurrence of an adverse reaction for the
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drug and comparators (e.g., placebo) must be presented, unless such data cannot be determined or presentation of
comparator rates would be misleading. If adverse reactions that occurred below the specified rate are included, they
must be included in a separate listing. If comparative rates of occurrence cannot be reliably determined (e.g., adverse reactions were observed only in the uncontrolled trial portion of the overall safety database), adverse reactions
must be grouped within specified frequency ranges as appropriate to the safety database for the drug (e.g., adverse
reactions occurring at a rate of less than 1/100, adverse reactions occurring at a rate of less than 1/500) or descriptively identified, if frequency ranges cannot be determined. For adverse reactions with significant clinical implications, the listings must be supplemented with additional detail about the nature, frequency, and severity of the
adverse reaction and the relationship of the adverse reaction to drug dose and demographic characteristics, if data
are available and important.
(B) Postmarketing experience. This section of the labeling must list the adverse reactions, as defined in paragraph
(c)(7) of this section, that are identified from domestic and foreign spontaneous reports. This listing must be separate
from the listing of adverse reactions identified in clinical trials.
(iii) Comparisons of adverse reactions between drugs. For drug products other than biological products, any claim
comparing the drug to which the labeling applies with other drugs in terms of frequency, severity, or character of
adverse reactions must be based on adequate and well-controlled studies as defined in § 314.126(b) of this chapter
unless this requirement is waived under § 201.58 or § 314.126(c) of this chapter. For biological products, any such
claim must be based on substantial evidence.
(8) 7 Drug interactions. (i) This section must contain a description of clinically significant interactions, either observed or predicted, with other prescription or over-the-counter drugs, classes of drugs, or foods (e.g., dietary supplements, grapefruit juice), and specific practical instructions for preventing or managing them. The mechanism(s) of
the interaction, if known, must be briefly described. Interactions that are described in the "Contraindications" or
"Warnings and Precautions" sections must be discussed in more detail under this section. Details of drug interaction
pharmacokinetic studies that are included in the "Clinical Pharmacology" section that are pertinent to clinical use of
the drug must not be repeated in this section.
(ii) This section must also contain practical guidance on known interference of the drug with laboratory tests.
(9) 8 Use in specific populations. This section must contain the following subsections:
Note that the regulations require all drugs to be categorized according to their risk in pregnancy, by being placed one of five
categories designated by the letters A, B, C, D, and X, with the fetal risk increasing as the designation shifts from A to X.
(i) 8.1 Pregnancy. This subsection may be omitted only if the drug is not absorbed systemically and the drug is not
known to have a potential for indirect harm to the fetus. For all other drugs, this subsection must contain the following information:
(A) Teratogenic effects. Under this subheading, the labeling must identify one of the following categories that applies
to the drug, and the labeling must bear the statement required under the category:
(1) Pregnancy category A. If adequate and well-controlled studies in pregnant women have failed to demonstrate a
risk to the fetus in the first trimester of pregnancy (and there is no evidence of a risk in later trimesters), the labeling
must state: "Pregnancy Category A. Studies in pregnant women have not shown that (name of drug) increases the
risk of fetal abnormalities if administered during the first (second, third, or all) trimester(s) of pregnancy. If this drug
is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm, however, (name of drug) should be used during pregnancy only if clearly needed." The labeling must also
contain a description of the human studies. If animal reproduction studies are also available and they fail to demonstrate a risk to the fetus, the labeling must also state: "Reproduction studies have been performed in (kinds of
animal(s)) at doses up to (x) times the human dose and have revealed no evidence of impaired fertility or harm to the
fetus due to (name of drug)." The labeling must also contain a description of available data on the effect of the drug
on the later growth, development, and functional maturation of the child.
(2) Pregnancy category B. If animal reproduction studies have failed to demonstrate a risk to the fetus and there are
no adequate and well-controlled studies in pregnant women, the labeling must state: "Pregnancy Category B. Reproduction studies have been performed in (kind(s) of animal(s)) at doses up to (x) times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to (name of drug). There are, however, no adequate
39
and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of
human response, this drug should be used during pregnancy only if clearly needed." If animal reproduction studies
have shown an adverse effect (other than decrease in fertility), but adequate and well-controlled studies in pregnant
women have failed to demonstrate a risk to the fetus during the first trimester of pregnancy (and there is no evidence
of a risk in later trimesters), the labeling must state: "Pregnancy Category B. Reproduction studies in (kind(s) of
animal(s)) have shown (describe findings) at (x) times the human dose. Studies in pregnant women, however, have
not shown that (name of drug) increases the risk of abnormalities when administered during the first (second, third,
or all) trimester(s) of pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote, if the drug is used during pregnancy. Nevertheless, because the studies in humans cannot rule out the possibility of harm, (name of drug) should be used during pregnancy only if clearly needed." The labeling must also contain a
description of the human studies and a description of available data on the effect of the drug on the later growth, development, and functional maturation of the child.
(3) Pregnancy category C. If animal reproduction studies have shown an adverse effect on the fetus, if there are no
adequate and well-controlled studies in humans, and if the benefits from the use of the drug in pregnant women may
be acceptable despite its potential risks, the labeling must state: "Pregnancy Category C. (Name of drug) has been
shown to be teratogenic (or to have an embryocidal effect or other adverse effect) in (name(s) of species) when given
in doses (x) times the human dose. There are no adequate and well-controlled studies in pregnant women. (Name of
drug) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus." The labeling must contain a description of the animal studies. If there are no animal reproduction studies and no adequate
and well-controlled studies in humans, the labeling must state: "Pregnancy Category C. Animal reproduction studies
have not been conducted with (name of drug). It is also not known whether (name of drug) can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity. (Name of drug) should be given to a pregnant woman only if clearly needed." The labeling must contain a description of any available data on the effect of the
drug on the later growth, development, and functional maturation of the child.
(4) Pregnancy category D. If there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in
pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening
situation or serious disease for which safer drugs cannot be used or are ineffective), the labeling must state:
"Pregnancy Category D. See 'Warnings and Precautions' section." Under the "Warnings and Precautions" section,
the labeling must state: "(Name of drug) can cause fetal harm when administered to a pregnant woman. (Describe
the human data and any pertinent animal data.) If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus."
(5) Pregnancy category X. If studies in animals or humans have demonstrated fetal abnormalities or if there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both,
and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer
drugs or other forms of therapy are available), the labeling must state: "Pregnancy Category X. See
'Contraindications' section." Under "Contraindications," the labeling must state: "(Name of drug) may (can) cause
fetal harm when administered to a pregnant woman. (Describe the human data and any pertinent animal data.)
(Name of drug) is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy,
or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a
fetus."
(B) Nonteratogenic effects. Under this subheading the labeling must contain other information on the drug's effects
on reproduction and the drug's use during pregnancy that is not required specifically by one of the pregnancy categories, if the information is relevant to the safe and effective use of the drug. Information required under this heading
must include nonteratogenic effects in the fetus or newborn infant (for example, withdrawal symptoms or hypoglycemia) that may occur because of a pregnant woman's chronic use of the drug for a preexisting condition or disease.
(ii) 8.2 Labor and delivery. If the drug has a recognized use during labor or delivery (vaginal or abdominal delivery), whether or not the use is stated in the Indications and Usage section, this subsection must describe the available
information about the effect of the drug on the mother and the fetus, on the duration of labor or delivery, on the possibility that forceps delivery or other intervention or resuscitation of the newborn will be necessary, and the effect of
the drug on the later growth, development, and functional maturation of the child. If any information required under
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this subsection is unknown, it must state that the information is unknown.
(iii) 8.3 Nursing mothers. (A) If a drug is absorbed systemically, this subsection must contain, if known, information
about excretion of the drug in human milk and effects on the nursing infant. Pertinent adverse effects observed in animal offspring must be described.
(B) If a drug is absorbed systemically and is known to be excreted in human milk, this subsection must contain one of
the following statements, as appropriate. If the drug is associated with serious adverse reactions or if the drug has a
known tumorigenic potential, the labeling must state: "Because of the potential for serious adverse reactions in nursing infants from (name of drug) (or, "Because of the potential for tumorigenicity shown for (name of drug) in (animal
or human) studies), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into
account the importance of the drug to the mother." If the drug is not associated with serious adverse reactions and
does not have a known tumorigenic potential, the labeling must state: "Caution should be exercised when (name of
drug) is administered to a nursing woman."
(C) If a drug is absorbed systemically and information on excretion in human milk is unknown, this subsection must
contain one of the following statements, as appropriate. If the drug is associated with serious adverse reactions or
has a known tumorigenic potential, the labeling must state: "It is not known whether this drug is excreted in human
milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in
nursing infants from (name of drug) (or, "Because of the potential for tumorigenicity shown for (name of drug) in
(animal or human) studies), a decision should be made whether to discontinue nursing or to discontinue the drug,
taking into account the importance of the drug to the mother." If the drug is not associated with serious adverse reactions and does not have a known tumorigenic potential, the labeling must state: "It is not known whether this drug is
excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when (name of
drug) is administered to a nursing woman."
(iv) 8.4 Pediatric use. (A) Pediatric population(s)/pediatric patient(s): For the purposes of paragraphs (c)(9)(iv)(B)
through (c)(9)(iv)(H) of this section, the terms pediatric population(s) and pediatric patient(s) are defined as the pediatric age group, from birth to 16 years, including age groups often called neonates, infants, children, and adolescents.
(B) If there is a specific pediatric indication different from those approved for adults that is supported by adequate
and well-controlled studies in the pediatric population, it must be described under the "Indications and Usage" section, and appropriate pediatric dosage information must be given under the "Dosage and Administration" section.
The "Pediatric use" subsection must cite any limitations on the pediatric indication, need for specific monitoring,
specific hazards associated with use of the drug in any subsets of the pediatric population (e.g., neonates), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric
use of the drug. Data summarized in this subsection should be discussed in more detail, if appropriate, under the
"Clinical Pharmacology" or "Clinical Studies" section. As appropriate, this information must also be contained in
the "Contraindications" and/or "Warnings and Precautions" section(s).
(C) If there are specific statements on pediatric use of the drug for an indication also approved for adults that are
based on adequate and well-controlled studies in the pediatric population, they must be summarized in the "Pediatric
use" subsection and discussed in more detail, if appropriate, under the "Clinical Pharmacology" and "Clinical Studies" sections. Appropriate pediatric dosage must be given under the "Dosage and Administration" section. The
"Pediatric use" subsection of the labeling must also cite any limitations on the pediatric use statement, need for specific monitoring, specific hazards associated with use of the drug in any subsets of the pediatric population (e.g., neonates), differences between pediatric and adult responses to the drug, and other information related to the safe and
effective pediatric use of the drug. As appropriate, this information must also be contained in the "Contraindications"
and/or "Warnings and Precautions" section(s).
(D)(1) When a drug is approved for pediatric use based on adequate and well-controlled studies in adults with other
information supporting pediatric use, the "Pediatric use" subsection of the labeling must contain either the following
statement or a reasonable alternative:
The safety and effectiveness of (drug name) have been established in the age groups --- to --- (note any limitations,
e.g., no data for pediatric patients under 2, or only applicable to certain indications approved in adults). Use of
(drug name) in these age groups is supported by evidence from adequate and well-controlled studies of (drug name)
in adults with additional data (insert wording that accurately describes the data submitted to support a finding of
41
substantial evidence of effectiveness in the pediatric population).
(2) Data summarized in the preceding prescribed statement in this subsection must be discussed in more detail, if appropriate, under the "Clinical Pharmacology" or the "Clinical Studies" section. For example, pediatric pharmacokinetic or pharmacodynamic studies and dose response information should be described in the "Clinical
Pharmacology" section. Pediatric dosing instructions must be included in the "Dosage and Administration" section.
Any differences between pediatric and adult responses, need for specific monitoring, dosing adjustments, and any
other information related to safe and effective use of the drug in pediatric patients must be cited briefly in the
"Pediatric use" subsection and, as appropriate, in the "Contraindications," "Warnings and Precautions," and
"Dosage and Administration" sections.
(E) If the requirements for a finding of substantial evidence to support a pediatric indication or a pediatric use statement have not been met for a particular pediatric population, the "Pediatric use" subsection must contain an appropriate statement such as "Safety and effectiveness in pediatric patients below the age of (--) have not been
established." If use of the drug in this pediatric population is associated with a specific hazard, the hazard must be
described in this subsection, or, if appropriate, the hazard must be stated in the "Contraindications" or "Warnings
and Precautions" section and this subsection must refer to it.
(F) If the requirements for a finding of substantial evidence to support a pediatric indication or a pediatric use statement have not been met for any pediatric population, this subsection must contain the following statement: "Safety
and effectiveness in pediatric patients have not been established." If use of the drug in premature or neonatal infants,
or other pediatric subgroups, is associated with a specific hazard, the hazard must be described in this subsection,
or, if appropriate, the hazard must be stated in the "Contraindications" or "Warnings and Precautions" section and
this subsection must refer to it.
(G) If the sponsor believes that none of the statements described in paragraphs (c)(9)(iv)(B) through (c)(9)(iv)(F) of
this section are appropriate or relevant to the labeling of a particular drug, the sponsor must provide reasons for
omission of the statements and may propose alternative statement(s). FDA may permit use of an alternative statement
if FDA determines that no statement described in those paragraphs is appropriate or relevant to the drug's labeling
and that the alternative statement is accurate and appropriate.
(H) If the drug product contains one or more inactive ingredients that present an increased risk of toxic effects to neonates or other pediatric subgroups, a special note of this risk must be made, generally in the "Contraindications" or
"Warnings and Precautions" section.
(v) 8.5 Geriatric use. (A) A specific geriatric indication, if any, that is supported by adequate and well-controlled
studies in the geriatric population must be described under the "Indications and Usage" section, and appropriate geriatric dosage must be stated under the "Dosage and Administration" section. The "Geriatric use" subsection must
cite any limitations on the geriatric indication, need for specific monitoring, specific hazards associated with the geriatric indication, and other information related to the safe and effective use of the drug in the geriatric population.
Unless otherwise noted, information contained in the "Geriatric use" subsection must pertain to use of the drug in
persons 65 years of age and older. Data summarized in this subsection must be discussed in more detail, if appropriate, under "Clinical Pharmacology" or the "Clinical Studies" section. As appropriate, this information must also be
contained in the "Warnings and Precautions" and/or "Contraindications" section(s).
(B) Specific statements on geriatric use of the drug for an indication approved for adults generally, as distinguished
from a specific geriatric indication, must be contained in the "Geriatric use" subsection and must reflect all information available to the sponsor that is relevant to the appropriate use of the drug in elderly patients. This information
includes detailed results from controlled studies that are available to the sponsor and pertinent information from
well-documented studies obtained from a literature search. Controlled studies include those that are part of the marketing application and other relevant studies available to the sponsor that have not been previously submitted in the
investigational new drug application, new drug application, biologics license application, or a supplement or amendment to one of these applications (e.g., postmarketing studies or adverse drug reaction reports). The "Geriatric use"
subsection must contain the following statement(s) or reasonable alternative, as applicable, taking into account
available information:
(1) If clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether elderly
subjects respond differently from younger subjects, and other reported clinical experience has not identified such differences, the "Geriatric use" subsection must include the following statement:
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Clinical studies of (name of drug) did not include sufficient numbers of subjects aged 65 and over to determine
whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should
be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
(2) If clinical studies (including studies that are part of marketing applications and other relevant studies available
to the sponsor that have not been submitted in the sponsor's applications) included enough elderly subjects to make it
likely that differences in safety or effectiveness between elderly and younger subjects would have been detected, but
no such differences (in safety or effectiveness) were observed, and other reported clinical experience has not identified such differences, the "Geriatric use" subsection must contain the following statement:
Of the total number of subjects in clinical studies of (name of drug), -- percent were 65 and over, while -- percent
were 75 and over. (Alternatively, the labeling may state the total number of subjects included in the studies who were
65 and over and 75 and over.) No overall differences in safety or effectiveness were observed between these subjects
and younger subjects, and other reported clinical experience has not identified differences in responses between the
elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
(3) If evidence from clinical studies and other reported clinical experience available to the sponsor indicates that use
of the drug in elderly patients is associated with differences in safety or effectiveness, or requires specific monitoring
or dosage adjustment, the "Geriatric use" subsection must contain a brief description of observed differences or specific monitoring or dosage requirements and, as appropriate, must refer to more detailed discussions in the
"Contraindications," "Warnings and Precautions," "Dosage and Administration," or other sections.
(C)(1) If specific pharmacokinetic or pharmacodynamic studies have been carried out in the elderly, they must be
described briefly in the "Geriatric use" subsection and in detail under the "Clinical Pharmacology" section. The
"Clinical Pharmacology" and "Drug Interactions" sections ordinarily contain information on drug/disease and
drug/drug interactions that is particularly relevant to the elderly, who are more likely to have concomitant illness
and to use concomitant drugs.
(2) If a drug is known to be substantially excreted by the kidney, the "Geriatric use" subsection must include the
statement:
This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be
greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal
function, care should be taken in dose selection, and it may be useful to monitor renal function.
(D) If use of the drug in the elderly appears to cause a specific hazard, the hazard must be described in the
"Geriatric use" subsection, or, if appropriate, the hazard must be stated in the "Contraindications" or "Warnings and
Precautions" section, and the "Geriatric use" subsection must refer to those sections.
(E) Labeling under paragraphs (c)(9)(v)(A) through (c)(9)(v)(C) of this section may include statements, if they are
necessary for safe and effective use of the drug, and reflect good clinical practice or past experience in a particular
situation, e.g., for a sedating drug, it could be stated that:
Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on
low doses of (name of drug) and observed closely.
(F) If the sponsor believes that none of the requirements described in paragraphs (c)(9)(v)(A) through (c)(9)(v)(E) of
this section are appropriate or relevant to the labeling of a particular drug, the sponsor must provide reasons for
omission of the statements and may propose an alternative statement. FDA may permit omission of the statements if
FDA determines that no statement described in those paragraphs is appropriate or relevant to the drug's labeling.
FDA may permit use of an alternative statement if the agency determines that such statement is accurate and appropriate.
(vi) Additional subsections. Additional subsections may be included, as appropriate, if sufficient data are available
concerning the use of the drug in other specified subpopulations (e.g., renal or hepatic impairment).
(10) 9 Drug abuse and dependence. This section must contain the following information, as appropriate:
(i) 9.1 Controlled substance. If the drug is controlled by the Drug Enforcement Administration, the schedule in which
it is controlled must be stated.
(ii) 9.2 Abuse. This subsection must state the types of abuse that can occur with the drug and the adverse reactions
pertinent to them, and must identify particularly susceptible patient populations. This subsection must be based pri-
43
marily on human data and human experience, but pertinent animal data may also be used.
(iii) 9.3 Dependence. This subsection must describe characteristic effects resulting from both psychological and
physical dependence that occur with the drug and must identify the quantity of the drug over a period of time that
may lead to tolerance or dependence, or both. Details must be provided on the adverse effects of chronic abuse and
the effects of abrupt withdrawal. Procedures necessary to diagnose the dependent state and the principles of treating
the effects of abrupt withdrawal must be described.
(11) 10 Overdosage. This section must be based on human data. If human data are unavailable, appropriate animal
and in vitro data may be used. The following specific information must be provided:
(i) Signs, symptoms, and laboratory findings associated with an overdosage of the drug;
(ii) Complications that can occur with the drug (for example, organ toxicity or delayed acidosis);
(iii) Concentrations of the drug in biologic fluids associated with toxicity or death; physiologic variables influencing
excretion of the drug, such as urine pH; and factors that influence the dose response relationship of the drug, such as
tolerance. The pharmacokinetic data given in the "Clinical Pharmacology" section also may be referenced here, if
applicable to overdoses;
(iv) The amount of the drug in a single dose that is ordinarily associated with symptoms of overdosage and the
amount of the drug in a single dose that is likely to be life threatening;
(v) Whether the drug is dialyzable; and
(vi) Recommended general treatment procedures and specific measures for support of vital functions (e.g., proven
antidotes, gastric lavage, forced diuresis, or as per Poison Control Center). Such recommendations must be based on
data available for the specific drug or experience with pharmacologically related drugs. Unqualified recommendations for which data are lacking for the specific drug or class of drugs must not be stated.
(12) 11 Description. (i) This section must contain:
(A) The proprietary name and the established name, if any, as defined in section 502(e)(2) of the act, of the drug or,
for biological products, the proper name (as defined in § 600.3 of this chapter) and any appropriate descriptors;
(B) The type of dosage form(s) and the route(s) of administration to which the labeling applies;
(C) The same qualitative and/or quantitative ingredient information as required under § 201.100(b) for drug labels
or §§ 610.60 and 610.61 of this chapter for biological product labels;
(D) If the product is sterile, a statement of that fact;
(E) The pharmacological or therapeutic class of the drug;
(F) For drug products other than biological products, the chemical name and structural formula of the drug; and
(G) If the product is radioactive, a statement of the important nuclear physical characteristics, such as the principal
radiation emission data, external radiation, and physical decay characteristics.
(ii) If appropriate, other important chemical or physical information, such as physical constants or pH, must be stated.
(13) 12 Clinical pharmacology. (i) This section must contain information relating to the human clinical pharmacology and actions of the drug in humans. Pharmacologic information based on in vitro data using human biomaterials
or pharmacologic animal models, or relevant details about in vivo study designs or results (e.g., drug interaction
studies), may be included in this section if essential to understand dosing or drug interaction information presented
in other sections of the labeling. This section must include the following subsections:
(A) 12.1 Mechanism of action. This subsection must summarize what is known about the established mechanism(s) of
the drug's action in humans at various levels (e.g., receptor, membrane, tissue, organ, whole body). If the mechanism
of action is not known, this subsection must contain a statement about the lack of information.
(B) 12.2 Pharmacodynamics. This subsection must include a description of any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drug's clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity. Exposure-response relationships (e.g.,
concentration-response, dose-response) and time course of pharmacodynamic response (including short-term clinical response) must be included if known. If this information is unknown, this subsection must contain a statement
about the lack of information. Detailed dosing or monitoring recommendations based on pharmacodynamic information that appear in other sections (e.g., "Warnings and Precautions" or "Dosage and Administration") must not be
repeated in this subsection, but the location of such recommendations must be referenced.
(C) 12.3 Pharmacokinetics. This subsection must describe the clinically significant pharmacokinetics of a drug or
44
active metabolites, (i.e., pertinent absorption, distribution, metabolism, and excretion parameters). Information regarding bioavailability, the effect of food, minimum concentration (C[min]), maximum concentration (C[max]), time
to maximum concentration (T[max]), area under the curve (AUC), pertinent half-lives (t[1/2]), time to reach steady
state, extent of accumulation, route(s) of elimination, clearance (renal, hepatic, total), mechanisms of clearance (e.g.,
specific enzyme systems), drug/drug and drug/food (e.g., dietary supplements, grapefruit juice) pharmacokinetic interactions (including inhibition, induction, and genetic characteristics), and volume of distribution (V[d]) must be
presented if clinically significant. Information regarding nonlinearity in pharmacokinetic parameters, changes in
pharmacokinetics over time, and binding (plasma protein, erythrocyte) parameters must also be presented if clinically significant. This section must also include the results of pharmacokinetic studies (e.g., of metabolism or interaction) that establish the absence of an effect, including pertinent human studies and in vitro data. Dosing
recommendations based on clinically significant factors that change the product's pharmacokinetics (e.g., age, gender, race, hepatic or renal dysfunction, concomitant therapy) that appear in other sections (e.g., "Warnings and Precautions," "Dosage and Administration" or "Use in Specific Populations") must not be repeated in this subsection,
but the location of such recommendations must be referenced.
(ii) Data that demonstrate activity or effectiveness in in vitro or animal tests and that have not been shown by adequate and well-controlled clinical studies to be pertinent to clinical use may be included under this section only under the following circumstances:
(A) In vitro data for anti-infective drugs may be included if the data are immediately preceded by the statement "The
following in vitro data are available but their clinical significance is unknown."
(B) For other classes of drugs, in vitro and animal data that have not been shown by adequate and well-controlled
studies, as defined in § 314.126(b) of this chapter, to be necessary for the safe and effective use may be included in
this section only if a waiver is granted under § 201.58 or § 314.126(c) of this chapter.
(14) 13 Nonclinical toxicology. This section must contain the following subsections as appropriate:
(i) 13.1 Carcinogenesis, mutagenesis, impairment of fertility. This subsection must state whether long term studies in
animals have been performed to evaluate carcinogenic potential and, if so, the species and results. If results from
reproduction studies or other data in animals raise concern about mutagenesis or impairment of fertility in either
males or females, this must be described. Any precautionary statement on these topics must include practical, relevant advice to the prescriber on the significance of these animal findings. Human data suggesting that the drug may
be carcinogenic or mutagenic, or suggesting that it impairs fertility, as described in the "Warnings and Precautions"
section, must not be included in this subsection of the labeling.
(ii) 13.2 Animal toxicology and/or pharmacology. Significant animal data necessary for safe and effective use of the
drug in humans that is not incorporated in other sections of labeling must be included in this section (e.g., specifics
about studies used to support approval under § 314.600 or § 601.90 of this chapter, the absence of chronic animal
toxicity data for a drug that is administered over prolonged periods or is implanted in the body).
(15) 14 Clinical studies. This section must discuss those clinical studies that facilitate an understanding of how to use
the drug safely and effectively. Ordinarily, this section will describe the studies that support effectiveness for the labeled indication(s), including discussion of study design, population, endpoints, and results, but must not include an
encyclopedic listing of all, or even most, studies performed as part of the product's clinical development program. If
a specific important clinical study is mentioned in any section of the labeling required under §§ 201.56 and 201.57
because the study is essential to an understandable presentation of the information in that section of the labeling, any
detailed discussion of the study must appear in this section.
(i) For drug products other than biological products, any clinical study that is discussed in prescription drug labeling that relates to an indication for or use of the drug must be adequate and well-controlled as described in §
314.126(b) of this chapter and must not imply or suggest indications or uses or dosing regimens not stated in the
"Indications and Usage" or "Dosage and Administration" section. For biological products, any clinical study that is
discussed that relates to an indication for or use of the biological product must constitute or contribute to substantial
evidence and must not imply or suggest indications or uses or dosing regimens not stated in the "Indications and Usage" or "Dosage and Administration" section.
(ii) Any discussion of a clinical study that relates to a risk from the use of the drug must also refer to the other sections of the labeling where the risk is identified or discussed.
(16) 15 References. When prescription drug labeling must summarize or otherwise rely on a recommendation by an
45
authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions, the labeling may include a reference to the source of the information.
(17) 16 How supplied/storage and handling. This section must contain information on the available dosage forms to
which the labeling applies and for which the manufacturer or distributor is responsible. The information must include, as appropriate:
(i) The strength or potency of the dosage form in metric system (e.g., 10 milligram tablets) and, if the apothecary system is used, a statement of the strength in parentheses after the metric designation;
(ii) The units in which the dosage form is ordinarily available for prescribing by practitioners (e.g., bottles of 100);
(iii) Appropriate information to facilitate identification of the dosage forms, such as shape, color, coating, scoring,
imprinting, and National Drug Code number; and
(iv) Special handling and storage conditions.
Note below that the package insert specifies information that should be conveyed to patients regarding drugs prescribed for
patients and dispensed to them. This information relates to how a drug is used, rather than to the choice of whether to use a
drug.
(18) 17 Patient counseling information. This section must contain information necessary for patients to use the drug
safely and effectively (e.g., precautions concerning driving or the concomitant use of other substances that may have
harmful additive effects). Any FDA-approved patient labeling must be referenced in this section and the full text of
such patient labeling must be reprinted immediately following this section or, alternatively, accompany the prescription drug labeling. Any FDA-approved patient labeling printed immediately following this section or accompanying
the labeling is subject to the type size requirements in paragraph (d)(6) of this section, except for a Medication Guide
to be detached and distributed to patients in compliance with § 208.24 of this chapter. Medication Guides for distribution to patients are subject to the type size requirements set forth in § 208.20 of this chapter.
(d) Format requirements. All labeling information required under paragraphs (a), (b), and (c) of this section must be
printed in accordance with the following specifications:
(1) All headings and subheadings required by paragraphs (a) and (c) of this section must be highlighted by bold type
that prominently distinguishes the headings and subheadings from other labeling information. Reverse type is not
permitted as a form of highlighting.
(2) A horizontal line must separate the information required by paragraphs (a), (b), and (c) of this section.
(3) The headings listed in paragraphs (a)(5) through (a)(13) of this section must be presented in the center of a horizontal line.
(4) If there are multiple subheadings listed under paragraphs (a)(4) through (a)(13) of this section, each subheading
must be preceded by a bullet point.
(5) The labeling information required by paragraphs (a)(1) through (a)(4), (a)(11)(ii) through (a)(11)(iv), and
(a)(14) of this section must be in bold print.
(6) The letter height or type size for all labeling information, headings, and subheadings set forth in paragraphs (a),
(b), and (c) of this section must be a minimum of 8 points, except for labeling information that is on or within the
package from which the drug is to be dispensed, which must be a minimum of 6 points.
(7) The identifying numbers required by § 201.56(d) and paragraphs (c)(1) through (c)(18) of this section must be
presented in bold print and must precede the heading or subheading by at least two square em's (i.e., two squares of
the size of the letter "m" in 8 point type).
(8) The information required by paragraph (a) of this section, not including the information required under paragraph (a)(4) of this section, must be limited in length to an amount that, if printed in 2 columns on a standard sized
piece of typing paper (8 1/2 by 11 inches), single spaced, in 8 point type with 1/2-inch margins on all sides and between columns, would fit on one-half of the page.
(9) Sections or subsections of labeling that are identified as containing recent major changes under paragraph (a)(5)
of this section must be highlighted in the full prescribing information by the inclusion of a vertical line on the left
edge of the new or modified text.
(10) For the information required by paragraph (b) of this section, each section heading must be in bold print. Each
subheading within a section must be indented and not bolded.
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B.
Special Labeling
For some products, the FDA has determined that the general labeling requirements that apply to all drugs are inadequate. Under these circumstances, special labeling requirements are imposed to reflect the particular situation of risk presented by a
product. Several past examples of drugs (prescription and OTC) that were required to have specific warning requirements
include isoproterenol inhalation preparations, drugs with thyroid hormone activity for human use , and Ipecac syrup. Specific
labeling requirements for specific drug products can be found in title 21 of the Code of Federal Regulations (CFR). The special labeling requirements for Ipecac and isoproterenol are provided below as an example.
Sec. 201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale.
(a) It is estimated that each year about 500,000 accidental poisonings occur in the United States and result in approximately 1,500 deaths, of which over 400 are children. In the emergency treatment of these poisonings, ipecac
syrup is considered the emetic of choice. The immediate availability of this drug for use in such situations is critical,
since rapid treatment may be the difference between life and death. The restriction of this drug to prescription sale
limits its availability in emergencies. On the other hand, it is the consensus of informed medical opinion that ipecac
syrup should be used only under medical supervision in the emergency treatment of poisonings. In view of these facts,
the question of whether ipecac syrup labeled as an emergency treatment for use in poisonings should be available
over the counter has been controversial.
(b) In connection with its study of this problem, the Food and Drug Administration has obtained the views of medical
authorities. It is the unanimous recommendation of the American Academy of Pediatrics, the American Association
of Poison Control Centers, the American Medical Association, and the Medical Advisory Board of the Food and
Drug Administration that ipecac syrup in 1 fluid ounce containers be permitted to be sold without prescription so
that it will be readily available in the household for emergency treatment of poisonings, under medical supervision,
and that the drug be appropriately packaged and labeled for this purpose.
(c) In view of the above recommendations, the Commissioner of Food and Drugs has determined that it is in the interest of the public health for ipecac syrup to be available for sale without prescription, provided that it is packaged
in a quantity of 1 fluid ounce (30 milliliters), and its label bears, in addition to other required label information, the
following, in a prominent and conspicuous manner:
(1) A statement conspicuously boxed and in red letters, to the effect: "For emergency use to cause vomiting in poisoning. Before using, call physician, the Poison Control Center, or hospital emergency room immediately for advice."
(2) A warning to the effect: "Warning--Keep out of reach of children. Do not use in unconscious persons. Ordinarily,
this drug should not be used if strychnine, corrosives such as alkalies (lye) and strong acids, or petroleum distillates
such as kerosine, gasoline, coal oil, fuel oil, paint thinner, or cleaning fluid have been ingested."
(3) Usual dosage: 1 tablespoon (15 milliliters) in persons over 1 year of age.
Sec. 201.305 Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use;
warnings.
(a) Accumulating reports have been received by the Food and Drug Administration and have appeared in the medical literature of severe paradoxical bronchoconstriction associated with repeated, excessive use of isoproterenol inhalation preparations in the treatment of bronchial asthma and other chronic bronchopulmonary disorders. The
cause of this paradoxical reaction is unknown; it has been observed, however, that patients have not responded completely to other forms of therapy until use of the isoproterenol inhalation preparation was discontinued. In addition,
sudden unexpected deaths have been associated with the excessive use of isoproterenol inhalation preparations. The
mechanism of these deaths and their relationship, if any, to the cases of severe paradoxical bronchospasm are not
clear. Cardiac arrest was noted in several of these cases of sudden death.
(b) On the basis of the above information and after discussion with and concurrence of the Respiratory and Anesthetic Drugs Advisory Committee for Food and Drug Administration, the Commissioner of Food and Drugs concludes
that in order for the labeling of such drugs to bear adequate information for their safe use, as required by 201.100,
such labeling must include the following:
Warning: Occasional patients have been reported to develop severe paradoxical airway resistance with repeated,
excessive use of isoproterenol inhalation preparations. The cause of this refractory state is unknown. It is advisable
47
that in such instances the use of this preparation be discontinued immediately and alternative therapy instituted,
since in the reported cases the patients did not respond to other forms of therapy until the drug was withdrawn.
Deaths have been reported following excessive use of isoproterenol inhalation preparations and the exact cause is
unknown. Cardiac arrest was noted in several instances.
(c)(1) The Commissioner also concludes that in view of the manner in which these preparations are self-administered
for relief of attacks of bronchial asthma and other chronic bronchopulmonary disorders, it is necessary for the protection of users that warning information to patients be included as a part of the label and as part of any instructions
to patients included in the package dispensed to the patient as follows:
Warning: Do not exceed the dose prescribed by your physician. If difficulty in breathing persists, contact your physician immediately.
(2) The warning on the label may be accomplished (i) by including it on the immediate container label with a statement directed to pharmacists not to remove the label or (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the container prior to dispensing.
C.
Direct to Consumer Labeling
There is a complex but relatively brief history of FDA efforts to mandate prescription pharmaceutical labeling that would be
directed toward the consumer, rather than toward the health care provider. A program that would have mandated so-called
“Patient Package Inserts” for consumers was developed during the presidency of Jimmy Carter, but was not fully implemented during President Carter’s single term, and was repealed during the presidency of Ronald Reagan. At that time, the rational
in repealing the rule was that private interests could provide written information for patients more efficiently than a federal
program. More recently, a program known as “Medication Guide” has been passed, going into effect on June 1, 1999. Under
this program, the word-for-word language of leaflets will not be developed by the FDA, as it would have been under the Patient Package Insert program, but instead manufacturers are required to meet specific standards for labeling directed to patients. Medication Guides are not required for all drugs. They are required only for specific drugs that are determined by the
FDA to be particularly in need of this sort of risk management labeling. The language of the FDA regulations follow. Numerations refer to Sections of Title 21 of the Code of Federal Regulations.
Sec. 208.1 Scope and purpose.
(a) This part sets forth requirements for patient labeling for human prescription drug products, including biological
products, that the Food and Drug Administration (FDA) determines pose a serious and significant public health concern requiring distribution of FDA-approved patient information. It applies primarily to human prescription drug
products used on an outpatient basis without direct supervision by a health professional. This part shall apply to new
prescriptions and refill prescriptions.
(b) The purpose of patient labeling for human prescription drug products required under this part is to provide information when the FDA determines in writing that it is necessary to patients' safe and effective use of drug products.
(c) Patient labeling will be required if the FDA determines that one or more of the following circumstances exists:
(1) The drug product is one for which patient labeling could help prevent serious adverse effects.
(2) The drug product is one that has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risk(s) could affect patients' decision to use, or to continue to use, the product.
(3) The drug product is important to health and patient adherence to directions for use is crucial to the drug's effectiveness.
§ 208.20 Content and format of a Medication Guide.
(a) A Medication Guide shall meet all of the following conditions:
(1) The Medication Guide shall be written in English, in nontechnical, understandable language, and shall not be
promotional in tone or content.
(2) The Medication Guide shall be scientifically accurate and shall be based on, and shall not conflict with, the approved professional labeling for the drug product under § 201.57 of this chapter, but the language of the Medication
Guide need not be identical to the sections of approved labeling to which it corresponds.
(3) The Medication Guide shall be specific and comprehensive.
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(4) The letter height or type size shall be no smaller than 10 points (1 point = 0.0138 inches) for all sections of the
Medication Guide, except the manufacturer's name and address and the revision date.
(5) The Medication Guide shall be legible and clearly presented. Where appropriate, the Medication Guide shall also
use boxes, bold or underlined print, or other highlighting techniques to emphasize specific portions of the text.
(6) The words "Medication Guide" shall appear prominently at the top of the first page of a Medication Guide. The
verbatim statement "This Medication Guide has been approved by the U.S. Food and Drug Administration" shall appear at the bottom of a Medication Guide.
(7) The brand and established or proper name of the drug product shall appear immediately below the words
"Medication Guide." The established or proper name shall be no less than one-half the height of the brand name.
(b) A Medication Guide shall contain those of the following headings relevant to the drug product and to the need for
the Medication Guide in the specified order. Each heading shall contain the specific information as follows:
(1) The brand name (e.g., the trademark or proprietary name), if any, and established or proper name. Those products not having an established or proper name shall be designated by their active ingredients. The Medication Guide
shall include the phonetic spelling of either the brand name or the established name, whichever is used throughout
the Medication Guide.
(2) The heading, "What is the most important information I should know about (name of drug)?" followed by a statement describing the particular serious and significant public health concern that has created the need for the Medication Guide. The statement should describe specifically what the patient should do or consider because of that
concern, such as, weighing particular risks against the benefits of the drug, avoiding particular behaviors (e.g., activities, drugs), observing certain events (e.g., symptoms, signs) that could prevent or mitigate a serious adverse effect, or engaging in particular behaviors (e.g., adhering to the dosing regimen).
(3) The heading, "What is (name of drug)?" followed by a section that identifies a drug product's indications for use.
The Medication Guide may not identify an indication unless the indication is identified in the indications and usage
section of the professional labeling for the product required under 201.57 of this chapter. In appropriate circumstances, this section may also explain the nature of the disease or condition the drug product is intended to treat, as
well as the benefit(s) of treating the condition.
(4) The heading, "Who should not take (name of drug)?" followed by information on circumstances under which the
drug product should not be used for its labeled indication (its contraindications). The Medication Guide shall contain directions regarding what to do if any of the contraindications apply to a patient, such as contacting the licensed
practitioner or discontinuing use of the drug product.
(5) The heading, "How should I take (name of drug)?" followed by information on the proper use of the drug product, such as:
(i) A statement stressing the importance of adhering to the dosing instructions, if this is particularly important;
(ii) A statement describing any special instructions on how to administer the drug product, if they are important to
the drug's safety or effectiveness;
(iii) A statement of what patients should do in case of overdose of the drug product; and
(iv) A statement of what patients should do if they miss taking a scheduled dose(s) of the drug product, where there
are data to support the advice, and where the wrong behavior could cause harm or lack of effect.
(6) The heading "What should I avoid while taking (name of drug)?" followed by a statement or statements of specific, important precautions patients should take to ensure proper use of the drug, including:
(i) A statement that identifies activities (such as driving or sunbathing), and drugs, foods, or other substances (such
as tobacco or alcohol) that patients should avoid when using the medication;
(ii) A statement of the risks to mothers and fetuses from the use of the drug during pregnancy, if specific, important
risks are known;
(iii) A statement of the risks of the drug product to nursing infants, if specific, important risks are known;
(iv) A statement about pediatric risks, if the drug product has specific hazards associated with its use in pediatric patients;
(v) A statement about geriatric risks, if the drug product has specific hazards associated with its use in geriatric patients; and
(vi) A statement of special precautions, if any, that apply to the safe and effective use of the drug product in other
identifiable patient populations.
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(7) The heading, "What are the possible or reasonably likely side effects of (name of drug)?" followed by:
(i) A statement of the adverse reactions reasonably likely to be caused by the drug product that are serious or occur
frequently.
(ii) A statement of the risk, if there is one, of patients' developing dependence on the drug product.
(iii) For drug products approved under section 505 of the act, the following verbatim statement: "Call your doctor
for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088."
(8) General information about the safe and effective use of prescription drug products, including:
(i) The verbatim statement that "Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide" followed by a statement that patients should ask health professionals about any concerns, and a reference to the availability of professional labeling;
(ii) A statement that the drug product should not be used for a condition other than that for which it is prescribed, or
given to other persons;
(iii) The name and place of business of the manufacturer, packer, or distributor of a drug product that is not also a
biological product, or the name and place of business of the manufacturer or distributor of a drug product that is also a biological product, and in any case the name and place of business of the dispenser of the product may also be
included; and
(iv) The date, identified as such, of the most recent revision of the Medication Guide placed immediately after the last
section.
(9) Additional headings and subheadings may be interspersed throughout the Medication Guide, if appropriate.
Note from the language above the specific content format for Medication Guides. The question-and-answer format is a key
element of the Medication Guide standards. From the language below, it is important to note that the manufacturer must receive approval from the FDA for the Medication Guide; that the manufacturer must supply the Medication Guides to the dispensers; and that the dispenser (e.g., pharmacist) must provide the Medication Guide to the patient for each fill.
Sec. 208.24 Distributing and dispensing a Medication Guide.
(a) The manufacturer of a drug product for which a Medication Guide is required under this part shall obtain FDA
approval of the Medication Guide before the Medication Guide may be distributed.
(b) Each manufacturer who ships a container of drug product for which a Medication Guide is required under this
part is responsible for ensuring that Medication Guides are available for distribution to patients by either:
(1) Providing Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers to permit
the authorized dispenser to provide a Medication Guide to each patient receiving a prescription for the drug product; or
(2) Providing the means to produce Medication Guides in sufficient numbers to distributors, packers, or authorized
dispensers to permit the authorized dispenser to provide a Medication Guide to each patient receiving a prescription
for the drug product.
(c) Each distributor or packer that receives Medication Guides, or the means to produce Medication Guides, from a
manufacturer under paragraph (b) of this section shall provide those Medication Guides, or the means to produce
Medication Guides, to each authorized dispenser to whom it ships a container of drug product.
(d) The label of each container or package, where the container label is too small, of drug product for which a Medication Guide is required under this part shall instruct the authorized dispenser to provide a Medication Guide to
each patient to whom the drug product is dispensed, and shall state how the Medication Guide is provided. These
statements shall appear on the label in a prominent and conspicuous manner.
(e) Each authorized dispenser of a prescription drug product for which a Medication Guide is required under this
part shall, when the product is dispensed to a patient (or to a patient's agent), provide a Medication Guide directly to
each patient (or to the patient's agent) unless an exemption applies under 208.26.
In addition to the general Medication Guide program, a very few drugs continue to be subject to special requirements for patient package inserts. This is not a vestige of the repealed larger program on patient package inserts from the Carter-Reagan
years, but instead is a small scale effort to assure that patients receiving drugs that relate in some way to lifestyle choices have
sufficient scientific information upon which to make personal decisions. These patient package inserts are required for estro-
50
gen drugs and oral contraceptives. The language of the FDA regulation describing the requirement for estrogens follows.
Numerations refer to Sections of Title 21 of the Code of Federal Regulations.
§ 310.515 Patient package inserts for estrogens.
(a) Requirement for a patient package insert. FDA concludes that the safe and effective use of drug products containing estrogens requires that patients be fully informed of the benefits and risks involved in the use of these drugs.
Accordingly, except as provided in paragraph (e) of this section, each estrogen drug product restricted to prescription distribution, including products containing estrogens in fixed combinations with other drugs, shall be dispensed
to patients with a patient package insert containing information concerning the drug's benefits and risks. An estrogen
drug product that does not comply with the requirements of this section is misbranded under section 502(a) of the
Federal Food, Drug, and Cosmetic Act.
(b) Distribution requirements. (1) For estrogen drug products, the manufacturer and distributor shall provide a patient package insert in or with each package of the drug product that the manufacturer or distributor intends to be
dispensed to a patient.
(2) In the case of estrogen drug products in bulk packages intended for multiple dispensing, and in the case of injectables in multiple-dose vials, a sufficient number of patient labeling pieces shall be included in or with each package
to assure that one piece can be included with each package or dose dispensed or administered to every patient. Each
bulk package shall be labeled with instructions to the dispenser to include one patient labeling piece with each package dispensed or, in the case of injectables, with each dose administered to the patient. This section does not preclude the manufacturer or labeler from distributing additional patient labeling pieces to the dispenser.
(3) Patient package inserts for estrogens dispensed in acute-care hospitals or long-term care facilities will be considered to have been provided in accordance with this section if provided to the patient before administration of the first
estrogen and every 30 days thereafter, as long as the therapy continues.
(c) Patient package insert contents. A patient package insert for an estrogen drug product is required to contain the
following information:
(1) The name of the drug.
(2) The name and place of business of the manufacturer, packer, or distributor.
(3) A statement regarding the benefits and proper uses of estrogens.
(4) The contraindications to use, i.e., when estrogens should not be used.
(5) A description of the most serious risks associated with the use of estrogens.
(6) A brief summary of other side effects of estrogens.
(7) Instructions on how a patient may reduce the risks of estrogen use.
(8) The date, identified as such, of the most recent revision of the patient package insert.
(e) Exemptions. This section does not apply to estrogen-progestogen oral contraceptives. Labeling requirements for
these products are set forth in § 310.501.
(f) Requirement to supplement approved application. Holders of approved applications for estrogen drug products
that are subject to the requirements of this section must submit supplements under § 314.70(c) of this chapter to provide for the labeling required by paragraph (a) of this section. Such labeling may be put into use without advance
approval by the Food and Drug Administration.
Note that this is simply one more example of the special labeling required by FDA for specific drugs. This labeling is directed to patients, rather than to health care professionals.
D.
Imprinting on Solid Oral Dosage Forms
Avoidance of dispensing errors is a particularly important goal of pharmacy practice, and the identification of dosage units is
very helpful as a means to recognize and resolve errors. Pharmacist, pharmacy technicians and patients are able to visualize
dosage forms that bear unique identification marks, and recognize when an error has occurred. The FDA requires such identification as a means to avoid errors and to otherwise facilitate identification of drug products. The language of the FDA regulation describing the requirement for estrogens follows. Numerations refer to Sections of Title 21 of the Code of Federal
Regulations.
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§ 206.10 Code imprint required.
(a) Unless exempted under Sec. 206.7, no drug product in solid oral dosage form may be introduced or delivered
for introduction into interstate commerce unless it is clearly marked or imprinted with a code imprint that, in conjunction with the product's size, shape, and color, permits the unique identification of the drug product and the manufacturer or distributor of the product. Identification of the drug product requires identification of its active
ingredients and its dosage strength. Inclusion of a letter or number in the imprint, while not required, is encouraged
as a more effective means of identification than a symbol or logo by itself. Homeopathic drug products are required
only to bear an imprint that identifies the manufacturer and their homeopathic nature.
(b) A holder of an approved application who has supplemented its application to provide for a new imprint is not
required to bring its product into compliance with this section during the pendency of the agency's review. Once the
review is complete, the drug product is subject to the requirements of the rule.
(c) A solid oral dosage form drug product that does not meet the requirement for imprinting in paragraph (a) of
this section and is not exempt from the requirement may be considered adulterated and misbranded and may be an
unapproved new drug.
(d) For purposes of this section, code imprint means any single letter or number or any combination of letters and
numbers, including, e.g., words, company name, and National Drug Code, or a mark, symbol, logo, or monogram, or
a combination of letters, numbers, and marks or symbols, assigned by a drug firm to a specific drug product.
Although the basic requirement is for solid oral dosage forms to be identified through an imprint, exceptions are recognized
in the law, when it would be impractical or unnecessary to use an imprint, due to the unique characteristics of a particular
drug product.
E.
Side Effects Statement
In October, 2008, the FDA published a final rule implementing a provision of the Food and Drug Administration Amendments Act of 2007 (FDAAA) which requires medication labeling of prescription and non-prescription products to include a
toll-free number (1-800-FDA-1088) for the purpose of receiving reports of drug-related adverse events. For OTC drugs, the
requirements can be found in the Title 21 of the Code of Federal Regulations (CFR), section 201.66, and for drugs requiring
Medication Guides, the requirement can be found in section 208.20. However, pharmacies are also required to distribute a
side effects statement (the toll-free number and the reporting statement) with new and refill medications. In the outpatient
setting, pharmacies can distribute the statement by: attaching a sticker to the unit package, vial, or container of the drug product; using a preprinted pharmacy prescription vial cap; using a separate sheet of paper; including the required statement on
consumer medication information (CMI); or delivering a Medication Guide that contains the statement. The requirement for
pharmacies to distribute the side effects statement, provided below, is also found in Title 21 of the CFR.
Sec. 209.1 Scope and purpose.
(a) This part sets forth requirements for human prescription drug products approved under section 505 of the Federal Food, Drug, and Cosmetic Act and dispensed by authorized dispensers and pharmacies to consumers. This part
requires distribution of a side effects statement and applies to new and refill prescriptions. This part is not intended
to apply to authorized dispensers dispensing or administering prescription drug products to inpatients in a hospital
or health care facility under an order of a licensed practitioner, or as part of supervised home health care.
(b) The purpose of providing the side effects statement is to enable consumers to report side effects of prescription
drug products to FDA. Sec.
209.2 Definitions. For the purposes of this part, the following definitions apply: Act means the Federal Food, Drug,
and Cosmetic Act (sections 201- 907 (21 U.S.C. 301-397)). Authorized dispenser means an individual licensed, registered, or otherwise permitted by the jurisdiction in which the individual practices to provide drug products on prescription in the course of professional practice. Consumer medication information means written information
voluntarily provided to consumers by dispensing pharmacists as part of patient medication counseling activities.
Medication Guide means FDA-approved patient labeling conforming to the specifications set forth in part 208 of this
chapter and other applicable regulations. Pharmacy includes, but is not limited to, a retail, mail order, Internet, hospital, university, or clinic pharmacy, or a public health agency, regularly and lawfully engaged in dispensing pre-
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scription drugs. Side effects statement means the following verbatim statement: ``Call your doctor for medical advice
about side effects. You may report side effects to FDA at 1-800-FDA-1088.''
Sec. 209.10 Content and format of the side effects statement.
(a) Content. The side effects statement provided with each prescription drug product approved under section 505 of
the act must read: ``Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.''
(b) Format. The side effects statement must be in a single, clear, easy-to-read type style. The letter height or type size
used for the side effects statement in accordance with paragraphs (b)(1) and (b)(2) of Sec. 209.11 must be no smaller
than 6 points (1 point = 0.0138 inch). The letter height or type size for the side effects statement under paragraphs
(b)(3), (b)(4), and (b)(5) of Sec. 209.11 must be no smaller than 10 points.
Sec. 209.11 Dispensing and distributing the side effects statement.
(a) Each authorized dispenser or pharmacy must distribute the side effects statement with each prescription drug
product approved under section 505 of the act and dispensed. The side effects statement must be distributed with new
and refill prescriptions.
(b) An authorized dispenser or pharmacy must choose one or more of the following options to distribute the side effects statement:
(1) Distribute the side effects statement on a sticker attached to the unit package, vial, or container of the drug product;
(2) Distribute the side effects statement on a preprinted pharmacy prescription vial cap;
(3) Distribute the side effects statement on a separate sheet of paper;
(4) Distribute the side effects statement in consumer medication information; or
(5) Distribute the appropriate FDA-approved Medication Guide that contains the side effects statement.
VI.
Non-Prescription Drugs
Those drugs that are capable of being labeled for safe and effective use without medical supervision may be sold without a
prescription. In fact, non-prescription sale is becoming far more prevalent now than in the past, because beliefs about what is
safe without medical supervision have expanded in recent years. Many products that were at one time viewed to be safe only
if available with a prescription are now freely available for self-supervised use. A process known as the “OTC Review” resulted in many products being reformulated with more safe and effective ingredients, and it stimulated the switching of prescription-only products to OTC status.
A.
OTC Monographs
One way to bring to market a non-prescription drug is through an NDA, in the same way that a prescription drug would be
brought to the market. But a much less burdensome way, and the most common way, is through the OTC monographs. A
monograph covers a class of drugs (i.e., analgesics, sleep aids) and specifies the ingredients that may be included in a product
marketed OTC for such ailments. Not only does the monograph specify the ingredients, it specifies also the labeling that may
be used for such products. FDA has fully described the OTC monograph process. The language of the FDA regulation follows. Numerations refer to Sections of Title 21 of the Code of Federal Regulations.
§ 330.10 Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded,
and for establishing monographs.
For purposes of classifying over-the-counter (OTC) drugs as drugs generally recognized among qualified experts as
safe and effective for use and as not misbranded drugs, the following regulations shall apply:
(a) Procedure for establishing OTC drug monographs -- (1) Advisory review panels. The Commissioner shall appoint advisory review panels of qualified experts to evaluate the safety and effectiveness of OTC drugs, to review
OTC drug labeling, and to advise him on the promulgation of monographs establishing conditions under which OTC
drugs are generally recognized as safe and effective and not misbranded. A single advisory review panel shall be established for each designated category of OTC drugs and every OTC drug category will be considered by a panel.
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The members of a panel shall be qualified experts (appointed by the Commissioner) and may include persons from
lists submitted by organizations representing professional, consumer, and industry interests. The Commissioner shall
designate the chairman of each panel. Summary minutes of all meetings shall be made.
Note that the OTC monograph process is very specific in its deference to advisory review panels. The standards for review of
OTC ingredients are clearly defined in FDA regulations. Labeling requirements are spelled out also. Monograph development is done in a stepwise fashion, beginning with a proposed monograph, followed by a tentative monograph, and a then a
final monograph being issued only after abundant opportunity for public review and reaction.
B.
OTC Labeling
To promote consistency in labeling, and to prevent confusion by the public, the FDA has specified the content and format requirements for labeling of non-prescription drugs. The format uses standardized headings and subheadings and terms that are
more familiar to consumers. It will also require the information to appear in a standardized order, described below:
Drug Facts - title
Active ingredient(s) - including amount in each dosage unit
Purpose - pharmacologic class
Use(s) - indications
Warnings
Do not use - absolute contraindications, when the product should not be used under any circumstances
Ask a doctor before use if you have - warnings for persons with certain preexisting conditions and for persons experiencing
certain symptoms
Ask a doctor or pharmacist before use if you are - drug/drug and drug/food interactions
When using this product - side effects that could occur and substances or activities to avoid
Stop use and ask a doctor if - signs of toxicity and other serious reactions that would require consumers to stop using the
product immediately
Pregnancy/breast-feeding warning
Keep out of reach of children/Accidental overdose warnings
Direction - dosage and when, how, or how often to take
Other information
Inactive ingredients
Questions? (Optional) - followed by telephone number
The language of the FDA regulation follows. Numerations refer to Sections of Title 21 of the Code of Federal Regulations.
Sec. 201.66 Format and content requirements for over-the-counter (OTC) drug product labeling.
(a)Scope. This section sets forth the content and format requirements for the labeling of all OTC drug products...
(c)Content requirements. The outside container or wrapper of the retail package, or the immediate container label if
there is no outside container or wrapper, shall contain the title, headings, subheadings, and information set forth in
paragraphs (c)(1) through (c)(8) of this section, and may contain the information under the heading in paragraph
(c)(9) of this section, in the order listed.
(1) (Title) "Drug Facts". If the drug facts labeling appears on more than one panel, the title "Drug Facts
(continued)" shall appear at the top of each subsequent panel containing such information.
(2) "Active ingredient" or "Active ingredients" "(in each [insert the dosage unit stated in the directions for use (e.g.,
tablet, 5 mL teaspoonful) or in each gram as stated in 333.110 and 333.120 of this chapter])", followed by the established name of each active ingredient and the quantity of each active ingredient per dosage unit. Unless otherwise
provided in an applicable OTC drug monograph or approved drug application, products marketed without discrete
dosage units (e.g., topicals) shall state the proportion (rather than the quantity) of each active ingredient.
(3) "Purpose" or "Purposes", followed by the general pharmacological category(ies) or the principal intended
action(s) of the drug or, where the drug consists of more than one ingredient, the general pharmacological categories or the principal intended actions of each active ingredient. When an OTC drug monograph contains a statement
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of identity, the pharmacological action described in the statement of identity shall also be stated as the purpose of the
active ingredient.
(4) "Use" or "Uses", followed by the indication(s) for the specific drug product.
(5) "Warning" or "Warnings", followed by one or more of the following, if applicable:
(i) "For external use only" [in bold type] for topical drug products not intended for ingestion, or "For" (select one of
the following, as appropriate: "rectal" or "vaginal") "use only" [in bold type].
(ii) All applicable warnings listed in paragraphs (c)(5)(ii)(A) through (c)(5)(ii)(G) of this section with the appropriate subheadings highlighted in bold type:
(A) Reye's syndrome warning for drug products containing salicylates set forth in 201.314(h)(1). This warning shall
follow the subheading "Reye's syndrome:"
(B) Allergic reaction warnings set forth in any applicable OTC drug monograph or approved drug application for
any product that requires a separate allergy warning. This warning shall follow the subheading "Allergy alert:"
(C) Flammability warning, with appropriate flammability signal word(s) (e.g., 341.74(c)(5)(iii), 344.52(c),
358.150(c), and 358.550(c) of this chapter). This warning shall follow a subheading containing the appropriate flammability signal word(s) described in an applicable OTC drug monograph or approved drug application.
(D) Water soluble gums warning set forth in 201.319. This warning shall follow the subheading "Choking:"
(E) Alcohol warning set forth in 201.322. This warning shall follow the subheading "Alcohol warning:"
(F) Sore throat warning set forth in 201.315. This warning shall follow the subheading "Sore throat warning:"
(G) Warning for drug products containing sodium phosphates set forth in 201.307(b)(2)(i) or (b)(2)(ii). This warning
shall follow the subheading "Dosage warning:"
(H) Sexually transmitted diseases (STDs) warning for vaginal contraceptive and spermicide drug products containing nonoxynol 9 set forth in 201.325(b)(2). This warning shall follow the subheading "Sexually transmitted diseases
(STDs) alert:"
(iii) "Do not use" [in bold type], followed by all contraindications for use with the product. These contraindications
are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis
has been established by a doctor or for situations in which certain consumers should not use the product under any
circumstances regardless of whether a doctor or health professional is consulted.
(iv) "Ask a doctor before use if you have" [in bold type] or, for products labeled only for use in children under 12
years of age, "Ask a doctor before use if the child has" [in bold type], followed by all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The
warnings under this heading are those intended only for situations in which consumers should not use the product
until a doctor is consulted.
(v) "Ask a doctor or pharmacist before use if you are" [in bold type] or, for products labeled only for use in children
under 12 years of age, "Ask a doctor or pharmacist before use if the child is" [in bold type], followed by all drugdrug and drug-food interaction warnings.
(vi) "When using this product" [in bold type], followed by the side effects that the consumer may experience, and the
substances (e.g., alcohol) or activities (e.g., operating machinery, driving a car, warnings set forth in 369.21 of this
chapter for drugs in dispensers pressurized by gaseous propellants) to avoid while using the product.
(vii) "Stop use and ask a doctor if" [in bold type], followed by any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product. For all OTC drug products under an approved drug application whose packaging does not include a toll-free number through which consumers can report complaints to the
manufacturer or distributor of the drug product, the following text shall immediately follow the subheading: "[Bullet]
side effects occur. You may report side effects to FDA at 1-800-FDA-1088." The telephone number must appear in a
minimum 6-point bold letter height or type size.
(viii) Any required warnings in an applicable OTC drug monograph, other OTC drug regulations, or approved drug
application that do not fit within one of the categories listed in paragraphs (c)(5)(i) through (c)(5)(vii), (c)(5)(ix),
and (c)(5)(x) of this section.
(ix) The pregnancy/breast-feeding warning set forth in 201.63(a); the third trimester warning set forth in 201.63(e)
for products containing aspirin or carbaspirin calcium; the third trimester warning set forth in approved drug applications for products containing ketoprofen, naproxen sodium, and ibuprofen (not intended exclusively for use in children).
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(x) The "Keep out of reach of children" warning and the accidental overdose/ingestion warning set forth in 330.1(g)
of this chapter.
(6) "Directions", followed by the directions for use described in an applicable OTC drug monograph or approved
drug application.
(7) "Other information", followed by additional information that is not included under paragraphs (c)(2) through
(c)(6), (c)(8), and (c)(9) of this section, but which is required by or is made optional under an applicable OTC drug
monograph, other OTC drug regulation, or is included in the labeling of an approved drug application.
(i) Required information about certain ingredients in OTC drug products (e.g., sodium in 201.64(b), calcium in
201.70(b), magnesium in 201.71(b), and potassium in 201.72(b)) shall appear as follows: "each (insert appropriate
dosage unit) contains:" [in bold type (insert name(s) of ingredient(s) (in alphabetical order) and the quantity of each
ingredient). This information shall be the first statement under this heading.
(ii) The phenylalanine/aspartame content required by 201.21(b), if applicable, shall appear as the next item of information.
(iii) Additional information that is authorized to appear under this heading shall appear as the next item(s) of information. There is no required order for this subsequent information.
(8) "Inactive ingredients", followed by a listing of the established name of each inactive ingredient. If the product is
an OTC drug product that is not also a cosmetic product, then the inactive ingredients shall be listed in alphabetical
order. If the product is an OTC drug product that is also a cosmetic product, then the inactive ingredients shall be
listed as set forth in 701.3(a) or (f) of this chapter, the names of cosmetic ingredients shall be determined in accordance with 701.3(c) of this chapter, and the provisions in 701.3(e), (g), (h), (l), (m), (n), and (o) of this chapter and
720.8 of this chapter may also apply, as appropriate. If there is a difference in the labeling provisions in this 201.66
and 701.3 and 720.8 of this chapter, the labeling provisions in this 201.66 shall be used.
(9) "Questions?" or "Questions or comments?", followed by the telephone number of a source to answer questions
about the product. It is recommended that the days of the week and times of the day when a person is available to respond to questions also be included. A graphic of a telephone or telephone receiver may appear before the heading.
The telephone number must appear in a minimum 6-point bold type.
(d)Format requirements. The title, headings, subheadings, and information set forth in paragraphs (c)(1) through
(c)(9) of this section shall be presented on OTC drug products in accordance with the following specifications. In the
interest of uniformity of presentation, FDA strongly reccommends that the Drug Facts labeling be presented using
the graphic specifications set forth in appendix A to part 201.
(1) The title "Drug Facts" or "Drug Facts (continued)" shall use uppercase letters for the first letter of the words
"Drug" and "Facts." All headings and subheadings in paragraphs (c)(2) through (c)(9) of this section shall use an
uppercase letter for the first letter in the first word and lowercase letters for all other words. The title, headings, and
subheadings in paragraphs (c)(1), (c)(2), and (c)(4) through (c)(9) of this section shall be left justified.
(2) The letter height or type size for the title "Drug Facts" shall appear in a type size larger than the largest type size
used in the Drug Facts labeling. The letter height or type size for the title "Drug Facts (continued)" shall be no
smaller than 8-point type. The letter height or type size for the headings in paragraphs (c)(2) through (c)(9) of this
section shall be the larger of either 8-point or greater type, or 2-point sizes greater than the point size of the text. The
letter height or type size for the subheadings and all other information described in paragraphs (c)(2) through (c)(9)
of this section shall be no smaller than 6-point type.
(3) The title, heading, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section shall be legible and clearly presented, shall have at least 0.5-point leading (i.e., space between two lines of text), and shall not
have letters that touch. The type style for the title, headings, subheadings, and all other required information described in paragraphs (c)(2) through (c)(9) of this section shall be any single, clear, easy-to-read type style, with no
more than 39 characters per inch. The title and headings shall be in bold italic, and the subheadings shall be in bold
type, except that the word "(continued)" in the title "Drug Facts (continued)" shall be regular type. The type shall be
all black or one color printed on a white or other contrasting background, except that the title and the headings may
be presented in a single, alternative, contrasting color unless otherwise provided in an approved drug application,
OTC drug monograph (e.g., current requirements for bold print in 341.76 and 341.80 of this chapter), or other OTC
drug regulation (e.g., the requirement for a box and red letters in 201.308(c)(1)).
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(4) When there is more than one statement, each individual statement listed under the headings and subheadings in
paragraphs (c)(4) through (c)(7) of this section shall be preceded by a solid square or solid circle bullet of 5-point
type size. Bullets shall be presented in the same shape and color throughout the labeling. The first bulleted statement
on each horizontal line of text shall be either left justified or separated from an appropriate heading or subheading
by at least two square "ems" (i.e., two squares of the size of the letter "M"). If more than one bulleted statement is
placed on the same horizontal line, the end of one bulleted statement shall be separated from the beginning of the
next bulleted statement by at least two square "ems" and the complete additional bulleted statement(s) shall not continue to the next line of text. Additional bulleted statements appearing on each subsequent horizontal line of text under a heading or subheading shall be vertically aligned with the bulleted statements appearing on the previous line.
(5) The title, headings, subheadings, and information set forth in paragraphs (c)(1) through (c)(9) of this section may
appear on more than one panel on the outside container of the retail package, or the immediate container label if
there is no outside container or wrapper. The continuation of the required content and format onto multiple panels
must retain the required order and flow of headings, subheadings, and information. A visual graphic (e.g., an arrow)
shall be used to signal the continuation of the Drug Facts labeling to the next adjacent panel.
(6) The heading and information required under paragraph (c)(2) of this section shall appear immediately adjacent
and to the left of the heading and information required under paragraph (c)(3) of this section. The active ingredients
and purposes shall be aligned under the appropriate headings such that the heading and information required under
paragraph (c)(2) of this section shall be left justified and the heading and information required under paragraph
(c)(3) of this section shall be right justified. If the OTC drug product contains more than one active ingredient, the
active ingredients shall be listed in alphabetical order. If more than one active ingredient has the same purpose, the
purpose need not be repeated for each active ingredient, provided the information is presented in a manner that
readily associates each active ingredient with its purpose (i.e., through the use of brackets, dot leaders, or other
graphical features). The information described in paragraphs (c)(4) and (c)(6) through (c)(9) of this section may
start on the same line as the required headings. None of the information described in paragraph (c)(5) of this section
shall appear on the same line as the "Warning" or "Warnings" heading.
(7) Graphical images (e.g., the UPC symbol) and information not described in paragraphs (c)(1) through (c)(9) of
this section shall not appear in or in any way interrupt the required title, headings, subheadings, and information in
paragraphs (c)(1) through (c)(9) of this section. Hyphens shall not be used except to punctuate compound words.
(8) The information described in paragraphs (c)(1) through (c)(9) of this section shall be set off in a box or similar
enclosure by the use of a barline. A distinctive horizontal barline extending to each end of the "Drug Facts" box or
similar enclosure shall provide separation between each of the headings listed in paragraphs (c)(2) through (c)(9) of
this section. When a heading listed in paragraphs (c)(2) through (c)(9) of this section appears on a subsequent panel
immediately after the "Drug Facts (continued)" title, a horizontal hairline shall follow the title and immediately precede the heading. A horizontal hairline extending within two spaces on either side of the "Drug Facts" box or similar
enclosure shall immediately follow the title and shall immediately precede each of the subheadings set forth in paragraph (c)(5) of this section, except the subheadings in paragraphs (c)(5)(ii)(A) through (c)(5)(ii)(G) of this section.
(9) The information set forth in paragraph (c)(6) of this section under the heading "Directions" shall appear in a table format when dosage directions are provided for three or more age groups or populations. The last line of the table may be the horizontal barline immediately preceding the heading of the next section of the labeling.
(10) If the title, headings, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section, printed in
accordance with the specifications in paragraphs (d)(1) through (d)(9) of this section, and any other FDA required
information for drug products, and, as appropriate, cosmetic products, other than information required to appear on
a principle display panel, requires more than 60 percent of the total surface area available to bear labeling, then the
Drug Facts labeling shall be printed in accordance with the specifications set forth in paragraphs (d)(10)(i) through
(d)(10)(v) of this section. In determining whether more than 60 percent of the total surface area available to bear labeling is required, the indications for use listed under the "Use(s)" heading, as set forth in paragraph (c)(4) of this
section, shall be limited to the minimum required uses reflected in the applicable monograph, as provided in
330.1(c)(2) of this chapter.
(i) Paragraphs (d)(1), (d)(5), (d)(6), and (d)(7) of this section shall apply.
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(ii) Paragraph (d)(2) of this section shall apply except that the letter height or type size for the title "Drug Facts
(continued)" shall be no smaller than 7-point type and the headings in paragraphs (c)(2) through (c)(9) of this section shall be the larger of either 7-point or greater type, or 1-point size greater than the point size of the text.
(iii) Paragraph (d)(3) of this section shall apply except that less than 0.5-point leading may be used, provided the
ascenders and descenders do not touch.
(iv) Paragraph (d)(4) of this section shall apply except that if more than one bulleted statement is placed on the same
horizontal line, the additional bulleted statements may continue to the next line of text, and except that the bullets under each heading or subheading need not be vertically aligned.
(v) Paragraph (d)(8) of this section shall apply except that the box or similar enclosure required in paragraph (d)(8)
of this section may be omitted if the Drug Facts labeling is set off from the rest of the labeling by use of color contrast.
VII.
Drug Diversion
In the 1980s it became evident that the medications being dispensed by pharmacists were not always medications that had
been distributed through the normal channels of distribution. Some pharmaceutical products had been exported to foreign
countries and then imported back into the United States. Others had been purchased at huge volume discounts by hospitals or
nonprofit agencies, and then sold to for-profit businesses. Sample drugs had been diverted back into the for-sale distribution
chain. There were even more creative, and potentially harmful schemes to provide pharmacists with pharmaceuticals that had
not necessarily benefitted from the integrity of the traditional distribution system. The problem, of course, is that when pharmaceuticals are diverted from the system, and then brought back into the system, there is no assurance that they have been
stored correctly or handled appropriately while outside the system. The Prescription Drug Marketing Act of 1987 sought to
close the loopholes in drug distribution and assure the integrity of pharmaceutical products by preventing the diversion of
drugs from the normal stream of distribution. The language of the act follows. Numerations refer to subsections of Section
353, Title 21, of the United States Code.
(c) Sales restrictions.
(1) No person may sell, purchase, or trade or offer to sell, purchase, or trade any drug sample. For purposes of this
paragraph and subsection (d), the term "drug sample" means a unit of a drug, subject to subsection (b), which is not
intended to be sold and is intended to promote the sale of the drug. Nothing in this paragraph shall subject an officer
or executive of a drug manufacturer or distributor to criminal liability solely because of a sale, purchase, trade, or
offer to sell, purchase, or trade in violation of this paragraph by other employees of the manufacturer or distributor.
(2) No person may sell, purchase, or trade, offer to sell, purchase, or trade, or counterfeit any coupon. For purposes of this paragraph, the term "coupon" means a form which may be redeemed, at no cost or at a reduced cost, for a
drug which is prescribed in accordance with subsection (b).
(3) (A) No person may sell, purchase, or trade, or offer to sell, purchase, or trade, any drug-(i) which is subject to subsection (b), and
(ii) (I) which was purchased by a public or private hospital or other health care entity, or
(II) which was donated or supplied at a reduced price to a charitable organization described in section
501(c)(3) of the Internal Revenue Code of 1954 [26 USCS § 501(c)(3)].
(B) Subparagraph (A) does not apply to-(i) the purchase or other acquisition by a hospital or other health care entity which is a member of a group purchasing organization of a drug for its own use from the group purchasing organization or from other hospitals or
health care entities which are members of such organization,
(ii) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by an organization described in subparagraph (A)(ii)(II) to a nonprofit affiliate of the organization to the extent otherwise permitted by
law,
(iii) a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other
health care entities which are under common control,
(iv) a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical
reasons, or
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(v) a sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug
pursuant to a prescription executed in accordance with subsection (b).
For purposes of this paragraph, the term "entity" does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law and the term "emergency medical reasons" includes transfers of a drug between
health care entities or from a health care entity to a retail pharmacy undertaken to alleviate temporary shortages of
the drug arising from delays in or interruptions of regular distribution schedules.
Note the clear prohibition against the sale or other transfer of sample drugs for any purpose other than sampling. This prohibition keeps sample drugs from being diverted into the for-sale distribution chain. In addition, other drugs that have been
purchased by nonprofit entities may also not be diverted into the for-sale distribution chain.
(d) Distribution of drug samples.
(1) Except as provided in paragraphs (2) and (3), no person may distribute any drug sample. For purposes of this
subsection, the term "distribute" does not include the providing of a drug sample to a patient by a-(A) practitioner licensed to prescribe such drug,
(B) health care professional acting at the direction and under the supervision of such a practitioner, or
(C) pharmacy of a hospital or of another health care entity that is acting at the direction of such a practitioner
and that received such sample pursuant to paragraph (2) or (3).
(2) (A) The manufacturer or authorized distributor of record of a drug subject to subsection (b) may, in accordance
with this paragraph, distribute drug samples by mail or common carrier to practitioners licensed to prescribe such
drugs or, at the request of a licensed practitioner, to pharmacies of hospitals or other health care entities. Such a distribution of drug samples may only be made-(i) in response to a written request for drug samples made on a form which meets the requirements of subparagraph (B), and
(ii) under a system which requires the recipient of the drug sample to execute a written receipt for the drug
sample upon its delivery and the return of the receipt to the manufacturer or authorized distributor of record.
(B) A written request for a drug sample required by subparagraph (A)(i) shall contain-(i) the name, address, professional designation, and signature of the practitioner making the request,
(ii) the identity of the drug sample requested and the quantity requested,
(iii) the name of the manufacturer of the drug sample requested, and
(iv) the date of the request.
(C) Each drug manufacturer or authorized distributor of record which makes distributions by mail or common
carrier under this paragraph shall maintain, for a period of 3 years, the request forms submitted for such distributions and the receipts submitted for such distributions and shall maintain a record of distributions of drug samples
which identifies the drugs distributed and the recipients of the distributions. Forms, receipts, and records required to
be maintained under this subparagraph shall be made available by the drug manufacturer or authorized distributor
of record to Federal and State officials engaged in the regulation of drugs and in the enforcement of laws applicable
to drugs.
(3) The manufacturer or authorized distributor of record of a drug subject to subsection (b) may, by means other
than mail or common carrier, distribute drug samples only if the manufacturer or authorized distributor of record
makes the distributions in accordance with subparagraph (A) and carries out the activities described in subparagraphs (B) through (F) as follows:
(A) Drug samples may only be distributed-(i) to practitioners licensed to prescribe such drugs if they make a written request for the drug samples, or
(ii) at the written request of such a licensed practitioner, to pharmacies of hospitals or other health care entities.
A written request for drug samples shall be made on a form which contains the practitioner's name, address, and
professional designation, the identity of the drug sample requested, the quantity of drug samples requested, the name
of the manufacturer or authorized distributor of record of the drug sample, the date of the request and signature of
the practitioner making the request.
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(B) Drug manufacturers or authorized distributors of record shall store drug samples under conditions that will
maintain their stability, integrity, and effectiveness and will assure that the drug samples will be free of contamination, deterioration, and adulteration.
(C) Drug manufacturers or authorized distributors of record shall conduct, at least annually, a complete and accurate inventory of all drug samples in the possession of representatives of the manufacturer or authorized distributor of record. Drug manufacturers or authorized distributors of record shall maintain lists of the names and address
of each of their representatives who distribute drug samples and of the sites where drug samples are stored. Drug
manufacturers or authorized distributors of record shall maintain records for at least 3 years of all drug samples distributed, destroyed, or returned to the manufacturer or authorized distributor of record, of all inventories maintained
under this subparagraph, of all thefts or significant losses of drug samples, and of all requests made under subparagraph (A) for drug samples. Records and lists maintained under this subparagraph shall be made available by the
drug manufacturer or authorized distributor of record to the Secretary upon request.
(D) Drug manufacturers or authorized distributors of record shall notify the Secretary of any significant loss of
drug samples and any known theft of drug samples.
(E) Drug manufacturers or authorized distributors of record shall report to the Secretary any conviction of their
representatives for violations of section 503(c)(1) [subsec. (c)(1) of this section] or a State law because of the sale,
purchase, or trade of a drug sample or the offer to sell, purchase, or trade a drug sample.
(F) Drug manufacturers or authorized distributors of record shall provide to the Secretary the name and telephone number of the individual responsible for responding to a request for information respecting drug samples.
Note that the net effect of this rule is to make it illegal for community pharmacies to possess pharmaceutical samples. The
result is that to even have samples in a community pharmacy is a violation of the law; regardless of what has been done or is
intended to be done with the samples.
VIII. Compounding
Pharmacists have for centuries, in fact for millenia, extemporaneously compounded products to meet the specific needs of
individual patients. Because patients differ in their needs for medications, it is important not to limit patients to only those
strengths, dosage forms and combinations that are available from manufacturers. Manufacturers cannot know individual patients’ needs, because the need by an individual does not occur until long after a manufacturer has prepared a product and
placed it on the market. Pharmacists can know individual needs and respond to them in a timely fashion. Despite the obvious value of contemporaneous compounding by pharmacists, questions have arisen about large-scale compounding that begins to resemble manufacturing. Since compounding does not require FDA approval of an NDA, and since it need not
necessarily meet many of the other requirements of the FDCA, some large scale distributors have attempted to use compounder status to avoid the restrictiveness of laws that would apply to manufacturers. The FDA Modernization Act of 1997
clarifies the difference between compounding and manufacturing. The Act carved out a “safe harbor” for pharmacists who
adhere to the traditional compounding role, making it clear that such activity is outside the realm of regulation as manufacturing. However, the pharmacy compounding provisions of the Act were ruled unconstitutional by the Supreme Court of the
United States. Until a new law is passed by United States Congress, the following FDA compliance policy is in effect.
Generally, FDA will continue to defer to state authorities regarding less significant
violations of the Act related to pharmacy compounding of human drugs. FDA
anticipates that, in such cases, cooperative efforts between the states and the
Agency will result in coordinated investigations, referrals, and follow-up actions by
the states.
However, when the scope and nature of a pharmacy's activities raise the kinds of
concerns normally associated with a drug manufacturer and result in significant
violations of the new drug, adulteration, or misbranding provisions of the Act,
FDA has determined that it should seriously consider enforcement action. In
determining whether to initiate such an action, the Agency will consider whether
the pharmacy engages in any of the following acts:
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1. Compounding of drugs in anticipation of receiving prescriptions, except in very
limited quantities in relation to the amounts of drugs compounded after receiving
valid prescriptions.
2. Compounding drugs that were withdrawn or removed from the market for
safety reasons.
3. Compounding finished drugs from bulk active ingredients that are not
components of FDA approved drugs without an FDA sanctioned investigational
new drug application (IND) in accordance with 21 U.S.C. § 355(i) and 21 CFR
312.
4. Receiving, storing, or using drug substances without first obtaining written
assurance from the supplier that each lot of the drug substance has been made in
an FDA-registered facility.
5. Receiving, storing, or using drug components not guaranteed or otherwise
determined to meet official compendia requirements.
6. Using commercial scale manufacturing or testing equipment for compounding
drug products.
7. Compounding drugs for third parties who resell to individual patients or offering
compounded drug products at wholesale to other state licensed persons or
commercial entities for resale.
8. Compounding drug products that are commercially available in the marketplace
or that are essentially copies of commercially available FDA-approved drug
products. In certain circumstances, it may be appropriate for a pharmacist to
compound a small quantity of a drug that is only slightly different than an
FDA-approved drug that is commercially available. In these circumstances, FDA
will consider whether there is documentation of the medical need for the particular
variation of the compound for the particular patient.
9. Failing to operate in conformance with applicable state law regulating the
practice of pharmacy.
The foregoing list of factors is not intended to be exhaustive. Other factors may be
appropriate for consideration in a particular case.
IX.
Product Tampering
Widely publicized reports of deaths in 1982 due to tampering with Tylenol and other pharmaceutical products resulted in federal legislation designed to assure that pharmaceutical products purchased by consumers are either tamper-resistant or tamper-evident (but not tamper-proof). The FDA has promulgated regulations to implement this legislation. The language of the
FDA regulation follows. Numerations refer to Sections of Title 21 of the Code of Federal Regulations.
§ 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
(a) General. The Food and Drug Administration has the authority under the Federal Food, Drug, and Cosmetic
Act (the act) to establish a uniform national requirement for tamper-evident packaging of OTC drug products that
will improve the security of OTC drug packaging and help assure the safety and effectiveness of OTC drug products.
An OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale that is not
packaged in a tamper-evident package or that is not properly labeled under this section is adulterated under section
501 of the act or misbranded under section 502 of the act, or both.
(b) Requirements for tamper-evident package. (1) Each manufacturer and packer who packages an OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale shall package the product in a
tamper-evident package, if this product is accessible to the public while held for sale. A tamper-evident package is
one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to
provide visible evidence to consumers that tampering has occurred. To reduce the likelihood of successful tampering
and to increase the likelihood that consumers will discover if a product has been tampered with, the package is re-
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quired to be distinctive by design or by the use of one or more indicators or barriers to entry that employ an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture). For purposes of this section, the
term "distinctive by design" means the packaging cannot be duplicated with commonly available materials or
through commonly available processes. A tamper-evident package may involve an immediate-container and closure
system or secondary-container or carton system or any combination of systems intended to provide a visual indication of package integrity. The tamper-evident feature shall be designed to and shall remain intact when handled in a
reasonable manner during manufacture, distribution, and retail display.
(2) In addition to the tamper-evident packaging feature described in paragraph (b)(1) of this section, any two-piece,
hard gelatin capsule covered by this section must be sealed using an acceptable tamper-evident technology.
(c) Labeling. (1) In order to alert consumers to the specific tamper-evident feature(s) used, each retail package of an
OTC drug product covered by this section (except ammonia inhalant in crushable glass ampules, containers of compressed medical oxygen, or aerosol products that depend upon the power of a liquefied or compressed gas to expel
the contents from the container) is required to bear a statement that:
(i) Identifies all tamper-evident feature(s) and any capsule sealing technologies used to comply with paragraph (b) of
this section;
(ii) Is prominently placed on the package; and
(iii) Is so placed that it will be unaffected if the tamper-evident feature of the package is breached or missing.
(2) If the tamper-evident feature chosen to meet the requirements in paragraph (b) of this section uses an identifying
characteristic, that characteristic is required to be referred to in the labeling statement. For example, the labeling
statement on a bottle with a shrink band could say "For your protection, this bottle has an imprinted seal around the
neck."
Note that although the law recognizes exemptions from the tamper-evident requirement, when the requirement is not necessary to protect the public, these general rules must otherwise be followed.
X.
Poison Prevention Packaging
A law that is closely related to the FDCA is the Poison Prevention Packaging Act of 1970 (PPPA). Designed to protect children from accidental poisoning with a variety of toxic substances, the PPPA is currently enforced by the Consumer
Products Safety Commission (CPSC). Of the many significant provisions of the law, the one most relevant to pharmacy is
the requirement that child-resistant closures be used when dispensing medications pursuant to a prescription. From this general rule there are numerous exceptions. A physician may request that a prescribed medication not be dispensed in child-resistant closures, and this request will be honored as long as it is made for each prescription to which it applies (i.e., no
“blanket requests”). Patients may request that all dispensed drugs not be placed in child-resistant containers. Although this
request need not be made in writing under the law, it is a prudent move for pharmacists to request that there be a written document recording such a request. There are some drugs that need not ever be dispensed in child-resistant closures. The list of
these drugs makes little sense. It is set out in CPSC regulations. The language of the CPSC regulation follows. Numerations
refer to Sections of Title 16 of the Code of Federal Regulations.
(10) Prescription drugs. Any drug for human use that is in a dosage form intended for oral administration and that is
required by Federal law to be dispensed only by or upon an oral or written prescription of a practitioner licensed by
law to administer such drug shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c), except for the
following:
(i) Sublingual dosage forms of nitroglycerin.
(ii) Sublingual and chewable forms of isosorbide dinitrate in dosage strengths of 10 milligrams or less.
(iii) Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in packages containing not more
than 8 grams of the equivalent of erythromycin.
(iv) Cyclically administered oral contraceptives in manufacturers' mnemonic (memory-aid) dispenser packages that
rely solely upon the activity of one or more progestogen or estrogen substances.
(v) Anhydrous cholestyramine in powder form.
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(vi) All unit dose forms of potassium supplements, including individually-wrapped effervescent tablets, unit dose vials
of liquid potassium, and powdered potassium in unit-dose packets, containing not more than 50 milliequivalents of
potassium per unit dose.
(vii) Sodium fluoride drug preparations including liquid and tablet forms, containing not more than 110 milligrams
of sodium fluoride (the equivalent of 50 mg of elemental fluoride) per package or not more than a concentration of
0.5 percent elemental fluoride on a weight-to-volume basis for liquids or a weight-to-weight basis for non-liquids
and containing no other substances subject to this § 1700.14(a)(10).
(viii) Betamethasone tablets packaged in manufacturers' dispenser packages, containing no more than 12.6 milligrams betamethasone.
(ix) Pancrelipase preparations in tablet, capsule, or powder form and containing no other substances subject to this
§ 1700.14(a)(10).
(x) Prednisone in tablet form, when dispensed in packages containing no more than 105 mg. of the drug, and containing no other substances subject to this § 1700.14(a)(10).
(xiii) Mebendazole in tablet form in packages containing not more than 600 mg. of the drug, and containing no other
substance subject to the provisions of this section.
(xiv) Methylprednisolone in tablet form in packages containing not more than 84 mg of the drug and containing no
other substance subject to the provisions of this section.
(xv) Colestipol in powder form in packages containing not more than 5 grams of the drug and containing no other
substance subject to the provisions of this section.
(xvi) Erythromycin ethylsuccinate tablets in packages containing no more than the equivalent of 16 grams erythromycin.
(xvii) Conjugated Estrogens Tablets, U.S.P., when dispensed in mnemonic packages containing not more than 32.0
mg of the drug and containing no other substances subject to this § 1700.14(a)(10).
(xviii) Norethindrone Acetate Tablets, U.S.P., when dispensed in mnemonic packages containing not more than 50
mg of the drug and containing no other substances subject to this § 1700.14(a)(10).
(xix) Medroxyprogesterone acetate tablets.
(xx) Sacrosidase (sucrase) preparations in a solution of glycerol and water.
Note the lack of similarity between the drugs chosen for inclusion in this list. Since there is no rhyme or reason for the drugs
included, the best way to know the list is to simply memorize it.
Poison Prevention Packaging: A Guide For Healthcare Professionals (revised 2005)
The CPSC provides guidance designed to educate pharmacists, physicians, and other healthcare professionals about
their responsibilities under the PPPA. Available at http://www.cpsc.gov/cpscpub/pubs/384.pdf, the following is the language
found in the most current guide:
PART I
The History of Poison Prevention Background
"A child learns by doing. He gains experience by investigating the world around him. For his experiences to be constructive,
they must be conducted in an environment where hazards are kept to a minimum."1
Before the Poison Prevention Packaging Act (PPPA) was enacted in 1970, poisonings by common household substances, including medicines, had long been considered by pediatricians to be the leading cause of injuries among children under 5 years
of age. At one point, state death certificates reported about 500 fatalities a year in children under 5 due to poisoning caused
by unintentional ingestion of drugs and household products. As a result of the many injuries, individual poison control centers were established to provide specialized diagnoses and treatment for poisonings within their communities. The first poison
control center started in Chicago in 1953.
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As these centers proliferated, the need for a coordinating body became apparent so that duplicative work could be avoided. In
1957, the National Clearinghouse for Poison Control Centers was established with the mandate to collect data from the centers and provide them with diagnostic and therapeutic information on the myriad of household products involved in childhood
poisonings.2 The Clearinghouse became the largest repository of poisoning case reports in the world. These reports became
the primary source of data to evaluate the incidence of childhood poisoning. The Clearinghouse data collection ended in
1984. Poisoning cases reported to poison control centers are currently documented in the Toxic Exposure Surveillance System (TESS) maintained by the American Association of Poison Control Centers. The National Electronic Injury Surveillance
System (NEISS) run by the U.S. Consumer Product Safety Commission (CPSC) is a source of national estimates of poisoning cases treated in hospital emergency rooms and it provides a follow-up mechanism when additional details about a particular drug or type of incident are needed.
A review of reports from poison control centers revealed a direct relationship between the stage of a child's development and
the type of substance being ingested.3 For example, youngsters still in the crawling stage were much more apt to get into
those products stored on the floor of the bathroom or the cabinet below the kitchen sink (soaps and detergents, drain, and
bowl cleaners). Toddlers were able to reach products left on low lying tables (uncapped bottles of furniture polish, for example). By the time youngsters were able to climb, they were reaching into the medicine cabinet.
Early Preventive Programs
The earliest attempts at controlling the problem of poisonings of young children surfaced after World War II, when there was
a proliferation of household chemicals. Working with the American Medical Association (AMA) and industry, the Food and
Drug Administration (FDA) drafted what in 1960 became the Hazardous Substances Labeling Act. This law stated that certain products, identified as “hazardous substances” within the meaning of the law, had to carry on their labels specific cautionary statements. Later, amendments to the law provided the authority to ban substances found too hazardous to be used
safely around the household - notwithstanding cautionary labeling.4
Another activity geared to the prevention and control of childhood poisonings was the passage of Public Law 87-319 which
requested the President to designate the third week in March each year as National Poison Prevention Week (NPPW), “… to
aid in encouraging the American people to learn of the dangers of unintentional poisoning and to take such preventive measures as are warranted by the seriousness of the danger.”5 It was a pharmacist who was the driving force behind the Resolution. In 1950, Homer George, of Cape Girardeau, Missouri, convinced his mayor to proclaim a Poison Prevention Week in
his community. Mr. George then followed this up with the Governor of Missouri and subsequently prevailed on his congressman to introduce national legislation for a nationwide observance of poison prevention week.6
The introduction of a poison prevention week on a nationwide scale provided community organizations an opportunity to initiate poison prevention programs or highlight ongoing ones. While NPPW was beneficial in developing and fostering community interest, child poisonings and deaths continued.
In 1966, to address his concern about the number of aspirin ingestions, Dr. James Goddard, Commissioner of the FDA, convened a conference of aspirin producers, representatives of poison control centers, and public health officials.7 One of the
results of the conference was a voluntary agreement on the part of the manufacturers to restrict the number of children’s aspirin tablets in a single container to 36, 1¼-grain tablets, generally accepted as a not highly toxic dose. Although this limitation
would do little to affect the frequency of ingestions, it was hoped it would have an effect on severity should a child gain access to the aspirin.
Creating A Barrier
Another decision of the conferees laid the groundwork for a far-reaching change in U.S. consumers’ experiences with the
packaging of household products. The Chairman of the FDA Industry Committee, Dr. Edward Press, appointed a subcommittee to look into the state of the art with respect to child-resistant packaging in 1966. One major manufacturer of children’s
aspirin was already using safety packaging for its product on a voluntary basis. The firm offered to make available whatever
data it had that might be useful to the Subcommittee.8 As part of this new approach to the prevention of poisonings, two independent studies were undertaken.
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One of these took place in the State of Washington in the Fort Lewis-McChord Air Force Base area.9,10 Prescription drugs
were dispensed to the military population serviced by this area in packaging that utilized two dissimilar motions for opening
(pushing and turning). The study included a preliminary test program (May 1967 – December 1970) which demonstrated that
the new package design was much more effective in preventing access by young children than the standard screw caps and
snap caps that were used on prescription vials. The effectiveness of this approach in controlling unintentional ingestions was
shown by a decrease in ingestions. There were 27 incidents reported instead of the 210 ingestions that would have been anticipated during this time period.11
The other study took place in Essex County in Ontario, Canada, where there had been a vigorous educational campaign in
effect for 10 years trying to reduce childhood unintentional ingestions. The campaign met with little success. A program to
use child-resistant packaging for all prescription tablets and capsules was initiated by area pediatricians and pharmacists. The
reduction in ingestions was as dramatic as that in the U.S.12
Backed by this and related information showing that childhood ingestions could be reduced through the use of child-resistant
packaging, Congress enacted legislation. In 1970, the Congress passed, and the President signed, Public Law 91-601, the Poison Prevention Packaging Act (PPPA).13 The legislation formed the basis for a new attack on the problem of unintentional
poisoning among young children. It was now possible to control the agents responsible for these toxic episodes by creating a
barrier between the harmful chemical and the child.
The FDA was responsible for enforcing the PPPA until 1973 when jurisdiction was transferred to the newly formed CPSC.14
The PPPA gives the CPSC the authority to require “special packaging” of household products and drugs to protect children
from serious injury or illness.
The PPPA defines special packaging as, “…packaging that is designed or constructed to be significantly difficult for children
under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time
and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time."15 Human performance tests were developed to measure child-resistance and adult-use effectiveness. Children aged 42 to 51 months were chosen as the test subjects. The test method was
developed to try to mimic the situation found at home. The test involved giving packages to pairs of children. The children
were given 5 minutes to try to open the package. If they did not open their package within that time period, the children were
given a single visual demonstration and then given another 5 minutes to attempt to open the package. The package was considered to be child-resistant if not more than 20 percent of 200 children tested could open the package.
The packages also had to be opened and properly closed by adults. Adults aged 18 to 45 years were chosen as the test subjects. The adults had a 5-minute time period to open and properly close the package. If 90 percent of 100 adults tested could
open and close the childresistant package, it passed.
Improving the Packaging
The test methods and standards described above were adopted in the early 1970s. The CPSC enforced these standards to
make sure that special packaging on the market complied. Packaged products that did not meet the standards were recalled.
The CPSC staff continued to monitor ingestions. In 1986, the CPSC conducted an ingestion study with the AAPCC.16 The
results indicated that children were being poisoned by drugs that belonged to their grandparents. Many of these incidents occurred because special packaging was not being used properly; the closures were loose or left off. In other cases, the drugs
were not in special packaging at all.
The CPSC tested the packaging with adults over a wide range of ages up to 75 years. Many adults, especially seniors, could
not open special packaging. Children were being poisoned because adults could not use the packaging properly. The CPSC
worked with the industry to revise the adult test methods to increase the age of adults tested. In 1995, the CPSC issued new
requirements that amended the test procedures.17 Adults aged 50 to 70 years old are now tested to measure adult-use effectiveness for most packages. These changes became effective in January 1998.
Special packaging is improving. Packages are easier for adults to use properly while still maintaining child-resistance.
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Success
Special packaging saves lives. CPSC analyzed child fatality data for unintentional ingestions of oral prescription medicines
during the 1964 through 1992 timeframe. The results of the analysis showed that the death rates for oral prescription medicines declined even after taking into account the changes in the consumption of the medications over time and the long-term
decline in the overall unintentional death rate of children from all causes.18
The CPSC study showed that special packaging reduced the oral prescription medicine-related death rate by up to 1.4 deaths
per million children under age 5. This represents a reduction in the rate of fatalities of up to 45 percent from levels that would
have been projected in the absence of special packaging requirements, and equates to about 24 fewer child deaths annually.19
A similar study of the effectiveness of special packaging of aspirin estimated that special packaging reduced the aspirin-related mortality rate by 34 percent. This equates to about 90 fewer child deaths from aspirin during the 1973-1990 study
period.20
When combining the statistics for aspirin with those for prescription drugs, the staff of the CPSC estimates that special packaging saved the lives of more than 900 children since the requirements went into effect in the early 1970's.
This estimate relates to aspirin and oral prescription medicines only and does not include additional lives that may have been
saved by special packaging on other products.
PART II
Substances Covered by Regulation
Background
The PPPA gives the Commission the authority to require special packaging of hazardous household substances to protect
children. Section 3 of the PPPA details the findings that the Commission must make prior to promulgating a special packaging standard. The Commission may require special packaging of a household substance if it finds that:
The degree or nature of the hazard to children in the availability of such substance, by reason of its packaging, is such that
special packaging is required to protect children from serious personal injury or serious illness resulting from handling, using,
or ingesting such substance; and
The special packaging to be required by such standard is technically feasible, practicable, and appropriate for such substance.
In establishing a standard the Commission also considers:
1. the reasonableness of such standard;
2. available scientific, medical, and engineering data concerning special packaging and concerning childhood unintentional
ingestions, illness, and injury caused by household substances;
3. the manufacturing practices of industries affected by the PPPA; and
4. the nature and use of the household substance.
The scope of products, which may potentially be subject to special packaging standards is quite broad and includes products
customarily produced for use in or around the household. Foods, drugs, cosmetics, as defined by the Federal Food, Drug and
Cosmetic Act, hazardous substances as defined by the Federal Hazardous Substances Act (FHSA), and pre-packaged fuels
are all within the jurisdiction of the legislation.
The responsibility for administration and enforcement of child-resistant packaging for pesticides (including cleaning products
that make antimicrobial claims) lies entirely with the Environmental Protection Agency (EPA) under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). It should be noted that the same test methods for determining whether a package is
child-resistant and senior friendly apply to pesticides because the FIFRA was amended to recognize packaging and labeling
violations under the PPPA.
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In the years since enactment of the PPPA, many household chemicals or categories of household substances have been added
to the list of regulated substances21. Those standards dealing with drug products, particularly prescription drug products, will
be discussed in somewhat greater detail. A list of substances that require special packaging as of 2005, is presented below.
Please refer to the PPPA regulations at 16 CFR § 1700.14 for the most current list of regulated substances and for the specific
details of each regulation.
Substances Regulated At 16 CFR § 1700.14
• Aspirin: Any aspirin-containing preparation for human use in oral dosage form.
• Furniture Polish: Low-viscosity, nonemulsion type liquid furniture polish containing 10 percent or more petroleum distillates, unless packaged in pressurized spray containers. (These products also require restricted flow so that not more than 2
milliliters is obtained when the package is inverted, squeezed or otherwise activated once.)
• Methyl Salicylate (oil of wintergreen): Liquid preparations containing more than 5 percent by weight, unless packaged in
pressurized spray containers.
• Controlled Drugs: Preparations intended for oral human use, which are subject to the Comprehensive Drug Abuse Prevention and Control Act of 1970.
• Sodium and/or Potassium Hydroxide: Household substances in dry form (granules, powders, flakes, etc.) containing 10 percent or more by weight and all other household substances (aerosols, liquids, pastes) containing 2 percent or more by weight,
of chemically unneutralized sodium and/or potassium hydroxide.
• Turpentine: Household substances in liquid form containing 10 percent or more by weight of turpentine.
• Kindling and/or Illuminating Preparations: Prepackaged low viscosity substances (i.e., cigarette lighter fluids, charcoal
lighter fluids, camping equipment fuel, torch fuel, and fuel for decorative or functional lanterns) which contain 10 percent or
more by weight of petroleum distillates.
• Methyl Alcohol (Methanol): Household substances in liquid form containing 4 percent or more by weight of methyl alcohol, unless packaged in a pressurized container.
• Sulfuric Acid: Household substances containing 10 percent or more by weight of sulfuric acid, except in wet cell storage
batteries.
• Prescription Drugs: Any drug for human use in oral dosage form and which is required by federal law to be dispensed only
by or upon an oral or written prescription of a practitioner licensed to administer such drug.
• Ethylene Glycol: Household substances in liquid form containing 10 percent or more by weight of ethylene glycol.
• Iron-Containing Drugs: Non-injectable animal and human drugs providing iron for therapeutic or prophylactic purposes
which contain a total amount of elemental iron equivalent to 250 milligrams or more per package.
• Iron-Containing Dietary Supplements: Most dietary supplements that contain an equivalent of 250 milligrams or more of
elemental iron per package.
• Solvents for Paint or Similar Surface Coatings: Prepackaged low-viscosity liquid solvents for paints or other surface-coating
material that contain 10 percent or more by weight of benzene, toluene, xylene, petroleum distillates, or any combination
thereof.
• Acetaminophen: Preparations for human use in oral dosage forms containing more than 1 gram of acetaminophen in a single
package.
• Diphenhydramine: Preparations for human use in oral dosage forms containing more than the equivalent of 66 milligrams of
diphenhydramine base in a single package.
• Glue removers containing acetonitrile: Household glue removers in a liquid form containing more than 500 milligrams of
acetonitrile in a single container.
• Permanent wave neutralizers: Liquid home permanent wave neutralizers, containing more than 600 milligrams of sodium
bromate or more than 50 milligrams of potassium bromate in a single container.
• Ibuprofen: Preparations for human use in oral dosage forms containing 1 gram or more of ibuprofen in a single package.
• Loperamide: Preparations for human use in oral dosage forms containing more than 0.045 milligrams of loperamide in a
single package.
• Mouthwash: Most mouthwash containing 3 grams or more of ethanol in a single package.
• Lidocaine: Products containing more than 5 milligrams of lidocaine in a single package.
• Dibucaine: Products containing more than 0.5 milligrams of dibucaine in a single package.
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• Naproxen: Preparations for human use in oral dosage forms containing 250 milligrams or more of naproxen in a single
package.
• Ketoprofen: Preparations for human use in oral dosage forms containing more than 50 milligrams of ketoprofen in a single
package.
• Fluoride: Products containing more than 50 milligrams of elemental fluoride and more than 0.5 percent fluoride in a single
package.
• Minoxidil: Preparations for human use containing more than 14 milligrams of minoxidil in a single package.
• Methacrylic Acid: Liquid products containing more than 5 percent (weight to volume) methacrylic acid in a single package.
• Over-the-Counter Drug Products: Preparations in oral dosage forms that contain any active ingredient that was previously
available for oral administration only by prescription.
• Hazardous substances containing lowviscosity hydrocarbons: Products containing 10 percent or more hydrocarbon by
weight with a viscosity of less than 100 SUS at 100ºF.
• Drugs and cosmetics containing low viscosity hydrocarbons: Products containing 10 percent or more hydrocarbon by
weight with a viscosity of less than 100 SUS at 100ºF.
Review of the list of categories reveals a wide range of household products and chemicals. Healthcare professionals are more
directly involved with those regulations dealing with drug products than household chemical products.
Aspirin and Acetaminophen
Aspirin was the first substance to be regulated under the PPPA. Note that while acetaminophen is regulated at a level of more
than 1 gram per package, no level has been established for aspirin and aspirin-containing products. Thus a substance containing any amount of aspirin is required to be in special packaging. There are two exemptions to each of these regulations; each
based primarily upon physical characteristics of the dosage forms, which have been found to inhibit or limit unintentional ingestion of these products by children. These exemptions are:
1. Effervescent tablets or granules containing not more than 15 percent acetaminophen or aspirin, provided the dry tablet or
granules have an oral LD50 of 5 grams or more per kilogram of body weight.
2. Unflavored acetaminophen or aspirin containing preparations in powder form (other than those intended for pediatric use)
that are packaged in unit doses providing not more than 13 grains of acetaminophen or 15.4 grains of aspirin per unit dose.
Methyl Salicylate
This regulation covers liquid preparations containing more than 5 percent by weight of the substance and specifically exempts pressurized spray containers. The cream and ointment preparations are not included.
Controlled Drugs
All controlled drugs intended for oral administration to humans are covered without exception, including over-the-counter
preparations.
Iron-Containing Drugs and Dietary Supplements
Iron-containing drugs and dietary supplements that contain 250 mg or more elemental iron have required special packaging
since 1978. Iron was responsible for many poisoning deaths. Consumers may be unaware of the toxicity of iron. It is important for Healthcare Professionals to educate their patients about the toxicity of iron.
Lidocaine, Dibucaine, and Minoxidil
All three of these drugs are available in topical formulations. The regulations for lidocaine and dibucaine, two topical local
anesthetic drugs, are noteworthy because they extend to all dosage forms including creams, sprays, and transdermal patches.
Minoxidil is available as an oral prescription drug used for hypertension; this formulation requires special packaging under
the prescription drug rule.
Minoxidil is also available in topical form for hair regrowth. The CPSC regulated minoxidil to require the topical forms to be
sold in special packaging. Many minoxidil preparations are sold with applicators (i.e., droppers or spray pumps) that are intended to replace the original closure on the package of minoxidil. The package is required to comply with the special pack-
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aging requirements of the PPPA for the life of the product. Thus the package must continue to meet the special packaging
requirements when the provided applicators are affixed to the package.22
Human Oral Prescription Drugs
The special packaging requirement for oral prescription drugs, which became effective on April 16, 1974, has had great impact on both pharmacists and drug manufacturers. As described previously, the PPPA requires that a number of findings be
made before a special packaging standard can be promulgated. The key finding is the establishment that the substance, because of the way it is packaged, has a significant potential for causing serious personal injury or illness in children. However,
some human oral prescription drugs may not have the potential to cause serious injury or illness to children. Why then did the
Federal government choose to require all human oral prescription drugs to be dispensed in special packaging?
The answer is twofold. First, it provides the best protection of children. Second, it eliminates the formidable task for dispensing pharmacists of having to maintain complete and accurate listings of regulated and non-regulated drugs. Since new drugs
and drug classes are being approved by the FDA at an increased rate, promulgation of separate regulations for drugs or classes of drugs known to be a potential hazard to young children upon unintentional ingestion would have been an extremely
onerous task. In addition, the burden upon individual pharmacists would have been great since they would have to check each
drug, dosage strength, and amount before dispensing.
These problems were resolved by regulating all human oral prescription drugs and then establishing a procedure for exempting products that do not pose a hazard to children (described below). This approach was possible with the support and cooperation of the various pharmaceutical, trade, and professional associations.
Oral investigational drugs for outpatient clinical trials require special packaging under the Human Oral Prescription Drug
Rule. Because of the special circumstances surrounding the use of investigational drugs, the CPSC staff has issued guidance
on the packaging of theseproducts.23
Oral prescription drug samples and “starter kits” dispensed by the prescribing practitioners require special packaging. However, the current CPSC position is that manufacturers are not responsible for the special packaging of these products since
they are distributed by a licensed medical practitioner who has the authority to specify non-complying packaging for his/her
patients. This is not the case for oral prescription drugs, including samples, that are dispensed by pharmacists, since pharmacists do not have the authority to specify that prescriptions be dispensed in non-complying packaging.24
Drugs Switched from Rx to OTC Status
Diphenhydramine, ibuprofen, loperamide, naproxen, and ketoprofen are drugs that were originally available by prescription.
The FDA allowed the over-the-counter (OTC) sale of certain formulations of these drugs. When these drugs were granted
OTC status, they were no longer required to be packaged in special packaging under the oral prescription drug rule.
The CPSC had to initiate separate rulemaking activity in order to require special packaging of each drug. In 2001, the CPSC
issued a rule to require special packaging of oral prescription drugs that are granted over-the-counter (OTC) status by the
FDA. This will ensure that special packaging will continue to be required for these products when they are more readily
available to the public. Separate rulemakings such as those for diphenhydramine, ibuprofen, loperamide, naproxen, and ketoprofen will be unnecessary in the future for these types of drugs.
Exceptions and Exemptions
The section above describes the substances that must be in special packaging. However, there are several situations when special packaging is not required. Since the PPPA applies only to substances used in or around the household, the special packaging requirements do not extend to products used in institutional settings such as hospitals and traditional nursing homes.
However, if the patients are taking the drugs home, including assisted-living types of homes where patients are responsible
for taking their medication, the substances need to be in special packaging. Congress had concerns about the ability of elderly
or handicapped individuals to access products in special packaging. Therefore, the PPPA contains provisions to facilitate access of products by these special populations. Section 4(a) of the PPPA provides for the marketing of "non-complying" or
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non-special packages of regulated substances other than prescription drugs in order to facilitate access to regulated products
by the elderly and handicapped.25
A manufacturer or packager may package any over-the-counter household substance (subject to a PPPA standard) in packaging of a single size that does not comply with such standard if:
1. The manufacturer (or packager) also supplies such substance in packages that comply with such standard; and
2. The packages of such substance that do not meet such standard bear conspicuous labeling stating: "This package for households without young children"; (or “Package Not Child-Resistant” for small packages).
As a result, manufacturers of over-the- counter household products regulated under the PPPA, have the option of marketing
one size in a conventional package as long as that same product is supplied in popular-sized complying packages. There is
one exception. Under the Federal Hazardous Substances Act, household products containing more than 10 percent
sodium/potassium hydroxide are banned unless marketed in special packaging.26 The effect of this is to essentially remove
the option of producing a single non-complying package of the substance.
Section 4(b) of the PPPA addresses the need for facilitating access to prescription drugs by elderly and handicapped individuals who have difficulty using special packaging.27
"In the case of a household substance which is subject to such a [PPPA] standard and which is dispensed pursuant to an order
of a physician, dentist, or other licensed medical practitioner authorized to prescribe, such substance may be dispensed in
noncomplying packages only when directed in such order or when requested by the purchaser.”
The pharmacist's role in implementing this section is further discussed in Chapter III. In addition to the scenarios described
above, the regulations of the PPPA contain a procedure whereby exemptions from special packaging requirements may be
granted by the Commission. An exemption request, in the form of a formal petition, is generally initiated by the manufacturer
of a product. The majority of such requests are from manufacturers of human oral prescription drugs. Generally such requests
seek exemption for a specific package size of a drug, normally a package designed for direct dispensing to the consumer after
appropriate labeling by the pharmacist.
The petitioner must submit various data relating to the toxicity of the product, and, generally must establish that the amount
of product contained within the requested exemption would not be harmful to a child under 5 years of age. Formal exemption
criteria exist to guide manufacturers in submitting petitions.28 The exemption procedure involves rulemaking by the Commission.
As of 2005, the following prescription drugs are exempt from the PPPA standards and may be dispensed in conventional
packaging, as long as they contain no other substance subject to 16 CFR § 1700.14(a).29 The specific exemptions are in the
PPPA regulations at 16 CFR § 1700 (a)(10).
1. Sublingual dosage forms of nitroglycerin,
2. Sublingual and chewable forms of isosorbide dinitrate in dosage strengths of 10 milligrams or less.
3. Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in packages containing not more than 8
grams or the equivalent of erythromycin.
4. Erythromycin ethylsuccinate tablets in packages containing no more than the equivalent of 16 grams erythromycin.
5. Anhydrous cholestyramine in powder form.
6. Potassium supplements in unit dose forms, including individually wrapped effervescent tablets, unit dose vials of liquid
potassium, and powdered potassium in unit dose packets, containing not more than 50 milliequivalents per unit dose.
7. Sodium fluoride drug preparations, including liquid and tablet forms, containing no more than 264 milligrams of sodium
fluoride per package.
8. Betamethasone tablets packaged in manufacturers' dispenser packages containing no more than 12.6 milligrams betamethasone.
9. Mebendazole in tablet form in packages containing not more than 600 milligrams of the drug.
10. Methylprednisolone in tablet form in packages containing not more than 84 milligrams of the drug.
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11. Colestipol in powder form in packages containing not more than 5 grams of the drug.
12. Pancrelipase preparations in tablet, capsule, or powder form.
13. Cyclically administered oral contraceptives in mnemonic (memory-aid) dispenser packages which rely solely upon the
activity of one or more progestogen or estrogen substances.
14. Prednisone in tablet form when dispensed in packages containing no more than 105 milligrams of the drug.
15. Conjugated estrogen tablets when dispensed in mnemonic dispenser packages containing not more than 32.0 milligrams
of the drug.
16. Norethindrone acetate tablets in mnemonic dispenser packages containing not more than 50 milligrams of the drug.
17. Medroxyprogesterone acetate tablets.
18. Sacrosidase (sucrase) preparations in a solution of glycerol and water.
19. Hormone Replacement Therapy products that rely solely upon the activity of one or more progestogen or estrogen substances.
CHAPTER III
Responsibilities Under the Act – Frequently Asked Questions
Prescribers/Dispensers of Medications
Q. What is the responsibility of the pharmacist under the PPPA?
A. The pharmacist must dispense oral prescription drugs in special packaging unless the drug is exempted or the patient or
prescribing practitioner requests nonspecial packaging.
Q. May an individual request that all of his/her prescriptions be filled in conventional (nonspecial) packaging?
A. Yes, the law does not preclude a pharmacist from relying upon a specific request from a patient to have all of his/her medications placed in non-special packaging. Many pharmacies choose to have this request in writing, i.e., a blanket waiver. However, a single request from a patient to dispense a specific prescription in non-special packaging is not a basis for the
pharmacist to infer the patient wants all subsequent prescriptions to be dispensed in non-special packaging. Such a request is
not a blanket waiver. A patient who previously requested blanket non-special packaging may later change his/her mind about
the use of such packaging because of changing personal circumstances, but may not remember to inform the pharmacist of
the change in packaging preference. It is a prudent practice for the dispensing pharmacist to periodically check with all patients who have blanket waiver requests on file to ensure that noncomplying packaging continues to be the preferred packaging choice for the patients' prescription drugs.
Q. If the pharmacist is aware that one of his/her customers prefers conventional packaging for his/her prescriptions, can the
pharmacist make this decision without the customer's specific request?
A. No. The pharmacist may advise the customer that he/she has the option of having the prescription dispensed in noncomplying packaging, but the choice must be that of the customer.
Q. Must the customer make the choice for conventional packaging in writing?
A. Although many pharmacists do require a written waiver, the law and regulations do not require a written request. The CPSC staff recommends, however, that the pharmacist get a request in writing particularly when a blanket waiver is being requested. This will assist the pharmacist during inspections of the pharmacy by regulatory agencies.
Q. May a pharmacist dispense a prescription drug in a noncomplying package in response to a standing order from a physician that it be so dispensed?
A. This can be done only when it applies to refills of a prescription where the physician has prescribed noncomplying packaging for that prescription. However, a drug dispensed to the same person on a different prescription of the same or another
prescriber must be dispensed in special packaging, unless the prescription directs the use of noncomplying packaging or the
purchaser requests it.
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Q. Can a physician simply check a box on a prescription blank to indicate to the pharmacist that a drug be dispensed in noncomplying packaging?
A. Yes. However, the CPSC staff discourages the use by physicians of prescription blanks having a box to check for noncomplying packaging, on the basis that the practice would tend to encourage excessive use of noncomplying packaging.
Q. Who is responsible for determining at the retail level whether a prescription drug must be packaged in accordance with
PPPA standards?
A. It is the responsibility of the dispensing pharmacist. Unless a prescription drug is expressly exempted from the regulations, or the customer or prescribing physician request noncomplying packaging, the drug must be dispensed in a special
package.
Q. How does a pharmacist or physician become aware of which drugs are exempted from PPPA standards?
A. This information listed in the PPPA regulations at 16 CFR § 1700.14 and is available on the CPSC website,
http://www.cpsc.gov/businfo/notices.html. Announcements are published in the Federal Register, and in news releases issued
by CPSC (which may be published in the local press). In addition, the journals and newsletters of pharmaceutical and medical
groups, as well as the trade press, publicize these exemptions.
Q. In the case of an antibiotic drug provided by the manufacturer in a granular form to be reconstituted by the pharmacist,
who is responsible for providing the special package the pharmacist or the manufacturer?
A. If the product is in the same container intended to be given to the purchaser, the manufacturer and the pharmacist are both
responsible.
Q. Does the same rule apply to drugs dispensed in dropper bottles?
A. Yes.
Q. In the case of refills, can prescription bottles and vials be reused?
A. As a general rule, no. This prohibition is based on the wear associated with a plastic vial, which could compromise the
package’s effectiveness. Since such wear or undetected damage with a glass container is negligible, the CPSC staff has indicated that it would have no objection to the reuse of a glass container, provided a new closure is used. This same consideration would be given to any other package type that is not prone to wear.
Q. Does the regulatory reference to “dosage forms intended for oral administration” include drugs intended for topical application to the teeth or mouth, or in a dosage form intended for inhalation?
A. No. The regulations intend “oral administration” to pertain to drugs that are taken by mouth for a systemic and not local
effect. Sublingual preparations are considered “orally administered” even though they are not swallowed. Their effect is systemic and not local to the mouth. Because of the need for quick access to the drug, sublingual nitroglycerin was excluded
from the oral prescription drug regulation when it was adopted in 1973.30
Q. When a prescription drug is dispensed in a special package, would the pharmacist be in violation of the regulations if he or
she included a separate non-complying closure with the package?
A. Although this practice is not prohibited, the CPSC staff discourages the practice in that it is likely to result in the use of
noncomplying packaging by those who are able to use special packaging without difficulty.
Q. Are Investigational New Drugs (INDs) subject to the PPPA standards?
A. Yes. Oral INDs are subject to the oral prescription drug regulation, if the IND is a drug that is for oral administration to
humans, can be dispensed only on or by an order of a licensed medical practitioner, and is to be dispensed directly to the patient. Such drugs must be packaged in a special package except as described at http://www.cpsc.gov/BUSINFO/trials.pdf. In
addition, if INDs contain any substances regulated under any of the other PPPA regulations, they would be required to be
packaged in special packaging if they are dispensed for household use.
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Q. May a pharmacist legally use reversible or other types of dual-purpose packaging for dispensing prescription drugs?
A. Although this type of packaging is not prohibited, the CPSC staff discourages its use because it is likely to result in the use
of non-special packaging. The potential for children being poisoned thus increases.
Q. What should I advise a consumer who calls for information when there is a suspected poisoning or childhood ingestion
emergency?
A. If you are unable to provide the necessary emergency information for the caller or advise him or her as to the proper
course of action, refer the caller to the Poison Control Center or nearest hospital emergency room. The national Poison Control Center phone number is 1-800-222-1222. This number should be on or near your telephone, along with those of the fire
and police departments. It also would be prudent to suggest that the caller follow up with his/her physician.
Q. May I, as a hospital pharmacist, dispense a regulated drug in a conventional package for use by a patient in the hospital?
A. Yes, provided that the patient is confined in the hospital. Drugs dispensed for outpatient use must be packaged in accordance with the applicable regulations for special packaging.
Q. Our local hospital sometimes calls upon my pharmacy to provide drugs for patient use within the hospital. Must these
drugs be dispensed in special packaging?
A. No, provided they are to be used for institutionalized patients. The test is whether the package is likely to enter a home.
Q. My pharmacy provides drugs to a nursing home. Must these drugs be dispensed in special packaging?
A. No, traditional nursing homes where the nursing home staff administers doses to residents are considered to be institutions. This would not be true of senior citizen apartment complexes or assisted living facilities where residents store their
drugs in their households. The test is whether the package is likely to enter a home.
Q. I know of several physicians who dispense prescription drugs for a fee. Are they subject to the provisions of the PPPA?
A. Yes. Physicians who dispense drugs (including drug samples), are, and always have been, subject to the regulations under
the PPPA. It is important to note, however, that for the purpose of accommodating elderly and disabled consumers who have
difficulty using special packaging, Section 4(b) of the PPPA gives medical practitioners the authority to specify conventional
packaging for drugs they prescribe.
Q. How can a pharmacist or pharmacy determine if the prescription packages they use meet the special packaging standards?
A. The pharmacy should request special packaging test data from the manufacturer or supplier of the prescription packages.
When ordering packaging, pharmacists should be aware that vials and closures from different manufacturers may not function properly when used together. Pharmacists are responsible for ensuring that the packages they use comply with the PPPA.
Manufacturers and Packagers
Q. What is the responsibility of manufacturers of prescription drugs subject to the PPPA?
A. If the manufacturer intends that the package of a particular oral prescription drug is to be dispensed directly to the patient
by the pharmacist, the CPSC interprets the PPPA to require the manufacturer to market that drug in special packaging.31
Such packages are readily recognizable for the most part and often only require relabeling by the pharmacists prior to dispensing. The pharmacist, however, bears the ultimate responsibility for repackaging the drug into special packaging if a manufacturer has failed to comply.32
Q. May the manufacturer supply to the pharmacist one size of a regulated prescription drug in a conventional package under
Section 4 of the PPPA in the same manner as supplying a non-complying size for over-the-counter drugs?
A. There is no provision for a manufacturer or packager to market a single size of a prescription drug in noncomplying packaging as is the case for over-the-counter medications. Every unit of a prescription drug subject to the PPPA which is packaged by the manufacturer in a package intended to be dispensed to a consumer must be in special packaging. Regulated
prescription drugs may be dispensed in non-special packaging only when the prescribing physician directs its use, or the pur-
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chaser requests noncomplying packaging. In those cases, the pharmacist would have to repackage the drug with a conventional, non-special package.
Q. Can a supplier of special packaging include an equal number of noncomplying closures with each carton of complying
packaging shipped to pharmacies?
A. Yes.
Q. Does the drug manufacturer or packager have to test the packaging to determine if it complies with the PPPA standards?
A. The packages must meet the standards. Failure to meet the standards is a violation of federal law. Most packaging manufacturers will test their packaging to determine if it is complies.
Q. Is unit dose packaging considered to be child-resistant?
A. Any package that contains a substance regulated under the PPPA must meet the special packaging standards regardless of
the package type. This includes unit dose packaging such as blisters or pouches. Unit dose packaging is popular for many
drugs, especially OTC drugs. The package is evaluated using the same test methods; however, the definition of a package
failure is different than that of a bottle/closure package. If a child opens or gains access to a bottle/closure package, it is
counted as a failure for that package. However, a failure for unit dose packaging is defined as occurring when a child opens
or gains access to more than eight individual units or the number of units representing a toxic amount, whichever is less. The
level of child-resistance required of the unit packaging depends on the toxicity of the product in it. A unit package that is
compliant for one drug may not be able to be used to package another more toxic drug.
The Regulatory Agency
Q. What role does the U.S. Consumer Product Safety Commission play in informing and educating the public in the use of,
and need for, special packaging?
A. The Commission has issued news releases and other audio-visual material encouraging the use of special packaging. In
addition, the CPSC is the Secretary of the Poison Prevention Week Council and plays an important role in Poison Prevention
Week each year.
Q. What role does the Commission play in the professional education of health care personnel with respect to the special
packaging program?
A. The CPSC staff interacts with the State Boards of Pharmacy. CPSC personnel participate in meetings with pharmaceutical,
medical, and packaging groups and prepare articles for publication in their journals. One of the areas where the CPSC staff
has been particularly active has been in encouraging pharmacists to demonstrate special package usage to their customers
who need help with the proper method of opening and closing a special package.
Q. Precisely what does the term "special packaging” mean?
A. Congress defined the term special packaging in the PPPA. The term "special packaging" means packaging that is designed
or constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the
substance within a reasonable time and not difficult for normal adults to use properly. However, "special packaging" does not
mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time. Normal
adults are regarded as those with no overt physical handicaps, which would preclude their manipulating the package. To meet
PPPA standards, all children need not be prevented from gaining access to the regulated product. This is why the packaging is
called child-resistant and not childproof. Further, all adults need not be able to gain entry into the package. The PPPA does
not allow the CPSC to mandate package designs. These stipulations were included in the legislation so that industrial ingenuity would not be stifled.
Q. What is the basis for determining which products will be covered by the PPPA?
A. The Commission must establish a relationship between a particular household substance (because of the way it is packaged) and the potential for serious injury or illness to young children as a result of ingesting, handling, or using that substance. Some substances do not lend themselves to this requirement. Ingestion of a product by children does not automatically
74
result in the need for special packaging. For example, many soaps and detergents are frequently ingested but do not cause serious injury or illness to children. Alternatively, it is not necessary to document serious injury to children for the Commission
to require special packaging of a toxic product.
Q. Suppose a pharmacist dispenses a prescription drug in a conventional package. What is the CPSC’s position?
A. The law requires that the pharmacist dispense regulated drugs in special packaging. The only exceptions are those instances when the consumer or prescribing physician stipulates that a noncomplying package be used. Pharmacists who violate the
regulations may be criminally prosecuted. Individuals may be sentenced to 1 year imprisonment and fined up to $250,000.
Organizations may be fined up to $500,000. The Commission could also seek court orders enjoining violators or authorizing
seizure of noncomplying products supplied by manufacturers in consumer packages.
Q. What is the basis for selecting the noncomplying package, which the law permits for over-the-counter drugs, regulated under the PPPA?
A. The manufacturer may select one of its package sizes as its noncomplying package so long as it also supplies the product
in popular size packages, which comply with the PPPA standards. The Commission may require a manufacturer to use only
special packaging if the manufacturer has not supplied the product in popular size packages which comply with the standards
and the Commission finds, after the opportunity for a hearing, that the exclusive use of special packaging is necessary to accomplish the child protection intended by the PPPA.
Q. The FDA requires tamper-evident packaging for over-the-counter drugs. Does this replace the requirement for special
packaging?
A. No, the two systems are independent of one another. Although there are some special packages which are also tamperevident (blisters, unit-of-use), a tamperevident package is not necessarily childresistant. The FDA requires that evidence of tampering be visually determined on initial contact.33 Special packages must meet specific performance standards. These include
maintaining their childresistance for the number of openings and closings customary for the life of the product.
Q. What types of special packaging have been approved by the Commission for use with prescription drugs and other regulated household substances?
A. The Commission does not approve or certify special packaging. In fact, the PPPA itself specifically prohibits the Commission from prescribing specific package designs, product content, package quantity, and, with the exception of appropriate labeling for allowable single, noncomplying package sizes, labeling. The ultimate determination of whether a particular
package complies with the standards is the responsibility of the manufacturer. The Commission assesses compliance on the
basis of human performance tests.
Q. What should a pharmacist or physician do if they know or suspect that PPPA regulations are being violated?
A. Contact CPSC Headquarters either by phone, letter, or e-mail. The CPSC operates a toll-free hotline at (800) 638-2772.
However, we recommend that you contact the Office of Compliance directly by phone at 301-504-7913, via fax at 301-5040359, or via e-mail at [email protected]. CPSC staff will review the complaint and take appropriate action as warranted.
Q. Can a State or other political subdivision establish packaging regulations that are more stringent than those promulgated
by the CPSC?
A. No. With certain narrow exceptions, they must be identical. However, a State may require child-resistant packaging of a
substance not regulated by CPSC.
Q. Can a State or other political subdivision establish packaging regulations that are less stringent than those promulgated by
the CPSC?
A. No.
Endnotes
1Eason, L.A. “The Evolutions and Interest Conflicts Involved in the Poison Prevention Packaging Act of 1970,” Unpublished, Auburn University, Alabama, 8/25/72, p. 3.
75
2Verhulst, H.L. “National Clearinghouse for Poison Control Centers,” Military Medicine, 1(122): 321, 1958.
3Cann, Howard M., M.D. Iskrant, Albert, P., and Neyman, Dorthory, S. “Epidemiological Aspects of Poisoning Accidents,”
American Journal of Public Health, 50(12): December 1960, p. 1922.
4Federal Hazardous Substances Act, Public Law 86-613, 74 Stat. 372, July 12, 1960; 15 U.S.C. 1261-1276
5National Poison Prevention Week, Public Law 87-319, 75 Stat, 681, September 26,1961
6"The Legacy of Homer George,” FDA Consumer. March 1973.
7Corrigan, J.J. "The Poison Prevention Packaging Act,” FDA Papers, March 1973, p. 1.
8"Prevention of Accidental Ingestion of Salicylate Products By Children," FDA Papers, March 1967, p. 7
9Scherzo, RAG., Strainer, MAC., "We Can Prevent Accidental Poisonings By Using Child-Resistant Containers," Unpublished paper presented at the Congress De Pediatria, Bogota, Columbia, July 25-30, 1970.
10Scherz, R.G., Stracener, M.C., "Prevention of Accidental Poisonings With Child-Resistant Closures.” Unpublished paper
presented to the American Academy of Pediatrics, Military Section, and October 21, 1969.
11Scherz, Robert G. Performance Standards Development – A Chronicle of Government-Industry- Medicine Joint Effort – II,
Safety Packaging in the ‘70’s, Proceedings of a Conference Sponsored by the Scientific Development Committee of the Proprietary Association, December 9, 1970.
12Breast, H.J., "Five Years With Five Million Child-Resistant Containers.” Unpublished paper presented at the 15th Annual
Meeting, American Association of Poison Control Centers, October, 1972.
13Poison Prevention Packaging Act of 1970, (PPPA) Public Law 91-601, 84 Stat.1670, December 30, 1970, Sec. 3; 15
U.S.C. 1472
14Consumer Product Safety Act, Public Law 92-573; 86 Stat. 1207, October 27, 1972, Sec. 30; 15 U.S.C. 2079
15The Poison Prevention Packaging Act, 15 U.S.C.1471, Sec. 2(4).
16Jacobson, B., Rock, A., Cohn, M, and Litovitz, T. “Accidental Ingestions of Oral Prescription Drugs: A Multicenter Survey,” American Journal of Public Health, 79:853-856, 1989.
1760 FR 37710, Requirements for the Special Packaging of Household Substances, Final Rule, July 21, 1995.
XI.
Federal Laws Affecting Pharmacy Practice
Although federal law is primarily concerned with the distribution of drugs, it has an indirect effect on the practice of
pharmacy because pharmacists are the primary handlers of drugs. Federal laws directly affecting pharmacy are uncommon,
but they do exist. These laws are becoming more pervasive.
A. OBRA 90
One of the most important laws to ever affect the practice of pharmacy was passed without great fanfare or significant attention in late 1990. This law provides the framework for Drug Use Review, within which pharmacist play a critical
role. Adopted as a condition of participation in the federally funded, but state administered, Medicaid program, OBRA 90
establishes expanded standards of pharmacy practice that states must adopt to continue receiving funds under the prescription
benefit program of Medicaid. Most states have now adopted these expanded practice standards, although states differ in they
way they have fine-tuned the standards for their state. Although technically not a part of the FDCA, the OBRA 90 standards
are a significant influence on drug therapy and pharmacy practice. The language of the act follows. Numerations refer to
subsections of Section 1396r-8, Title 42, of the United States Code.
(g) Drug use review.
(1) In general.
(A) ... a State shall provide... for a drug use review program... for covered outpatient drugs in order to assure
that prescriptions (i) are appropriate, (ii) are medically necessary, and (iii) are not likely to result in adverse medical
results. The program shall be designed to educate physicians and pharmacists to identify and reduce the frequency of
patterns of fraud, abuse, gross overuse, or inappropriate or medically unnecessary care, among physicians, pharmacists, and patients, or associated with specific drugs or groups of drugs, as well as potential and actual severe adverse reactions to drugs including education on therapeutic appropriateness, overutilization and underutilization,
appropriate use of generic products, therapeutic duplication, drug-disease contraindications, drug-drug interactions,
incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse/misuse.
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(2) Description of program. Each drug use review program shall meet the following requirements for covered outpatient drugs:
(A) Prospective drug review.
(i) The State plan shall provide for a review of drug therapy before each prescription is filled or delivered to an
individual receiving benefits under this title, typically at the point-of-sale or point of distribution. The review shall
include screening for potential drug therapy problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions (including serious interactions with nonprescription or over-the-counter drugs), incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse/misuse. Each State
shall use the compendia and literature referred to in paragraph (1)(B) as its source of standards for such review.
(ii) As part of the State's prospective drug use review program under this subparagraph applicable State law
shall establish standards for counseling of individuals receiving benefits under this title by pharmacists which includes at least the following:
(I) The pharmacist must offer to discuss with each individual receiving benefits under this title or caregiver of
such individual (in person, whenever practicable, or through access to a telephone service which is toll-free for longdistance calls) who presents a prescription, matters which in the exercise of the pharmacist's professional judgment
(consistent with State law respecting the provision of such information), the pharmacist deems significant including
the following:
(aa) The name and description of the medication.
(bb) The route, dosage form, dosage, route of administration, and duration of drug therapy.
(cc) Special directions and precautions for preparation, administration and use by the patient.
(dd) Common severe side or adverse effects or interactions and therapeutic contraindications that may be
encountered, including their avoidance, and the action required if they occur.
(ee) Techniques for self-monitoring drug therapy.
(ff) Proper storage.
(gg) Prescription refill information.
(hh) Action to be taken in the event of a missed dose.
(II) A reasonable effort must be made by the pharmacist to obtain, record, and maintain at least the following
information regarding individuals receiving benefits under this title:
(aa) Name, address, telephone number, date of birth (or age) and gender.
(bb) Individual history where significant, including disease state or states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices.
(cc) Pharmacist comments relevant to the individuals [individual"s] drug therapy.
Nothing in this clause shall be construed as requiring a pharmacist to provide consultation when an individual
receiving benefits under this title or caregiver of such individual refuses such consultation.
Note that prospective drug use review (ProDUR) is forward-looking. It includes patient education and the detection of potential problems with medication use.
(B) Retrospective drug use review. The program shall provide, through its mechanized drug claims processing
and information retrieval systems or otherwise, for the ongoing periodic examination of claims data and other records in order to identify patterns of fraud, abuse, gross overuse, or inappropriate or medically unnecessary care,
among physicians, pharmacists and individuals receiving benefits under this title, or associated with specific drugs
or groups of drugs.
(C) Application of standards. The program shall, on an ongoing basis, assess data on drug use against explicit
predetermined standards... including but not limited to monitoring for therapeutic appropriateness, overutilization
and underutilization, appropriate use of generic products, therapeutic duplication, drug-disease contraindications,
drug-drug interactions, incorrect drug dosage or duration of drug treatment, and clinical abuse/misuse and, as necessary, introduce remedial strategies, in order to improve the quality of care and to conserve program funds or personal expenditures.
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Note that retrospective drug use review (RetroDUR) is backward-looking. It includes the application of data from a performance database (developed from claims submissions by pharmacies) to an ideal of practice represented by criteria and standards.
(D) Educational program. The program shall, through its State drug use review board established under paragraph (3), either directly or through contracts with accredited health care educational institutions, State medical societies or State pharmacists associations/societies or other organizations as specified by the State, and using data
provided by the State drug use review board on common drug therapy problems, provide for active and ongoing educational outreach programs... to educate practitioners on common drug therapy problems with the aim of improving
prescribing or dispensing practices.
(3) State drug use review board.
(A) Establishment. Each State shall provide for the establishment of a drug use review board (hereinafter referred to as the "DUR Board") either directly or through a contract with a private organization.
(B) Membership. The membership of the DUR Board shall include health care professionals who have recognized
knowledge and expertise in one or more of the following:
(i) The clinically appropriate prescribing of covered outpatient drugs.
(ii) The clinically appropriate dispensing and monitoring of covered outpatient drugs.
(iii) Drug use review, evaluation, and intervention.
(iv) Medical quality assurance. The membership of the DUR Board shall be made up at least 1/3 but no more
than 51 percent licensed and actively practicing physicians and at least 1/3 licensed and actively practicing pharmacists.
(C) Activities. The activities of the DUR Board shall include but not be limited to the following:
(i) Retrospective DUR...
(ii) Application of standards...
(iii) Ongoing interventions for physicians and pharmacists, targeted toward therapy problems or individuals
identified in the course of retrospective drug use reviews performed under this subsection. Intervention programs
shall include, in appropriate instances, at least:
(I) information dissemination sufficient to ensure the ready availability to physicians and pharmacists in the
State of information concerning its duties, powers, and basis for its standards;
(II) written, oral, or electronic reminders containing patient-specific or drug-specific (or both) information
and suggested changes in prescribing or dispensing practices, communicated in a manner designed to ensure the privacy of patient-related information;
(III) use of face-to-face discussions between health care professionals who are experts in rational drug therapy and selected prescribers and pharmacists who have been targeted for educational intervention, including discussion of optimal prescribing, dispensing, or pharmacy care practices, and follow-up face-to-face discussions; and
(IV) intensified review or monitoring of selected prescribers or dispensers.
The Board shall re-evaluate interventions after an appropriate period of time to determine if the intervention
improved the quality of drug therapy, to evaluate the success of the interventions and make modifications as necessary.
Note that the state DUR Board, a truly multi-disciplinary committee, oversees educational programs designed to improve the
use of medications so that problems with drug therapy will decrease and criteria and standards will be more consistently met.
B.
HIPAA
The Health Insurance Portability and Accountability Act is a far-reaching piece of legislation that has an affect on
virtually every aspect of patient care. It is often viewed as being primarily a federal patient confidentiality requirement. This
is unfortunate. In fact, HIPAA introduces very few new rules for confidentiality, beyond a massive requirement for paperwork that threatens to convert confidentiality into a game rather than a fundamental principle of patient care. For decades the
pharmacy profession has recognized the importance of patient confidentiality, because this principle shows respect for patients as individuals, it provides evidence that pharmacy is a health care profession and not a retail business, and it encourages
patients to have their embarrassing prescriptions filled because they know the entire community will not be told of them.
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Now that HIPAA has become federal law, every breach of confidentiality is viewed as a “HIPAA violation” rather than a violation of a core principle to which the profession has adhered for decades. An in depth listing of HIPAA provisions is beyond
the scope of this study guide. The most salient points are listed below:
Ÿ HIPAA applies to “Protected Health Information” (referred to as “PHI”) that is transmitted or maintained on electronic or
paper records or is orally communicated.
Ÿ All health care providers that transmit PHI in any electronic form are covered under the act.
Ÿ Patients must be given a notice of their privacy rights.
Ÿ Patients must provide informed consent before PHI may be disclosed by a covered health care provider, except under certain circumstances such as the reporting of product recalls, the reporting of adverse events, the conduct of post-marketing
surveillance, or other situations in which the law requires disclosure (such as public health agencies investigating communicable diseases or a report of child abuse).
Ÿ Patients may request access to their own private medical record and PHI.
Ÿ In communicating with other health care providers who have a responsibility for a patient’s care, it is important not to
disclose any more PHI than the “minimum amount necessary.” However, health care providers who communicate with
each other for treatment purposes are not constrained by the “minimum amount necessary” limit, and this limit also does
not apply to any communication to which the patient has given informed consent.
Specific excerpts from the federal medical privacy standards under HIPAA follow. These are lengthy and complex regulations. For further information about HIPAA, consult article 45 of the Code of Federal Regulations, or visit the U.S. Department of Health and Human Services (HHS) website at http://www.hhs.gov/ocr/privacy/index.html.
§ 164.104 Applicability.
(a) Except as otherwise provided, the standards, requirements, and implementation specifications adopted under this
part apply to the following entities:
(1) A health plan.
(2) A health care clearinghouse.
(3) A health care provider who transmits any health information in electronic form in connection with a transaction
covered by this subchapter.
§ 164.502 Uses and disclosures of protected health information: general rules.
(a) Standard. A covered entity may not use or disclose protected health information, except as permitted...
(1) Permitted uses and disclosures. A covered entity is permitted to use or disclose protected health information as
follows:
(i) To the individual;
(ii) For treatment, payment, or health care operations...;
(iii) Incident to a use or disclosure otherwise permitted or required by this subpart, provided that the covered entity
has complied with the applicable requirements...
(2) Required disclosures. A covered entity is required to disclose protected health information:
(i) To an individual, when requested... ; and
(ii) When required by the Secretary... to investigate or determine the covered entity's compliance with this subpart.
(b) Standard: Minimum necessary. (1) Minimum necessary applies. When using or disclosing protected health information or when requesting protected health information from another covered entity, a covered entity must make
reasonable efforts to limit protected health information to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request.
(2) Minimum necessary does not apply. This requirement does not apply to:
(i) Disclosures to or requests by a health care provider for treatment;
(ii) Uses or disclosures made to the individual...
(d) Standard: Uses and disclosures of de-identified protected health information.
(1) Uses and disclosures to create de-identified information. A covered entity may use protected health information
to create information that is not individually identifiable health information or disclose protected health information
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only to a business associate for such purpose, whether or not the de-identified information is to be used by the covered entity.
§ 164.506 Uses and disclosures to carry out treatment, payment, or health care operations.
(a) Standard: Permitted uses and disclosures. Except with respect to uses or disclosures that require an authorization under § 164.508(a)(2) and (3), a covered entity may use or disclose protected health information for treatment,
payment, or health care operations as set forth in paragraph (c) of this section, provided that such use or disclosure
is consistent with other applicable requirements of this subpart.
(b) Standard: Consent for uses and disclosures permitted. (1) A covered entity may obtain consent of the individual
to use or disclose protected health information to carry out treatment, payment, or health care operations...
(c) Implementation specifications: Treatment, payment, or health care operations.
(1) A covered entity may use or disclose protected health information for its own treatment, payment, or health care
operations.
(2) A covered entity may disclose protected health information for treatment activities of a health care provider.
(3) A covered entity may disclose protected health information to another covered entity or a health care provider for
the payment activities of the entity that receives the information.
(4) A covered entity may disclose protected health information to another covered entity for health care operations
activities of the entity that receives the information, if each entity either has or had a relationship with the individual
who is the subject of the protected health information being requested, the protected health information pertains to
such relationship, and the disclosure is:
(i) For a purpose listed in paragraph (1) or (2) of the definition of health care operations; or
(ii) For the purpose of health care fraud and abuse detection or compliance.
(5) A covered entity that participates in an organized health care arrangement may disclose protected health information about an individual to another covered entity that participates in the organized health care arrangement for
any health care operations activities of the organized health care arrangement.
In an effort to improve health information technology and protect health information, as the use of electronic information
increases, the Health Information Technology and Economic and Clinical Health Act (HITECH) was passed in 2009 that expands the scope of HIPAA. The HITECH Act includes various new provisions, including the requirement to notify patients
and HHS of PHI security breaches without unreasonable delay. The act also expands the reach of HIPAA data privacy and
security requirements to include the business associates of covered entities (such as pharmacies). Examples of business associates are companies like accounting firms, billing agencies, law firms or others that provide services to the covered entities.
C.
Medicare Modernization Act (MMA)
On January 1, 2006, the MMA went into effect. This act offers senior citizens and persons with disabilities a voluntary prescription drug benefit. This is generally referred to as “Part D” of the Medicare program. It is a huge piece of legislation, but the effect on pharmacy is felt primarily in the area of medication therapy management (MTM), federal electronic
prescribing standards and recordkeeping requirements. Refer to Title 42 of the Code of Federal Regulations for additional
information regarding Medicare Part D.
The MTM program is included within the provisions of the MMA related to quality assurance:
§ 423.153 Drug utilization management, quality assurance, and medication therapy management programs
(MTMPs).
(a) General rule. Each Part D sponsor must have established, for covered Part D drugs furnished through a Part D
plan, a drug utilization management program, quality assurance measures and systems, and an MTMP as described
in paragraphs (b), (c), and (d) of this section.
(b) Drug utilization management. A Part D sponsor must have established a reasonable and appropriate drug utilization management program that -(1) Includes incentives to reduce costs when medically appropriate;
(2) Maintains policies and systems to assist in preventing over-utilization and under-utilization of prescribed medica-
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tions; and
(3) Provides CMS with information concerning the procedures and performance of its drug utilization management
program, according to guidelines specified by CMS.
(c) Quality assurance. A Part D sponsor must have established quality assurance measures and systems to reduce
medication errors and adverse drug interactions and improve medication use that include all of the following -(1) Representation that network providers are required to comply with minimum standards for pharmacy practice as
established by the States.
(2) Concurrent drug utilization review systems, policies, and procedures designed to ensure that a review of the prescribed drug therapy is performed before each prescription is dispensed to an enrollee in a sponsor's Part D plan,
typically at the point-of-sale or point of distribution. The review must include, but not be limited to,
(i) Screening for potential drug therapy problems due to therapeutic duplication.
(ii) Age/gender-related contraindications.
(iii) Over-utilization and under-utilization.
(iv) Drug-drug interactions.
(v) Incorrect drug dosage or duration of drug therapy. (vi) Drug-allergy contraindications.
(vii) Clinical abuse/misuse.
(3) Retrospective drug utilization review systems, policies, and procedures designed to ensure ongoing periodic examination of claims data and other records, through computerized drug claims processing and information retrieval
systems, in order to identify patterns of inappropriate or medically unnecessary care among enrollees in a sponsor's
Part D plan, or associated with specific drugs or groups of drugs.
(4) Internal medication error identification and reduction systems.
(5) Provision of information to CMS regarding its quality assurance measures and systems, according to guidelines
specified by CMS.
(d) Medication therapy management program (MTMP).
(1) General rule. A Part D sponsor must have established a MTMP that -(i) Is designed to ensure that covered Part D drugs prescribed to targeted beneficiaries described in paragraph
(d)(2) of this section are appropriately used to optimize therapeutic outcomes through improved medication use;
(ii) Is designed to reduce the risk of adverse events, including adverse drug interactions, for targeted beneficiaries
described in paragraph (d)(2) of this section;
(iii) May be furnished by a pharmacist or other qualified provider; and
(iv) May distinguish between services in ambulatory and institutional settings.
(2) Targeted beneficiaries. Targeted beneficiaries for the MTMP described in paragraph (d)(1) of this section are
enrollees in the sponsor's Part D plan who -(i) Have multiple chronic diseases;
(ii) Are taking multiple Part D drugs; and
(iii) Are likely to incur annual costs for covered Part D drugs that exceed a predetermined level as specified by the
Secretary.
(3) Use of experts. The MTMP must be developed in cooperation with licensed and practicing pharmacists and physicians.
(4) Coordination with care management plans. The MTMP must be coordinated with any care management plan established for a targeted individual under a chronic care improvement program (CCIP) under section 1807 of the Act.
A Part D sponsor must provide drug claims data to CCIPs for those beneficiaries that are enrolled in CCIPs in a
manner specified by CMS.
(5) Considerations in pharmacy fees. An applicant to become a Part D sponsor must -(i) Describe in its application how it takes into account the resources used and time required to implement the MTMP it chooses to adopt in establishing fees for pharmacists or others providing MTMP services for covered Part D
drugs under a Part D plan.
(ii) Disclose to CMS upon request the amount of the management and dispensing fees and the portion paid for MTMP services to pharmacists and others upon request.
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The provisions related to electronic prescribing establish foundation standards for the use of that technology, and they specify
that the federal standards preempt state standards to the extent that any state standard would make it impossible for a prescriber to electronically transmit prescriptions for a Medicare-eligible patient.
§ 423.160 Standards for electronic prescribing.
(a) General rules. (1) Part D sponsors must establish and maintain an electronic prescription drug program that
complies with the applicable standards in paragraph (b) of this section when transmitting, directly or through an intermediary, prescriptions and prescription-related information using electronic media for covered Part D drugs for
Part D eligible individuals.
(2) Except as provided in paragraph (a)(3) of this section, prescribers and dispensers that transmit, directly or
through an intermediary, prescriptions and prescription-related information using electronic media must comply
with the applicable standards in paragraph (b) of this section when e-prescribing for covered Part D drugs for Part
D eligible individuals.
(3) Exemptions. (i) Entities transmitting prescriptions or prescription-related information by means of computer-generated facsimile are exempt from the requirement to use the NCPDP SCRIPT Standard adopted by this section in
transmitting such prescriptions or prescription-related information.
(ii) Entities may use either HL7 messages or the NCPDP SCRIPT Standard to transmit prescriptions or prescriptionrelated information internally when the sender and the recipient are part of the same legal entity. If an entity sends
prescriptions outside the entity (for example, from an HMO to a non-HMO pharmacy), it must use the adopted NCPDP SCRIPT Standard or other applicable adopted standards. Any pharmacy within an entity must be able to receive
electronic prescription transmittals for Medicare beneficiaries from outside the entity using the adopted NCPDP
SCRIPT Standard. This exemption does not supersede any HIPAA requirement that may require the use of a HIPAA
transaction standard within an organization.
(iii) Entities transmitting prescriptions or prescription-related information where the prescriber is required by law to
issue a prescription for a patient to a non-prescribing provider (such as a nursing facility) that in turn forwards the
prescription to a dispenser are exempt from the requirement to use the NCPDP SCRIPT Standard adopted by this
section in transmitting such prescriptions or prescription-related information.
(4) In accordance with section 1860D-4(e)(5) of the Act, the standards under this paragraph (b) of this section supersede any State law or regulation that -(i) Is contrary to the standards or restricts the ability to carry out Part D of Title XVIII of the Act; and
(ii) Pertains to the electronic transmission of medication history and of information on eligibility, benefits, and prescriptions with respect to covered Part D drugs under Part D of Title XVIII of the Act.
The provisions of the MMA also require that pharmacists retain all prescriptions for 10 years. Paper prescriptions need be
retained only for 3 years, while the remaining 7 years of prescriptions may be kept in some electronic format.
D.
Tamper-Resistant Prescriptions
Since 2008, in order for Medicaid outpatient drugs to be reimbursable by the federal government, all written, nonelectronic prescriptions must contain at least three tamper-resistant features, one from each of the three baseline characteristics outlined in guidance issued by the Centers for Medicare & Medicaid Services (CMS). Although CMS has outlined three
baseline characteristics of tamper-resistant prescriptions, each State will define which features it will require to meet those
characteristics in order to be considered tamper-resistant. The baseline characteristics must: (1) prevent unauthorized copying
of a completed or blank prescription form; (2) prevent the erasure or modification of information written on the prescription
by the prescriber; or (3) prevent the use of counterfeit prescription forms. CMS has also provided situations where this requirements does not apply: when the prescription is communicated by the prescriber to the pharmacy electronically, verbally,
or by fax; a managed care entity pays for the prescription; or in most situations when drugs are provided in certain institutional and clinical facilities. Emergency fills are also allowed as long as a prescriber provides a verbal, faxed, electronic, or compliant written prescription within 72 hours. For detailed information on the requirements, please refer to the CMS website.
The statute language for tamper-resistant prescriptions is included below.
42 U.S.C. 1936b(i)
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(23) with respect to amounts expended for medical assistance for covered outpatient drugs (as defined in section
1927(k)(2) [42 USCS § 1396r-8(k)(2)]) for which the prescription was executed in written (and non-electronic) form
unless the prescription was executed on a tamper-resistant pad.
XII.
Patient Safety Quality Improvement Act of 2005
The Patient Safety and Quality Improvement Act of 2005 (Public Law 109-41) was signed into law on July 29, 2005. It was
enacted in response to growing concern about patient safety in the United States and the IOM 1999 report, To Err is Human:
Building a Safer Health System The goal of the Act is to improve patient safety by encouraging voluntary and confidential
reporting of events that adversely affect patients. The Act creates Patient Safety Organizations (PSOs) to collect, aggregate,
and analyze confidential information reported by health care providers. The Act also provides a federal legal privilege for
information that is assembled and reported by providers to PSOs. For further information about this law, visit
www.ahrq.gov/qual/psoact.htm.
XIII. Medical Devices
Any article that is intended to achieve its therapeutic goal through mechanisms other than chemical mechanisms is a medical
device. Medical devices are classified by the FDA according to their relative danger to the public, and the need to restrict
them or require premarketing approval. The language of the act follows. Numerations refer to subsections of Section 360c,
Title 21, of the United States Code.
(a) Classes of devices.
(1) There are established the following classes of devices intended for human use:
(A) Class I, general controls.
(i) A device for which the controls authorized by or under section 501, 502, 510, 516, 518, 519, or 520 [21
USCS § 351, 352, 360, 360f, 360h, 360i, or 360j] or any combination of such sections are sufficient to provide reasonable assurance of the safety and effectiveness of the device.
(ii) A device for which insufficient information exists to determine that the controls referred to in clause (i) are
sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls
to provide such assurance, but because it
(I) is not purported or represented to be for a use in supporting or sustaining human life or for a use which is
of substantial importance in preventing impairment of human health, and
(II) does not present a potential unreasonable risk of illness or injury, is to be regulated by the controls referred to in clause (i).
(B) Class II, special controls. A device which cannot be classified as a class I device because the general controls
by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for
which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance
with section 510(k) [21 USCS § 360(k)]), recommendations, and other appropriate actions as the Secretary deems
necessary to provide such assurance. For a device that is purported or represented to be for a use in supporting or
sustaining human life, the Secretary shall examine and identify the special controls, if any, that are necessary to provide adequate assurance of safety and effectiveness and describe how such controls provide such assurance.
(C) Class III, premarket approval. A device which because
(i) it (I) cannot be classified as a class I device because insufficient information exists to determine that the application of general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, and (II) cannot be classified as a class II device because insufficient information exists to determine that the
special controls described in subparagraph (B) would provide reasonable assurance of its safety and effectiveness,
and
(ii) (I) is purported or represented to be for a use in supporting or sustaining human life or for a use which is of
substantial importance in preventing impairment of human health, or
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(II) presents a potential unreasonable risk of illness or injury, is to be subject, in accordance with section
515 [21 USCS § 360e], to premarket approval to provide reasonable assurance of its safety and effectiveness. If
there is not sufficient information to establish a performance standard for a device to provide reasonable assurance
of its safety and effectiveness, the Secretary may conduct such activities as may be necessary to develop or obtain
such information.
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Chapter 3: The Drug Enforcement Administration
The Drug Enforcement Administration (DEA) enforces the federal laws regarding controlled substances. What follows in this section is a description of the DEA that has been issued by the agency itself, and a brief overview by the agency
of the approach it takes to enforcement.
The Drug Enforcement Administration (DEA) is the primary agency within the Federal Government responsible for the enforcement of the Controlled Substances Act (CSA). In cooperation with state authorities and other federal agencies, DEA is
tasked with preventing the diversion of controlled substances for illicit purposes. In carrying out its mission, DEA complies
with international treaty obligations, works closely with foreign as well as domestic state and local governments, private industry, and other organizations concerned with drug abuse and diversion.
The CSA, which became effective May 1, 1971, consolidates into one piece of legislation many diverse laws passed by Congress since the Harrison Narcotics Act of 1914, the first comprehensive federal legislation to control addicting drugs. Subsequent amendments to the CSA include the 1984 Diversion Control Amendments, the Controlled Substance Registrant
Protection Act of 1984, the Narcotic Addict Treatment Act of 1984, the Chemical Diversion and Trafficking Act of 1988, the
Domestic Chemical Diversion Control Act of 1993, and the Comprehensive Methamphetamine Control Act of 1996.
The provisions of the CSA are designed to improve the administration and regulation of the manufacture, import/export, distribution and dispensing of controlled substances by providing a "closed system" for distribution. Under this closed system, a
controlled substance can be traced from the time it is manufactured to the time it is dispensed to the ultimate user. This system has proven effective in reducing the diversion of these substances from legitimate channels to the illicit market.
1. Schedules of Controlled Substances
The controlled substances and their derivatives listed under the CSA can be found in the Code of Federal Regulations, Title
21 under "Part 1308--Schedules of Controlled Substances."
The drugs and drug products under the jurisdiction of the CSA are divided into five schedules. Controlled substances in
Schedules II-V have an accepted medical use in the United States, and Schedule I substances do not. The characteristics and
some examples of the drugs in each schedule are outlined below.
Schedule I Substances
The substances in this schedule have a high abuse potential and no accepted medical use in the United States. This is the only
schedule that includes drugs that are not available for prescribing, dispensing or administering. DEA does allow for research
involving Schedule I substances. This requires a separate registration as a researcher.
Examples of substances classified as Schedule I narcotics include heroin, certain clandestinely made fentanyl analogs, and
propiram Some hallucinogenic substances found in Schedule I include LSD, marijuana, and MDMA (Ecstasy).
Other examples of Schedule I substances are the depressants methaqualone and gamma hydroxybutyric acid (GHB) and the
stimulant methcathinone.
Schedule II Substances
Substances in Schedule II have a high abuse potential with severe psychological or physical dependence liability, have an accepted medical use in the United States, and are available for practitioners to prescribe, dispense and administer.
Some examples of single entity Schedule II narcotics include morphine, codeine, hydrocodone, and opium. Other Schedule II
narcotic substances and their common name brand products include: hydromorphone (Dilaudid®), methadone (Dolophine®),
meperidine (Demerol®), oxycodone (Percodan®) and fentanyl (Sublimaze®).
Some examples of Schedule II stimulants include amphetamine (Dexedrine®), Adderall ®), methamphetamine (Desoxyn®)
and methylphenidate (Ritalin®).
Other Schedule II substances include cocaine, amobarbital, glutethimide, pentobarbital and secobarbital.
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Schedule III Substances
The substances in this schedule have an abuse potential which is less than those in Schedule II, but more than Schedule IV
substances.
Some examples of Schedule III narcotics include products containing less than 15 milligrams of hydrocodone per dosage unit
(i.e., Vicodin®, Lorcet®, Tussionex®, and products containing not more than 90 milligrams of codeine per dosage unit (i.e.,
codeine with acetaminophen, aspirin or ibuprofen).
Other Schedule III substances include anabolic steroids benzphetamine (Didrex®) phendimetrazine, buprenorphine
(Buprenex®) and any compound, mixture, preparation or suppository dosage form containing amobarbital, secobarbital, pentobarbital, dronabinol (Marinol ®) or ketamine.
Schedule IV Substances
The substances in this schedule have an abuse potential less than those listed in Schedule III and more than those in Schedule
V.
Some examples of Schedule IV narcotics include propoxyphene (Darvon®), butorphanol (Stadol®), and pentazocine
(Talwin-NX®).
The following benzodiazepine substances are also found in Schedule IV. They include alprazolam (Xanax®), clonazepam
(Klonopin®), clorazepate (Tranxene®), diazepam (Valium®), flurazepam (Dalmane®), halazepam (Paxipam®), lorazepam
(Ativan®), midazolam (Versed®), orazepam (Serax®), prazepam (Verstran®), temazepam (Restoril®), triazolam
(Halcion®), and quazepam (Doral®).
Other Schedule IV substances include barbital, phenobarbital, chloral hydrate, ethchlorvynol (Placidyl®), chlordiazepoxide
(Librium®), ethinamate, meprobamate, paraldehyde, methohexital, phentermine, diethylpropion, pemoline (Cylert®), mazindol (Sanorex®), and sibutramine (Meridia®).
Schedule V Substances
The substances in this schedule have an abuse potential less than those listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotic and stimulant drugs generally for antitussive, antidiarrheal and analgesic
purposes. Some examples are cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or
per 100 grams (Robitussin AC®, Phenergan with Codeine®).
2.
Registration Requirements
Every pharmacy which dispenses any controlled substance must be registered with the DEA. Since DEA does not register
pharmacists, they must obtain their license to practice pharmacy from their state regulatory authority. To obtain a DEA registration, a pharmacy can request a DEA Form-224 (Application for New Registration, from any DEA Registration Field Office or from the DEA Headquarters). DEA Form 224 is also available online and in PDF format at
www.DEAdiversion.usdoj.gov. The DEA Form 224 is fully interactive, including the acceptance of electronic credit card
payments.
Pharmacy registrations must be renewed every three years. The cost of the registration is annotated on the application form.
The certificate of registration must be maintained at the registered location and kept available for official inspection. If a person owns and operates more than one pharmacy, each place of business must be registered.
Every pharmacy currently registered with DEA will receive a renewal application approximately 45 days before the registration expiration date. The renewal application will be sent to the address listed on the current registration certificate. If the renewal form is not received within 30 days before the expiration date of the current registration, the pharmacy should contact
the DEA registration unit for their state, and request a renewal registration form.
Chemical Registration Requirements
Under DEA’s Chemical Control regulations there is an exemption from the registration requirement for a retail distributor. A
retail distributor is defined as a grocery store, general merchandise store, drug store, or other entity or person whose activities
as a distributor of legal drug products containing listed chemicals pseudoephedrine, phenylpropanolamine (PPA), combination ephedrine and single-entity ephedrine are limited almost exclusively to sales for personal use, both in number and vol-
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ume of sales, either directly to walk-in customers or in face to face transactions. Personal use means the distribution of below
"threshold quantities" in a single transaction to an individual for legitimate medical use.
Federal law requires any person who is engaged in the wholesale distribution of drug products containing List I chemicals to
obtain a registration as a chemical distributor. A distributor who does not meet all the requirements for a retail distributor is a
wholesale distributor.
Retail pharmacies that are registered to handle controlled substances need not obtain a separate DEA chemical registration for
retail distribution of the drug products containing pseudoephedrine, phenylpropanolamine (PPA), combination ephedrine and
single-entity ephedrine which are regulated as List I chemicals. If a pharmacy desires to engage in the wholesale distribution
of bulk quantities of these drug products, the pharmacy will have to register with DEA as a Chemical Distributor because
these activities fall outside of the definition of retail distributor. Therefore, the pharmacy would be subject to the registration
requirements that apply to wholesale distributors.
To obtain a DEA Chemical Distributor registration, a pharmacy can request DEA Form-510 (Application for Registration)
from any DEA Registration Field Office.
New Pharmacy Registration
Pharmacies seeking to become registered for the first time must request a DEA Form-224 (Application for New Registration)
from any DEA Registration Field Office or the DEA Registration Unit in Washington, D.C.
Any pharmacy engaged in co-op buying of controlled substances must also register as a distributor with the DEA. To obtain
this registration, a pharmacy must meet distributor (wholesaler) security and recordkeeping requirements.
An affidavit system for expediting pharmacy applications may be used to obtain a DEA registration number for a new pharmacy or for transferring ownership of an existing pharmacy. If the pharmacy has been registered by the state licensing agency, the applicant may include an affidavit to verify the existence of the state license with their application.
Change of Business Address
Any time a pharmacy moves to a new physical location or the postal address changes at the same location, a new DEA certificate reflecting the new address must be obtained. It is the pharmacy's responsibility to notify DEA about a change of address
before the effective date of the move. A written request for modification of registration should be sent to the DEA Registration Field Office responsible for their state. If the modification is approved, DEA will issue a new certificate of registration
and, if requested, new Schedule II order forms (DEA Form-222, Official Order Form). A Renewal Application for Registration (DEA Form-224a) will only be sent to the registered address on file with DEA. It cannot be forwarded.
Affidavit for Renewal of Retail/Chain Pharmacy Registration
Corporations that own or operate a chain of pharmacies may submit a single DEA Form-224b (Retail Pharmacy Registration
Affidavit for Chain Renewal) that covers all the chain's pharmacy registrants. This affidavit along with a list of the corporation's registrations is provided in lieu of a separate DEA application for each pharmacy registration. No registration may be
issued unless the completed affidavit is received by DEA. The corporation should retain a copy of this affidavit with their
readily retrievable records for the duration of the registration covered by the affidavit. The corporation must answer the questions listed on the affidavit as they pertain to each registrant.
Denial, Revocation or Suspension of Registration
Diversion of legitimately manufactured controlled substances is a serious problem in the United States. Registrants serve as
the nation's primary guardians for preventing diversion and controlling legitimate access to these drugs. The CSA provides
the Federal Government with additional legal resources for taking action against those registrants who contribute to the diversion problem. The U.S. Attorney General has the authority to suspend or revoke a DEA registration upon a finding that the
registrant has:
Materially falsified any application filed.
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Been convicted of a felony relating to a controlled substance or a List I Chemical.
Had his/her state license or registration suspended, revoked or denied.
Committed an act which would render his registration inconsistent with the public interest.
Been excluded from participation in a Medicaid or Medicare program.
Denial of Registration in the Public Interest
The CSA gives the U.S. Attorney General authority to deny any application for DEA registration or renewal if it is determined that issuing a controlled substance registration would be inconsistent with the public interest. In determining the public
interest, the CSA states the following factors will be considered:
The recommendation of the appropriate state licensing board or professional disciplinary authority.
The applicant's experience in dispensing or conducting research with respect to controlled substances.
The applicant's conviction record under federal or state laws relating to the manufacture, distribution or dispensing of controlled substances.
Compliance with applicable state, federal or local laws relating to controlled substances.
Such other conduct which may threaten the public health and safety.
Termination of Registration
Any registrant who discontinues his/her business or transfers it to another person must notify the nearest DEA Registration
Field Office in writing before terminating the pharmacy's registration. Along with the notification of termination of registration, the pharmacist should send the DEA Certificate of Registration and any unused Official Order Forms (DEA Form-222).
The pharmacist should write or stamp the word "VOID" across the face of each Official Order Form before returning them to
DEA. The notification to DEA should also indicate where the controlled substance inventories and records will be kept and
how the controlled substances were transferred or destroyed. Records involving controlled substances must be kept available
for two years for inspection and copying by the DEA. This requirement applies even though the business has been discontinued.
Transfer of Business
A registrant transferring a pharmacy business to another registrant shall notify the nearest DEA Registration Field Office at
least 14 days before the date of the proposed transfer and provide the following information:
The name, address, registration number of the registrant discontinuing business;
The name, address, registration number of the registrant acquiring the pharmacy;
Whether the business activities will be continued at the location registered by the current business owner or moved to another
location. If the latter, give the address of the new location.
The date on which the controlled substances will be transferred to the person acquiring the pharmacy.
On the day the controlled substances are transferred, a complete controlled substances inventory must be taken and a copy of
the inventory must be included in the records of both the person transferring the business and the person acquiring the business.
If the registrant acquiring the pharmacy owns at least one other pharmacy licensed in the same state as the pharmacy being
transferred, the registrant may apply for a new DEA registration prior to the date of transfer. DEA will issue a registration
which will authorize the registrant to obtain controlled substances at the time of transfer. But the registrant may not dispense
controlled substances until the pharmacy has been issued a valid state pharmacy license.
A DEA registration application for transferring ownership of an existing pharmacy can be expedited if the applicant includes
an affidavit verifying that the pharmacy has been registered by the state licensing agency. The affidavit verifying the existence of the state license should be attached to the initial application for registration.
3.
Disposal of Controlled Substances
The pharmacy may hire an outside firm to inventory, package and arrange for the transfer of its controlled substances to another pharmacy, supplier or manufacturer. The pharmacy is responsible for the actual transfer of the controlled substances
and for the accuracy of the inventory and records. The pharmacy may also transfer the drugs to a distributor registered with
DEA to destroy drugs (reverse distributor). The pharmacy may not turn over any controlled substances to a distributor unless
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the reverse distributor is registered to destroy controlled substances. The pharmacy is responsible for verifying that the reverse distributor is registered with DEA.
The records involving the transfer or destruction of controlled substances must be kept readily available for two years for inspection and copying by the DEA. The two primary methods for disposing of controlled substances are transfer to another
registrant or destruction as explained in the following section.
4.
Transfer of Controlled Substances
If a pharmacy goes out of business or is acquired by a new pharmacy, it may transfer the controlled substances to another
pharmacy, supplier, manufacturer or distributor registered to dispose of controlled substances.
To transfer Schedule II substances, the receiving registrant must issue an Official Order Form (DEA Form-222, U.S. Official
Order Forms - Schedules I & II) to the registrant transferring the drugs.
The transfer of Schedule III-V controlled substances must be documented in writing to show the drug name, dosage form,
strength, quantity and date transferred. The document must include the names, addresses and DEA registration numbers of
the parties involved in the transfer of the controlled substances.
To Another Pharmacy
On the day the controlled substances are transferred, a complete inventory must be taken which documents the drug name,
dosage form, strength, quantity, and date transferred. In addition DEA Form-222 (Official Order Form) must be prepared to
document the transfer of Schedule II controlled substances. This inventory will serve as the final inventory for the registrant
going out of business and transferring the controlled substances. It will also serve as the initial inventory for the registrant
acquiring the controlled substances. A copy of the inventory must be included in the records of each person. It is not necessary to send a copy of the inventory to the DEA. The person acquiring the controlled substances must maintain all records
involved in the transfer of the controlled substances for two years.
See also the section entitled "Controlled Substance Distribution by Pharmacy".
To Another Supplier or Manufacturer
Any pharmacy may transfer controlled substances to a supplier or a manufacturer. The pharmacist must maintain a written
record showing:
The date of the transaction.
The name, strength, form and quantity of the controlled substance.
The supplier’s or manufacturer’s name, address, and, if known, registration number.
The DEA Form-222 will be the official record for the transfer of Schedule II substances.
To a Reverse Distributor Registered to Dispose of Substances
Any pharmacy may forward controlled substances to DEA-registered reverse distributors who handle the disposal of drugs.
For further instructions see, Disposal of Controlled Substances.
Destruction of Controlled Substances
DEA recommends that any pharmacy seeking to dispose of controlled substances first contact the nearest DEA Diversion
Field Office for disposal instructions. In no case should drugs be forwarded to the DEA unless the registrant has received prior approval from the DEA. The DEA procedures established for the destruction of controlled substances shall not be construed as altering in any way the state laws or regulations for the disposal of controlled substances. Requests from registrants
seeking authorization to destroy controlled substances without DEA presence, or requests from non-registrants desiring to
dispose of controlled substances will be handled as follows:
Once-a-Year DEA Authorization for Destruction
Once each calendar year retail pharmacies may request DEA authorization to destroy damaged, outdated or otherwise unwanted controlled substances. The pharmacy must complete DEA Form-41 (Registrants Inventory of Drugs Surrendered),
listing all drugs to be destroyed. In addition, the pharmacy must prepare a letter requesting permission to destroy the controlled substances, proposing a date and method of destruction, and listing the names of at least two people who will witness
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the destruction. The witnesses should be either a licensed physician, pharmacist, mid-level practitioner, nurse, or a state or
local law enforcement officer. Both documents must be received by the nearest DEA Diversion Field Office at least two
weeks prior to the proposed destruction date. After reviewing all available information, the DEA office will then notify the
registrant in writing of its decision. Once the controlled substances have been destroyed, signed copies of the DEA Form-41
must be forwarded to DEA. The pharmacist should contact local environmental authorities prior to implementing the proposed method of destruction to ascertain that hazards are not associated with the destruction.
Exception to DEA Authorization for Destruction
Prior DEA authorization to destroy controlled substances is not necessary when an authorized member of a state law enforcement authority or regulatory agency witnesses the destruction. Copies of a DEA Form-41 or state controlled substance destruction form must be forwarded to the local DEA Diversion Office after the destruction.
Reverse Distributors Authorized to Destroy Substances
A pharmacy may at any time forward controlled substances to DEA registered reverse distributors who handle the disposal of
drugs. The pharmacist may contact their local DEA Diversion Field Office for an updated list of those reverse distributors in
their area. When a pharmacy transfers Schedule II substances to a reverse distributor for destruction, the distributor must issue an Official Order Form (DEA Form-222) to the pharmacy. When Schedule III-V controlled substances are transferred to
a reverse distributor for destruction, the pharmacy should document in writing the drug name, dosage form, strength, quantity
and date transferred. The DEA registered reverse distributor who will destroy the controlled substances is responsible for submitting a DEA Form-41 to DEA when the drugs have been destroyed. A DEA Form-41 should not be used to record the
transfer of controlled substances between the pharmacy and the registered reverse distributor disposing the drugs.
"Blanket Authorization" for Destruction of Controlled Substances
DEA will issue a "Blanket Authorization" for destruction of controlled substances on a very limited basis to those registrants
who are associated with hospitals, clinics or other registrants having to dispose of used needles, syringes or other injectable
objects only. This limited exception is granted because of the probability that those objects have been contaminated by hazardous bodily fluids. The pharmacist should contact their local DEA Diversion Field Office for information about how to request such an authorization. DEA will evaluate requests for a blanket authorization based on the following guidelines:
Frequency of destruction (i.e., daily, weekly) and volume of drugs involved that warrant such authorization.
Method of destruction. Drugs must be destroyed in such a manner that they are beyond reclamation.
Registrant’s past history.
Security at the pharmacy or registered location.
Name and position of the individual responsible for the destruction.
Those registrants granted blanket authorization to destroy controlled substances must complete DEA Form-41 (Registrants
Inventory of Drugs Surrendered).
5.
Security Requirements
The DEA requires pharmacies to keep Schedules II, III, IV and V controlled substances in a locked cabinet or dispersed
through the non-controlled stock to deter theft. An electronic alarm system is recommended.
Request for Employment Waiver for Pharmacy Employees
A pharmacy registrant (i.e., the registrant or corporation which owns the pharmacy) must not employ in a position which allows access to controlled substances, anyone who has been convicted of a felony relating to controlled substances, or who, at
any time, has had an application for DEA registration denied, revoked, or surrendered for cause. "For cause" means surrendering a registration in lieu of, or as a consequence of, any federal or state administrative, civil or criminal action resulting
from an investigation of the individual’s handling of controlled substances.
However, pharmacies desiring to employ an individual who meets this definition may request an exception to this requirement from DEA. The employer must have a waiver approved before hiring the applicant. A waiver request should be sent to
DEA Headquarters.
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A pharmacy registrant who applies for such a waiver should understand that the following factors will be considered:
A detailed description of the nature and extent of the applicant’s past controlled substances violations.
Activities of the applicant since the violation.
Current status of the applicant’s state licensure.
Extent of applicant’s proposed access to controlled substances.
Registrant’s proposed physical and professional safeguards to prevent diversion by the applicant if employed.
Status of employing registrant regarding handling of controlled substances.
Other pertinent information uncovered by DEA in its investigation of the applicant’s or registrant’s handling of controlled
substances.
Such a waiver should not be considered unless there are valid reasons to believe that diversion is unlikely to occur.
6.
Controlled Substance Theft or Loss
(1) Notify DEA and Local Police
Immediately upon discovery of a theft or significant loss of controlled substances, a pharmacy, as required by regulation,
must contact the nearest DEA Diversion Field Office by telephone, facsimile or by a brief written message explaining the circumstances. A pharmacy should also notify the local police as may be required by state law. If there is a question as to whether a theft has occurred or a loss is significant, a registrant should err on the side of caution and report it to DEA.
DEA must be notified directly. This requirement is not satisfied by reporting the theft or significant loss in any other manner.
For example, a corporation which owns/operates multiple registered sites and wishes to channel all notifications through corporate management or any other internal department responsible for security must still provide notice directly to DEA "upon
discovery" and keep a copy for its records.
(2) Complete DEA Form-106
A pharmacy shall also complete a DEA Form-106 (Report of Theft or Loss of Controlled Substances). To obtain a DEA
Form-106, contact the nearest DEA Diversion Field Office. The DEA Form-106 will formally document the actual circumstances of the theft or significant loss and the quantities of controlled substances involved, once this information has been determined conclusively. The pharmacy should send the original DEA Form-106 and a copy to the DEA Diversion Field Office
and keep a copy for its records.
The DEA Form 106 must include the following information:
Name and address of firm (pharmacy)
DEA registration number
Date of theft
Name and telephone number of local police department notified
Type of theft (night break in, armed robbery, etc.)
Listing of symbols or cost code used by pharmacy in marking containers (if any)
Listing of controlled substances missing from theft or significant loss
(3) If Investigation Finds No Theft or Loss
If after an investigation of the circumstances surrounding the theft or significant loss it is determined that no such theft or significant loss occurred, no DEA Form-106 need be filed.
However, the registrant should notify DEA in writing of this fact in order to resolve the initial report and explain why no
DEA Form-106 was filed regarding the incident.
(4) Registrant’s Responsibility for Identifying "Significant Loss"
Although the CSA regulations do not define the term "significant loss," it is the responsibility of the registrant to use his/her
best judgment to take appropriate action. A significant loss depends, in large part, on the business of the pharmacy and the
likelihood of a rational explanation for a particular occurrence. What would constitute a significant loss for a pharmacy may
be viewed as comparatively insignificant for a hospital or distributor.
Further, the loss of a small quantity of controlled substances, repeated over a period of time, may indicate a significant problem for a registrant, a problem which must be reported to DEA, even though the individual amounts of missing controlled
substances are not, in and of themselves, significant. Registrants must report a loss upon discovery. In particular, a pharma-
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cist should be alert for suspicious or unexplained losses. Any signs of a break in, physical entry or armed robbery should be
reported. The burden of responsibility is on the registrant to identify what is a significant loss and make the required report to
DEA.
Some factors to consider for determining significant loss include:
The schedule of the missing items.
The abuse potential of the missing items.
The abuse potential in your area of the missing substance.
The quantity missing (one tablet vs. one bottle or container).
Is this the first time this loss has occurred? Has a similar loss occurred before?
Was this loss reported to local law enforcement authorities?
If there is a question as to whether a loss is significant, a registrant should err on the side of caution and report it to DEA.
If it is determined that the loss is not significant, place a record of the occurrence in your theft and loss file for future reference.
In-Transit Loss
When all or part of a shipment disappears, or never reaches its intended destination, the supplier is responsible for reporting
the in-transit loss of controlled substances to DEA. A pharmacy is responsible for reporting any loss of controlled substances
after a pharmacist has signed for or taken custody of a shipment. If it’s discovered after that point that an in-transit loss or
theft has occurred, the pharmacist must submit a DEA Form-106.
Breakage/Spillage
DEA further wishes to clarify that the breakage of controlled substances does not constitute a "loss" of controlled substances.
When there is breakage, damage or spillage or some other form of destruction, any recoverable controlled substances must be
disposed of according to DEA requirements. Damaged goods may be disposed of through shipment to a "reverse distributor"
or by a DEA approved process as defined in (Destruction of Controlled Substances). When this disposal occurs, it must be
reported to DEA on a DEA Form-41 (Registrants Inventory of Drugs Surrendered).
7.
Recordkeeping Requirements
Every pharmacy must maintain complete and accurate records on a current basis for each controlled substance purchased, received, distributed, dispensed or otherwise disposed of. All records of controlled substances must be maintained for two
years.
This recordkeeping system allows a controlled substance to be tracked from the time it is manufactured to the time it is dispensed to the ultimate user. All records concerning controlled substances must be maintained for at least two years for inspection and copying by duly authorized DEA officials. Records and inventories of Schedule II controlled substances must be
maintained separately from all other records of the registrant. All records and inventories of Schedule III, IV and V controlled
substances must be maintained either separately from all other records or in such a form that the information required is readily retrievable from the ordinary business records. Readily retrievable means that:
Certain records are kept by automatic data processing systems or other electronic or mechanized recordkeeping systems in
such a manner that they can be separated out from all other records in a reasonable time.
And/or records are kept on which certain items are asterisked, redlined or in some other manner visually identifiable apart
from other items appearing on the records.
Records that Must be Maintained
Official Order Forms (DEA Form-222).
Power of Attorney authorization to sign Order Forms.
Receipts and invoices for Schedule III, IV, and V controlled substances as well as "threshold quantities" of List I chemicals.
All inventory records of controlled substances, including the initial and biennial inventories.
Records of controlled substances distributed or dispensed (i.e., prescriptions) and threshold amounts of List I chemicals distributed.
Report of Theft or Loss (DEA Form-106).
Inventory of Drugs Surrendered for Disposal (DEA Form-41).
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Records of transfers of controlled substances between pharmacies.
DEA registration certificate.
DEA's Official Order Forms are the required records of receipt and sale for Schedule II controlled substances.
The quantity of a particular chemical, above which recordkeeping and other control provisions of the CSA apply.
8.
Central Recordkeeping
A registrant desiring to maintain shipping and financial records at a central location other than the registered location must
notify the nearest DEA Diversion Field Office. Unless the registrant is informed by the DEA that the permission to keep central records is denied, the registrant may begin maintaining central records 14 days after notifying DEA. Central recordkeeping requirements are described in 21 CFR 1304.04. Central recordkeeping permits are no longer issued by the DEA.
Prescription Records
Pharmacies have three options for filing prescription records under the Code of Federal Regulations. If there is a conflict between federal and state requirements for filing prescriptions, DEA recognizes that the pharmacy must choose a filing system
that would comply with both federal and state law.
All prescription records must be readily retrievable for DEA inspection. Controlled substance prescriptions must be filed in
one of the following three ways:
Option 1 (Three separate files)
A file for Schedule II drugs dispensed,
A file for Schedule III, IV and V drugs dispensed, and
A file for prescription orders for all noncontrolled drugs dispensed.
Option 2 (Two separate files)
A file for all Schedule II drugs dispensed,
A file for all other drugs dispensed (noncontrolled and those in Schedule III, IV and V). If this method is used, a prescription
for a Schedule III, IV and V drug must be made readily retrievable by use of a red "C" stamp not less than one inch high.
Option 3 (Two separate files)
A file for all Schedule II-V controlled substances. If this method is used, a prescription for a Schedule III, IV and V drug
must be made readily retrievable by use of a red "C" stamp not less than one inch high.
A file for prescription orders for all noncontrolled drugs dispensed.
If a pharmacy has an electronic recordkeeping system for prescriptions which permits identification by prescription number
and retrieval of original documents by prescriber's name, patient's name, drug dispensed and date filled, then the requirements
to mark the hard copy prescription with a red "C" is waived.
9.
Inventory Requirements
Inventory means a complete and accurate list of all stocks and forms of controlled substances in the possession of the registrant as determined by an actual physical count. The CFR also requires that all inventories be maintained at the registered location in a readily retrievable manner for at least two years for copying and inspection. In addition, the inventory of Schedule
II controlled substances must be kept separate from those for all other controlled substances.
Initial Inventory
When issued a DEA registration, a registrant must take an initial inventory, which is an actual physical count of all controlled
substances in their possession. If there are no stocks of controlled substances on hand, the registrant should make a record
showing a zero inventory. There is no requirement to submit a copy of the inventory to the DEA.
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The Code of Federal Regulations (CFR) requires that the inventory include:
The inventory date.
The time the inventory is taken (i.e., opening or close of business).
The drug name.
The drug strength.
The drug form (e.g., tablet, capsule, etc.).
The number of units/volume.
The total quantity.
DEA recommends that the inventory record include:
The name, address and DEA registration number of the registrant.
The signature of the person or persons responsible for taking the inventory.
Biennial Inventory
Following the initial inventory, the registrant is required to take a biennial inventory (every two years), which requires the
same information as the initial inventory (see list above) of all controlled substances on hand. The biennial inventory may be
taken on any date within two years of the previous inventory date. There is no requirement to submit a copy of the inventory
to DEA.
When taking the inventory of Schedule II controlled substances, an actual physical count must be made. For the inventory of
Schedules III, IV and V controlled substances, an estimated count may be made. An actual physical count must be made if
the container holds more than 1,000 dosage units and has been opened.
Inventorying Newly Scheduled Controlled Substances
When a drug not previously controlled is scheduled, the drug must be inventoried as of the effective date of scheduling.
Inventory of Drugs for Destruction or No Longer Saleable
Each controlled substance that is (1) damaged, defective, or impure and is awaiting disposal, (2) held for quality control purposes, or (3) maintained for extemporaneous compoundings, must be inventoried.
The Code of Federal Regulations (CFR) requires that the inventory include:
The inventory date.
The drug name.
The drug strength.
The drug form (e.g., tablet, capsule, etc.).
The total quantity or total number of units/volume.
The reason why the substance is being maintained.
Whether substance is capable of being used in the manufacture of any controlled substance in finished form.
10.
Ordering Controlled Substances
Only Schedule I and II controlled substances are ordered with a DEA Form-222. An Official Order Form is required for each
distribution, purchase or transfer of a Schedule II controlled substance.
When a controlled substance has been transferred by DEA from Schedule II to another Schedule at the federal level, in many
states it remains in Schedule II pending any legislative or administrative actions that may result from the federal action. Many
states require that transactions involving substances that they classify as Schedule II be made via DEA Form-222 Official Order Forms. Where federal and state laws or regulations are different, the stricter applies. When the use of DEA Form-222 Official Order Forms for the transfer of a controlled substance is not required under federal law, its use as mandated by these
states does not violate federal law and is therefore permitted.
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Requesting Official Order Forms
Official Order Forms can be initially requested on the application for new registration (DEA Form-224). There is no charge.
Once a registrant has received Official Order Forms (DEA Form-222), a separate requisition form (DEA Form-222a) will be
mailed to the registrant to request additional Official Order Forms. The registrant may also request Official Order Forms by
calling either the DEA Headquarters Registration Unit or the nearest DEA Registration Field Office.
Each book of DEA Official Order Forms consists of seven sets of forms. Each pharmacy is provided a maximum of six books
at one time unless its needs exceed this limit. In such a case, the pharmacy should contact the DEA Registration Field Office
serving their state.
Completing Official Order Forms
When ordering Schedule II substances, the pharmacist is responsible for filling in the number of packages, the size of the
package and the name of the item. Each Official Order Form must be signed and dated by a person authorized to sign a registration application. (See Power of Attorney to Sign an Official Order Form). When the items are received, the pharmacist
must document on the purchaser’s copy (copy 3) the actual number of packages received and the date received. Official Order Forms must be maintained separately from the pharmacy’s other business records. However, this does not preclude a registrant from attaching a copy of the supplier's invoice to the related Order Form.
The Code of Federal Regulations requires that the Official Order Form must be "complete, legible, and properly prepared,
with no signs of alteration, erasure or change of any description." A supplier may refuse to accept an order for any of these
reasons. However, DEA has acknowledged some minor changes or alterations may be accepted by a supplier. For example,
suppliers may correct Official Order Forms that have:
Minor errors, which lack inconsequential information or
An incorrect date unintentionally annotated by the purchaser.
If an order is refused, the supplier should return Official Order Form copies 1 and 2 to the purchaser with a statement explaining the reason the order was refused.
DEA policy does not preclude the substitution of identical products differing in packaging size from those initially ordered,
provided that the actual quantity received does not exceed the amount initially ordered and that the National Drug Code number reflected is that of the actual product shipped. For example, a distributor may substitute 5 bottles of 100, 2mg tablets for 1
bottle of 500, 2mg tablets or any variation thereof.
Power of Attorney to Sign an Official Order Form
Any registrant (pharmacy) may authorize one or more individuals, whether or not they are located at the registered location,
to obtain and execute Official Order Forms by granting a power of attorney to each such individual. The power of attorney
must be signed by the same person who signed the most recent application for registration or renewal registration, as well as
the individual being authorized to obtain and execute Official Order Forms. The power of attorney may be revoked at any
time by the person who signed the power of attorney. It is necessary to grant a new power of attorney when the pharmacy
completes a renewal registration, only if the renewal application is signed by a different person. The power of attorney should
be filed with executed Official Order Forms as a readily retrievable record. The power of attorney is not submitted to DEA.
Suggested formats for granting and revoking power of attorney follow:
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POWER OF ATTORNEY FOR DEA ORDER FORMS
_________________________(Name of registrant)
_________________________(Address of registrant)
_________________________(DEA registration number)
I, _______________________________________________(name of person granting power), the undersigned, who is authorized to sign the current application for registration of the above named registrant under the Controlled Substances Act or
Controlled Substances Import and Export Act, have made, constituted, and appointed, and by these present, do make, constitute, and appoint _________________________________(name of attorney-in-fact), my true and lawful attorney for me in
my name, place, and stead, to execute applications for books of official order forms and to sign such order forms in requisition for Schedule I and II controlled substances, in accordance with Section 308 of the Controlled Substances Act (21 U.S.C,
828) and part 1305 of Title 21 of the Code of Federal Regulations. I hereby ratify and confirm all that said attorney shall lawfully do or cause to be done by virtue hereof.
(Signature of person granting power) I, _______________________(name of attorney-in-fact), hereby affirm that I am the
person named herein as attorney-in-fact and that the signature affixed hereto is my signature.
Witnesses:
1. _______________________
2. _______________________
Signed and dated on the ____ day of ______________in the year_____ at _______________________________.
NOTICE OF REVOCATION OF POWER OF ATTORNEY
The foregoing power of attorney is hereby revoked by the undersigned, who is authorized to sign the current application for
registration of the above-named registrant under the Controlled Substances Act or the Controlled Substances Import and Export Act. Written notice of this revocation has been given to the attorney-in-fact ____________________________ this same
day. (Signature of person revoking power)
Witnesses:
1. ______________________
2. ______________________
Signed and dated on the _____ day of _______________, in the year_____ at _____________________________.
Lost or Stolen Order Forms
When the pharmacist has not received a shipment of controlled substances, he/she should first contact the supplier to determine whether the original DEA Form-222 was received. If the original order form has been lost or stolen, the pharmacist
must complete a second order form so the supplier can fill the original order. The pharmacist must also prepare a statement
which includes the first order form’s serial number and date, and verify that the drugs ordered were never received. Attach a
copy of the statement to the second order form that is sent to the supplier. The pharmacist must keep a copy of the statement
with copy 3 from the first and second order forms.
A pharmacy, upon discovery of the loss or theft of unused order forms, must immediately report the loss to the nearest DEA
Diversion Field Office, and provide the serial numbers of each lost or stolen order form. If an entire book or multiple books
of order forms are lost or stolen, and the serial numbers of the missing forms cannot be identified, the pharmacist must report
the approximate date of issuance (in lieu of the serial numbers) to the DEA. If an unused order form reported stolen or lost is
later recovered or found, the pharmacy must immediately notify the nearest DEA Diversion Field Office.
Schedule III-V Substances
The registrant (pharmacy) must keep a receipt (i.e., invoice or packing slip) on which they record the date the drugs were received and confirm that the order is accurate. Receipts must be maintained in a readily retrievable manner for inspection by
the DEA.
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11.
Prescription Requirements
To dispense controlled substances, a pharmacist must know the requirements for a valid prescription which are described in
this section. A prescription is an order for medication which is dispensed to or for an ultimate user. A prescription is not an
order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to
an inpatient for immediate administration in a hospital is not a prescription.)
A prescription for a controlled substance must be dated and signed on the date when issued. The prescription must include the
patient’s full name and address, and the practitioner’s name, address, and registration number. The prescription must also include the drug name, strength, dosage form, quantity prescribed, directions for use, and number of refills. Where an oral prescription is not permitted, a prescription must be written in ink or indelible pencil or typewritten and must be manually signed
by the practitioner. An individual (i.e., secretary or nurse) may be designated by the practitioner to prepare prescriptions for
his/her signature. The practitioner is responsible for making sure that the prescription conforms in all essential respects to the
law and regulations.
Who May Issue
A prescription order for a controlled substance may be issued only by a physician, dentist, podiatrist, veterinarian, mid-level
practitioner or other registered practitioner who is:
Authorized to prescribe controlled substances by the jurisdiction in which he/she is licensed to practice; and
Registered with DEA or exempted from registration (i.e., Public Health Service and Bureau of Prison physicians).
Construction of Valid DEA Registration Numbers for Practitioners
Knowing how a DEA registration number is constructed can be a useful tool for recognizing a forged prescription. Prior to
October 1, 1985, DEA registration numbers for physicians, dentists, veterinarians and other practitioners started with the letter A. New registration numbers issued to practitioners after that date begin with the letter B. Now that B has been exhausted,
the DEA uses the letter F. Registration numbers issued to mid-level practitioners begin with the letter M. The first letter of
the registration number is followed by the first letter of the registrant’s last name. (e.g., J for Jones or S for Smith), and then a
computer generated sequence of seven numbers (such as MJ3614511). To verify the DEA number, the following steps can
be used: (1) add the first, third, and fifth digits; (2) add the second, fourth, and sixth digits, then multiply the result by 2; (3)
add the result of (1) and (2), and the last digit of this sum must be the same as the last digit of the DEA number.
Practitioner’s Use of a Hospital’s DEA Registration Number
An individual practitioner (e.g., intern, resident, staff physician, mid-level practitioner) who is an agent or employee of a hospital or other institution may, when acting in the usual course of business or employment, administer, dispense or prescribe
controlled substances under the registration of the hospital or other institution in which he or she is employed, provided that:
The dispensing, administering, or prescribing is in the usual course of professional practice;
The practitioner is authorized to do so by the state in which he or she is practicing;
The hospital or institution has verified that the practitioner is permitted to dispense, administer or prescribe controlled substances within the state;
The practitioner acts only within the scope of employment in the hospital or institution;
The hospital or institution authorizes the practitioner to dispense or prescribe under its registration and assigns a specific internal code number for each practitioner so authorized (See example of a specific internal code number below);
A current list of internal codes and the corresponding individual practitioners is to be kept by the hospital or other institution.
This list is to be available at all times to other registrants and law enforcement agencies upon request for the purpose of verifying the authority of the prescribing individual practitioner. Pharmacists should contact the hospital or other institution for
verification if they have any doubts in dispensing such a prescription.
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Exception to the Registration Requirement for Public Health Service or Bureau of Prisons Personnel
Any official of the Public Health Service or Bureau of Prisons who is authorized to prescribe, dispense or administer, but not
to procure or purchase, controlled substances in the course of his or her official duties, is not required to be registered with
DEA. Such officials must specify their agency and service identification number of the issuing official in lieu of a DEA registration number on any prescriptions for controlled substances. The service identification number for a public Health Service
employee is his/her Social Security Number.
Registration Requirement for Military Personnel
The requirement for registration is waived for military physicians who prescribe, dispense, or administer, but do not procure
or purchase, controlled substances in the course of official duties. Military physicians issuing prescriptions must indicate the
branch of service or agency and the service identification number in lieu of the registration number required on prescriptions.
Such prescriptions may be filled off base at community pharmacies.
Many computer systems at pharmacies are programmed to accept a DEA registration number and the use of a service identification number causes delays when dispensing a prescription. As a result, DEA has begun to issue DEA registrations to active
duty military physicians to expedite the filling of prescriptions at community pharmacies. Therefore, a prescription from a
military physician must contain either the service identification number or a DEA registration number of the prescriber.
DEA will not issue registrations to mid-level practitioners (MLP) in the military unless they are specifically licensed in the
state where they are stationed and the state allows the MLP to dispense controlled substances.
Physicians and MLPs must obtain a separate DEA registration for any work outside of official duties and they must follow
the requirements of the jurisdiction in which they are performing the non-official work.
Mid-Level Practitioners
Mid-level practitioners (MLP) are registered and authorized by the DEA and the state in which they practice to dispense, administer and prescribe controlled substances in the course of professional practice. Examples of MLPs include, but are not
limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists, physician assistants, optometrists, ambulance services, animal shelters, veterinarian euthanasia technicians, nursing homes and
homeopathic physicians.
MLPs may receive individual DEA registration granting controlled substance privileges. However, such registration is contingent upon authority granted by the state in which they are licensed. DEA registers MLPs whose states clearly authorize
them to prescribe, dispense and administer controlled substances in one or more schedules. The fact that an MLP has been
issued a valid DEA registration number (beginning with the letter M) will be evidence that he/she is authorized to prescribe,
dispense and/or administer at least some controlled substances.
However, it will still be incumbent upon the pharmacist who fills the prescription to ensure that the MLP is prescribing within the parameters established by the state in which he/she practices. MLP authority to prescribe controlled substances varies
greatly by state. Check with your state licensing or controlled substances authority to determine which MLP disciplines are
authorized to prescribe controlled substances in your state.
Purpose of Issue
To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting
in the usual course of sound professional practice. The practitioner is responsible for the proper prescribing and dispensing of
controlled substances. However, a corresponding responsibility rests with the pharmacist who dispenses the prescription. An
order for controlled substances which purports to be a valid prescription, but is not issued in the usual course of professional
treatment, or for legitimate and authorized research, is not a valid prescription within the meaning and intent of the CSA. The
individual who knowingly dispenses such a purported prescription, as well as the individual issuing it, will be subject to criminal and/or civil penalties and administrative sanctions.
A prescription may not be issued in order for an individual practitioner to obtain a supply of controlled substances for the
purpose of general dispensing to his/her patients. Therefore, a prescription written for office stock or "medical bag" use is not
valid.
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12.
Schedule II substances require a written prescription which must be signed by the practitioner. There is no time limit when a
Schedule II prescription must be filled after being signed by the physician. However, the pharmacist must determine that the
prescription is still needed by the patient (e.g., a narcotic prescription filled several weeks after being written.) Federal regulations place no quantity limits on any prescriptions. For Schedule II substances, an oral order is only permitted in an emergency situation. (See Emergency Dispensing of Schedule II Controlled Substances.)
Refills
Refilling a Schedule II prescription is prohibited.
Facsimile Prescriptions for Schedule II Substances
In order to expedite filling the prescription, a prescriber may fax the Schedule II prescription to the pharmacy, as authorized
in a final rule published in May 1994. This rule requires that the original Schedule II prescription be presented to the pharmacist and verified against the facsimile at the time the controlled substance is actually dispensed. The pharmacist must make
sure the original document is properly annotated and filed with the records that are required to be kept.
In an emergency, a practitioner may transmit a prescription for a Schedule II controlled substance by facsimile or telephone
to the pharmacy, and the pharmacist may dispense the prescription. However, the prescribing practitioner must provide a
written, signed prescription to the pharmacist within seven days, and the pharmacist must notify DEA if he/she does not receive the prescription. (See Emergency Dispensing of Schedule II Controlled Substances.)
Exceptions for Schedule II Facsimile Prescriptions
DEA also granted three exceptions to the facsimile prescription requirements for Schedule II controlled substances. The facsimile of a Schedule II prescription may serve as the original prescription as follows:
A practitioner prescribing Schedule II narcotic controlled substances for a patient undergoing home
infusion/intravenous (IV) pain therapy, may transmit the prescription by facsimile. The practitioner’s agent may also
transmit the prescription to the pharmacy. The pharmacy will consider the facsimile prescription a "written prescription" and no further prescription is required. All normal requirements of a legal prescription must be followed.
Practitioners prescribing Schedule II controlled substances for patients in Long Term Care Facilities (LTCF), which
are normally filled and delivered to the facility by the pharmacy, may transmit a prescription by facsimile to the dispensing pharmacy. The practitioner’s agent may also transmit the prescription to the pharmacy. The facsimile prescription serves as the original written prescription for the pharmacy. No further original prescription is required.
A practitioner prescribing a Schedule II narcotic substance for a patient in hospice care as certified by Medicare under Title XVIII or licensed by the state, may transmit a prescription to the dispensing pharmacy by facsimile regardless of whether the patient resides in a hospice facility or other care setting. The practitioner’s agent may also
transmit the prescription to the pharmacy. The practitioner will note on the prescription that it is for a hospice patient.
The facsimile serves as the original written prescription.
13.
Schedule III-V Substances
A prescription for controlled substances in Schedules III, IV and V issued by a practitioner may be communicated either orally, in writing or by facsimile to the pharmacist and may be refilled if so authorized on the prescription.
Refills
Schedule III and IV controlled substances may be refilled if authorized on the prescription. However, the prescription may
only be refilled up to five times within six months after the date of issue. After five refills or after six months, whichever occurs first, a new prescription is required. A patient is permitted to request a refill of an existing Schedule III-V controlled substance prescription by sending an e-mail to the pharmacy or by telephone. Schedule V controlled substances may only be
refilled as authorized on the prescription by the prescribing practitioner.
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When a prescription for any controlled substance in Schedule III, IV, or V is refilled, the following information must be entered on the back of the prescription: the dispensing pharmacist’s initials, the date the prescription was refilled, and the
amount of drug dispensed on the refill. If the pharmacist only initials and dates the back of the prescription, the pharmacist
will be deemed to have dispensed a refill for the full face amount of the prescription.
Computerization of Prescription Information
A pharmacy is permitted to use a data processing system as an alternative to the manual method for the storage and retrieval
of prescription order refill information for Schedules III, IV and V controlled substances.
The computer system must provide on-line retrieval of original prescription information for those prescriptions which are currently authorized for refill. The information must include, but is not limited to the original prescription number, date of issuance, full name and address of the patient, the prescriber’s name, address, and DEA registration number; the name, strength,
dosage form and quantity of the controlled substance prescribed; and the total number of refills authorized by the prescriber.
In addition, the computer system must provide on-line retrieval of the current refill history for Schedule III, IV, or V controlled substance prescriptions. This information must include, but is not limited to: the name of the controlled substance, the
date of refill, the quantity dispensed, the dispensing pharmacist’s identification code, or name/initials for each refill, and the
total number of refills dispensed to date for that prescription. The pharmacist must verify and document that the refill data
entered into the system is correct. All computer generated prescription/refill documentation must be stored in a separate file at
the pharmacy and be maintained for a two-year period from the dispensing date. To meet the CFR recordkeeping requirements, the pharmacy’s computer must comply with the following guidelines:
If the system provides a hard copy printout of each day’s controlled substance prescription refills, each pharmacist who refilled those prescriptions shall verify their accuracy by signing and dating the printout as he/she would sign a check or legal
document.
This printout must be provided to each pharmacy which uses the computer system within 72 hours of the date on which the
refill was dispensed. The printout must be verified and signed by each pharmacist who dispensed the refills.
In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file in which each pharmacist involved
in the day’s dispensing signs a statement verifying that the refill information entered into the computer that day has been reviewed by him/her and is correct.
A pharmacy computer system shall have the capability of printing out any refill data which the pharmacy must maintain under the Controlled Substances Act. For example, this would include a refill-by-refill audit trail for any specified strength and
dosage form of any controlled substance, by either brand or generic name or both, dispensed by the pharmacy. Such a printout must include:
Prescribing practitioner’s name.
Patient’s name and address.
Quantity dispensed on each refill.
Dispensing date for each refill.
Name or identification code of the dispensing pharmacist.
Original prescription number.
In any computerized system employed by a user pharmacy, the central recordkeeping location must be capable of providing a
printout to a requesting pharmacy of the above information within 48 hours.
In case a pharmacy's computer system experiences downtime, the pharmacy must have a back-up procedure to document in
writing refills of Schedule III, IV and V substances. This procedure must ensure that refills are authorized by the original prescription, that the maximum number of refills has not been exceeded, and that all required data is retained for on-line entry as
soon as possible.
A pharmacy may use only one of the two systems described (i.e., manual or computer).
Facsimile Prescriptions for Schedule III-V Substances
Prescriptions for Schedules III-V controlled substances may be transmitted by facsimile from the practitioner or an employee
or agent of the individual practitioner. The facsimile is considered to be equivalent to an original prescription.
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Telephone Authorization for Schedule III-V Prescriptions
Only the practitioner can prescribe controlled substances and this authority cannot be delegated to anyone else. A prescription
issued by a practitioner may be called in to a pharmacist by the practitioner or an employee or agent of the individual practitioner. It is the pharmacist’s responsibility to insure that these telephone prescriptions are valid and properly authorized by
the practitioner.
Transfer of Prescription Information
DEA will allow the transfer of original prescription information for Schedules III, IV and V controlled substances for the purpose of refill dispensing between pharmacies on a one time basis, if permissible under state law. Pharmacies electronically
sharing a real time, online database may transfer up to the maximum refills permitted by law and the prescriber’s authorization. Such systems must contain the information required for a valid prescription.
Prescription Monitoring Programs
A prescription monitoring program is a state-administered data collection system used to gather prescription information.
This information may be made available to state and federal investigators on a need-to-know basis.
Many states have adopted either a multiple copy prescription program or an electronic data transmission system because they
have proven to be an effective tool for detecting pharmaceutical diversion, for developing pharmacist and physician medical
education programs that heighten awareness about diversion, prescription drug abuse, drug trends, and for tracking effective
use of prescription medication within a state. For the pharmacist, the data can be used to identify potential "doctor shoppers,"
and those who attempt to obtain controlled substances by fraud, forgery or deceit.
In the states that have adopted these programs, a large part of their success has been attributed to the pharmacists’ participation. DEA strongly endorses prescription monitoring programs and works closely with the states on these programs.
14.
Dispensing Requirements
Required Information on Prescription Labels
The pharmacist dispensing a prescription for a controlled substance must affix to the container a label showing the pharmacy
name and address, the serial (prescription) number, date of initial dispensing, the name of the patient, the name of the prescribing practitioner, and directions for use and cautionary statements, if any, contained on the prescription as required by
law.
Federal Food and Drug Administration (FDA) regulations require that the label of any drug listed as a "Controlled Substance"
in Schedules II, III, or IV of the Controlled Substances Act must, when dispensed to or for a patient, contain the following
warning: CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.
A pharmacist may dispense a Schedule II controlled substance, which is a prescription drug as determined under the Federal
Food, Drug and Cosmetic Act, only pursuant to a written prescription signed by the practitioner, except in an emergency situation as described in the following section.
Emergency Dispensing
Emergency means that the immediate administration of the drug is necessary for proper treatment of the intended ultimate
user, that no alternative treatment is available (including a drug which is not a Schedule II controlled substance), and it is not
possible for the prescribing practitioner to provide a written prescription for the drug at that time.
In a bona fide emergency, a practitioner may telephone a Schedule II prescription to the pharmacy or transmit the prescription
by facsimile to the pharmacy, and the pharmacist may dispense the prescription provided that:
The drug prescribed and dispensed must be limited to the amount needed to treat the patient during the emergency period.
Prescribing or dispensing beyond the emergency period must be pursuant to a written prescription order.
The prescription order must be immediately reduced to writing by the pharmacist and must contain all information, except for
the prescribing practitioner’s signature.
If the prescriber is not known to the pharmacist, the pharmacist must make a reasonable effort to determine that the phone
authorization came from a valid practitioner, by verifying the practitioner’s telephone number with that listed in the directory
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and by making other good faith efforts to insure proper identity.
Within seven days after authorizing an emergency telephone prescription, the prescribing practitioner must furnish the pharmacist a written, signed prescription for the controlled substance prescribed. The prescription must have written on its face
"Authorization for Emergency Dispensing." The written prescription may be delivered in person or by mail, which must be
postmarked within the seven day period. Upon receipt, the dispensing pharmacist must attach this written prescription to the
oral prescription reduced to writing by the pharmacist. By law the pharmacist must notify the nearest DEA Diversion Field
Office if the prescriber fails to provide a written prescription within seven days. If the pharmacist fails to do so, his/her authority to dispense without a written prescription will be void.
Partial Dispensing
The pharmacist may partially dispense a prescription for a Schedule II controlled substance if he/she is unable to supply the
full quantity in a written or emergency oral (telephone) prescription, provided the pharmacist notes the quantity supplied on
the front of the written prescription (or on a written record of the emergency oral prescription). The remaining portion may be
dispensed within 72 hours of the first partial dispensing. However, if the remaining portion is not or cannot be dispensed
within the 72-hour period, the pharmacist must notify the prescribing practitioner. No further quantity may be supplied beyond the 72 hours, except on a new prescription.
Exception for Schedule II Prescriptions at Long Term Care Facilities
An exception has been made for patients in Long Term Care Facilities (LTCF) and patients who have been diagnosed with a
terminal illness. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist must
contact the practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing practitioner have a
corresponding responsibility to assure that the controlled substance is for a terminally ill patient. The pharmacist must record
on the prescription whether the patient is "terminally ill" or an "LTCF patient." A prescription that is partially filled and does
not contain the notation "terminally ill" or "LTCF patient" will be deemed to have been filled in violation of the CSA. In such
cases, prescriptions may be filled in partial quantities, including single dosage units. For each partial filling, the pharmacist
must note on the prescription (or other uniformly maintained, readily retrievable record) the date the prescription was partially filled, the quantity dispensed, the remaining quantity and the identification of the dispensing pharmacist. Such prescriptions are valid for a maximum of 60 days from the date of issue, unless terminated earlier by discontinuance of the
medication.
Internet Pharmacy
The actual physical location of the pharmacy which purchases, stores, and dispenses controlled substances pursuant to prescription orders processed by the Internet site must be registered with DEA. Under the Ryan Haight Act of 2008, any person
who operates a web site that fits within the definition of an “online pharmacy” must obtain from DEA a modification of its
DEA pharmacy registration that expressly authorizes such online activity. Only DEA-registered pharmacies are eligible under
the Act to obtain such a modification of registration.
The pharmacy must have a license from the state in which the controlled substances are stored and dispensed and, in most
instances, from any state in which it is planned to conduct business with customers. Pharmacists should also be aware that
many states require licenses for the web site itself since these sites often provide services like patient counseling. Being an
Internet pharmacy does not change the pharmacy’s responsibilities under DEA regulations. The pharmacy is still authorized
to sell controlled substances only when there is a valid prescription from a DEA-registered practitioner who issued the prescription in the usual course of his or her professional practice.
A pharmacist may dispense a Schedule II controlled substance only after the patient or prescriber provides an original signed
prescription prior to dispensing. The label on the prescription filled must indicate the location that dispensed the controlled
substance.
Some Internet pharmacies have doctors who prescribe substances based on an on-line questionnaire. Federal law requires that
"A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his professional practice" (21 CFR 1306.04(a)) . Every state separately imposes a
similar acting requirement under its laws. Under Federal and state law, for a doctor to be acting in the usual course of professional practice, there must be a bona fide doctor/patient relationship.
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For purpose of state law, many state authorities, with the endorsement of medical societies, consider the existence of the following four elements as an indication that the legitimate doctor/patient relationship has been established:
-A patient has a medical complaint;
-A medical history has been taken;
-A physical examination has been performed; and
-Some logical connection exists between the medical complaint, the medical history, the physical examination, and the drug
prescribed.
Electronic Transmission of Prescriptions
DEA is currently engaged in a project to establish the requirements for secure electronic transmission of all controlled substance prescriptions between the practitioner and the pharmacy. The interim final rule allowing e-prescribing of of controlled
substances was published on March 31, 2010 in the Federal Register, Volume 75, Number 61. (The DEA regulations will be
updated in this document after the final rule is published). The summary from the interim final rule reads:
The Drug Enforcement Administration (DEA) is revising its regulations to provide practitioners with the option of writing
prescriptions for controlled substances electronically. The regulations will also permit pharmacies to receive, dispense, and
archive these electronic prescriptions. These regulations are in addition to, not a replacement of, the existing rules. The regulations provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance
prescriptions while maintaining the closed system of controls on controlled substances dispensing; additionally, the regulations will reduce paperwork for DEA registrants who dispense controlled substances and have the potential to reduce prescription forgery. The regulations will also have the potential to reduce the number of prescription errors caused by illegible
handwriting and misunderstood oral prescriptions. Moreover, they will help both pharmacies and hospitals to integrate prescription records into other medical records more directly, which may increase efficiency, and potentially reduce the amount
of time patients spend waiting to have their prescriptions filled.
Schedule III-V Controlled Substance Prescriptions
A pharmacist may dispense a Schedule III, IV, or V controlled substance having received either a written prescription signed
by a practitioner, a facsimile of that prescription transmitted by the practitioner or his/her agent to the pharmacy, or an oral
prescription made by an individual practitioner. The pharmacist must promptly reduce the oral prescription to writing, including all required information. At this time, DEA does not permit a prescription received via the internet to be filled. If prescription information in received via the internet, the pharmacist must contact the prescriber via telephone and receive an oral
prescription for the controlled substance including the full name and address of the patient, the drug name, strength, dosage
form, quantity, prescribed directions for use, and the name, address, and registration number of the practitioner. The pharmacist must then immediately reduce the oral prescription to writing.
Partial Dispensing
The pharmacist may partially dispense a prescription for a Schedule III-V controlled substance if the pharmacist notes the
quantity dispensed and initials the back of the prescription order. The partial dispensing may not exceed the total amount authorized in the prescription order. The dispensing of all refills must be within the six month limit.
It is permissible to dispense a prescription for a quantity less than the face amount prescribed resulting in the actual number
of dispensings being greater than the number of refills indicated on the prescription.
15.
Dispensing Without a Prescription
In states where limited quantities of Schedule V preparations may be sold over-the-counter, the pharmacist is responsible for
making sure that such sales comply with state law. Schedule V controlled substances or any controlled substance listed in
Schedule II, III or IV which is not a prescription item under the Federal Food, Drug, and Cosmetic Act may be dispensed
without a prescription at retail provided that:
Such distribution is made only by a pharmacist and not by a non-pharmacist employee, even if under the direct supervision of
a pharmacist. However, after the pharmacist has fulfilled professional and legal responsibilities, the actual cash, credit transaction or delivery may be completed by a non-pharmacist.
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Because there is no physician determining the medical necessity for a Schedule V over-the-counter product, the pharmacist
must ensure the medical necessity of the need for the product.
Not more than 240 ml. (8 fluid ounces) or not more than 48 solid dosage units of any substance containing opium, not more
than 120 ml. (4 fluid ounces) or not more than 24 solid dosage units of any other controlled substance, may be distributed at
retail to the same purchaser in any given 48-hour period without a valid prescription.
The purchaser at a retail outlet is at least 18 years of age.
For the retail purchase of a Schedule V controlled substance, every customer the pharmacist does not know should be required to provide suitable identification, including proof of age, where appropriate.
A Schedule V bound record book is maintained which contains the name and address of the purchaser, name and quantity of
controlled substance purchased, date of each sale, and initials of the dispensing pharmacist. This record book must be maintained for a period of two years from the date of the last transaction entered in such record book, and it must be made available for inspection and copying by officers of the United States, as authorized by the U.S. Attorney General.
Other federal, state or local law does not require a prescription.
16.
Central Fill Pharmacy
A "central fill" pharmacy fills prescriptions for controlled substances on behalf of retail pharmacies with which central fill
pharmacies have a contractual agreement to provide such services or with which the pharmacies share a common owner.
When one retail pharmacy receives a prescription and a second pharmacy prepares and subsequently delivers the controlled
substance medication to the first retail pharmacy for dispensing to the patient, the second pharmacy is engaging in a "central
fill activity". Records must be maintained by both the central fill pharmacy and the retail pharmacy that completely reflect the
disposition of all controlled substance prescriptions dispensed. Central fill pharmacies are required to comply with the same
security requirements applicable to retail pharmacies including the general requirement to maintain effective controls and
procedures to guard against theft and diversion of controlled substances. Retail pharmacies that also perform central fill activities are allowed to do so without a separate DEA registration, separate inventories, or separate records.
Central fill pharmacies are permitted to prepare both initial and refill prescriptions, subject to all applicable state and federal
regulations. Only a licensed pharmacist may fill the prescription. Both the pharmacist employed by the pharmacy and the
pharmacist who dispenses the prescription to the patient have a corresponding responsibility to ensure that the prescription
was issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice
and otherwise in the manner specified by DEA regulations.
A central fill pharmacy will not be permitted to prepare prescriptions provided directly by the patient or individual practitioner or to mail or otherwise deliver a filled prescription directly to a patient or individual practitioner. Retail pharmacies are
permitted to transmit prescription information to a central fill pharmacy in two ways. First, a facsimile of a prescription for a
controlled substance in Schedule II-V may be provided by the retail pharmacy to the central fill pharmacy. The retail pharmacy must maintain the original hard copy of the prescription and the central fill pharmacy must maintain the facsimile of the
prescription. DEA is also allowing for the prescription information to be transmitted electronically by the retail pharmacy to
the central fill pharmacy. Both pharmacies must maintain the prescription information in a readily retrievable manner and
comply with all applicable federal and state recordkeeeping requirements.
17.
Long Term Care Facilities
A Long Term Care Facility (LTCF) is defined in the Code of Federal Regulations as a nursing home, retirement care, mental
care or other facility or institution which provides extended health care to resident patients. In most cases, these facilities are
not registered with DEA. Yet these care facilities routinely maintain controlled substances issued via prescription to their residents. These controlled substances are already outside the CSA closed drug distribution system since they have been dispensed to the ultimate user (i.e., patient). LTCFs frequently need to dispose of unused medications due to a change in patient
medication or the patient’s demise. For drug disposal instructions, contact the nearest DEA Diversion Field Office. In most
cases these LTCFs are regulated by state agencies and other federal mandates (FDA, Federal Nursing Home Guidelines, etc.).
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DEA is aware of the issues currently facing most LTCFs concerning the dispensing and handling of controlled substances.
These are affected by a variety of state laws and circumstances. Pharmacists should check with their state agency for guidelines concerning controlled substances at LTCFs.
Emergency Kits for Long Term Care Facilities
The DEA has issued a policy statement which provides individual state licensing and regulatory boards with general guidelines for establishing specific rules concerning controlled substances used in emergency kits at Long Term Care Facilities.
Pharmacists should check with their state agency for guidelines regarding emergency kits at LTCFs.
18.
Narcotic Treatment Programs
The Narcotic Addict Treatment Act of 1974 is the law that governs the use of narcotics and the treatment of addiction in the
United States. In addition, the law designates which government agencies have responsibility for narcotic treatment programs, defines the terms "maintenance" and "detoxification," and explains who has to register to treat patients for drug dependence.
There are separate recordkeeping and security requirements for Narcotic Treatment Programs. The CFR requirements for narcotic treatment programs include:
Official Order Forms (DEA Form-222) are required for all Schedule II narcotic transactions between a narcotic treatment program and any registrant, including a manufacturer, distributor, practitioner or another narcotic treatment program.
A narcotic treatment program registered with DEA can handle only the narcotic substances applied for on the DEA Form-363
and that are approved for use in maintenance or detoxification.
Controlled substances for treatment of conditions other than narcotic addiction cannot be administered, dispensed or stored
on the premises of a narcotic treatment program unless a physician has a valid practitioner registration at the program location.
Use of Methadone Outside a Narcotic Treatment Program
A practitioner may prescribe methadone or any other narcotic to a narcotic addict for analgesic purposes. However, a practitioner may not prescribe methadone or any other narcotic medication solely for the treatment of a patient's narcotic addiction.
The individual must receive the narcotics at a registered narcotic treatment program. In this case, the narcotics can be dispensed or administered but not prescribed. (The regulations do not prohibit the prescribing, administering or dispensing of
methadone for analgesic purposes for medical conditions other than addiction.)
A practitioner who is not part of a narcotic treatment program may administer narcotic substances to an addicted individual to
relieve that individual’s acute withdrawal symptoms while the practitioner makes arrangements to refer the individual to a
narcotic treatment program. Not more than one day’s medication may be administered at one time. This treatment cannot last
more than three days and may not be renewed or extended.
A hospital that has no narcotic treatment program on the premises may administer narcotics to a drug dependent individual
for either detoxification or maintenance purposes, if the individual is being treated for a medical condition other than narcotic
addiction. If you have questions regarding any part of the Narcotic Addict Treatment Act of 1974 or its regulations, contact
the nearest DEA Diversion Field Office.
19.
Narcotics for Patients with Terminal Illnesses or Intractable Pain
Controlled substances, particularly narcotic analgesics, may be used in the treatment of pain experienced by a patient with a
terminal illness or intractable pain. These drugs have legitimate uses and a pharmacist should not hesitate to dispense them
when a prescription indicates they are for a legitimate medical purpose. (The CSA requires that a controlled substance prescription must be issued for a legitimate medical purpose by a practitioner acting in the course of professional practice. The
CSA does not define "legitimate medical practice" nor does it set forth "standards of medical practice.")
A pharmacist need not fear DEA action if he/she dispenses controlled substances in good faith pursuant to a prescription issued for a legitimate medical purpose. It is the position of the DEA that controlled substances should be prescribed and dispensed when there is a legitimate medical need.
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Inappropriate prescribing and dispensing of controlled substances, including opioid analgesics, may lead to drug diversion
and abuse by individuals who seek these drugs for purposes other than legitimate medical use. However, pharmacists should
recognize that drug tolerance and physical dependence may develop as a consequence of the patient’s sustained use of opioid
analgesics for the legitimate treatment of chronic pain. It is also important to understand that the quantity of drugs prescribed
and frequency of prescriptions filled alone are not indicators of fraud or improper prescribing.
A pharmacist’s professional judgement is the first step in determining the appropriate course of action when the pharmacist is
presented with a prescription that appears questionable. The pharmacist’s judgement, in consultation with the prescriber, is
the best way to verify that the prescription is for a legitimate medical need. The pharmacist, in cooperation with the prescribing practitioner, has a responsibility to continue to monitor the patient receiving the controlled substance in order to prevent
abuse or diversion.
20.
Other Controlled Substance Regulations
Controlled Substances for Medical Missions and Humanitarian Charitable Solicitations
DEA assists organizations and practitioners who provide charitable medical, dental and veterinary treatment in foreign countries. In order for practitioners to hand carry controlled substances overseas, they must obtain approval from DEA and the
appropriate authority in the foreign country. Practitioners interested in cooperating with such medical missions should contact
their local DEA Diversion Field Office or the International Drug Unit, DEA, Office of Diversion Control, Washington, D.C.
20537, for instructions. Allow at least 30 days to obtain the necessary approvals.
If a pharmacy is asked to donate controlled substances to charitable organizations, contact your state controlled substance
agency to determine if you have state authority to do so and your local DEA Diversion Field Office for further guidance. The
shipment of controlled substances abroad is considered to be an export, which may only be done by a DEA registered exporter.
Controlled Substance Distribution by a Pharmacy
A pharmacy registered to dispense controlled substances may distribute such substances (without being registered as a distributor) to another pharmacy or to a practitioner to dispense, provided that the following conditions are met:
The pharmacy or practitioner is registered under the CSA to dispense controlled substances.
The pharmacy records that it distributed the controlled substances, and the recipient pharmacy or practitioner records that
they received the controlled substances.
If a Schedule II controlled substance is distributed, the transfer must be documented on an Official Order Form (DEA Form222). The distributing pharmacy must record the following information on an Official Order Form:
The name of the substance, the dosage form, and the quantity.
The name, address and DEA registration number of the pharmacy or practitioner to whom it is distributed.
Five Percent Rule. The total number of dosage units of controlled substances distributed by a pharmacy may not exceed five
percent of all controlled substances dispensed by the pharmacy during a calendar year. If at any time the controlled substances distributed exceeds five percent, the pharmacy is also required to register as a distributor.
U.S. Postal Service Mailing Requirements forSubstances
U.S. Postal Service regulations permit mailing any controlled substances, provided that they are not outwardly dangerous or
of their own force could cause injury to a person’s life or health, if the following preparation and packaging standards are
met:
The inner container of any parcel containing controlled substances is marked and sealed under the provisions of the Controlled Substances Act and its implementing regulations, and placed in a plain outer container or securely wrapped in plain
paper.
If the controlled substances consist of prescription medicines, the inner container is also labeled to show the name and address of the pharmacy, practitioner or other person dispensing the prescription.
The outside wrapper or container is free of markings that would indicate the nature of the contents.
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Delivery of a Controlled Substance or Drug Product Containing Listed Chemicals to Persons in Another Country
Controlled substances that are dispensed pursuant to a legitimate prescription may not be delivered or shipped to individuals
in another country without proper authorization. Any such delivery or shipment is an export under the CSA, and cannot be
conducted unless the person sending the controlled substances:
Has registered with DEA as an "exporter", and
Has obtained the necessary permit(s), or submitted the necessary declaration(s) for export as outlined in 21 CFR 1312 or 21
CFR 1313 for chemicals.
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Chapter 4: Federal Controlled Substances Law
I.
The Federal Controlled Substances Act
A significant component of the federal Comprehensive Drug Abuse Prevention and Control Act of 1970, the federal
Controlled Substances Act (CSA) establishes rules that empower the Drug Enforcement Administration (DEA) to assure that
drugs intended for medical use are not diverted to nonmedical uses. Pharmacists, as custodians of the nation’s medicinal
drug supply find themselves significantly involved in police activities in which they have little interest and no training. However, there is no escaping the reality that the law requires pharmacists to do their best to assure that the drugs pharmacists
control do not end up in the wrong hands. The basic structure of the CSA is to place all potentially abused drugs in one of
five schedules. People and places that are authorized to possess these drugs are then required to be registered with the DEA.
Specific records must be kept so that the whereabouts of any controlled substance can be followed from cradle to grave. Of
particular interest to pharmacists are rules relating to dispensing of controlled substances pursuant to a prescription. The failure to keep controlled substances within authorized medical channels exposes to discipline the person or persons responsible
for diversion outside authorized medical channels.
A.
Definitions
The CSA uses specific words and phrases in ways that might not be anticipated from their ordinary day-to-day meaning. To
fully appreciate the functioning of the CSA, one must understand how the act uses these words and phrases. Some of the
most important definitions follow. The language is quoted directly from the CSA. Numerations refer to subsections of Section 802, Title 21, of the United States Code.
As used in this title:
(1) The term "addict" means any individual who habitually uses any narcotic drug so as to endanger the public
morals, health, safety, or welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power of
self-control with reference to his addiction.
Note that a patient who is using controlled substances to treat a medical condition, and who becomes habituated to the controlled substances, is not an “addict” under the CSA.
(2) The term "administer" refers to the direct application of a controlled substance to the body of a patient or research subject by-(A) a practitioner (or, in his presence, by his authorized agent), or
(B) the patient or research subject at the direction and in the presence of the practitioner,
whether such application be by injection, inhalation, ingestion, or any other means.
(6) The term "controlled substance" means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this title [21 USCS § 812]. The term does not include distilled spirits, wine, malt
beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1954 [26
USCS §§ 5001 et seq.].
(8) The terms "deliver" or "delivery" mean the actual, constructive, or attempted transfer of a controlled substance
or a listed chemical, whether or not there exists an agency relationship.
(10) The term "dispense" means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance
and the packaging, labeling, or compounding necessary to prepare the substance for such delivery. The term
"dispenser" means a practitioner who so delivers a controlled substance to an ultimate user or research subject.
(12) The term "drug" has the meaning given that term by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act [21 USCS § 321(g)(1)].
(21) The term "practitioner" means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or
other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.
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B.
Controlled Substance Schedules
Under the CSA, the DEA is given responsibility to schedule controlled substances in five categories knows as Schedules I
through V. The restrictions on controlled substances vary according the schedule in which the controlled substance has been
placed. Controlled substances in Schedule I are the most restrictively controlled, and controlled substances in Schedule V are
the least restrictively controlled. Of course, there are many medicinal agents that are not controlled at all because they have
no abuse potential, and these drugs are the least restricted because they fall into no schedule. The language below is quoted
directly from the CSA. Numerations refer to subsections of Section 812, Title 21, of the United States Code.
a) Establishment. There are established five schedules of controlled substances, to be known as schedules I, II, III,
IV, and V. Such schedules shall initially consist of the substances listed in this section. The schedules… shall be updated and republished on a semiannual basis during the two-year period beginning one year after the date of enactment of this title [enacted Oct. 27, 1970] and shall be updated and republished on an annual basis thereafter.
(b) Placement on schedules; findings required. Except where control is required by United States obligations under
an international treaty, convention, or protocol, in effect on the effective date of this part, and except in the case of
an immediate precursor, a drug or other substance may not be placed in any schedule unless the findings required
for such schedule are made with respect to such drug or other substance. The findings required for each of the schedules are as follows:
(1) SCHEDULE I.
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has no currently accepted medical use in treatment in the United States.
(C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.
(2) SCHEDULE II.
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.
(C) Abuse of the drug or other substances may lead to severe psychological or physical dependence.
(3) SCHEDULE III.
(A)The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I
and II.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological
dependence.
(4) SCHEDULE IV.
(A)The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III.
(C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence
relative to the drugs or other substances in schedule III.
(5) SCHEDULE V.
(A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV.
(C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence
relative to the drugs or other substances in schedule IV.
Note that the schedules of controlled substances are based on the potential for abuse, the recognition of a medical use, and the
possibility of physical or psychological dependence.
C.
Registration
Under the CSA, only certain parties are permitted to possess controlled substances legally. These parties must be registered
with the DEA, or they must be exempt from registration. For example, a pharmacist who meets the licensure requirements of
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the state where the pharmacist is practicing, may dispense controlled substances to patients as long as the pharmacist practices in a pharmacy that is registered with the DEA. The pharmacist need not personally be registered with the DEA. The language below is quoted directly from the CSA. Numerations refer to subsections of Section 822, Title 21, of the United States
Code.
(a) Annual registration.
(1) Every person who manufactures or distributes any controlled substance or list I chemical, or who proposes to
engage in the manufacture or distribution of any controlled substance or list I chemical, shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him.
(2) Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him. The Attorney
General shall, by regulation, determine the period of such registrations. In no event, however, shall such registrations be issued for less than one year nor for more than three years.
(b) Authorized activities. Persons registered by the Attorney General under this title to manufacture, distribute, or
dispense controlled substances or list I chemicals are authorized to possess, manufacture, distribute, or dispense
such substances or chemicals (including any such activity in the conduct of research) to the extent authorized by their
registration and in conformity with the other provisions of this title.
(d) Waiver. The Attorney General may, by regulation, waive the requirement for registration of certain manufacturers, distributors, or dispensers if he finds it consistent with the public health and safety.
(e) Separate registration. A separate registration shall be required at each principal place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances or list I chemicals.
(f) Inspection. The Attorney General is authorized to inspect the establishment of a registrant or applicant for registration in accordance with the rules and regulations promulgated by him.
Note that the registration for dispensers is currently effective for a period of three years.
D.
Records
Every transaction in which controlled substances change hands must be recorded. This means generally that the receipt of
controlled substances must be recorded as must the dispersal of controlled substances. In addition, there are requirements for
the periodic inventory of controlled substances. Based on records kept of controlled substances, it should be possible to discern, for any registrant, what controlled substances are on hand, where they came from, and where controlled substances have
gone to. The language below is quoted directly from the CSA. Numerations refer to subsections of Section 827, Title 21, of
the United States Code.
(b) Availability of records. Every inventory or other record required under this section (1) shall be in accordance
with, and contain such relevant information as may be required by, regulations of the Attorney General, (2) shall (A)
be maintained separately from all other records of the registrant, or (B) alternatively, in the case of nonnarcotic controlled substances, be in such form that information required by the Attorney General is readily retrievable from the
ordinary business records of the registrant, and (3) shall be kept and be available, for at least two years, for inspection and copying by officers or employees of the United States authorized by the Attorney General.
E.
Prescriptions
The most frequent method through which controlled substances are dispersed by a pharmacy is through a prescription, issued
by a licensed prescriber and filled for a patient. Because this method of dispersion is so commonplace, specific rules have
been developed to guide appropriateness of it. These rules are intended to assure that all prescriptions filled by pharmacists
for controlled substances have been issued for a medical purpose, and will not result in diversion to nonmedical use. The
DEA issues regulations that expand on the CSA requirements, to assure that prescriptions are in such a form as to make it
likely that they have been issued for a medical purpose. The language below is quoted directly from the CSA. Numerations
refer to subsections of Section 829, Title 21, of the United States Code.
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(a) Schedule II substances. Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate
user, no controlled substance in schedule II, which is a prescription drug as determined under the Federal Food,
Drug, and Cosmetic Act [21 USCS §§ 301 et seq.], may be dispensed without the written prescription of a practitioner, except that in emergency situations, as prescribed by the Secretary by regulation after consultation with the Attorney General, such drug may be dispensed upon oral prescription in accordance with section 503(b) of that Act [21
USCS § 353(b)]. Prescriptions shall be retained in conformity with the requirements of section 307 of this title [21
USCS § 827]. No prescription for a controlled substance in schedule II may be refilled.
Note that Schedule II prescriptions must be in writing, except in the case of particular narrowly circumscribed situations in
which oral prescriptions are permitted. Schedule II prescriptions may never be refilled. Never! End of story!!
(b) Schedule III and IV substances. Except when dispensed directly by a practitioner, other than a pharmacist, to an
ultimate user, no controlled substance in schedule III or IV, which is a prescription drug as determined under the
Federal Food, Drug, and Cosmetic Act [21 USCS § 301 et seq.], may be dispensed without a written or oral prescription in conformity with section 503(b) of that Act [21 USCS § 353(b)]. Such prescriptions may not be filled or
refilled more than six months after the date thereof or be refilled more than five times after the date of the prescription unless renewed by the practitioner.
This is the “five times in six months’ rule under which Schedule III and IV prescriptions may be refilled if authorized by the
prescriber, during the six months following the issuance of the prescription.
(c) Schedule V substances. No controlled substance in schedule V which is a drug may be distributed or dispensed
other than for a medical purpose.
Note that for prescriptions issued for Schedule V controlled substances there is no hard and fast time limit on refills, but there
is the basic requirement of a medical purpose.
II.
Application of the CSA to Dispensing
The federal government regulates controlled substances not as a health care matter but as a law enforcement matter.
The closed system of distribution for controlled substances aims to prevent inappropriate use of abusable drugs for purposes
other than medical use. Pharmacists are given the responsibility to assure that patients who need controlled substances get
them when a prescription has been appropriately generated, but also that people who do not need controlled substances are
prevented from acquiring them. All pharmacists would wish to be perfectly accurate in dispensing, and not dispense a drug
to a person who has no need for it, while at the same time always dispense a drug to a person who does have a need for it.
Unfortunately, such perfection is not possible. Sometimes a person who has no medical need for a drug mistakenly receives
it through a fraudulent prescription, and another person who does have a medical need is mistakenly denied it by an overly
suspicious pharmacist. The rules developed by the Drug Enforcement Administration (DEA) are intended to assure that pharmacists have available to them the documentation they need to make appropriate decisions about access to controlled substances. Checks and balances exist to preserve the integrity of the system.
III.
Classification of Controlled Substances
The first step in controlling drugs of abuse is to define which drugs are considered to be subject to abuse. The CSA
does this by enumerating five Schedules of drugs and describing the criteria for placing drugs into one of the five Schedules.
These criteria were listed in the Lesson I. It is important to note that there is a difference between a Scheduled drug and a
legend drug. This fundamental distinction is sometimes overlooked by pharmacists. A legend drug is one that may be distributed only pursuant to a prescription. The opposite of legend drug is non-prescription drug. A Scheduled drug is one that
is regulated under the CSA due to its potential for abuse. The opposite of Scheduled drug is non-Scheduled drug. Thus,
there are four possible combinations. A drug may be a Scheduled, legend drug. This would mean that it is has an abuse potential and requires a prescription. Morphine and benzodiazepines are examples of Scheduled, legend drugs. Alternatively, a
drug may be a non-Scheduled, legend drug. This would mean that it does not have an abuse potential but it requires a prescription. Oral antibiotics and antihypertensives are examples of non-Scheduled, legend drugs. A third possibility is that a
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drug could be a non-Scheduled, non-legend drug. This would mean that the drug does not have an abuse potential and requires no prescription. Aspirin and ranitidine are examples of non-Scheduled, non-legend drugs. The fourth possibility is the
most rarely occurring and it sometimes takes some convincing before people believe there are really drugs of this kind; a drug
that has abuse potential and requires no prescription. Products that contain low strengths of opium to treat diarrhea and products that contain low strengths of codeine to treat cough are examples of such drugs. These products are limited to dispensing
by a pharmacist under the CSA and they do not require a prescription under the FDCA, thus they occupy a very unusual category regulated drugs.
With five different Schedules, one might think that there would be five different sets of rules to learn. But the reality
for pharmacists is that three sets of rules will actually suffice. Since Schedule I controlled substances have no currently recognized medical use, they are generally not found in pharmacies. Only when such drugs are being used under clinical protocols would they be of concern to pharmacists, and that classification restricts them to research institutions. Schedule II
controlled substances are the most highly restricted of those drugs that are ordinarily found in pharmacies, so the rules applicable to them are numerous and somewhat burdensome. At the dispensing level, Schedule III and IV controlled substances
are handled in essentially the same way, so no distinction need be drawn between them. The rules for Schedule V controlled
substances are similar to those for Schedules III and IV, but there are differences that warrant considering them separately.
So as a general rule, it is possible to learn three sets of rules, those applicable to Schedule II drugs, those applicable to Schedules III and IV, and those applicable to Schedule V. The other rules of the CSA depend on this drug classification scheme.
IV.
Registration
Those individuals and institutions that are authorized to possess drugs classified as controlled substances are subject
to a registration requirement. In registering with the DEA, an individual or institution receives a DEA number. The number
begins with a two-letter combination that is followed by seven numbers. The first of the two letters signifies the status of the
registrant. Practitioners and dispensers were at one time always given a DEA number beginning with the letter “A,” but the
DEA ran out of numbers and began giving such registrants numbers beginning with the letter “B.” When the letter “B” ran
out, the DEA began using the letter “F”. Mid-level practitioners receive DEA numbers beginning with the letter “M,” while
distributors receive DEA numbers beginning with either the letter “P” or the letter “R.” The second letter of the two-letter
initial sequence is usually the first letter of the last name of the registrant. Because rules change from time to time, it is important to not become overly concerned about a DEA number simply because it begins with letters that seem not to fit the
registrant. Careful questioning may disclose that there is a very good reason for an apparent mismatch, and that there is no
cause for concern.
The seven number sequence that follows the two initial letters should always match a formula that the DEA has established to evaluate legitimacy of a DEA number. To check whether the formula has been followed, do this: (1) Add the
first, third and fifth digits of the seven numbers that follow the first two letters; (2) Then add the second, fourth and sixth of
those seven numbers, double the result and add this figure to the first sum; (3) Compare the number in the “ones column” of
the result (the right-most digit) and determine whether this number matches the seventh and final number of the nine-figure
letter-and-number combination. If there is a match, then the DEA number looks valid. If there is no match, then it looks invalid. Of course, this is not so complicated a process that drug addicts and pushers are unable to figure it out. Simply because a DEA number looks valid does not mean that a prescription is guaranteed to be valid. Many other factors must be
considered in an evaluation of validity.
A.
Persons Required to Register
Every person who manufactures, distributes, or dispenses any controlled substance or who proposes to engage in the manufacture, distribution, or dispensing of any controlled substance must obtain a registration unless exempted by law. Law enforcement personnel, agents and employees of registrants, and certain military and other personnel are exempt from
registration. Only persons actually engaged in activities with controlled substances are required to register. For example, a
stockholder or parent corporation of a corporation dispensing controlled substances is not required to register.
B.
Separate Registration for Independent Activities
DEA registration is determined by what you are doing, not who you are. A pharmacist may be required to register in several
different categories, depending on what activities are being undertaken by the pharmacist. DEA regulations describe the in-
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dependent activities that require separate registration. The regulations follow. Numerations refer to sections of Title 21,
Code of Federal Regulations.
§ 1301.13 Application for registration; time for application; expiration date; registration for independent activities;
application forms, fees, contents and signature; coincident activities.
(a) Any person who is required to be registered and who is not so registered may apply for registration at any
time. No person required to be registered shall engage in any activity for which registration is required until the application for registration is granted and a Certificate of Registration is issued by the Administrator to such person.
(d) At the time a retail pharmacy, hospital/clinic, practitioner or teaching institution is first registered, that business
activity shall be assigned to one of twelve groups, which shall correspond to the months of the year. The expiration
date of the registrations of all registrants within any group will be the last day of the month designated for that
group. In assigning any of the above business activities to a group, the Administration may select a group the expiration date of which is not less than 28 months nor more than 39 months from the date such business activity was registered. After the initial registration period, the registration shall expire 36 months from the initial expiration date.
(e) Any person who is required to be registered and who is not so registered, shall make application for registration
for one of the following groups of controlled substances activities, which are deemed to be independent of each other.
Application for each registration shall be made on the indicated form, and shall be accompanied by the indicated fee.
Fee payments shall be made in the form of a personal, certified, or cashier's check or money order made payable to
the "Drug Enforcement Administration". The application fees are not refundable. Any person, when registered to engage in the activities described in each subparagraph in this paragraph, shall be authorized to engage in the coincident activities described without obtaining a registration to engage in such coincident activities, provided that,
unless specifically exempted, he/she complies with all requirements and duties prescribed by law for persons registered to engage in such coincident activities. Any person who engages in more than one group of independent activities shall obtain a separate registration for each group of activities, except as provided in this paragraph under
coincident activities. A single registration to engage in any group of independent activities listed below may include
one or more controlled substances listed in the Schedules authorized in that group of independent activities. A person
registered to conduct research with controlled substances listed in Schedule I may conduct research with any substances listed in Schedule I for which he/she has filed and had approved a research protocol.
There follows in the law a list of activities for which separate registration is required. These activities are: manufacturing,
distributing, dispensing, research (Schedule I drugs), research (Schedule II through V drugs), narcotic treatment program, exporting, and chemical analysis. Of note for pharmacists is the authority to prepare an aqueous or oleaginous solution or solid
dosage form containing a narcotic controlled substance not to exceed 20 percent of the complete product, without the need to
register as a manufacturer. Likewise, a pharmacist may distribute controlled substances to other registrants, as long as the
total number of dosage units does not exceed 5 percent of the total units of controlled substances distributed and dispensed in
one year, without the need to register as a distributor.
§ 1307.11 Distribution by dispenser to another practitioner or reverse distributor.
(a) A practitioner who is registered to dispense a controlled substance may distribute (without being registered to
distribute) a quantity of such substance to -(1) Another practitioner for the purpose of general dispensing by the practitioner to patients, provided that -(i) The practitioner to whom the controlled substance is to be distributed is registered under the Act to dispense that
controlled substance;
(ii) The distribution is recorded by the distributing practitioner in accordance with § 1304.22(c) of this chapter and
by the receiving practitioner in accordance with § 1304.22(c) of this chapter;
(iii) If the substance is listed in Schedule I or II, an order form is used as required in part 1305 of this chapter; and
(iv) The total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section and § 1301.25 of this chapter during each calendar year in which the practitioner is registered to dispense does
not exceed 5 percent of the total number of dosage units of all controlled substances distributed and dispensed by the
practitioner during the same calendar year.
(2) A reverse distributor who is registered to receive such controlled substances.
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(b) If, during any calendar year in which the practitioner is registered to dispense, the practitioner has reason to believe that the total number of dosage units of all controlled substances which will be distributed by him pursuant to
paragraph (a)(1) of this section and § 1301.25 of this chapter will exceed 5 percent of this total number of dosage
units of all controlled substances distributed and dispensed by him during that calendar year, the practitioner shall
obtain a registration to distribute controlled substances.
(c) The distributions that a registered retail pharmacy makes to automated dispensing systems at long term care facilities for which the retail pharmacy also holds registrations do not count toward the 5 percent limit in paragraphs
(a)(1)(iv) and (b) of this section.
C.
Separate Registration for Separate Locations
For obvious reasons, a DEA registration is limited to a specific location. If this were not the case, then missing controlled
substances could always be claimed to be located at another place controlled by the registrant, and it would be impossible to
determine whether controlled substances had in fact been diverted from the chain of distribution. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
§ 1301.12 Separate registrations for separate locations.
(a) A separate registration is required for each principal place of business or professional practice at one general
physical location where controlled substances are manufactured, distributed… or dispensed by a person.
(b) The following locations shall be deemed not to be places where controlled substances are manufactured, distributed, or dispensed:
(1) A warehouse where controlled substances are stored by or on behalf of a registered person, unless such substances are distributed directly from such warehouse to registered locations other than the registered location from which
the substances were delivered or to persons not required to register by virtue of subsection 302(c)(2) or subsection
1007(b)(1)(B) of the Act (21 U.S.C. 822(c)(2) or 957(b)(1)(B));
(2) An office used by agents of a registrant where sales of controlled substances are solicited, made, or supervised
but which neither contains such substances (other than substances for display purposes or lawful distribution as
samples only) nor serves as a distribution point for filling sales orders; and
(3) An office used by a practitioner (who is registered at another location) where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office, and where no supplies of controlled substances are maintained.
D.
Employee Responsibility
Within its registration rules, the DEA specifies security requirements that must be met by registrants. These requirements
will be well known to pharmacies at which pharmacists become employed. One specific section is worthy of note, because it
imposes a responsibility specifically on the employee rather than the employer. This section has to do with the reporting of
drug diversion by another employee. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
§ 1301.91 Employee responsibility to report drug diversion.
Reports of drug diversion by fellow employees is not only a necessary part of an overall employee security program but also serves the public interest at large. It is, therefore, the position of DEA that an employee who has
knowledge of drug diversion from his employer by a fellow employee has an obligation to report such information to
a responsible security official of the employer. The employer shall treat such information as confidential and shall
take all reasonable steps to protect the confidentiality of the information and the identity of the employee furnishing
information. A failure to report information of drug diversion will be considered in determining the feasibility of continuing to allow an employee to work in a drug security area. The employer shall inform all employees concerning
this policy.
V.
Labeling and Package Requirements
It is important for pharmacists and others who legally possess and distribute controlled substances to be able to distinguish controlled substances from other medications that do not fall into this category. It is also important to know what
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Schedule a controlled substance falls into, because the manner in which controlled substances must be handled differs depending on the Schedule to which a controlled substance has been assigned. By requiring specific and obvious labeling of
controlled substances, the CSA assures that those who legally possess them know what they have and how it must be handled.
A.
Symbol requirement
Under DEA regulations, a standard symbol is required for identification of controlled substances. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
§ 1302.03 Symbol required; exceptions.
(a) Each commercial container of a controlled substance (except for a controlled substance excepted by the Administrator pursuant to § 1308.31 of this chapter) shall have printed on the label the symbol designating the Schedule in which such controlled substance is listed. Each such commercial container, if it otherwise has no label, must
bear a label complying with the requirement of this part.
(b) Each manufacturer shall print upon the labeling of each controlled substance distributed by him the symbol designating the Schedule in which such controlled substance is listed.
(c) The following symbols shall designate the Schedule corresponding thereto:
Schedule
Symbol
Schedule I
CI or C-I.
Schedule II
CII or C-II.
Schedule III
CIII or C-III.
Schedule IV
CIV or C-IV.
Schedule V
CV or C-V.
The word "Schedule" need not be used. No distinction need be made between narcotic and nonnarcotic substances.
(d) The symbol is not required on a carton or wrapper in which a commercial container is held if the symbol is easily
legible through such carton or wrapper.
(e) The symbol is not required on a commercial container too small or otherwise unable to accommodate a label, if
the symbol is printed on the box or package from which the commercial container is removed upon dispensing to an
ultimate user.
(f) The symbol is not required on a commercial container containing, or on the labeling of, a controlled substance
being utilized in clinical research involving blind and double blind studies.
Note that the symbol requirement makes it easy to know into what Schedule a controlled substance has been classified. One
need only look at the label of the stock bottle to learn this information. In practice there is no need to memorize lists of drugs
and their Schedule. However, standardized exams usually require those taking the exam to know the schedule of all drugs.
Those who are preparing to take a standardized exam should study the schedule of controlled substances at the DEA website.
http://www.deadiversion.usdoj.gov/21cfr/index.html. A complete list of all controlled substances and their schedule is beyond the scope of this review guide.
B.
Location and Size of Symbol
DEA regulations not only specify what the symbol must be, they state where the symbol must be and how large is must be.
The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
§ 1302.04 Location and size of symbol on label and labeling.
The symbol shall be prominently located on the label or the labeling of the commercial container and/or the panel
of the commercial container normally displayed to dispensers of any controlled substance. The symbol on labels
shall be clear and large enough to afford easy identification of the Schedule of the controlled substance upon inspection without removal from the dispenser's shelf. The symbol on all other labeling shall be clear and large enough to
afford prompt identification of the controlled substance upon inspection of the labeling.
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VI.
Records
One of the basic principles of controlled substance law is the ability to know at all times where controlled substances
are and how they got there. Extensive recordkeeping requirements are used to meet this goal. As a rule of thumb, every registrant should bear in mind that it is important to be able to provide information to an outside observer regarding what controlled substances are on hand, what controlled substances were received, and what controlled substances were dispersed. If a
registrant is unable to produce an inventory, records of receipt and records of dispersal, then the registrant is simply asking
for trouble. Faced with this reality, the observer will have to conclude that controlled substances are missing and must have
been diverted to nonmedical uses. Because it would be overly burdensome to require that registrants maintain constantly upto-date inventories, records of receipt and records of dispersal, the law does not impose this requirement. Rather, the law requires that registrants have the ability to create these records quickly, based on information readily at hand. Unfortunately, at
times pharmacists become victimized by theft, and there is also the possibility that controlled substances will be lost. In the
event of theft of loss of controlled substances, DEA requires that a report be made to the nearest DEA office and to the local
police. The theft or significant loss must then be reported on DEA form 106. DEA has clarified what a “significant” loss is
interpreted to be within a section related to security matters.
§ 1301.76 Other security controls for practitioners.
(a) The registrant shall not employ, as an agent or employee who has access to controlled substances, any person
who has been convicted of a felony offense relating to controlled substances or… had a DEA registration revoked or
has surrendered a DEA registration for cause. For purposes of this subsection, the term "for cause" means a surrender in lieu of, or as a consequence of, any federal or state administrative, civil or criminal action resulting from an
investigation of the individual's handling of controlled substances.
(b) The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or
significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant
shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the loss or theft.
When determining whether a loss is significant, a registrant should consider, among others, the following factors:
(1) The actual quantity of controlled substances lost in relation to the type of business;
(2) The specific controlled substances lost;
(3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
(4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts
taken to resolve the losses; and, if known,
(5) Whether the specific controlled substances are likely candidates for diversion;
(6) Local trends and other indicators of the diversion potential of the missing controlled substance.
(c) Whenever the registrant distributes a controlled substance (without being registered as a distributor, as permitted
in § 1301.13(e)(1) and/or §§ 1307.11-1307.12) he/she shall comply with the requirements imposed on nonpractitioners in § 1301.74(a), (b), and (e).
A.
General Recordkeeping Rules
Under DEA rules, dispensers of controlled substances are required to maintain records of them, but prescribers are not required to keep records if they simply prescribe or administer drugs in the course of their practice, and do not dispense them.
§ 1304.03 Persons required to keep records and file reports.
(a) Each registrant shall maintain the records and inventories and shall file the reports required by this part, except
as exempted by this section. Any registrant who is authorized to conduct other activities without being registered to
conduct those activities, either pursuant to § 1301.22(b) of this chapter or pursuant to §§ 1307.11-1307.15 of this
chapter, shall maintain the records and inventories and shall file the reports required by this part for persons registered to conduct such activities. This latter requirement should not be construed as requiring stocks of controlled
substances being used in various activities under one registration to be stored separately, nor that separate records
are required for each activity. The intent of the Administration is to permit the registrant to keep one set of records
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which are adapted by the registrant to account for controlled substances used in any activity. Also, the Administration does not wish to acquire separate stocks of the same substance to be purchased and stored for separate activities. Otherwise, there is no advantage gained by permitting several activities under one registration.
(b) A registered individual practitioner is required to keep records, as described in § 1304.04, of controlled substances in Schedules II, III, IV, and V which are dispensed, other than by prescribing or administering in the lawful
course of professional practice.
(c) A registered individual practitioner is not required to keep records of controlled substances in Schedules II, III,
IV, and V which are prescribed in the lawful course of professional practice, unless such substances are prescribed
in the course of maintenance or detoxification treatment of an individual.
Under DEA rules, it is permissible to maintain records centrally, offsite. However, specific conditions must be met if this
option is chosen. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
§ 1304.04 Maintenance of records and inventories.
(a) Every inventory and other records required to be kept under this part shall be kept by the registrant and be
available, for at least 2 years from the date of such inventory or records, for inspection and copying by authorized
employees of the Administration, except that financial and shipping records (such as invoices and packing slips but
not executed order forms subject to § 1305.13 of this chapter) may be kept at a central location, rather than at the
registered location, if the registrant has notified the Administration of his intention to keep central records. Written
notification must be submitted by registered or certified mail, return receipt requested, in triplicate, to the Special
Agent in Charge of the Administration in the area in which the registrant is located. Unless the registrant is informed
by the Special Agent in Charge that permission to keep central records is denied, the registrant may maintain central
records commencing 14 days after receipt of his notification by the Special Agent in Charge.
All notifications must include:
(1) The nature of the records to be kept centrally.
(2) The exact location where the records will be kept.
(3) The name, address, DEA registration number and type of DEA registration of the registrant whose records are
being maintained centrally.
(4) Whether central records will be maintained in a manual, or computer readable form.
(b) All registrants that are authorized to maintain a central recordkeeping system shall be subject to the following
conditions:
(1) The records to be maintained at the central record location shall not include executed order forms, prescriptions
and/or inventories which shall be maintained at each registered location.
(2) If the records are kept on microfilm, computer media or in any form requiring special equipment to render the
records easily readable, the registrant shall provide access to such equipment with the records. If any code system is
used (other than pricing information), a key to the code shall be provided to make the records understandable.
(3) The registrant agrees to deliver all or any part of such records to the registered location within two business days
upon receipt of a written request from the Administration for such records, and if the Administration chooses to do so
in lieu of requiring delivery of such records to the registered location, to allow authorized employees of the Administration to inspect such records at the central location upon request by such employees without a warrant of any kind.
(4) In the event that a registrant fails to comply with these conditions, the Special Agent in Charge may cancel such
central recordkeeping authorization, and all other central recordkeeping authorizations held by the registrant without a hearing or other procedures. In the event of a cancellation of central recordkeeping authorizations under this
paragraph the registrant shall, within the time specified by the Special Agent in Charge, comply with the requirements of this section that all records be kept at the registered location.
(c) Registrants need not notify the Special Agent in Charge or obtain central recordkeeping approval in order to
maintain records on an in-house computer system.
DEA requires that records of controlled substances be maintained so as to be distinct from records of drugs that are not controlled substances, and that Schedule I and II controlled substance records be maintained separately. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
(h) Each registered pharmacy shall maintain the inventories and records of controlled substances as follows:
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(1) Inventories and records of all controlled substances listed in Schedules I and II shall be maintained separately
from all other records of the pharmacy, and prescriptions for such substances shall be maintained in a separate prescription file; and
(2) Inventories and records of controlled substances listed in Schedules III, IV, and V shall be maintained either separately from all other records of the pharmacy or in such form that the information required is readily retrievable
from ordinary business records of the pharmacy, and prescriptions for such substances shall be maintained either in
a separate prescription file for controlled substances listed in Schedules III, IV, and V only or in such form that they
are readily retrievable from the other prescription records of the pharmacy. Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter "C" no less than 1 inch high and filed either in the prescription file for controlled substances listed
in Schedules I and II or in the usual consecutively numbered prescription file for non-controlled substances. However, if a pharmacy employs an ADP system or other electronic recordkeeping system for prescriptions which permits
identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug
dispensed, and date filled, then the requirement to mark the hard copy prescription with a red "C" is waived.
Note that the requirement of a red “C” in the bottom right corner of a prescription for a controlled substance in Schedules III,
IV and V is waived if the pharmacy uses a computerized recordkeeping system and it is possible to generate a list of those
drugs from a computer file.
B.
Inventories
To form the basis of a determination of what controlled substances should be on hand at a registrant’s location, there must be
an inventory performed at a specific time. It is then possible to add to the inventory those controlled substances reflected in
records of receipt and deduct from the inventory those controlled substances reflected in records of dispersal. The result
should be an accurate reflection of what is on hand. If fewer controlled substances are on hand than the result of this calculation would indicate should be, then the conclusion may be reached that controlled substances have been diverted. It all starts
with the inventory. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
§ 1304.11 Inventory requirements.
(a) General requirements. Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken, and shall be maintained in written, typewritten, or printed form at the
registered location. An inventory taken by use of an oral recording device must be promptly transcribed. Controlled
substances shall be deemed to be "on hand" if they are in the possession of or under the control of the registrant, including substances returned by a customer, ordered by a customer but not yet invoiced, stored in a warehouse on behalf of the registrant, and substances in the possession of employees of the registrant and intended for distribution as
complimentary samples. A separate inventory shall be made for each registered location and each independent activity registered, except as provided in paragraph (e)(4) of this section. In the event controlled substances in the possession or under the control of the registrant are stored at a location for which he/she is not registered, the substances
shall be included in the inventory of the registered location to which they are subject to control or to which the person possessing the substance is responsible. The inventory may be taken either as of opening of business or as of the
close of business on the inventory date and it shall be indicated on the inventory.
(b) Initial inventory date. Every person required to keep records shall take an inventory of all stocks of controlled
substances on hand on the date he/she first engages in the manufacture, distribution, or dispensing of controlled substances, in accordance with paragraph (e) of this section as applicable. In the event a person commences business
with no controlled substances on hand, he/she shall record this fact as the initial inventory.
(c) Biennial inventory date. After the initial inventory is taken, the registrant shall take a new inventory of all stocks
of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is
within two years of the previous biennial inventory date.
(d) Inventory date for newly controlled substances. On the effective date of a rule by the Administrator pursuant to §§
1308.45, 1308.46, or 1308.47 of this chapter adding a substance to any Schedule of controlled substances, which
substance was, immediately prior to that date, not listed on any such Schedule, every registrant required to keep re-
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cords who possesses that substance shall take an inventory of all stocks of the substance on hand. Thereafter, such
substance shall be included in each inventory made by the registrant pursuant to paragraph (c) of this section.
(e) Inventories of manufacturers, distributors, dispensers, researchers, importers, exporters and chemical analysts.
Each person registered or authorized (by § 1301.13 or §§ 1307.11-1307.13 of this chapter) to manufacture, distribute, dispense, import, export, conduct research or chemical analysis with controlled substances and required to keep
records pursuant to § 1304.03 shall include in the inventory the information listed below.
(1) Inventories of manufacturers. Each person registered or authorized to manufacture controlled substances shall
include the following information in the inventory:
(iii) For each controlled substance in finished form the inventory shall include:
(A) The name of the substance;
(B) Each finished form of the substance (e.g., 10 milligram tablet or 10 milligram concentration per fluid ounce or
milliliter);
(C) The number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 3
milliliter vial); and
(D) The number of commercial containers of each such finished form (e.g. four 100 tablet bottles or six 3 milliliter
vials).
(iv) For each controlled substance not included in paragraphs (e)(1) (i), (ii) or (iii) of this section (e.g., damaged,
defective or impure substances awaiting disposal, substances held for quality control purposes, or substances maintained for extemporaneous compoundings) the inventories shall include:
(A) The name of the substance;
(B) The total quantity of the substance to the nearest metric unit weight or the total number of units of finished form;
and
(C) The reason for the substance being maintained by the registrant and whether such substance is capable of use in
the manufacture of any controlled substance in finished form.
(3) Inventories of dispensers and researchers. Each person registered or authorized to dispense or conduct research
with controlled substances shall include in the inventory the same information required of manufacturers pursuant to
paragraphs (e)(1) (iii) and (iv) of this section. In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the dispenser shall do as follows:
(i) If the substance is listed in Schedule I or II, make an exact count or measure of the contents, or
(ii) If the substance is listed in Schedule III, IV or V, make an estimated count or measure of the contents, unless the
container holds more than 1,000 tablets or capsules in which case he/she must make an exact count of the contents.
Note that the requirements for dispensers incorporate by reference two sections of the requirements for manufacturers. These
two sections, and only these, are included above.
C.
Records of Receipt and Dispersal
A record must be made of any controlled substances received or dispersed. The DEA regulation follows. Numerations refer
to sections of Title 21, Code of Federal Regulations.
§ 1304.22 Records for manufacturers, distributors, dispensers, researchers, importers and exporters.
Each person registered or authorized (by § 1301.13(e) or §§ 1307.11-1307.13 of this chapter) to manufacture, distribute, dispense, import, export or conduct research with controlled substances shall maintain records with the information listed below.
(a) Records for manufacturers. Each person registered or authorized to manufacture controlled substances shall
maintain records with the following information:
(2) For each controlled substance in finished form,
(i) The name of the substance;
(ii) Each finished form (e.g., 10 milligram tablet or 10 milligram concentration per fluid ounce or milliliter) and the
number of units or volume of finished form in each commercial container (e.g., 100 tablet bottle or 3 milliliter vial);
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(iv) The number of units of finished forms and/or commercial containers acquired from other persons, including the
date of and number of units and/or commercial containers in each acquisition to inventory and the name, address,
and registration number of the person from whom the units were acquired;
(vii) The number of commercial containers distributed to other persons, including the date of and number of containers in each reduction from inventory, and the name, address, and registration number of the person to whom the containers were distributed;
(ix) The number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant (e.g., by distribution of complimentary samples or by destruction), including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and
the quantity in finished form distributed or disposed.
(c) Records for dispensers and researchers. Each person registered or authorized to dispense or conduct research
with controlled substances shall maintain records with the same information required of manufacturers pursuant to
paragraph (a)(2) (i), (ii), (iv), (vii), and (ix) of this section. In addition, records shall be maintained of the number of
units or volume of such finished form dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the dispenser.
Note that the requirements for dispensers incorporate by reference three sections of the requirements for manufacturers.
These three sections, and only these, are included above.
D.
Special Order Forms
To order controlled substances in Schedules III through V, no special order form is required. However, to order controlled
substances in Schedules I or II, a special order form (DEA form 222) must be used. The manner of issuing the order form
and using it to record receipt of ordered controlled substances is specified in the law. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
§ 1305.06 Procedure for executing order forms.
(a) Order forms shall be prepared and executed by the purchaser simultaneously in triplicate by means of interleaved carbon sheets which are part of the DEA Form 222. Order forms shall be prepared by use of a typewriter,
pen, or indelible pencil.
(b) Only one item shall be entered on each numbered line. An item shall consist of one or more commercial or bulk
containers of the same finished or bulk form and quantity of the same substance. The number of lines completed shall
be noted on that form at the bottom of the form, in the space provided. Order forms for carfentanil, etorphine hydrochloride, and diprenorphine shall contain only these substances.
(c) The name and address of the supplier from whom the controlled substances are being ordered shall be entered on
the form. Only one supplier may be listed on any form.
(d) Each order form shall be signed and dated by a person authorized to sign an application for registration. The
name of the purchaser, if different from the individual signing the order form, shall also be inserted in the signature
space. Unexecuted order forms may be kept and may be executed at a location other than the registered location
printed on the form, provided that all unexecuted forms are delivered promptly to the registered location upon an
inspection of such location by any officer authorized to make inspections, or to enforce, any Federal, State, or local
law regarding controlled substances.
Note that the submission of DEA form 222 is not the only requirement for ordering controlled substances in Schedules I and
II. In addition, when these controlled substances are received, they must be logged in on DEA form 222. The failure to log
in Schedule II controlled substance on DEA form 222 upon their receipt has caused problems for pharmacists with the DEA.
§ 1305.07 Power of attorney.
Any purchaser may authorize one or more individuals, whether or not located at the registered location of the purchaser, to obtain and execute order forms on his/her behalf by executing a power of attorney for each such individual. The power of attorney shall be signed by the same person who signed the most recent application for registration
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or reregistration and by the individual being authorized to obtain and execute order forms. The power of attorney
shall be filed with the executed order forms of the purchaser, and shall be retained for the same period as any order
form bearing the signature of the attorney. The power of attorney shall be available for inspection together with other order form records. Any power of attorney may be revoked at any time by executing a notice of revocation, signed
by the person who signed (or was authorized to sign) the power of attorney or by a successor, whoever signed the
most recent application for registration or reregistration, and filing it with the power of attorney being revoked.
§ 1305.05 Procedure for obtaining order forms.
(a) Order Forms are issued in mailing envelopes containing either seven or fourteen forms, each form containing
an original duplicate and triplicate copy (respectively, Copy 1, Copy 2, and Copy 3). A limit, which is based on the
business activity of the registrant, will be imposed on the number of order forms which will be furnished on any requisition unless additional forms are specifically requested and a reasonable need for such additional forms is shown.
(b) Any person applying for a registration which would entitle him/her to obtain order forms may requisition such
forms by so indicating on the application form; order forms will be supplied upon the registration of the applicant.
Any person holding a registration entitling him/her to obtain order forms may requisition such forms for the first time
by contacting any Division Office or the Registration Unit of the Administration. Any person already holding order
forms may requisition additional forms on DEA Form 222a which is mailed to a registrant approximately 30 days
after each shipment of order forms to that registrant or by contacting any Division Office or the Registration Unit of
the Administration. All requisition forms (DEA Form 222a) shall be submitted to the Registration Unit, Drug Enforcement Administration, Department of Justice, Post Office Box 28083, Central Station, Washington, DC 20005.
(c) Each requisition shall show the name, address, and registration number of the registrant and the number of books
of order forms desired. Each requisition shall be signed and dated by the same person who signed the most recent
application for registration or for reregistration, or by any person authorized to obtain and execute order forms by a
power of attorney pursuant to § 1305.07.
(d) Order forms will be serially numbered and issued with the name, address and registration number of the registrant, the authorized activity and Schedules of the registrant. This information cannot be altered or changed by the
registrant; any errors must be corrected by the Registration Unit of the Administration by returning the forms with
notification of the error.
§ 1305.08 Persons entitled to fill order forms.
(c) A person registered to dispense such substances may distribute such substances to another dispenser pursuant to,
and only in the circumstances described in, § 1307.11 of this chapter.
Note that in transferring Schedule II controlled substances from one registrant to another, it is necessary to use DEA form
222. For example, if one pharmacy is temporarily out of a Schedule II controlled substance, and another pharmacy agrees to
transfer to that pharmacy one bottle of 100 tablets to “help out in a pinch,” the receiving pharmacy must send its DEA form
222 to the dispersing pharmacy. When the time comes to return the favor, the same process is followed. The restriction referred to above is that of the 5 percent rule described earlier.
The DEA permits, but does not require, Schedule I and Schedule II drugs to be ordered from a supplier electronically. This
does not mean that a prescriber can order these drugs for dispensing to patients electronically. Prescriptions still must be
written for Schedule II drugs. But the Controlled Substance Ordering System (CSOS—Pronounced like “sea sauce”) allows
ordering electronically as long as specific criteria have been met.
§ 1305.21 REQUIREMENTS FOR ELECTRONIC ORDERS.
(A) TO BE VALID, THE PURCHASER MUST SIGN AN ELECTRONIC ORDER FOR A SCHEDULE I OR II CONTROLLED SUBSTANCE WITH A DIGITAL SIGNATURE ISSUED TO THE PURCHASER, OR THE PURCHASER'S
AGENT, BY DEA AS PROVIDED IN PART 1311 OF THIS CHAPTER.
(B) THE FOLLOWING DATA FIELDS MUST BE INCLUDED ON AN ELECTRONIC ORDER FOR SCHEDULE I
AND II CONTROLLED SUBSTANCES:
(1) A UNIQUE NUMBER THE PURCHASER ASSIGNS TO TRACK THE ORDER. THE NUMBER MUST BE IN
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THE FOLLOWING 9-CHARACTER FORMAT: THE LAST TWO DIGITS OF THE YEAR, X, AND SIX CHARACTERS AS SELECTED BY THE PURCHASER.
(2) THE PURCHASER'S DEA REGISTRATION NUMBER.
(3) THE NAME OF THE SUPPLIER.
(4) THE COMPLETE ADDRESS OF THE SUPPLIER (MAY BE COMPLETED BY EITHER THE PURCHASER OR
THE SUPPLIER).
(5) THE SUPPLIER'S DEA REGISTRATION NUMBER (MAY BE COMPLETED BY EITHER THE PURCHASER
OR THE SUPPLIER).
(6) THE DATE THE ORDER IS SIGNED.
(7) THE NAME (INCLUDING STRENGTH WHERE APPROPRIATE) OF THE CONTROLLED SUBSTANCE
PRODUCT OR THE NATIONAL DRUG CODE (NDC) NUMBER (THE NDC NUMBER MAY BE COMPLETED BY
EITHER THE PURCHASER OR THE SUPPLIER).
(8) THE QUANTITY IN A SINGLE PACKAGE OR CONTAINER.
(9) THE NUMBER OF PACKAGES OR CONTAINERS OF EACH ITEM ORDERED.
(C) AN ELECTRONIC ORDER MAY INCLUDE CONTROLLED SUBSTANCES THAT ARE NOT IN SCHEDULES I
AND II AND NON-CONTROLLED SUBSTANCES.
§ 1305.25 UNACCEPTED AND DEFECTIVE ELECTRONIC ORDERS.
(A) NO ELECTRONIC ORDER MAY BE FILLED IF:
(1) THE REQUIRED DATA FIELDS HAVE NOT BEEN COMPLETED.
(2) THE ORDER IS NOT SIGNED USING A DIGITAL CERTIFICATE ISSUED BY DEA.
(3) THE DIGITAL CERTIFICATE USED HAD EXPIRED OR HAD BEEN REVOKED PRIOR TO SIGNATURE.
(4) THE PURCHASER'S PUBLIC KEY WILL NOT VALIDATE THE DIGITAL SIGNATURE.
(5) THE VALIDATION OF THE ORDER SHOWS THAT THE ORDER IS INVALID FOR ANY REASON.
(B) IF AN ORDER CANNOT BE FILLED FOR ANY REASON UNDER THIS SECTION, THE SUPPLIER MUST
NOTIFY THE PURCHASER AND PROVIDE A STATEMENT AS TO THE REASON (E.G., IMPROPERLY PREPARED OR ALTERED). A SUPPLIER MAY, FOR ANY REASON, REFUSE TO ACCEPT ANY ORDER, AND IF A
SUPPLIER REFUSES TO ACCEPT THE ORDER, A STATEMENT THAT THE ORDER IS NOT ACCEPTED IS
SUFFICIENT FOR PURPOSES OF THIS PARAGRAPH.
(C) WHEN A PURCHASER RECEIVES AN UNACCEPTED ELECTRONIC ORDER FROM THE SUPPLIER, THE
PURCHASER MUST ELECTRONICALLY LINK THE STATEMENT OF NONACCEPTANCE TO THE ORIGINAL
ORDER. THE ORIGINAL ORDER AND THE STATEMENT MUST BE RETAINED IN ACCORDANCE WITH §
1305.27.
(D) NEITHER A PURCHASER NOR A SUPPLIER MAY CORRECT A DEFECTIVE ORDER; THE PURCHASER
MUST ISSUE A NEW ORDER FOR THE ORDER TO BE FILLED.
§ 1305.26 LOST ELECTRONIC ORDERS.
(A) IF A PURCHASER DETERMINES THAT AN UNFILLED ELECTRONIC ORDER HAS BEEN LOST BEFORE
OR AFTER RECEIPT, THE PURCHASER MUST PROVIDE, TO THE SUPPLIER, A SIGNED STATEMENT CONTAINING THE UNIQUE TRACKING NUMBER AND DATE OF THE LOST ORDER AND STATING THAT THE
GOODS COVERED BY THE FIRST ORDER WERE NOT RECEIVED THROUGH LOSS OF THAT ORDER.
(B) IF THE PURCHASER EXECUTES AN ORDER TO REPLACE THE LOST ORDER, THE PURCHASER MUST
ELECTRONICALLY LINK AN ELECTRONIC RECORD OF THE SECOND ORDER AND A COPY OF THE STATEMENT WITH THE RECORD OF THE FIRST ORDER AND RETAIN THEM.
(C) IF THE SUPPLIER TO WHOM THE ORDER WAS DIRECTED SUBSEQUENTLY RECEIVES THE FIRST ORDER, THE SUPPLIER MUST INDICATE THAT IT IS "NOT ACCEPTED" AND RETURN IT TO THE PURCHASER. THE PURCHASER MUST LINK THE RETURNED ORDER TO THE RECORD OF THAT ORDER AND THE
STATEMENT.
§ 1305.27 PRESERVATION OF ELECTRONIC ORDERS.
(A) A PURCHASER MUST, FOR EACH ORDER FILLED, RETAIN THE ORIGINAL SIGNED ORDER AND ALL
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LINKED RECORDS FOR THAT ORDER FOR TWO YEARS. THE PURCHASER MUST ALSO RETAIN ALL COPIES OF EACH UNACCEPTED OR DEFECTIVE ORDER AND EACH LINKED STATEMENT.
(B) A SUPPLIER MUST RETAIN EACH ORIGINAL ORDER FILLED AND THE LINKED RECORDS FOR TWO
YEARS.
(C) IF ELECTRONIC ORDER RECORDS ARE MAINTAINED ON A CENTRAL SERVER, THE RECORDS MUST
BE READILY RETRIEVABLE AT THE REGISTERED LOCATION.
§ 1305.28 CANCELING AND VOIDING ELECTRONIC ORDERS.
(A) A SUPPLIER MAY VOID ALL OR PART OF AN ELECTRONIC ORDER BY NOTIFYING THE PURCHASER
OF THE VOIDING. IF THE ENTIRE ORDER IS VOIDED, THE SUPPLIER MUST MAKE AN ELECTRONIC
COPY OF THE ORDER, INDICATE ON THE COPY "VOID," AND RETURN IT TO THE PURCHASER. THE SUPPLIER IS NOT REQUIRED TO RETAIN A RECORD OF ORDERS THAT ARE NOT FILLED.
(B) THE PURCHASER MUST RETAIN AN ELECTRONIC COPY OF THE VOIDED ORDER.
(C) TO PARTIALLY VOID AN ORDER, THE SUPPLIER MUST INDICATE IN THE LINKED RECORD THAT
NOTHING WAS SHIPPED FOR EACH ITEM VOIDED.
§ 1305.29 REPORTING TO DEA.
A SUPPLIER MUST, FOR EACH ELECTRONIC ORDER FILLED, FORWARD EITHER A COPY OF THE ELECTRONIC ORDER OR AN ELECTRONIC REPORT OF THE ORDER IN A FORMAT THAT DEA SPECIFIES TO
DEA WITHIN TWO BUSINESS DAYS.
VII.
Prescriptions
Pharmacists fulfill many significant roles in health care, and there are enormous possibilities for expanded practice in
the future. However, the traditional role of the pharmacist has been in processing prescription orders. In the near future, it is
likely that robotics will replace this role and that pharmacists will find themselves primarily doing very important systems
organization activities related to order processing. Under both the traditional and expanded roles, pharmacists find themselves responsible for the integrity of the dispensing they do, and they must assure adherence to DEA regulations regarding
prescriptions.
A.
Persons Entitled to Issue Prescriptions
The DEA regulations specify who may issue a prescription. The DEA regulation follows. Numerations refer to sections of
Title 21, Code of Federal Regulations.
§ 1306.03 Persons entitled to issue prescriptions.
(a) A prescription for a controlled substance may be issued only by an individual practitioner who is:
(1) authorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession
and
(2) either registered or exempted from registration pursuant to §§ 1301.22(c) and 1301.23 of this chapter.
(b) A prescription issued by an individual practitioner may be communicated to a pharmacist by an employee or
agent of the individual practitioner.
Note that it is state law that determines who may issue a prescription. However, one need not be authorized by law to issue a
prescription in order to merely transmit the prescription to a pharmacy. An authorized prescriber’s agent may communicate
with the pharmacy and inform the pharmacy of the prescriber’s prescription. Of course, the pharmacy has a responsibility to
assure that the agent is really functioning on behalf of the prescriber.
B.
Purpose of Issuance of a Prescription
One of the most challenging regulations with which pharmacists must comply is the so-called “corresponding responsibility”
rule that requires of pharmacists a careful review of each controlled substance prescription to assure its validity. The DEA
regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
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§ 1306.04 Purpose of issue of prescription.
(a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the
usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law
relating to controlled substances.
(b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.
(c) A prescription may not be issued for "detoxification treatment" or "maintenance treatment," unless the prescription is for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use
in maintenance or detoxification treatment and the practitioner is in compliance with requirements in § 1301.28 of
this chapter.
Note that the most significant word in this section is “knowingly.” A pharmacist who knowingly fills a purported prescription has violated the law. In this sense, “knowingly” refers both to what a pharmacist actually knows and to what a pharmacist ought to know, given the relevant circumstances. The distinction a pharmacist is required to make is between medicine
and non-medicine, not between good medicine and bad medicine. Simply because a prescription for a controlled substance
may be a bit out of the ordinary does not trigger the responsibility to refuse filling. A pharmacist’s duty to refuse filling under this rule arises when the pharmacist knows the prescribed drug will be diverted to a non-medical use. A pharmacist may
fill a prescription for detoxification or maintenance only if the requirements for such a program have been met, as specified in
section 1301.28, described below in paragraph XI.
C.
Manner of Issuance of Prescriptions
It is not only important that the purpose of a prescription be valid, the prescription must also meet specific format requirements. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
§ 1306.05 Manner of issuance of prescriptions.
a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear
the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for
use and the name, address and registration number of the practitioner. In addition, a prescription for a Schedule III,
IV, or V narcotic drug approved by FDA specifically for "detoxification treatment" or "maintenance treatment" must
include the identification number issued by the Administrator under § 1301.28(d) of this chapter or a written notice
stating that the practitioner is acting under the good faith exception of § 1301.28(e). Where a prescription is for
gamma-hydroxybutyric acid, the practitioner shall note on the face of the prescription the medical need of the patient
for the prescription. A practitioner may sign a prescription in the same manner as he would sign a check or legal
document (e.g., J.H. Smith or John H. Smith). Where an oral order is not permitted, prescriptions shall be written
with ink or indelible pencil or typewriter and shall be manually signed by the practitioner. The prescriptions may be
prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible
in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not
prepared in the form prescribed by DEA regulations.
Note that the requirement above does not specify when the prescription must come to bear all of the listed information.
Therefore, it is generally considered acceptable for a pharmacist to fill in missing but required information, if the pharmacist
is able to do so. Obviously, the prescriber’s signature is not possible for a pharmacist to provide. However, if the pharmacist
knows the prescriber’s DEA number, for example, and it has not been provided by the prescriber, the pharmacist may place
that information on the prescription, along with any other missing and required information, prior to filling the prescription.
Note also the requirements for community based prescribing of drugs approved for detoxification and maintenance.
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(b) An individual practitioner exempted from registration under § 1301.22(c) of this chapter shall include on all prescriptions issued by him or her the registration number of the hospital or other institution and the special internal
code number assigned to him or her by the hospital or other institution as provided in § 1301.22(c) of this chapter, in
lieu of the registration number of the practitioner required by this section. Each written prescription shall have the
name of the physician stamped, typed, or handprinted on it, as well as the signature of the physician.
Interns and some other physicians, who are licensed to prescribe by the state in which they practice, may not have their own
individual DEA number. If this is the case, then they may use the DEA number of the hospital, along with a special code
they have been assigned by the hospital. These prescriptions are completely legitimate.
D.
Persons Entitled to Fill Prescriptions
To fill a prescription for a controlled substance, a pharmacist must either be registered with the DEA, or employed by a registered pharmacy. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
§ 1306.06 Persons entitled to fill prescriptions.
A prescription for controlled substances may only be filled by a pharmacist acting in the usual course of his professional practice and either registered individually or employed in a registered pharmacy or registered institutional
practitioner.
Note once again that pharmacists need not be individually registered with the DEA as long as they are practicing in a pharmacy that is registered with the DEA.
E.
Automated Dispensing Units in Nursing Homes
It is permitted by the DEA for a pharmacist to fill an order through the use of automated dispensing unit in a nursing home.
§ 1301.27 Separate registration by retail pharmacies for installation and operation of automated dispensing systems
at long term care facilities.
(a) A retail pharmacy may install and operate automated dispensing systems, as defined in § 1300.01 of this chapter,
at long term care facilities, under the requirements of § 1301.17. No person other than a registered retail pharmacy
may install and operate an automated dispensing system at a long term care facility.
(b) Retail pharmacies installing and operating automated dispensing systems at long term care facilities must maintain a separate registration at the location of each long term care facility at which automated dispensing systems are
located. If more than one registered retail pharmacy operates automated dispensing systems at the same long term
care facility, each retail pharmacy must maintain a registration at the long term care facility.
(c) A registered retail pharmacy applying for a separate registration to operate an automated dispensing system for
the dispensing of controlled substances at a long term care facility is exempt from application fees for any such additional registrations.
VIII.
Rules for Schedule II Controlled Substances
Because they are the most highly regulated of the controlled substances that are available in most pharmacies, Schedule II controlled substances are subject to very tight security. The requirements applicable to them must be followed very
carefully. Most problems pharmacists have with legal authorities, related to controlled substances, are due to the failure to
follow rules for Schedule II controlled substances.
A.
Requirement of a Written Prescription
Most prescriptions may be authorized either in writing or verbally. Such is not the case with Schedule II prescriptions, which
must be in writing. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
§ 1306.11 Requirement of prescription.
(a) A pharmacist may dispense directly a controlled substance listed in Schedule II, which is a prescription drug
as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to a written prescription signed by
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the practitioner, except as provided in paragraph (d) of this section. A prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment, provided that the original written, signed prescription is presented to the pharmacist for review prior to the actual
dispensing of the controlled substance, except as noted in paragraph (e), (f), or (g) of this section. The original prescription shall be maintained in accordance with § 1304.04(h) of this chapter.
(b) An individual practitioner may administer or dispense directly a controlled substance listed in Schedule II in the
course of his professional practice without a prescription, subject to § 1306.07.
(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed
in Schedule II only pursuant to a written prescription signed by the prescribing individual practitioner or to an order
for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate
user.
(d) In the case of an emergency situation, as defined by the Secretary in § 290.10 of this title, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that:
(1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency
period (dispensing beyond the emergency period must be pursuant to a written prescription signed by the prescribing
individual practitioner);
(2) The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information
required in § 1306.05, except for the signature of the prescribing individual practitioner;
(3) If the prescribing individual practitioner is not known to the pharmacist, he must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to
the prescribing individual practitioner using his phone number as listed in the telephone directory and/or other good
faith efforts to insure his identity; and
(4) Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall
cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In
addition to conforming to the requirements of § 1306.05, the prescription shall have written on its face
"Authorization for Emergency Dispensing," and the date of the oral order. The written prescription may be delivered
to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7 day period. Upon
receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription which had earlier
been reduced to writing. The pharmacist shall notify the nearest office of the Administration if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual
practitioner.
(e) A prescription prepared in accordance with § 1306.05 written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the pharmacy by facsimile.
The facsimile serves as the original written prescription for purposes of this paragraph (e) and it shall be maintained
in accordance with § 1304.04(h) of this chapter.
(f) A prescription prepared in accordance with § 1306.05 written for Schedule II substance for a resident of a Long
Term Care Facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by
facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (f) and it shall be
maintained in accordance with § 1304.04(h).
(g) A prescription prepared in accordance with § 1306.05 written for a Schedule II narcotic substance for a patient
enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program
which is licensed by the state may be transmitted by the practitioner or the practitioner's agent to the dispensing
pharmacy by facsimile. The practitioner or the practitioner's agent will note on the prescription that the patient is a
hospice patient. The facsimile serves as the original written prescription for purposes of this paragraph (g) and it
shall be maintained in accordance with § 1304.04(h).
Note that a facsimile may serve as the original of a Schedule II prescription, and may be filled by a pharmacist, under the
three situations described above. Of course, state law must also permit such a prescription to be filled.
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B.
No Refills Permitted
The message here is brief. No Schedule II prescription may be refilled. Never! End of story!! However, the DEA does permit the issuance of multiple prescriptions on the same day, all dated on the date of issuance, with instructions to the pharmacist to dispense the medications at a future time. The DEA regulation follows. Numerations refer to sections of Title 21,
Code of Federal Regulations.
§ 1306.12Refilling Prescriptions; Issuance of Multiple Prescriptions
(a) The refilling of a prescription for a controlled substance listed in Schedule II is prohibited.
(b)(1) An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a
90-day supply of a Schedule II controlled substance provided the following conditions are met:
(i) Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the
usual course of professional practice;
(ii) The individual practitioner provides written instructions on each prescription (other than the first prescription, if
the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on
which a pharmacy may fill each prescription;
(iii) The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does
not create an undue risk of diversion or abuse;
(iv) The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws;
and
(v) The individual practitioner complies fully with all other applicable requirements under the Act and these regulations as well as any additional requirements under state law.
(2) Nothing in this paragraph (b) shall be construed as mandating or encouraging individual practitioners to issue
multiple prescriptions or to see their patients only once every 90 days when prescribing Schedule II controlled substances. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often
to see their patients when doing so.
C.
Partial Filling
Although refilling of a Schedule II prescription is forbidden, partial filling is permitted subject to specific conditions. Refilling and partial filling are different. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal
Regulations.
§ 1306.13 Partial filling of prescriptions.
(a) The partial filling of a prescription for a controlled substance listed in Schedule II is permissible, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral
prescription). The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall so notify the
prescribing individual practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.
(b) A prescription for a Schedule II controlled substance written for a patient in a Long Term Care Facility (LTCF)
or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include
individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the
pharmacist must contact the practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally
ill patient. The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient." A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" shall
be deemed to have been filled in violation of the Act. For each partial filling, the dispensing pharmacist shall record
on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the
date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of
the dispensing pharmacist. The total quantity of Schedule II controlled substances dispensed in all partial fillings
must not exceed the total quantity prescribed. Schedule II prescriptions for patients in a LTCF or patients with a
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medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 60 days from the issue
date unless sooner terminated by the discontinuance of medication.
Note that partial filling of a Schedule II prescription, beyond the 72 hour limit for most prescriptions, is extended to 60 days
for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness.
(c) Information pertaining to current Schedule II prescriptions for patients in a LTCF or for patients with a medical
diagnosis documenting a terminal illness may be maintained in a computerized system if this system has the capability to permit:
(1) Output (display or printout) of the original prescription number, date of issue, identification of prescribing individual practitioner, identification of patient, address of the LTCF or address of the hospital or residence of the patient, identification of medication authorized (to include dosage, form, strength and quantity), listing of the partial
fillings that have been dispensed under each prescription and the information required in § 1306.13(b).
(2) Immediate (real time) updating of the prescription record each time a partial filling of the prescription is conducted.
(3) Retrieval of partially filled Schedule II prescription information is the same as required by § 1306.22(b) (4) and
(5) for Schedule III and IV prescription refill information.
D.
Labeling and Filing Prescriptions
Special rules for labeling and filing of Schedule II prescriptions have been promulgated. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
§ 1306.14 Labeling of substances and filing of prescriptions.
(a) The pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II
shall affix to the package a label showing date of filling, the pharmacy name and address, the serial number of the
prescription, the name of the patient, the name of the prescribing practitioner, and directions for use and cautionary
statements, if any, contained in such prescription or required by law.
(b) The requirements of paragraph (a) of this section do not apply when a controlled substance listed in Schedule II
is prescribed for administration to an ultimate user who is institutionalized: Provided, That:
(1) Not more than 7-day supply of the controlled substance listed in Schedule II is dispensed at one time;
(2) The controlled substance listed in Schedule II is not in the possession of the ultimate user prior to the administration;
(3) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule II; and
(4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product,
and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription
or required by law.
(c) All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with
requirements of § 1304.04(h) of this chapter.
(d) All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with
requirements of Sec. 1304.04(h) of this chapter.
(e) Where a prescription that has been prepared in accordance with section 1306.12(b) contains instructions from
the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may
fill the prescription before that date.
Note that this rule gives a huge break to hospitals when dispensing small quantities of Schedule II controlled substances to
inpatients. Otherwise, these small quantities would have to bear labels that would hardly fit on their small packages.
E.
Changing a C-II Prescription
Until recently, the DEA provided the following guidance as to what information can be changed on a C-II prescription:
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DEA Policy Regarding Information That Can Be Changed on a Schedule II Prescription
The majority of changes can be made only after the pharmacist contacts the prescribing practitioner. After consultation with the prescribing practitioner, the pharmacist is permitted to change the patient’s address, drug strength,
drug quantity, and directions for use. The pharmacist is permitted to make information additions that may be provided by the patient or bearer such as the patient’s address, and such additions should be verified. The pharmacist may
also add the dosage form to the prescription order after verification with the prescribing practitioner.
The pharmacist is never permitted to make changes to the patient’s name, controlled substances prescribed (except
for generic substitution permitted by State Law), or the prescriber’s signature. These types of changes challenge the
necessity of the original prescription and would require a new prescription from the prescribing practitioner. In
those cases where a prescriber either omits the strength, quantity, or directions, or where the pharmacist doing prospective drug utilization review discovers an error in any of these required elements, this policy allows the problem
to be dealt with by a telephone call rather than a trip back to the prescriber’s office. The pharmacist should always
document the time and date that the prescriber was contacted about the correction, and should always ask the prescriber to document the change in the patient’s chart so that both the prescriber and the pharmacist have a record of
the conversation. Please contact the local DEA office or the State Board of Pharmacy if you have any questions
about this policy.
However, this guidance was recently changed to the statement provided below. Shortly after, the website was again modified
to exclude the language underlined.
On November 19, 2007, the DEA published in the Federal Register (FR) the Final Rule entitled Issuance of Multiple
Prescriptions for Schedule II Controlled Substances (72 FR 64921).In the preamble to that Rule, DEA stated that
"the essential elements of the [schedule II] prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed)…may not be modified orally."
(The instructions contained in the Rule's preamble are in opposition to DEA's previous policy which permitted the
same changes a pharmacist may make to schedules III-V controlled substance prescriptions after oral consultation
with the prescriber. DEA recognizes the resultant confusion regarding this conflict and plans to resolve this matter
through a future rulemaking. Until that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber.)
IX.
Rules for Schedule III, IV and V Controlled Substances
Although less highly regulated than Schedule II controlled substances, drugs classified in Schedules III through V
nevertheless are subject to far more strict control than are drugs that do not fall into the category of controlled substances.
A.
Requirement of a Prescription
Controlled substances in Schedules III through V may be dispensed pursuant to a verbal prescription. The DEA regulation
follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
§ 1306.21 Requirement of prescription.
(a) A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to either a written prescription signed by a practitioner or a facsimile of a written, signed prescription transmitted by the practitioner or the
practitioner's agent to the pharmacy or pursuant to an oral prescription made by an individual practitioner and
promptly reduced to writing by the pharmacist containing all information required in § 1306.05, except for the signature of the practitioner.
(b) An individual practitioner may administer or dispense directly a controlled substance listed in Schedule III, IV, or
V in the course of his/her professional practice without a prescription, subject to § 1306.07.
(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed
in Schedule III, IV, or V only pursuant to a written prescription signed by an individual practitioner, or pursuant to a
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facsimile of a written prescription or order for medication transmitted by the practitioner or the practitioner's agent
to the institutional practitioner-pharmacist, or pursuant to an oral prescription made by an individual practitioner
and promptly reduced to writing by the pharmacist (containing all information required in Section 1306.05 except
for the signature of the individual practitioner), or pursuant to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user, subject to § 1306.07.
Note the distinction that is made between a prescription and an order for medication which is dispensed for immediate administration to an ultimate user in an institution. The law imposes strict requirements for the former, but not for the latter.
B.
Refills Permitted
Unlike prescriptions for controlled substances in Schedule II, prescriptions for controlled substances in Schedule III and IV
may be refilled, however specific limits apply. The DEA regulation follows. Numerations refer to sections of Title 21, Code
of Federal Regulations.
§ 1306.22 Refilling of prescriptions.
(a) No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six
months after the date on which such prescription was issued and no such prescription authorized to be refilled may
be refilled more than five times. Each refilling of a prescription shall be entered on the back of the prescription or on
another appropriate document. If entered on another document, such as a medication record, the document must be
uniformly maintained and readily retrievable. The following information must be retrievable by the prescription
number consisting of the name and dosage form of the controlled substance, the date filled or refilled, the quantity
dispensed, initials of the dispensing pharmacist for each refill, and the total number of refills for that prescription. If
the pharmacist merely initials and dates the back of the prescription it shall be deemed that the full face amount of
the prescription has been dispensed. The prescribing practitioner may authorize additional refills of Schedule III or
IV controlled substances on the original prescription through an oral refill authorization transmitted to the pharmacist provided the following conditions are met:
(1) The total quantity authorized, including the amount of the original prescription, does not exceed five refills nor
extend beyond six months from the date of issue of the original prescription.
(2) The pharmacist obtaining the oral authorization records on the reverse of the original prescription the date,
quantity of refill, number of additional refills authorized, and initials the prescription showing who received the authorization from the prescribing practitioner who issued the original prescription.
(3) The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription.
(4) The prescribing practitioner must execute a new and separate prescription for any additional quantities beyond
the five refill, six-month limitation.
(b) As an alternative to the procedures provided by subsection (a), an automated data processing system may be used
for the storage and retrieval of refill information for prescription orders for controlled substances in Schedule III
and IV, subject to the following conditions:
(1) Any such proposed computerized system must provide on-line retrieval (CRT display or hard-copy printout) of
original prescription order information for those prescription orders which are currently authorized for refilling.
This shall include, but is not limited to, data such as the original prescription number, date of issuance of the original prescription order by the practitioner, full name and address of the patient, name, address, and DEA registration
number of the practitioner, and the name, strength, dosage form, quantity of the controlled substance prescribed (and
quantity dispensed if different from the quantity prescribed), and the total number of refills authorized by the prescribing practitioner.
(2) Any such proposed computerized system must also provide on-line retrieval (via CRT display or hard-copy printout) of the current refill history for Schedule III or IV controlled substance prescription orders (those authorized for
refill during the past six months.) This refill history shall include, but is not limited to, the name of the controlled substance, the date of refill, the quantity dispensed, the identification code, or name or initials of the dispensing pharmacist for each refill and the total number of refills dispensed to date for that prescription order.
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(3) Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an
original prescription order for a Schedule III or IV controlled substance is correct must be provided by the individual
pharmacist who makes use of such a system. If such a system provides a hard-copy printout of each day's controlled
substance prescription order refill data, that printout shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order. The individual pharmacist must verify that the data indicated is correct
and then sign this document in the same manner as he would sign a check or legal document (e.g., J. H. Smith, or
John H. Smith). This document shall be maintained in a separate file at that pharmacy for a period of two years from
the dispensing date. This printout of the day's controlled substance prescription order refill data must be provided to
each pharmacy using such a computerized system within 72 hours of the date on which the refill was dispensed. It
must be verified and signed by each pharmacist who is involved with such dispensing. In lieu of such a printout, the
pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such
dispensing shall sign a statement (in the manner previously described) each day, attesting to the fact that the refill
information entered into the computer that day has been reviewed by him and is correct as shown. Such a book or file
must be maintained at the pharmacy employing such a system for a period of two years after the date of dispensing
the appropriately authorized refill.
(4) Any such computerized system shall have the capability of producing a printout of any refill data which the user
pharmacy is responsible for maintaining under the Act and its implementing regulations. For example, this would
include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance (by either
brand or generic name or both). Such a printout must include name of the prescribing practitioner, name and address of the patient, quantity dispensed on each refill, date of dispensing for each refill, name or identification code
of the dispensing pharmacist, and the number of the original prescription order. In any computerized system employed by a user pharmacy the central recordkeeping location must be capable of sending the printout to the pharmacy within 48 hours, and if a DEA Special Agent or Diversion Investigator requests a copy of such printout from
the user pharmacy, it must, if requested to do so by the Agent or Investigator, verify the printout transmittal capability of its system by documentation (e.g., postmark).
(5) In the event that a pharmacy which employs such a computerized system experiences system down-time, the pharmacy must have an auxiliary procedure which will be used for documentation of refills os Schedule III and IV controlled substance prescription orders. This auxiliary procedure must insure that refills are authorized by the original
prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data is
retained for on-line data entry as soon as the computer system is available for use again.
(c) When filing refill information for original prescription orders for Schedule III or IV controlled substances, a
pharmacy may use only one of the two systems described in paragraphs (a) or (b) of this section.
Note that computerized information for controlled substances is subject to a daily signoff by a pharmacist who verifies the
authenticity of the information contained in the printout for the day. Care must be taken by this pharmacist to assure that
what is being signed is in fact an accurate accounting of the daily activity.
C.
Partial Filling
The partial filling of prescriptions for controlled substances in Schedules III through V is permitted, subject to conditions far
less restrictive than those applicable to prescriptions for controlled substances in Schedule II. The DEA regulation follows.
Numerations refer to sections of Title 21, Code of Federal Regulations.
§ 1306.23 Partial filling of prescriptions.
The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible, provided that:
(a) Each partial filling is recorded in the same manner as a refilling,
(b) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and
(c) No dispensing occurs after 6 months after the date on which the prescription was issued.
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D.
Labeling and Filing
The labeling and filing requirements applicable to prescriptions for controlled substances in Schedules III through V are virtually the same as those applicable to prescriptions for controlled substances in Schedule II. The DEA regulation follows.
Numerations refer to sections of Title 21, Code of Federal Regulations.
§ 1306.24 Labeling of substances and filing of prescriptions.
(a) The pharmacist filling a prescription for a controlled substance listed in Schedule III, IV, or V shall affix to the
package a label showing the pharmacy name and address, the serial number and date of initial filling, the name of
the patient, the name of the practitioner issuing the prescription, and directions for use and cautionary statements, if
any, contained in such prescription as required by law.
(b) The requirements of paragraph (a) of this section do not apply when a controlled substance listed in Schedule III,
IV, or V is prescribed for administration to an ultimate user who is institutionalized: Provided, That:
(1) Not more than a 34-day supply or 100 dosage units, whichever is less, of the controlled substance listed in Schedule III, IV, or V is dispensed at one time;
(2) The controlled substance listed in Schedule III, IV, or V is not in the possession of the ultimate user prior to administration;
(3) The institution maintains appropriate safeguards and records the proper administration, control, dispensing, and
storage of the controlled substance listed in Schedule III, IV, or V; and
(4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product
and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription
or required by law.
(c) All prescriptions for controlled substances listed in Schedules III, IV, and V shall be kept in accordance with §
1304.04(h) of this chapter.
E.
Transfer of Prescriptions
In our mobile society, it is quite possible that a patient will need to have a prescription initially dispensed at a particular location, but require that refills be dispensed at a different location. This may be due to a prescriber’s office being far away from
the patient’s home, or it may be due to a vacation or other reason to be out of town. To prevent inconvenience to patients, the
DEA permits the transfer of prescriptions for controlled substances in Schedules III to V from one pharmacy to another. The
DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
§ 1306.25 Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes.
(a) The transfer of original prescription information for a controlled substance listed in Schedules III, IV or V for
the purpose of refill dispensing is permissible between pharmacies on a one time basis only. However, pharmacies
electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the
prescriber's authorization. Transfers are subject to the following requirements:
(1) The transfer is communicated directly between two licensed pharmacists and the transferring pharmacist records
the following information:
(i) Write the word "VOID" on the face of the invalidated prescription.
(ii) Record on the reverse of the invalidated prescription the name, address and DEA registration number of the
pharmacy to which is was transferred and the name of the pharmacist receiving the prescription information.
(b) The pharmacist receiving the transferred prescription information shall reduce to writing the following:
(1) Write the word "transfer" on the face of the transferred prescription.
(2) Provide all information required to be on a prescription pursuant to 21 CFR 1306.05 and include:
(i) Date of issuance of original prescription;
(ii) Original number of refills authorized on original prescription;
(iii) Date of original dispensing;
(iv) Number of valid refills remaining and date(s) and locations of previous refill(s);
(v) Pharmacy's name, address, DEA registration number and prescription number from which the prescription information was transferred;
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(vi) Name of pharmacist who transferred the prescription.
(vii) Pharmacy's name, address, DEA registration number and prescription number from which the prescription was
originally filled;
(3) The original and transferred prescription(s) must be maintained for a period of two years from the date of last
refill.
(c) Pharmacies electronically accessing the same prescription record must satisfy all information requirements of a
manual mode for prescription transferral.
(d) The procedure allowing the transfer of prescription information for refill purposes is permissible only if allowable under existing state or other applicable law.
X.
Nonprescription Dispensing
The crossover between the CSA and the FDCA was noted above. Due to this crossover, there is the possibility that
some drugs will be classified as controlled substances but not as legend drugs. As a practical matter, this possibility is restricted to those controlled substances in Schedule V, however, the DEA regulations reflect the theoretical possibility that any
available controlled substance may be a non-legend drug. Rules have been developed for non-prescription sales of controlled
substances. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
§ 1306.26 Dispensing without prescription.
A controlled substance listed in Schedules II, III, IV, or V which is not a prescription drug as determined under the
Federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at
retail, provided that:
(a) Such dispensing is made only by a pharmacist (as defined in part 1300 of this chapter), and not by a nonpharmacist employee even if under the supervision of a pharmacist (although after the pharmacist has fulfilled his professional and legal responsibilities set forth in this section, the actual cash, credit transaction, or delivery, may be
completed by a nonpharmacist);
(b) Not more than 240 cc. (8 ounces) of any such controlled substance containing opium, nor more than 120 cc. (4
ounces) of any other such controlled substance nor more than 48 dosage units of any such controlled substance containing opium, nor more than 24 dosage units of any other such controlled substance may be dispensed at retail to
the same purchaser in any given 48-hour period;
(c) The purchaser is at least 18 years of age;
(d) The pharmacist requires every purchaser of a controlled substance under this section not known to him to furnish
suitable identification (including proof of age where appropriate);
(e) A bound record book for dispensing of controlled substances under this section is maintained by the pharmacist,
which book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the substance to the purchaser (the book shall be maintained in accordance with the recordkeeping requirement of § 1304.04 of this
chapter); and
(f) A prescription is not required for distribution or dispensing of the substance pursuant to any other Federal, State
or local law.
XI.
Medical Treatment of Narcotic Addiction
The controversy over how to respond to the problem of drug abuse is widespread in American society. On the one
hand, there is an argument to continue strenuous efforts to criminalize narcotic possession and sale, penalizing those who are
involved with drug abuse. On the other hand, there is an argument that it is the criminalization of drug abuse that is the problem, and not drug abuse itself; and that narcotic use should be legalized rather than continue to lose battles in the “war against
drugs.” The government has taken one small step to strike a balance between these two views, by permitting the establishment of programs that treat narcotic addiction as a medical problem. But these programs are limited in scope and they must
be approved by both the appropriate state authorities and the FDA. Patients who are addicted to narcotic drugs must be treated within the parameters of the rules for narcotic addiction treatment programs. The pertinent regulations follow. Numerations refer to sections of Title 42, Code of Federal Regulations.
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§ 8.12 Federal opioid treatment standards.
(a) General. OTPs must provide treatment in accordance with the standards in this section and must comply with
these standards as a condition of certification.
(b) Administrative and organizational structure. An OTP's organizational structure and facilities shall be adequate
to ensure quality patient care and to meet the requirements of all pertinent Federal, State, and local laws and regulations. At a minimum, each OTP shall formally designate a program sponsor and medical director. The program
sponsor shall agree on behalf of the OTP to adhere to all requirements set forth in this part and any regulations regarding the use of opioid agonist treatment medications in the treatment of opioid addiction which may be promulgated in the future. The medical director shall assume responsibility for administering all medical services
performed by the OTP. In addition, the medical director shall be responsible for ensuring that the OTP is in compliance with all applicable Federal, State, and local laws and regulations.
(c) Continuous quality improvement. (1) An OTP must maintain current quality assurance and control plans that
include, among other things, annual reviews of program policies and procedures and ongoing assessment of patient
outcomes.
(2) An OTP must maintain a current "Diversion Control Plan" or "DCP" as part of its quality assurance program
that contains specific measures to reduce the possibility of diversion of controlled substances from legitimate treatment use and that assigns specific responsibility to the medical and administrative staff of the OTP for carrying out
the diversion control measures and functions described in the DCP.
(d) Staff credentials. Each person engaged in the treatment of opioid addiction must have sufficient education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. All physicians, nurses, and other licensed professional care providers, including addiction counselors, must comply with the
credentialing requirements of their respective professions.
(e) Patient admission criteria. -- (1) Maintenance treatment. An OTP shall maintain current procedures designed to
ensure that patients are admitted to maintenance treatment by qualified personnel who have determined, using accepted medical criteria such as those listed in the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV),
that the person is currently addicted to an opioid drug, and that the person became addicted at least 1 year before
admission for treatment. In addition, a program physician shall ensure that each patient voluntarily chooses maintenance treatment and that all relevant facts concerning the use of the opioid drug are clearly and adequately explained to the patient, and that each patient provides informed written consent to treatment.
(2) Maintenance treatment for persons under age 18. A person under 18 years of age is required to have had two
documented unsuccessful attempts at short-term detoxification or drug-free treatment within a 12-month period to
be eligible for maintenance treatment. No person under 18 years of age may be admitted to maintenance treatment
unless a parent, legal guardian, or responsible adult designated by the relevant State authority consents in writing to
such treatment.
(3) Maintenance treatment admission exceptions. If clinically appropriate, the program physician may waive the requirement of a 1-year history of addiction under paragraph (e)(1) of this section, for patients released from penal
institutions (within 6 months after release), for pregnant patients (program physician must certify pregnancy), and
for previously treated patients (up to 2 years after discharge).
(4) Detoxification treatment. An OTP shall maintain current procedures designed to ensure that patients are admitted to short- or long-term detoxification treatment by qualified personnel, such as a program physician, who determines that such treatment is appropriate for the specific patient by applying established diagnostic criteria. Patients
with two or more unsuccessful detoxification episodes within a 12-month period must be assessed by the OTP physician for other forms of treatment. A program shall not admit a patient for more than two detoxification treatment episodes in one year.
(f) Required services. -- (1) General. OTPs shall provide adequate medical, counseling, vocational, educational, and
other assessment and treatment services. These services must be available at the primary facility, except where the
program sponsor has entered into a formal, documented agreement with a private or public agency, organization,
practitioner, or institution to provide these services to patients enrolled in the OTP. The program sponsor, in any
event, must be able to document that these services are fully and reasonably available to patients.
(2) Initial medical examination services. OTPs shall require each patient to undergo a complete, fully documented
physical evaluation by a program physician or a primary care physician, or an authorized healthcare professional
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under the supervision of a program physician, before admission to the OTP. The full medical examination, including
the results of serology and other tests, must be completed within 14 days following admission.
(3) Special services for pregnant patients. OTPs must maintain current policies and procedures that reflect the special needs of patients who are pregnant. Prenatal care and other gender specific services or pregnant patients must
be provided either by the OTP or by referral to appropriate healthcare providers.
(4) Initial and periodic assessment services. Each patient accepted for treatment at an OTP shall be assessed initially and periodically by qualified personnel to determine the most appropriate combination of services and treatment.
The initial assessment must include preparation of a treatment plan that includes the patient's short-term goals and
the tasks the patient must perform to complete the short-term goals; the patient's requirements for education, vocational rehabilitation, and employment; and the medical, psychosocial, economic, legal, or other supportive services
that a patient needs. The treatment plan also must identify the frequency with which these services are to be provided.
The plan must be reviewed and updated to reflect that patient's personal history, his or her current needs for medical, social, and psychological services, and his or her current needs for education, vocational rehabilitation, and employment services.
(5) Counseling services. (i) OTPs must provide adequate substance abuse counseling to each patient as clinically
necessary. This counseling shall be provided by a program counselor, qualified by education, training, or experience
to assess the psychological and sociological background of patients, to contribute to the appropriate treatment plan
for the patient and to monitor patient progress.
(ii) OTPs must provide counseling on preventing exposure to, and the transmission of, human immunodeficiency virus (HIV) disease for each patient admitted or readmitted to maintenance or detoxification treatment.
(iii) OTPs must provide directly, or through referral to adequate and reasonably accessible community resources,
vocational rehabilitation, education, and employment services for patients who either request such services or who
have been determined by the program staff to be in need of such services.
(6) Drug abuse testing services. OTPs must provide adequate testing or analysis for drugs of abuse, including at
least eight random drug abuse tests per year, per patient in maintenance treatment, in accordance with generally accepted clinical practice. For patients in short-term detoxification treatment, the OTP shall perform at least one initial
drug abuse test. For patients receiving long-term detoxification treatment, the program shall perform initial and
monthly random tests on each patient.
(g) Recordkeeping and patient confidentiality. (1) OTPs shall establish and maintain a recordkeeping system that is
adequate to document and monitor patient care. This system is required to comply with all Federal and State reporting requirements relevant to opioid drugs approved for use in treatment of opioid addiction. All records are required
to be kept confidential in accordance with all applicable Federal and State requirements.
(2) OTPs shall include, as an essential part of the recordkeeping system, documentation in each patient's record that
the OTP made a good faith effort to review whether or not the patient is enrolled any other OTP. A patient enrolled
in an OTP shall not be permitted to obtain treatment in any other OTP except in exceptional circumstances. If the
medical director or program physician of the OTP in which the patient is enrolled determines that such exceptional
circumstances exist, the patient may be granted permission to seek treatment at another OTP, provided the justification for finding exceptional circumstances is noted in the patient's record both at the OTP in which the patient is enrolled and at the OTP that will provide the treatment.
(h) Medication administration, dispensing, and use. (1) OTPs must ensure that opioid agonist treatment medications
are administered or dispensed only by a practitioner licensed under the appropriate State law and registered under
the appropriate State and Federal laws to administer or dispense opioid drugs, or by an agent of such a practitioner,
supervised by and under the order of the licensed practitioner. This agent is required to be a pharmacist, registered
nurse, or licensed practical nurse, or any other healthcare professional authorized by Federal and State law to administer or dispense opioid drugs.
(2) OTPs shall use only those opioid agonist treatment medications that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in the treatment of
opioid addiction. In addition, OTPs who are fully compliant with the protocol of an investigational use of a drug and
other conditions set forth in the application may administer a drug that has been authorized by the Food and Drug
Administration under an investigational new drug application under section 505(i) of the Federal Food, Drug, and
Cosmetic Act for investigational use in the treatment of opioid addiction. Currently the following opioid agonist
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treatment medications will be considered to be approved by the Food and Drug Administration for use in the treatment of opioid addiction:
(i) Methadone; and
(ii) Levomethadyl acetate (LAAM).
(3) OTPs shall maintain current procedures that are adequate to ensure that the following dosage form and initial
dosing requirements are met:
(i) Methadone shall be administered or dispensed only in oral form and shall be formulated in such a way as to reduce its potential for parenteral abuse.
(ii) For each new patient enrolled in a program, the initial dose of methadone shall not exceed 30 milligrams and
the total dose for the first day shall not exceed 40 milligrams, unless the program physician documents in the patient's record that 40 milligrams did not suppress opiate abstinence symptoms.
(4) OTPs shall maintain current procedures adequate to ensure that each opioid agonist treatment medication used
by the program is administered and dispensed in accordance with its approved product labeling. Dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling. These
procedures must ensure that any significant deviations from the approved labeling, including deviations with regard
to dose, frequency, or the conditions of use described in the approved labeling, are specifically documented in the
patient's record.
(i) Unsupervised or "take-home" use. To limit the potential for diversion of opioid agonist treatment medications to
the illicit market, opioid agonist treatment medications dispensed to patients for unsupervised use shall be subject to
the following requirements.
(1) Any patient in comprehensive maintenance treatment may receive a single take-home dose for a day that the clinic is closed for business, including Sundays and State and Federal holidays.
(2) Treatment program decisions on dispensing opioid treatment medications to patients for unsupervised use beyond that set forth in paragraph (i)(1) of this section, shall be determined by the medical director. In determining
which patients may be permitted unsupervised use, the medical director shall consider the following take-home criteria in determining whether a patient is responsible in handling opioid drugs for unsupervised use.
(i) Absence of recent abuse of drugs (opioid or nonnarcotic), including alcohol;
(ii) Regularity of clinic attendance;
(iii) Absence of serious behavioral problems at the clinic;
(iv) Absence of known recent criminal activity, e.g., drug dealing;
(v) Stability of the patient's home environment and social relationships;
(vi) Length of time in comprehensive maintenance treatment;
(vii) Assurance that take-home medication can be safely stored within the patient's home; and
(viii) Whether the rehabilitative benefit the patient derived from decreasing the frequency of clinic attendance outweighs the potential risks of diversion.
(3) Such determinations and the basis for such determinations consistent with the criteria outlined in paragraph
(i)(2) of this section shall be documented in the patient's medical record. If it is determined that a patient is responsible in handling opioid drugs, the following restrictions apply:
(i) During the first 90 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) is
limited to a single dose each week and the patient shall ingest all other doses under appropriate supervision as provided for under the regulations in this subpart.
(ii) In the second 90 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) is two
doses per week.
(iii) In the third 90 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) is three
doses per week.
(iv) In the remaining months of the first year, a patient may be given a maximum 6-day supply of take-home medication.
(v) After 1 year of continuous treatment, a patient may be given a maximum 2-week supply of take-home medication.
(vi) After 2 years of continuous treatment, a patient may be given a maximum one-month supply of take-home medication, but must make monthly visits.
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(4) No medications shall be dispensed to patients in short-term detoxification treatment or interim maintenance
treatment for unsupervised or take-home use.
(5) OTPs must maintain current procedures adequate to identify the theft or diversion of take-home medications, including labeling containers with the OTP's name, address, and telephone number. Programs also must ensure that
take-home supplies are packaged in a manner that is designed to reduce the risk of accidental ingestion, including
child-proof containers.
(j) Interim maintenance treatment. (1) The program sponsor of a public or nonprofit private OTP may place an individual, who is eligible for admission to comprehensive maintenance treatment, in interim maintenance treatment if
the individual cannot be placed in a public or nonprofit private comprehensive program within a reasonable geographic area and within 14 days of the individual's application for admission to comprehensive maintenance treatment. An initial and at least two other urine screens shall be taken from interim patients during the maximum of 120
days permitted for such treatment. A program shall establish and follow reasonable criteria for establishing priorities for transferring patients from interim maintenance to comprehensive maintenance treatment. These transfer criteria shall be in writing and shall include, at a minimum, a preference for pregnant women in admitting patients to
interim maintenance and in transferring patients from interim maintenance to comprehensive maintenance treatment. Interim maintenance shall be provided in a manner consistent with all applicable Federal and State laws.
(2) The program shall notify the State health officer when a patient begins interim maintenance treatment, when a
patient leaves interim maintenance treatment, and before the date of mandatory transfer to a comprehensive program, and shall document such notifications.
Under a relatively new program, the DEA has promulgated regulations that permit the prescribing of Schedule III, IV and V
controlled substances for the treatment of the disease of addiction, as long as the prescribed drug has been approved for that
purpose by the FDA. The DEA regulation follows. Numerations refer to sections of Title 21, Code of Federal Regulations.
§ 1301.28 Exemption from separate registration for practitioners dispensing or prescribing Schedule III, IV, or V
narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment.
(a) An individual practitioner may dispense or prescribe Schedule III, IV, or V narcotic controlled drugs or combinations of narcotic controlled drugs which have been approved by the Food and Drug Administration (FDA) specifically for use in maintenance or detoxification treatment without obtaining the separate registration required by §
1301.13(e) if all of the following conditions are met:
(1) The individual practitioner meets the conditions specified in paragraph (b) of this section.
(2) The narcotic drugs or combination of narcotic drugs meet the conditions specified in paragraph (c) of this section.
(3) The individual practitioner is in compliance with either paragraph (d) or paragraph (e) of this section.
(b)(1) The individual practitioner must submit notification to the Secretary of Health and Human Services stating the
individual practitioner's intent to dispense or prescribe narcotic drugs under paragraph (a) of this section. The notice must contain all of the following certifications:
(i) The individual practitioner is registered under § 1301.13 as an individual practitioner and is a "qualifying physician" as defined in section 303(g)(2)(G) of the Act (21 U.S.C. 823(g)(2)(G)).
(ii) The individual practitioner has the capacity to refer the patients to whom the individual practitioner will provide
narcotic drugs or combinations of narcotic drugs for appropriate counseling and other appropriate ancillary services.
(iii) The total number of patients to whom the individual practitioner will provide narcotic drugs or combinations of
narcotic drugs under this section will not exceed 30 at any one time unless, not sooner than 1 year after the date on
which the practitioner submitted the initial notification to the Secretary of Health and Human Services, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients.
A second notification under this subparagraph shall contain the certifications required by subparagraphs (i) and (ii)
of this paragraph. The Secretary of Health and Human Services may promulgate regulations to change the total
number of patients.
(2) If an individual practitioner wishes to prescribe or dispense narcotic drugs pursuant to paragraph (e) of this sec-
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tion, the individual practitioner must provide the Secretary of Health and Human Services the following:
(i) Notification as required under paragraph (b)(1) of this section in writing, stating the individual practitioner's
name and DEA registration number issued under § 1301.13.
(ii) If the individual practitioner is a member of a group practice, the names of the other individual practitioners in
the group and the DEA registration numbers issued to the other individual practitioners under § 1301.13.
(c) The narcotic drugs or combination of narcotic drugs to be dispensed or prescribed under this section must meet
all of the following conditions:
(1) The drugs or combination of drugs have been approved for use in "maintenance treatment" or "detoxification
treatment" under the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act.
(2) The drugs or combination of drugs have not been the subject of an adverse determination by the Secretary of
Health and Human Services, after consultation with the Attorney General, that the use of the drugs or combination of
drugs requires additional standards respecting the qualifications of practitioners or the quantities of the drugs that
may be provided for unsupervised use.
(d)(1) After receiving the notification submitted under paragraph (b) of this section, the Secretary of Health and Human Services will forward a copy of the notification to the Administrator. The Secretary of Health and Human Services will have 45 days from the date of receipt of the notification to make a determination of whether the individual
practitioner involved meets all requirements for a waiver under section 303(g)(2)(B) of the Act (21 U.S.C.
823(g)(2)(B)). Health and Human Services will notify DEA of its determination regarding the individual practitioner.
If the individual practitioner has the appropriate registration under § 1301.13, then the Administrator will issue the
practitioner an identification number as soon as one of the following conditions occurs:
(i) The Administrator receives a positive determination from the Secretary of Health and Human Services before the
conclusion of the 45-day review period, or
(ii) The 45-day review period has concluded and no determination by the Secretary of Health and Human Services
has been made.
(2) If the Secretary denies certification to an individual practitioner or withdraws such certification once it is issued,
then DEA will not issue the individual practitioner an identification number, or will withdraw the identification number if one has been issued.
(3) The individual practitioner must include the identification number on all records when dispensing and on all prescriptions when prescribing narcotic drugs under this section.
(e) An individual practitioner may begin to prescribe or dispense narcotic drugs to a specific individual patient under this section before receiving an identification number from the Administrator if the following conditions are met:
(1) The individual practitioner has submitted a written notification under paragraph (b) of this section in good faith
to the Secretary of Health and Human Services.
(2) The individual practitioner reasonably believes that the conditions specified in paragraphs (b) and (c) of this section have been met.
(3) The individual practitioner reasonably believes that the treatment of an individual patient would be facilitated if
narcotic drugs are prescribed or dispensed under this section before the sooner of:
(i) Receipt of an identification number from the Administrator, or
(ii) Expiration of the 45-day period.
(4) The individual practitioner has notified both the Secretary of Health and Human Services and the Administrator
of his or her intent to begin prescribing or dispensing the narcotic drugs before expiration of the 45-day period.
(5) The Secretary has not notified the registrant that he/she is not qualified under paragraph (d) of this section.
(6) The individual practitioner has the appropriate registration under § 1301.13.
(f) If an individual practitioner dispenses or prescribes Schedule III, IV, or V narcotic drugs approved by the Food
and Drug Administration specifically for maintenance or detoxification treatment in violation of any of the conditions
specified in paragraphs (b), (c) or (e) of this section, the Administrator may revoke the individual practitioner's registration in accordance with § 1301.36.
XII.
Methamphetamine Control
In order to restrict access to pharmaceuticals that can be used as precursors in the illegal manufacture of
methamphetamine, the federal law requires pharmacists to be vigilant to the possibility that large purchases of pseudoephed-
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rine may be intended for illicit purposes. In December 2005, the House of Representatives passed the Combat Methamphetamine Epidemic Act of 2005, the first step in enacting a nationwide measure to require drugs containing ephedrine,
pseudoepedrine, and phenylpropanolamine to be kept behind pharmacy counters and purchased only after identification and
sign in of buyer, as well as limit purchases to no more than 3.6 grams per day and 9 grams per 30-day period. Pertinent sections of the law follow.
The term `scheduled listed chemical product' means... a product that—
(i) contains ephedrine, pseudoephedrine, or phenylpropanolamine; and
(ii) may be marketed or distributed lawfully in the United States under the Federal, Food, Drug, and Cosmetic Act as a nonprescription drug.
Each reference in clause (i) to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the
salts, optical isomers, and salts of optical isomers of such chemical.
The term `regulated seller' means a retail distributor (including a pharmacy or a mobile retail vendor), except that such term does not include an employee or agent of such distributor.
The term `mobile retail vendor' means a person or entity that makes sales at retail from a stand that is intended to be temporary, or is capable of being moved from one location to another, whether the stand is located within or on the premises of a fixed facility (such as a kiosk at a shopping center or an airport) or whether the stand is
located on unimproved real estate (such as a lot or field leased for retail purposes).
The term `at retail', with respect to the sale or purchase of a scheduled listed chemical product, means a
sale or purchase for personal use, respectively.
Restrictions on Sales Quantity; Behind-the-Counter Access; Logbook Requirement; Training of Sales Personnel; Privacy Protections...
(d) Scheduled Listed Chemicals; Restrictions on Sales Quantity; Requirements Regarding Nonliquid
Forms.--With respect to ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a scheduled listed
chemical product-(1) the quantity of such base sold at retail in such a product by a regulated seller, or a distributor required
to submit reports by subsection (b)(3) may not, for any purchaser, exceed a daily amount of 3.6 grams, without regard to the number of transactions; and
(2) such a seller or distributor may not sell such a product in nonliquid form (including gel caps) at retail
unless the product is packaged in blister packs, each blister containing not more than 2 dosage units, or where the
use of blister packs is technically infeasible, the product is packaged in unit dose packets or pouches.
(e) Scheduled Listed Chemicals; Behind-the-Counter Access; Logbook Requirement; Training of Sales Personnel; Privacy Protections.-(1) Requirements regarding retail transactions.—
(A) In general.--Each regulated seller shall ensure... sales by such seller of a scheduled listed chemical
product at retail are made in accordance with the following:
(i) In offering the product for sale, the seller places the product such that customers do not have direct access to the product before the sale is made (in this paragraph referred to as `behind-the-counter' placement). For
purposes of this paragraph, a behind-the-counter placement of a product includes circumstances in which the product is stored in a locked cabinet that is located in an area of the facility involved to which customers do have direct
access.
(ii) The seller delivers the product directly into the custody of the purchaser.
(iii) The seller maintains, in accordance with criteria issued by the Attorney General, a written or electronic
list of such sales that identifies the products by name, the quantity sold, the names and addresses of purchasers, and
the dates and times of the sales (which list is referred to in this subsection as the `logbook'), except that such requirement does not apply to any purchase by an individual of a single sales package if that package contains not more
than 60 milligrams of pseudoephedrine.
(iv) In the case of a sale to which the requirement of clause (iii) applies, the seller does not sell such a product unless--
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(I) the prospective purchaser-(aa) presents an identification card that provides a photograph and is issued by a State or the Federal Government, or a document that, with respect to identification, is considered acceptable for purposes of sections
274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B) of title 8, Code of Federal Regulations (as in effect on or after the date of
the enactment of the Combat Methamphetamine Epidemic Act of 2005); and
(bb) signs the logbook and enters in the logbook his or her name, address, and the date and time of the sale;
and
(II) the seller-(aa) determines that the name entered in the logbook corresponds to the name provided on such identification and that the date and time entered are correct; and
(bb) enters in the logbook the name of the product and the quantity sold.
(v) The logbook includes, in accordance with criteria of the Attorney General, a notice to purchasers that
entering false statements or misrepresentations in the logbook may subject the purchasers to criminal penalties under section 1001 of title 18, United States Code, which notice specifies the maximum fine and term of imprisonment
under such section.
(vi) The seller maintains each entry in the logbook for not fewer than two years after the date on which the
entry is made.
(vii) In the case of individuals who are responsible for delivering such products into the custody of purchasers or who deal directly with purchasers by obtaining payments for the products, the seller has submitted to the Attorney General a self-certification that all such individuals have, in accordance with criteria under subparagraph
(B)(ii), undergone training provided by the seller to ensure that the individuals understand the requirements that apply under this subsection and subsection (d).
(viii) The seller maintains a copy of such certification and records demonstrating that individuals referred to
in clause (vii) have undergone the training.
(ix) If the seller is a mobile retail vendor:
(I) The seller complies with clause (i) by placing the product in a locked cabinet.
(II) The seller does not sell more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in such products per customer during a 30-day period.
(B) Additional provisions regarding certifications and training.-(i) In general.--A regulated seller may not sell any scheduled listed chemical product at retail unless the
seller has submitted to the Attorney General the self-certification referred to in subparagraph (A)(vii). The certification is not effective for purposes of the preceding sentence unless, in addition to provisions regarding the training of
individuals referred to in such subparagraph, the certification includes a statement that the seller understands each
of the requirements that apply under this paragraph and under subsection (d) and agrees to comply with the requirements.
(ii) Issuance of criteria; self- certification.--The Attorney General shall by regulation establish criteria for
certifications under this paragraph. The criteria shall-(I) provide that the certifications are self-certifications provided through the program under clause (iii);
(II) provide that a separate certification is required for each place of business at which a regulated seller
sells scheduled listed chemical products at retail; and
(III) include criteria for training under subparagraph (A)(vii).
(iii) Program for regulated sellers.--The Attorney General shall establish a program regarding such certifications and training in accordance with the following:
(I) The program shall be carried out through an Internet site of the Department of Justice and such other
means as the Attorney General determines to be appropriate.
(II) The program shall inform regulated sellers that section 1001 of title 18, United States Code, applies to
such certifications.
(III) The program shall make available to such sellers an explanation of the criteria under clause (ii).
(IV) The program shall be designed to permit the submission of the certifications through such Internet site.
(V) The program shall be designed to automatically provide the explanation referred to in subclause (III),
and an acknowledgement that the Department has received a certification, without requiring direct interactions of
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regulated sellers with staff of the Department (other than the provision of technical assistance, as appropriate).
(iv) Availability of certification to state and local officials.--Promptly after receiving a certification under
subparagraph (A)(vii), the Attorney General shall make available a copy of the certification to the appropriate State
and local officials.
(C) Privacy protections.--In order to protect the privacy of individuals who purchase scheduled listed chemical products, the Attorney General shall by regulation establish restrictions on disclosure of information in logbooks
under subparagraph (A)(iii).
Such regulations shall-(i) provide for the disclosure of the information as appropriate to the Attorney General and to State and local law enforcement agencies; and
(ii) prohibit accessing, using, or sharing information in the logbooks for any purpose other than to ensure
compliance with this title or to facilitate a product recall to protect public health and safety.
(D) False statements or misrepresentations by purchasers.--For purposes of section 1001 of title 18, United
States Code, entering information in the logbook under subparagraph (A)(iii) shall be considered a matter within the
jurisdiction of the executive, legislative, or judicial branch of the Government of the United States.
(E) Good faith protection.--A regulated seller who in good faith releases information in a logbook under
subparagraph (A)(iii) to Federal, State, or local law enforcement authorities is immune from civil liability for such
release unless the release constitutes gross negligence or intentional, wanton, or willful misconduct.
mobile retail vendor may not in any 30-day period sell an individual purchaser more than 7.5 grams of ephedrine
base, 7.5 grams of pseudoephedrine base, or 7.5 grams of phenylpropanolamine base in scheduled listed chemical
products.
Regarding recordkeeping requirements for retail transactions, the DEA has provided the following:
Sec. 1314.30 Recordkeeping for retail transactions.
(a)(1) Except for purchase by an individual of a single sales package containing not more than 60 milligrams of pseu
doephedrine, the regulated seller must maintain, in accordance with criteria issued by the Administrator, a written or
electronic list of each scheduled listed chemical product sale that identifies the products by name, the quantity sold,
the names and addresses of the purchasers, and the dates and times of the sales (referred to as the "logbook''). The
logbook may be maintained on paper or in electronic form.
(2) Effective November 27, 2006, if a logbook is maintained on paper, it must be created and maintained in a bound
record book.
(b) The regulated seller must not sell a scheduled listed chemical product at retail unless the purchaser does the following:
Presents an identification card that provides a photograph and is issued by a State or the Federal Government, or a
document that, with respect to identification, is considered acceptable for purposes of 8 CFR 274a.2(b)(1)(v)(A) and
274a.2(b)(1)(v)(B).
Signs the logbook and enters in the logbook his or her name, address, and the date and time of the sale.
(c) For records created electronically, the regulated seller may use an electronic signature system to capture the signature and may have the computer automatically enter the date and time of the sale. The regulated seller may ask the
purchaser for their name and address and enter information if it is not feasible for the purchaser to enter the information electronically.
(d) The regulated seller must determine that the name entered in the logbook corresponds to the name provided on
identification presented and that the date and time entered are correct.
(e) The regulated seller must enter in the logbook the name of the product and the quantity sold. Examples of methods of recording the quantity sold include the weight of the product per package and number of packages of each
chemical, the cumulative weight of the product for each chemical, or quantity of product by Universal Product Code.
These examples do not exclude other methods of displaying the quantity sold. For electronic records, the regulated
seller may use a point-of-sale and bar code reader. Such electronic records must be provided pursuant to paragraph
(i) of this section in a human readable form such that the requirements of paragraph (a)(1) of this section are satisfied.
(f) The regulated seller must include in the logbook or display by the logbook, the following notice:
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Warning: Section 1001 of Title 18, United States Code, states that whoever, with respect to the logbook, knowingly
and willfully falsifies, conceals, or covers up by any trick, scheme, or device a material fact, or makes any materially
false, fictitious, or fraudulent statement or representation, or makes or uses any false writing or document knowing
the same to contain any materially false, fictitious, or fraudulent statement or entry, shall be fined not more than
$250,000 if an individual or $500,000 if an organization, imprisoned not more than five years, or both.
(g) The regulated seller must maintain each entry in the logbook for not fewer than 2 years after the date on which
the entry is made.
(h) A record under this section must be kept at the regulated seller's place of business where the transaction occurred, except that records may be kept at a single, central location of the regulated seller if the regulated seller has
notified the Administration of the intention to do so. Written notification must be submitted by registered or certified
mail, return receipt requested, to the Special Agent in Charge of the DEA Divisional Office for the area in which the
records are required to be kept.
(i) The records required to be kept under this section must be readily retrievable and available for inspection and
copying by authorized employees of the Administration under the provisions of 21 U.S.C. 880.
(j) A record developed and maintained to comply with a State law may be used to meet the requirements of this section if the record includes the information specified in this section.
XIII.
Internet Controlled Substance Prescriptions
The unlawful use of pharmaceutical controlled substances has reached alarming levels in the United States in recent
years, causing a substantial detrimental effect on the public health and safety. One of the main factors contributing to the nationwide increase in the diversion of pharmaceutical controlled substances has been the rise in the number of Internet sites
that sell or facilitate the sale of these drugs for other than legitimate medical purposes. While in-person “prescription mills”
(practitioners' offices that readily supply drug seekers with prescriptions for controlled substances without establishing a legitimate medical basis for doing so) have always been, and remain, a significant source of diversion, the advent of rogue Web
sites that cater to those who abuse pharmaceutical controlled substances has allowed the criminal operators of these sites to
exploit the anonymity of the Internet to generate illicit sales of controlled substances (and/or prescriptions therefor) that far
exceed those of any in-person prescription mill.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Pub. L. 110-425) was enacted on October 15,
2008. This Act amended the Controlled Substances Act (CSA) and Controlled Substances Import and Export Act (CSIEA) by
adding various provisions to prevent the illegal distribution and dispensing of controlled substances by means of the Internet.
The law became effective April 13, 2009. Thus, it is illegal under federal law to “deliver, distribute, or dispense a controlled
substance by means of the Internet, except as authorized by [the CSA]” or to aid or abet such activity. 21 U.S.C. 841(h)(1).
The Act applies to all controlled substances in all schedules.
Congress passed the Ryan Haight Act precisely because of “the increasing use of prescription controlled substances
by adolescents and others for nonmedical purposes, which has been exacerbated by drug trafficking on the Internet.” The
person for whom the Act was named, Ryan Haight, was a California high school honors student and athlete who died in 2001
from an overdose of controlled substances that he had purchased from a rogue online pharmacy. According to the Senate Report accompanying the legislation, “Ease of access to the Internet, combined with lack of medical supervision, has led to tragic consequences in the online purchase of prescription controlled substances.”
The following is a brief recitation of two of the most important new statutory requirements: the in-person medical
evaluation requirement for prescribing practitioners and the modified registration requirement for online pharmacies. A. Inperson medical evaluation requirement--One of the primary ways in which the Ryan Haight Act combats the use of the Internet to facilitate illegal sales of pharmaceutical controlled substances is by mandating, with limited exceptions, that the dispensing of controlled substances by means of the Internet be predicated on a valid prescription involving at least one
in-person medical evaluation. While the lack of an in-person medical evaluation has always been viewed as a “red flag” indicating that diversion might be occurring, the Ryan Haight Act makes it unambiguous that it is a per se violation of the CSA
for a practitioner to issue a prescription for a controlled substance by means of the Internet without having conducted at least
one in-person medical evaluation, except in certain specified circumstances. At the same time, it is crucial to bear in mind
that, as Congress expressly stated under the Act, the mere fact that the prescribing practitioner conducted one in-person medical evaluation does not demonstrate that the prescription was issued for a legitimate medical purpose within the usual course
of professional practice. Even where the prescribing practitioner has complied with the requirement of at least one in-person
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medical evaluation, a prescription for a controlled substance must still satisfy the additional, fundamental prerequisite that has
been legally mandated for more than 90 years: it must be issued for a legitimate medical purpose by a practitioner acting in
the usual course of professional practice. B. Requirement of modified registration for online pharmacies-- Another of the
core provisions of the Act is the requirement that any person who operates a Web site that fits within the definition of an
“online pharmacy” must obtain from DEA a modification of its DEA pharmacy registration that expressly authorizes such
online activity. Only DEA-registered pharmacies are eligible under the Act to obtain such a modification of registration. One
of the ramifications of this requirement is that those who are not DEA-registered pharmacies (for example, those nonregistrants who have heretofore facilitated unlawful Internet controlled substance sales by enlisting the services of unscrupulous
pharmacies and/or prescribing practitioners) are prohibited from operating online pharmacies. The Act's definition of “online
pharmacy” encompasses more than merely legitimate pharmacies that may obtain a modification of their DEA registrations
allowing them to dispense controlled substances by means of the Internet. As explained below, the definition of “online pharmacy” includes, among others, those persons who operate the types of rogue Web sites that the Act was designed to eliminate. Consistent with the longstanding structure of the CSA (since it was enacted in 1970), the Ryan Haight Act prohibits all
controlled substance activities by “online pharmacies” except those expressly authorized by the Act. Again, only DEA-registered pharmacies may obtain a modification of their registration authorizing them to operate as online pharmacies. In addition, a pharmacy that has obtained such a modification of its registration may not operate as an online pharmacy unless it has
notified DEA of its intent to do so and its Web site contains certain declarations designed to provide clear assurance that it is
operating legitimately and in conformity with the Act.
The Act adds several new definitions to the CSA. The following are two of the key definitions in the Act, which are
set forth in 21 U.S.C. 802: (51) The term “deliver, distribute, or dispense by means of the Internet” refers, respectively, to any
delivery, distribution, or dispensing of a controlled substance that is caused or facilitated by means of the Internet. This definition is plainly broad in scope, encompassing any activity utilizing the Internet that causes or facilitates the delivery, distribution, or dispensing of a controlled substance. This definition is incorporated into the Act's definition of an “online
pharmacy”. The term “online pharmacy” means [with certain exceptions] a person, entity, or Internet site, whether in the
United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver,
distribute, or dispense, a controlled substance by means of the Internet.
The Act adds two new criminal offenses to the CSA. The first new offense is set forth in 21 U.S.C. 841(h)(1), which
states: It shall be unlawful for any person to knowingly or intentionally- (A) Deliver, distribute, or dispense a controlled substance by means of the Internet, except as authorized by [the CSA]; or (B) Aid or abet (as such terms are used in section 2 of
title 18, United States Code) any activity described in subparagraph (A) that is not authorized by [the CSA].
XIV.
DEA Guidance
To promote voluntary compliance with laws applicable to controlled substances, the DEA has published several
handbooks and pamphlets on their website, and these are quite useful. One example includes the Pharmacist’s Manual, an
informational outline of the CSA, available at http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/2pharm_manual.pdf.
In addition, reproduced below is a series of questions and answers that the agency has published to clarify their understanding
of the statutes and regulations they enforce.
Question: What is a prescription?
Answer: A prescription is an order for medication which is dispensed to or for an ultimate user. A prescription is not an order
for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to an
inpatient for immediate administration in a hospital is not a prescription). To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a registered practitioner acting in the usual course of sound professional practice.
Question: What information is required on a prescription for a controlled substance?
Answer: A prescription for a controlled substance must include the following information:
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·
Date of issue;
·
Patient’s name and address;
·
Practitioner’s name, address, and DEA registration number;
·
Drug name;
·
Drug strength;
·
Dosage form;
·
Quantity prescribed;
·
Directions for use;
·
Number of refills (if any) authorized; and
·
Manual signature of prescriber.
A prescription must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner. An
individual may be designated by the practitioner to prepare the prescriptions for his/her signature. The practitioner is responsible for making sure that the prescription conforms in all essential respects to the law and regulation.
Prescriptions for schedule II controlled substances must be written and be signed by the practitioner. In emergency situations,
a prescription for a schedule II controlled substance may be telephoned to the pharmacy and the prescriber must follow up
with a written prescription being sent to the pharmacy within seven days. Prescriptions for schedules III through V controlled
substances may by written, oral or transmitted by fax.
Question: Can controlled substance prescriptions be refilled?
Answer: Prescriptions for schedule II controlled substances cannot be refilled. A new prescription must be issued. Prescriptions for schedules III and IV controlled substances may be refilled up to five times in six months. Prescriptions for schedule
V controlled substances may be refilled as authorized by the practitioner.
Question: Can controlled substance prescriptions for hospice patients be faxed to a pharmacy?
Answer: A prescription written for a schedule II narcotic substance for a patient enrolled in a hospice care program certified
and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may be transmitted by the
practitioner or the practitioner’s agent to the dispensing pharmacy by facsimile.
A pharmacist may dispense directly a controlled substance listed in schedules III, IV, or V pursuant to either a written prescription signed by a practitioner or a facsimile of a written, signed prescription transmitted by the practitioner or the
practitioner’s agent to the pharmacy or pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist.
Question: Is it appropriate to provide a DEA registration number on prescriptions written for medications other than
controlled substances?
Answer: DEA strongly opposes the use of a DEA registration number for any purpose other than the one for which it was
intended, to provide certification of DEA registration in transactions involving controlled substances. The use of DEA registration numbers as an identification number is not an appropriate use and could lead to a weakening of the registration system. Although DEA has repeatedly made its position known to industries such as insurance providers and pharmacy benefit
managers, there is currently no legal basis for DEA to prevent or preclude companies from requiring or requesting a
practitioner’s DEA registration number.
The Centers for Medicare and Medicaid Services has developed a National Provider Identification (NPI) number unique to
each healthcare provider. The Final Rule for establishment of the NPI system was published in the Federal Register (FR
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3434, Vol. 69, No. 15) by the Department of Health and Human Services on January 23, 2004. The effective date of this Final
Rule was May 23, 2005; all covered entities were to begin using the NPI in standard transactions by May 23, 2007. A contingency extension was provided to covered entities unable to meet the 2007 deadline. Contingency plans were to not extend
beyond May 23, 2008.
Question: Is it permissible to dispense a prescription for a quantity less than the face amount prescribed resulting in a
greater number of dispensations than the number of refills indicated on the prescription?
Answer: Yes. Partial refills of schedules III and IV controlled substance prescriptions are permissible under federal regulations provided that each partial filling is dispensed and recorded in the same manner as a refilling (i.e., date refilled, amount
dispensed, initials of dispensing pharmacist, etc.), the total quantity dispensed in all partial fillings does not exceed the total
quantity prescribed, and no dispensing occurs after six months past the date of issue.
Question: What changes may a pharmacist make to a prescription written for a controlled substance in schedule II?
Answer: On November 19, 2007, the DEA published in the Federal Register (FR) the Final Rule entitled Issuance of Multiple Prescriptions for Schedule II Controlled Substances (72 FR 64921). In the preamble to that Rule, DEA stated that "the
essential elements of the [schedule II] prescription written by the practitioner (such as the name of the controlled substance,
strength, dosage form, and quantity prescribed)…may not be modified orally."
Question: What changes may a pharmacist make to a prescription written for a controlled substance in schedules IIIV?
Answer: The pharmacist may add or change the patient’s address upon verification. The pharmacist may add or change the
dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the
prescribing practitioner. Such consultations and corresponding changes should be noted by the pharmacist on the prescription. Pharmacists and practitioners must comply with any state/local laws, regulations, or policies prohibiting any of these
changes to controlled substance prescriptions.
The pharmacist is never permitted to make changes to the patient’s name, controlled substance prescribed (except for generic
substitution permitted by state law) or the prescriber’s signature.
Question: Can a practitioner prescribe methadone for the treatment of pain?
Answer: Federal law and regulations do not restrict the prescribing, dispensing, or administering of any schedule II, III, IV,
or V narcotic medication, including methadone, for the treatment of pain, if such treatment is deemed medically necessary by
a registered practitioner acting in the usual course of professional practice.
Confusion often arises due to regulatory restrictions concerning the use of methadone for the maintenance or detoxification of
opioid addicted individuals, in which case the practitioner is required to be registered with the DEA as a Narcotic Treatment
Program (NTP).
Question: Can an individual return his/her controlled substance prescription medication to a pharmacy?
Answer: No. An individual patient may not return his/her unused controlled substance prescription medication to the pharmacy. Federal laws and regulations make no provisions for an individual to return the controlled substance prescription medication to a pharmacy for further dispensing or for disposal. There are no provisions in the Controlled Substances Act or Code
of Federal Regulations (CFR) for a DEA registrant (i.e., retail pharmacy) to acquire controlled substances from a non-registrant (i.e., individual patient).
The CFR does have a provision for an individual to return his/her unused controlled substance medication to the pharmacy in
the event of the controlled substance being recalled or a dispensing error has occurred.
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An individual may dispose of his/her own controlled substance medication without approval from DEA. Medications should
be disposed of in such a manner that does not allow for the controlled substances to be easily retrieved. In situations where an
individual has expired, a caregiver or hospice staff member may assist the family with the proper disposal of any unused controlled substance medications.
Question: Can controlled substance prescriptions for a resident of an LTCF be faxed to a pharmacy?
Answer: Yes. Schedules II-V controlled substance prescriptions may be transmitted by the practitioner or the practitioner’s
agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription.
Question: Can an LTCF store controlled substances in an emergency kit without being registered with DEA?
Answer: DEA published the following Statement of Policy in the April 9, 1980 Federal Register regarding the placement of
controlled substances in an emergency kit located in an LTCF.
STATEMENT OF POLICY
The placement of emergency kits containing controlled substances in non-federally registered Long Term Care Facilities
(LTCF) shall be deemed to be in compliance with the Comprehensive Drug Abuse Prevention and Control Act of 1970, if the
appropriate state agency or regulatory authority specifically approves such placement and promulgates procedures
which delineate:
A. The source from which an LTCF may obtain controlled substances for emergency kits. The source of supply must be a
DEA registered hospital/clinic, pharmacy, or practitioner.
B. Security safeguards for each emergency kit stored in the LTCF which include the designation of individuals who may have
access to the emergency kits and a specific limitation of the type and quantity of controlled substances permitted to be placed
in each emergency kit.
C. Responsibility for proper control and accountability of such emergency kits within the LTCF to include the requirement
that the LTCF and the providing DEA registered hospital/clinic, pharmacy, or practitioner maintain complete and accurate
records of the controlled substances placed in the emergency kit, the disposition of these controlled substances plus the requirement to take periodic physical inventories.
D. The emergency medical conditions under which the controlled substances may be administered to patients in the LTCF to
include the requirement that medication be administered by authorized personnel only as expressly authorized by an individual practitioner and in compliance with the provisions of 21 CFR 1306.11 and 21 CFR 1306.21.
E. Prohibited activities which can result in the state revocation, denial, or suspension of the privilege of having or placing
emergency kits, containing controlled substances, in an LTCF.
Question: Can an LTCF return a resident’s unused controlled substance medication to a pharmacy?
Answer: No. There are no provisions in the Controlled Substances Act for a DEA registrant (i.e., retail pharmacy) to acquire
controlled substances from a non-registrant (i.e., resident of an LTCF). Most LTFCs are not licensed by their respective state
to handle controlled substances and, therefore, are not registered with DEA. LTCFs act in a custodial capacity, holding controlled substances that, pursuant to a prescription, have been dispensed to and belong to the resident of the LTCF. Federal
laws and regulations make no provisions for controlled substances that have already been dispensed to patients, regardless of
the packaging method, to be returned to a pharmacy for further dispensing or disposal.
Question: Can a patient in an LTCF receive methadone for maintenance purposes?
Answer: If the LTCF is registered with DEA as a hospital/clinic, it need not be separately registered as a Narcotic Treatment
Program (NTP) to administer or dispense methadone as an adjunct to medical treatment of conditions other than addiction.
(21 CFR 1306.07(c))
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If an LTCF that is not registered with DEA has a patient who is also currently enrolled in a licensed NTP, the NTP may transfer medication to the LTCF with the approval of the State Methadone Authority.
(www.samhsa.gov/centers/csat/content/opat/statemeth.html)
If an individual is not currently enrolled in an NTP and is in an LTCF that is not registered with DEA, a practitioner may administer narcotic drugs to the individual for relieving acute withdrawal symptoms when necessary while arrangements are
being made for referral for treatment. No more than one day’s medication may be administered to the individual or for the
individual’s use at one time. Such emergency treatment may be carried out for no more than three days and may not be renewed or extended. (21 CFR 1306.07(b))
Question: What is meant by "readily retrievable?"
Answer: The term "readily retrievable" means the record is kept or maintained in such a manner that it can be separated out
from all other records in a reasonable time or that it is identified by an asterisk, redline, or some other identifiable manner
such that it is easily distinguishable from all other records.
Question: Is a practitioner required to keep records?
Answer: Each practitioner must maintain inventories and records of controlled substances listed in schedule II separately
from all other records maintained by the registrant. Likewise, inventories and records of controlled substances in schedules
III, IV, and V must be maintained separately or in such a form that they are readily retrievable from the ordinary business records of the practitioner. All records related to controlled substances must be maintained and be available for inspection for a
minimum of two years.
A registered practitioner is required to keep records of controlled substances that are dispensed to the patient, other than by
prescribing or administering, in the lawful course of professional practice. A registered practitioner is not required to keep
records of controlled substances that are prescribed in the lawful course of professional practice, unless such substances are
prescribed in the course of maintenance or detoxification treatment. A registered practitioner is not required to keep records
of controlled substances that are administered in the lawful course of professional practice unless the practitioner regularly
engages in the dispensing or administering of controlled substances and charges patients, either separately or together with
charges for other professional services, for substances so dispensed or administered.
Question: What reports must be filed if a practitioner experiences a theft or significant loss of controlled substances?
Answer: The practitioner shall notify the local DEA office, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The practitioner shall also complete and submit DEA Form
106 which may be found at www.DEAdiversion.usdoj.gov.
Question: How does a DEA registrant report breakage or spillage of controlled substances?
Answer: Breakage of controlled substances does not constitute a "loss" of controlled substances. When there is breakage,
damage, spillage, or some other form of destruction, any recoverable controlled substances must be disposed of according to
DEA requirements. Damaged goods may be disposed of through shipment to a "reverse distributor" or by a DEA approved
process. The DEA recommends that any registrant seeking to dispose of controlled substances first contact the nearest DEA
Diversion Field Office for disposal instructions. In no case should drugs be forwarded to the DEA unless the registrant has
received prior approval from the DEA.
If the breakage or spillage is not recoverable, the registrant must document the circumstances of the breakage in the inventory
records. Two individuals who witnessed the breakage must sign the inventory records indicating what they witnessed. The
submission of a DEA Form 41, Registrants Inventory of Drugs Surrendered, is not required for non-recoverable controlled
substances.
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The DEA procedures established for the destruction of controlled substances shall not be construed as altering in any way the
state laws or regulations for the disposal of controlled substances. When this disposal occurs, it must be reported to the DEA
on a DEA Form 41.
Question: Are there any special security requirements a practitioner should follow if a stock of controlled substances
is maintained in their office for dispensing and administering?
Answer: All controlled substances should be stored in a locked cabinet or other secure storage container with limited access
by the office staff.
Question: Is it appropriate to provide a DEA registration number when purchasing items other than controlled substances such as prescription drugs, over-the-counter drugs, or medical supplies from a distributor?
Answer: DEA strongly opposes the use of a DEA registration number for any purpose other than the one for which it was
intended, to provide certification of DEA registration in transactions involving controlled substances. The use of DEA registration numbers as an identification number is not an appropriate use and could lead to a weakening of the registration system. Although DEA has repeatedly made its position known to industries such as insurance providers and pharmacy benefit
managers, there is currently no legal basis for DEA to prevent or preclude companies from requiring or requesting a
practitioner’s DEA registration number.
The Centers for Medicare and Medicaid Services has developed a National Provider Identification (NPI) number unique to
each healthcare provider. The Final Rule for establishment of the NPI system was published in the Federal Register (FR
3434, Vol. 69, No. 15) by the Department of Health and Human Services on January 23, 2004. The effective date of this Final
Rule was May 23, 2005; all covered entities were to begin using the NPI in standard transactions by May 23, 2007. A contingency extension was provided to covered entities unable to meet the 2007 deadline. Contingency plans were to not extend
beyond May 23, 2008.
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State Pharmacy Law Review
Chapter 5: Florida Statutes
Most of the general framework of Florida pharmacy law is included within the Florida Pharmacy Act. The Act establishes the Florida Board of Pharmacy, and it grants to the Board the authority to promulgate rules that are consistent with the
purpose of the Act. The Act authorizes the Board to grant and revoke licenses for individuals who practice pharmacy, as well
as to grant and revoke permits for those who operate pharmacies. In this regard, pharmacy is unique among the health care
professions, because the Board of Pharmacy is the only agency authorized to regulate both the individuals who practice a
health care profession and the institutions by whom the practice environment is created and maintained. This dual regulatory
role is advantageous, because when things have not gone well, it is possible for the Board to call to account both the licensee
and the permittee, and to ask hard questions when one would point a finger at the other. The Florida Pharmacy Act also establishes several basic requirements for practice, upon which the Board amplifies in its administrative rules. Pharmacists who
wish to comply with the rule of law in Florida must check both the Florida Pharmacy Act and the Board of Pharmacy rules to
assure that they have “covered the bases” of legal authority.
A.
Background of Florida Pharmacy Laws and Definitions
The most important way in which the legislature promotes the competence of pharmacists in Florida is through the
Florida Pharmacy Act. This Act is intended to protect the public health and to promote competence in the pharmacy profession. The definitions within the act are important, because they establish the foundation for an understanding of the rules that
follow.
465.001 Short Title.--This chapter shall be known as the "Florida Pharmacy Act."
465.002 Legislative findings; intent.--The Legislature finds that the practice of pharmacy is a learned profession.
The sole legislative purpose for enacting this chapter is to ensure that every pharmacist practicing in this state and
every pharmacy meet minimum requirements for safe practice. It is the legislative intent that pharmacists who fall
below minimum competency or who otherwise present a danger to the public shall be prohibited from practicing in
this state.
465.003 Definitions.--As used in this chapter, the term:
(1)"Administration" means the obtaining and giving of a single dose of medicinal drugs by a legally authorized person to a patient for her or his consumption.
(2)"Board" means the Board of Pharmacy.
(3)"Consultant pharmacist" means a pharmacist licensed by the department and certified as a consultant pharmacist
pursuant to s. 465.0125.
(4)"Data communication device" means an electronic device that receives electronic information from one source
and transmits or routes it to another, including, but not limited to, any such bridge, router, switch, or gateway.
(5)"Department" means the Department of Health.
Note below that the actual sales transaction in which patients receive drugs, and the administration of drugs to a patient, are
not considered to be dispensing.
(6)"Dispense" means the transfer of possession of one or more doses of a medicinal drug by a pharmacist to the ultimate consumer or her or his agent. As an element of dispensing, the pharmacist shall, prior to the actual physical
transfer, interpret and assess the prescription order for potential adverse reactions, interactions, and dosage regimen she or he deems appropriate in the exercise of her or his professional judgment, and the pharmacist shall certify
that the medicinal drug called for by the prescription is ready for transfer. The pharmacist shall also provide counseling on proper drug usage, either orally or in writing, if in the exercise of her or his professional judgment counsel-
Copyright 2010 RxLaw.org, Inc. All Rights Reserved
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ing is necessary. The actual sales transaction and delivery of such drug shall not be considered dispensing. The
administration shall not be considered dispensing.
(7)"Institutional formulary system" means a method whereby the medical staff evaluates, appraises, and selects those
medicinal drugs or proprietary preparations which in the medical staff's clinical judgment are most useful in patient
care, and which are available for dispensing by a practicing pharmacist in a Class II institutional pharmacy.
(8)"Medicinal drugs" or "drugs" means those substances or preparations commonly known as "prescription" or
"legend" drugs which are required by federal or state law to be dispensed only on a prescription, but shall not include patents or proprietary preparations as hereafter defined.
(9)"Patent or proprietary preparation" means a medicine in its unbroken, original package which is sold to the public by, or under the authority of, the manufacturer or primary distributor thereof and which is not misbranded under
the provisions of the Florida Drug and Cosmetic Act.
(10)"Pharmacist" means any person licensed pursuant to this chapter to practice the profession of pharmacy.
(11)(a)"Pharmacy" includes a community pharmacy, an institutional pharmacy, a nuclear pharmacy, a special pharmacy, and an Internet pharmacy.
1. The term "community pharmacy" includes every location where medicinal drugs are compounded, dispensed,
stored, or sold or where prescriptions are filled or dispensed on an outpatient basis.
2. The term "institutional pharmacy" includes every location in a hospital, clinic, nursing home, dispensary, sanitarium, extended care facility, or other facility, hereinafter referred to as "health care institutions," where medicinal
drugs are compounded, dispensed, stored, or sold.
3. The term "nuclear pharmacy" includes every location where radioactive drugs and chemicals within the classification of medicinal drugs are compounded, dispensed, stored, or sold. The term "nuclear pharmacy" does not include
hospitals licensed under chapter 395 or the nuclear medicine facilities of such hospitals.
4. The term "special pharmacy" includes every location where medicinal drugs are compounded, dispensed, stored,
or sold if such locations are not otherwise defined in this subsection.
5. The term "Internet pharmacy" includes locations not otherwise licensed or issued a permit under this chapter,
within or outside this state, which use the Internet to communicate with or obtain information from consumers in this
state and use such communication or information to fill or refill prescriptions or to dispense, distribute, or otherwise
engage in the practice of pharmacy in this state. Any act described in this definition constitutes the practice of pharmacy as defined in subsection (13).
(b) The pharmacy department of any permittee shall be considered closed whenever a Florida licensed pharmacist is
not present and on duty. The term "not present and on duty" shall not be construed to prevent a pharmacist from exiting the prescription department for the purposes of consulting or responding to inquiries or providing assistance to
patients or customers, attending to personal hygiene needs, or performing any other function for which the pharmacist is responsible, provided that such activities are conducted in a manner consistent with the pharmacist's responsibility to provide pharmacy services.
(12)"Pharmacy intern" means a person who is currently registered in, and attending, a duly accredited college or
school of pharmacy, or who is a graduate of such a school or college of pharmacy, and who is duly and properly
registered with the department as provided for under its rules.
Under Florida law, the definition of the “practice of the profession of pharmacy” is expansive. Virtually anything that is
taught in a school or college of pharmacy is by definition included within the realm of pharmacy practice.
(13)"Practice of the profession of pharmacy" includes compounding, dispensing, and consulting concerning contents,
therapeutic values, and uses of any medicinal drug; consulting concerning therapeutic values and interactions of patent or proprietary preparations, whether pursuant to prescriptions or in the absence and entirely independent of such
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prescriptions or orders; and other pharmaceutical services. For purposes of this subsection, "other pharmaceutical
services" means the monitoring of the patient's drug therapy and assisting the patient in the management of his or
her drug therapy, and includes review of the patient's drug therapy and communication with the patient's prescribing
health care provider as licensed under chapter 458, chapter 459, chapter 461, or chapter 466, or similar statutory
provision in another jurisdiction, or such provider's agent or such other persons as specifically authorized by the patient, regarding the drug therapy. However, nothing in this subsection may be interpreted to permit an alteration of a
prescriber's directions, the diagnosis or treatment of any disease, the initiation of any drug therapy, the practice of
medicine, or the practice of osteopathic medicine, unless otherwise permitted by law. "Practice of the profession of
pharmacy" also includes any other act, service, operation, research, or transaction incidental to, or forming a part
of, any of the foregoing acts, requiring, involving, or employing the science or art of any branch of the pharmaceutical profession, study, or training, and shall expressly permit a pharmacist to transmit information from persons authorized to prescribe medicinal drugs to their patients. The practice of the profession of pharmacy also includes the
administration of influenza virus immunizations to adults pursuant to s. 465.189.
A “prescription” is an order. It is not a piece of paper. It is an authority to dispense, and it can be modified through communication by the prescriber to the pharmacist, even if the original piece of paper remains the same. An order for drugs can be
transmitted through any means of communication.
(14)"Prescription" includes any order for drugs or medicinal supplies written or transmitted by any means of communication by a duly licensed practitioner authorized by the laws of the state to prescribe such drugs or medicinal
supplies and intended to be dispensed by a pharmacist. The term also includes an orally transmitted order by the
lawfully designated agent of such practitioner. The term also includes an order written or transmitted by a practitioner licensed to practice in a jurisdiction other than this state, but only if the pharmacist called upon to dispense such
order determines, in the exercise of her or his professional judgment, that the order is valid and necessary for the
treatment of a chronic or recurrent illness. The term "prescription" also includes a pharmacist's order for a product
selected from the formulary created pursuant to s. 465.186. Prescriptions may be retained in written form or the
pharmacist may cause them to be recorded in a data processing system, provided that such order can be produced in
printed form upon lawful request.
(15)"Nuclear pharmacist" means a pharmacist licensed by the department and certified as a nuclear pharmacist pursuant to s. 465.0126.
(16)"Centralized prescription filling" means the filling of a prescription by one pharmacy upon request by another
pharmacy to fill or refill the prescription. The term includes the performance by one pharmacy for another pharmacy
of other pharmacy duties such as drug utilization review, therapeutic drug utilization review, claims adjudication,
and the obtaining of refill authorizations.
(17)"Automated pharmacy system" means a mechanical system that delivers prescription drugs received from a Florida licensed pharmacy and maintains related transaction information.
B.
The Florida Board of Pharmacy
Through professional self-regulation the pharmacists in Florida make decisions about the standards they must meet
and the pharmacists themselves enforce those standards. The Board has the authority to make rules that expand on the provisions of the pharmacy act, and to inspect pharmacies to assure compliance with those rules.
465.004 Board of Pharmacy.-(1) The Board of Pharmacy is created within the department and shall consist of nine members to be appointed by
the Governor and confirmed by the Senate.
(2) Seven members of the board must be licensed pharmacists who are residents of this state and who have been engaged in the practice of the profession of pharmacy in this state for at least 4 years and, to the extent practicable,
represent the various pharmacy practice settings. Of the pharmacist members, one must be currently engaged in the
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practice of pharmacy in a community pharmacy, one must be currently engaged in the practice of pharmacy in a
Class II institutional pharmacy or a Modified Class II institutional pharmacy, and five shall be pharmacists licensed
in this state irrespective of practice setting. The remaining two members must be residents of the state who have never been licensed as pharmacists and who are in no way connected with the practice of the profession of pharmacy.
No person may be appointed as a consumer member who is in any way connected with a drug manufacturer or
wholesaler. At least one member of the board must be 60 years of age or older.
(3) As the terms of the members expire, the Governor shall appoint successors for terms of 4 years, and such members shall serve until their successors are appointed.
(4) All provisions of chapter 456 relating to activities of the board shall apply.
465.005 Authority to make rules.--The Board of Pharmacy has authority to adopt rules pursuant to ss. 120.536(1)
and 120.54 to implement the provisions of this chapter conferring duties upon it.
465.006 Disposition of fees; expenditures.--All moneys received under this chapter shall be deposited and expended
pursuant to the provisions of s. 456.025. All expenditures for duties of the board authorized by this chapter shall be
paid upon presentation of vouchers approved by the executive director of the board.
465.0155 Standards of practice.--Consistent with the provisions of this act, the board shall adopt by rule standards
of practice relating to the practice of pharmacy which shall be binding on every state agency and shall be applied by
such agencies when enforcing or implementing any authority granted by any applicable statute, rule, or regulation,
whether federal or state.
465.017 Authority to inspect; disposal.-(1) Duly authorized agents and employees of the department shall have the power to inspect in a lawful manner at all
reasonable hours any pharmacy, hospital, clinic, wholesale establishment, manufacturer, physician's office, or any
other place in the state in which drugs and medical supplies are manufactured, packed, packaged, made, stored,
sold, offered for sale, exposed for sale, or kept for sale for the purpose of:
(a) Determining if any of the provisions of this chapter or any rule promulgated under its authority is being violated;
(b) Securing samples or specimens of any drug or medical supply after paying or offering to pay for such sample or
specimen; or
(c) Securing such other evidence as may be needed for prosecution under this chapter.
(2)(a) Except as permitted by this chapter, and chapters 406, 409, 456, 499, and 893, records maintained in a pharmacy relating to the filling of prescriptions and the dispensing of medicinal drugs shall not be furnished to any person other than to the patient for whom the drugs were dispensed, or her or his legal representative, or to the
department pursuant to existing law, or, in the event that the patient is incapacitated or unable to request said records, her or his spouse except upon the written authorization of such patient. Such records may be furnished in any
civil or criminal proceeding, upon the issuance of a subpoena from a court of competent jurisdiction and proper notice to the patient or her or his legal representative by the party seeking such records.
(b) The board shall adopt rules to establish practice guidelines for pharmacies to dispose of records maintained in a
pharmacy relating to the filling of prescriptions and the dispensing of medicinal drugs. Such rules shall be consistent
with the duty to preserve the confidentiality of such records in accordance with applicable state and federal law.
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C.
Pharmacist Licensure
Pharmacists become licensed in Florida either through examination or through endorsement of their license from another state. There are special licenses in Florida for particular types of pharmacy practice. It is illegal to practice pharmacy
without a license.
465.007 Licensure by examination.-(1) Any person desiring to be licensed as a pharmacist shall apply to the department to take the licensure examination. The department shall examine each applicant who the board certifies has:
(a) Completed the application form and remitted an examination fee set by the board not to exceed $100 plus the actual per applicant cost to the department for purchase of portions of the examination from the National Association
of Boards of Pharmacy or a similar national organization. The fees authorized under this section shall be established
in sufficient amounts to cover administrative costs.
(b) Submitted satisfactory proof that she or he is not less than 18 years of age and:
1. Is a recipient of a degree from a school or college of pharmacy accredited by an accrediting agency recognized
and approved by the United States Office of Education; or
2. Is a graduate of a 4-year undergraduate pharmacy program of a school or college of pharmacy located outside
the United States, has demonstrated proficiency in English by passing both the Test of English as a Foreign Language (TOEFL) and the Test of Spoken English (TSE), has passed the Foreign Pharmacy Graduate Equivalency Examination that is approved by rule of the board, and has completed a minimum of 500 hours in a supervised work
activity program within this state under the supervision of a pharmacist licensed by the department, which program
is approved by the board.
(c) Submitted satisfactory proof that she or he has completed an internship program approved by the board. No such
board-approved program shall exceed 2,080 hours, all of which may be obtained prior to graduation.
(2) The department may permit an applicant who has satisfied all requirements of subsection (1), except those relating to age or the internship program, to take the written examination, but the passing of the examination shall confer
no rights or privileges upon the applicant in connection with the practice of pharmacy in this state.
(3) Except as provided in subsection (2), the department shall issue a license to practice pharmacy to any applicant
who successfully completes the examination in accordance with this section.
465.0075 Licensure by endorsement; requirements; fee.-(1) The department shall issue a license by endorsement to any applicant who applies to the department and remits a
nonrefundable fee of not more than $100, as set by the board, and whom the board certifies:
(a) Has met the qualifications for licensure in s. 465.007(1)(b) and (c);
(b) Has obtained a passing score, as established by rule of the board, on the licensure examination of the National
Association of Boards of Pharmacy or a similar nationally recognized examination, if the board certifies that the applicant has taken the required examination;
(c)1. Has submitted evidence of the active licensed practice of pharmacy, including practice in community or public
health by persons employed by a governmental entity, in another jurisdiction for at least 2 of the immediately preceding 5 years or evidence of successful completion of board-approved postgraduate training or a board-approved clinical competency examination within the year immediately preceding application for licensure; or
2.Has completed an internship meeting the requirements of s. 465.007(1)(c) within the 2 years immediately preceding
application; and
(d) Has obtained a passing score on the pharmacy jurisprudence portions of the licensure examination, as required
by board rule.
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(2) An applicant licensed in another state for a period in excess of 2 years from the date of application for licensure
in this state shall submit a total of at least 30 hours of board-approved continuing education for the 2 calendar years
immediately preceding application.
(3) The department may not issue a license by endorsement to any applicant who is under investigation in any jurisdiction for an act or offense that would constitute a violation of this chapter until the investigation is complete, at
which time the provisions of s. 465.016 apply.
(4) The department may not issue a license by endorsement to any applicant whose license to practice pharmacy has
been suspended or revoked in another state or who is currently the subject of any disciplinary proceeding in another
state.
465.008 Renewal of license.-(1) The department shall renew a license upon receipt of the renewal application, verification of compliance with s.
465.009, and receipt of a fee set by the board not to exceed $250.
(2) The department shall adopt rules establishing a procedure for the biennial renewal of licenses.
(3) Any person licensed under this chapter for 50 years or more is exempt from the payment of the renewal or delinquent fee, and the department shall issue a lifetime license to such a person.
Pharmacists must complete continuing education to remain licensed. The statutory requirement is that the pharmacist complete 30 contact hours of continuing education coursework within each 2 year licensure period.
465.009 Continuing professional pharmaceutical education.-(1) No license renewal shall be issued by the department until the licensee submits proof satisfactory to the board
that during the 2 years prior to her or his application for renewal the licensee has participated in not less than 30
hours of continuing professional pharmaceutical education in courses approved by the board.
(2) The board shall approve only those courses that build upon the basic courses offered in the curricula of accredited colleges or schools of pharmacy, and the board shall require that the provider meets the educational standards
for the program design, administration, and evaluation established by the board.
(3) Upon initial licensure, the department may reduce the number of required hours consistent with the requirements
of biennial renewal.
(4) The department may make exception from the requirements of this section in an emergency or hardship case.
(5) The board may adopt rules within the requirements of this section that are necessary for its implementation, including a rule creating a committee composed of equal representation from the board, the colleges of pharmacy in
the state, and practicing pharmacists within the state, whose purpose shall be to approve the content of each course
offered for continuing education credit prior to the time such course is offered.
465.012 Reactivation of license; continuing education.-(1) The board shall prescribe by rule continuing education requirements as a condition of reactivating a license. The
continuing education requirements for reactivating a license shall be at least 15 classroom hours for each year the
license was inactive in addition to completion of the number of hours required for renewal on the date the license
became inactive.
(2) The board shall adopt rules relating to application procedures for inactive status, to the biennial renewal of inactive licenses, and to the reactivation of licenses. The board shall prescribe by rule an application fee for inactive status, a renewal fee for inactive status, a delinquency fee, and a fee for the reactivation of a license. None of these fees
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may exceed the biennial renewal fee established by the board for an active license. The department may not reactivate a license unless the inactive or delinquent licensee has paid any applicable biennial renewal or delinquency fee,
or both, and a reactivation fee.
465.0125 Consultant pharmacist license; application, renewal, fees; responsibilities; rules.-(1) The department shall issue or renew a consultant pharmacist license upon receipt of an initial or renewal application which conforms to the requirements for consultant pharmacist initial licensure or renewal as promulgated by
the board by rule and a fee set by the board not to exceed $250. The consultant pharmacist shall be responsible for
maintaining all drug records required by law and for establishing drug handling procedures for the safe handling
and storage of drugs. The consultant pharmacist may also be responsible for ordering and evaluating any laboratory
or clinical testing when, in the judgment of the consultant pharmacist, such activity is necessary for the proper performance of the consultant pharmacist's responsibilities. Such laboratory or clinical testing may be ordered only with
regard to patients residing in a nursing home facility, and then only when authorized by the medical director of the
nursing home facility. The consultant pharmacist must have completed such additional training and demonstrate
such additional qualifications in the practice of institutional pharmacy as shall be required by the board in addition
to licensure as a registered pharmacist.
(2) Notwithstanding the provisions of subsection (1), a consultant pharmacist or a doctor of pharmacy licensed in
this state may also be responsible for ordering and evaluating any laboratory or clinical testing for persons under
the care of a licensed home health agency when, in the judgment of the consultant pharmacist or doctor of pharmacy,
such activity is necessary for the proper performance of his or her responsibilities and only when authorized by a
practitioner licensed under chapter 458, chapter 459, chapter 461, or chapter 466. In order for the consultant pharmacist or doctor of pharmacy to qualify and accept this authority, he or she must receive 3 hours of continuing education relating to laboratory and clinical testing as established by the board.
(3) The board shall promulgate rules necessary to implement and administer this section.
465.0126 Nuclear pharmacist license; application, renewal, fees.--The department shall issue or renew a nuclear
pharmacist license upon receipt of an initial or renewal application which conforms to the requirements for nuclear
pharmacist initial licensure or biennial renewal as established by the board by rule and receipt of a fee established
by the board by rule not to exceed $250, which fee shall be in addition to the initial licensure or biennial renewal fee
for pharmacists. The nuclear pharmacist shall be responsible for the compounding and the dispensing of nuclear
pharmaceuticals, for maintaining all drug records required by law, for establishing drug handling procedures for the
safe handling and storage of radiopharmaceuticals and medicinal drugs, for providing the security of the prescription department, and for complying with such other rules as relate to the practice of the profession of pharmacy. The
nuclear pharmacist must have completed such additional training and must demonstrate such additional qualifications in the practice of nuclear pharmacy as is required by the board by rule in addition to licensure as a registered
pharmacist. The board shall adopt rules necessary to implement and administer this section. The requirements of this
section do not apply to hospitals licensed under chapter 395 or the nuclear medicine facilities of such hospitals.
465.013 Registration of pharmacy interns.--The department shall register as pharmacy interns persons certified by
the board as being enrolled in an intern program at an accredited school or college of pharmacy or who are graduates of accredited schools or colleges of pharmacy and are not yet licensed in the state. The board may refuse to certify to the department or may revoke the registration of any intern for good cause, including grounds enumerated in
this chapter for revocation of pharmacists' licenses.
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Note that the language of the following section which recently changed and will again in 2011.
465.014 Pharmacy technician.-(1) A person other than a licensed pharmacist or pharmacy intern may not engage in the practice of the profession of
pharmacy, except that a licensed pharmacist may delegate to pharmacy technicians who are registered pursuant to
this section those duties, tasks, and functions that do not fall within the purview of s. 465.003(13). All such delegated
acts shall be performed under the direct supervision of a licensed pharmacist who shall be responsible for all such
acts performed by persons under his or her supervision. A pharmacy registered technician, under the supervision of
a pharmacist, may initiate or receive communications with a practitioner or his or her agent, on behalf of a patient,
regarding refill authorization requests. A licensed pharmacist may not supervise more than one registered pharmacy
technician unless otherwise permitted by the guidelines adopted by the board. The board shall establish guidelines to
be followed by licensees or permittees in determining the circumstances under which a licensed pharmacist may supervise more than one but not more than three pharmacy technicians.
1(2) Any person who wishes to work as a pharmacy technician in this state must register by filing an application with
the board on a form adopted by rule of the board. The board shall register each applicant who has remitted a registration fee set by the board, not to exceed $50 biennially; has completed the application form and remitted a nonrefundable application fee set by the board, not to exceed $50; and is at least 17 years of age.
(3) A person whose license to practice pharmacy has been denied, suspended, or restricted for disciplinary purposes
is not eligible to register as a pharmacy technician.
(4) Notwithstanding the requirements of this section or any other provision of law, a pharmacy technician student
who is enrolled in a pharmacy technician training program that is approved by the board may be placed in a pharmacy for the purpose of obtaining practical training. A pharmacy technician student shall wear identification that
indicates his or her student status when performing the functions of a pharmacy technician, and registration under
this section is not required.
(5) Notwithstanding the requirements of this section or any other provision of law, a person who is licensed by the
state as a pharmacy intern may be employed as a registered pharmacy technician without paying a registration fee
or filing an application with the board to register as a pharmacy technician.
(6) As a condition of registration renewal, a registered pharmacy technician shall complete 20 hours biennially of
continuing education courses approved by the board or the Accreditation Council for Pharmacy Education, of which
4 hours must be via live presentation and 2 hours must be related to the prevention of medication errors and pharmacy law.
(7) The board shall adopt rules that require each registration issued by the board under this section to be displayed
in such a manner as to make it available to the public and to facilitate inspection by the department. The board may
adopt other rules as necessary to administer this section.
(8) If the board finds that an applicant for registration as a pharmacy technician or that a registered pharmacy technician has committed an act that constitutes grounds for discipline as set forth in s. 456.072(1) or has committed an
act that constitutes grounds for denial of a license or disciplinary action as set forth in this chapter, including an act
that constitutes a substantial violation of s. 456.072(1) or a violation of this chapter which occurred before the applicant or registrant was registered as a pharmacy technician, the board may enter an order imposing any of the penalties specified in s. 456.072(2) against the applicant or registrant.
1Note.--effective
January 1, 2011, to read:
(2) Any person who wishes to work as a pharmacy technician in this state must register by filing an application with
the board on a form adopted by rule of the board. The board shall register each applicant who has remitted a registration fee set by the board, not to exceed $50 biennially; has completed the application form and remitted a nonrefundable application fee set by the board, not to exceed $50; is at least 17 years of age; and has completed a
pharmacy technician training program approved by the Board of Pharmacy. Notwithstanding any requirements in
this subsection, any registered pharmacy technician registered pursuant to this section before January 1, 2011, who
has worked as a pharmacy technician for a minimum of 1,500 hours under the supervision of a licensed pharmacist
or received certification as a pharmacy technician by certification program accredited by the National Commission
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for Certifying Agencies is exempt from the requirement to complete an initial training program for purposes of registration as required by this subsection.
D.
Unlawful Acts and Consequences
It is illegal for anyone who is not a pharmacist to practice pharmacy or to commit any one of a number of other acts
that are deemed violations of the Florida Pharmacy Act. Pharmacists may be disciplined by the Board for committing any
one of a number of listed acts that are considered inappropriate.
465.015 Violations and penalties.-(1) It is unlawful for any person to own, operate, maintain, open, establish, conduct, or have charge of, either alone
or with another person or persons, a pharmacy:
(a) Which is not registered under the provisions of this chapter.
(b) In which a person not licensed as a pharmacist in this state or not registered as an intern in this state or in which
an intern who is not acting under the direct and immediate personal supervision of a licensed pharmacist fills, compounds, or dispenses any prescription or dispenses medicinal drugs.
(2) It is unlawful for any person:
(a) To make a false or fraudulent statement, either for herself or himself or for another person, in any application,
affidavit, or statement presented to the board or in any proceeding before the board.
(b) To fill, compound, or dispense prescriptions or to dispense medicinal drugs if such person does not hold an active
license as a pharmacist in this state, is not registered as an intern in this state, or is an intern not acting under the
direct and immediate personal supervision of a licensed pharmacist.
(c) To sell or dispense drugs as defined in s. 465.003(8) without first being furnished with a prescription.
(d) To sell samples or complimentary packages of drug products.
(3)(a) It is unlawful for any person other than a pharmacist licensed under this chapter to use the title "pharmacist"
or "druggist" or otherwise lead the public to believe that she or he is engaged in the practice of pharmacy.
(b) It is unlawful for any person other than an owner of a pharmacy registered under this chapter to display any sign
or to take any other action that would lead the public to believe that such person is engaged in the business of compounding, dispensing, or retailing any medicinal drugs. This paragraph shall not preclude a person not licensed as a
pharmacist from owning a pharmacy.
(c) It is unlawful for a person, firm, or corporation that is not licensed or registered under this chapter to:
1. Use in a trade name, sign, letter, or advertisement any term, including "drug," "pharmacy," "prescription drugs,"
"Rx," or "apothecary," which implies that the person, firm, or corporation is licensed or registered to practice pharmacy in this state.
2. Hold himself or herself out to others as a person, firm, or corporation licensed or registered to practice pharmacy
in this state.
(4) Any person who violates any provision of subsection (1) or subsection (3) commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083. Any person who violates any provision of subsection (2)
commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084. In any warrant,
information, or indictment, it shall not be necessary to negative any exceptions, and the burden of any exception shall
be upon the defendant.
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465.016 Disciplinary actions.-(1) The following acts constitute grounds for denial of a license or disciplinary action, as specified in s. 456.072(2):
(a) Obtaining a license by misrepresentation or fraud or through an error of the department or the board.
(b) Procuring or attempting to procure a license for any other person by making or causing to be made any false representation.
(c) Permitting any person not licensed as a pharmacist in this state or not registered as an intern in this state, or permitting a registered intern who is not acting under the direct and immediate personal supervision of a licensed pharmacist, to fill, compound, or dispense any prescriptions in a pharmacy owned and operated by such pharmacist or in
a pharmacy where such pharmacist is employed or on duty.
(d) Being unfit or incompetent to practice pharmacy by reason of:
1. Habitual intoxication.
2. The misuse or abuse of any medicinal drug appearing in any schedule set forth in chapter 893.
3. Any abnormal physical or mental condition which threatens the safety of persons to whom she or he might sell or
dispense prescriptions, drugs, or medical supplies or for whom she or he might manufacture, prepare, or package, or
supervise the manufacturing, preparation, or packaging of, prescriptions, drugs, or medical supplies.
(e) Violating chapter 499; 21 U.S.C. ss. 301-392, known as the Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss.
821 et seq., known as the Comprehensive Drug Abuse Prevention and Control Act; or chapter 893.
(f) Having been convicted or found guilty, regardless of adjudication, in a court of this state or other jurisdiction, of
a crime which directly relates to the ability to practice pharmacy or to the practice of pharmacy. A plea of nolo contendere constitutes a conviction for purposes of this provision.
(g) Using in the compounding of a prescription, or furnishing upon prescription, an ingredient or article different in
any manner from the ingredient or article prescribed, except as authorized in s. 465.019(6) or s. 465.025.
(h) Having been disciplined by a regulatory agency in another state for any offense that would constitute a violation
of this chapter.
(i) Compounding, dispensing, or distributing a legend drug, including any controlled substance, other than in the
course of the professional practice of pharmacy. For purposes of this paragraph, it shall be legally presumed that the
compounding, dispensing, or distributing of legend drugs in excessive or inappropriate quantities is not in the best
interests of the patient and is not in the course of the professional practice of pharmacy.
(j) Making or filing a report or record which the licensee knows to be false, intentionally or negligently failing to file
a report or record required by federal or state law, willfully impeding or obstructing such filing, or inducing another
person to do so. Such reports or records include only those which the licensee is required to make or file in her or his
capacity as a licensed pharmacist.
(k) Failing to make prescription fee or price information readily available by failing to provide such information upon request and upon the presentation of a prescription for pricing or dispensing. Nothing in this section shall be construed to prohibit the quotation of price information on a prescription drug to a potential consumer by telephone.
Note that the law does not forbid accepting back dispensed drugs from a patient, but it does forbid placing those drugs back
in stock, with some exceptions applicable to unit-dose medications dispensed to institutionalized patients.
(l) Placing in the stock of any pharmacy any part of any prescription compounded or dispensed which is returned by
a patient; however, in a hospital, nursing home, correctional facility, or extended care facility in which unit-dose
medication is dispensed to inpatients, each dose being individually sealed and the individual unit dose or unit-dose
system labeled with the name of the drug, dosage strength, manufacturer's control number, and expiration date, if
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any, the unused unit dose of medication may be returned to the pharmacy for redispensing. Each pharmacist shall
maintain appropriate records for any unused or returned medicinal drugs.
(m) Being unable to practice pharmacy with reasonable skill and safety by reason of illness, use of drugs, narcotics,
chemicals, or any other type of material or as a result of any mental or physical condition. A pharmacist affected under this paragraph shall at reasonable intervals be afforded an opportunity to demonstrate that she or he can resume
the competent practice of pharmacy with reasonable skill and safety to her or his customers.
(n) Violating a rule of the board or department or violating an order of the board or department previously entered
in a disciplinary hearing.
(o) Failing to report to the department any licensee under chapter 458 or under chapter 459 who the pharmacist
knows has violated the grounds for disciplinary action set out in the law under which that person is licensed and who
provides health care services in a facility licensed under chapter 395, or a health maintenance organization certificated under part I of chapter 641, in which the pharmacist also provides services.
(p) Failing to notify the Board of Pharmacy in writing within 20 days of the commencement or cessation of the practice of the profession of pharmacy in Florida when such commencement or cessation of the practice of the profession
of pharmacy in Florida was a result of a pending or completed disciplinary action or investigation in another jurisdiction.
(q) Using or releasing a patient's records except as authorized by this chapter and chapter 456.
(r) Violating any provision of this chapter or chapter 456, or any rules adopted pursuant thereto.
(s) Dispensing any medicinal drug based upon a communication that purports to be a prescription as defined by s.
465.003(14) or s. 893.02 when the pharmacist knows or has reason to believe that the purported prescription is not
based upon a valid practitioner-patient relationship.
Note below that the listed rules that can lead to the revocation of the license of a practicing pharmacist are the same rules that
can prevent a not-yet-licensed person from becoming licensed as a pharmacist.
(2) The board may enter an order denying licensure or imposing any of the penalties in s. 456.072(2) against any
applicant for licensure or licensee who is found guilty of violating any provision of subsection (1) of this section or
who is found guilty of violating any provision of s. 456.072(1).
(3) The board shall not reinstate the license of a pharmacist, or cause a license to be issued to a person it has
deemed unqualified, until such time as it is satisfied that she or he has complied with all the terms and conditions set
forth in the final order and that such person is capable of safely engaging in the practice of pharmacy.
(4) The board shall by rule establish guidelines for the disposition of disciplinary cases involving specific types of
violations. Such guidelines may include minimum and maximum fines, periods of supervision or probation, or conditions of probation or reissuance of a license.
E.
Pharmacy Permits
Not only must a pharmacist be licensed to practice, the practice site must have a permit before pharmacy can be practiced at the site. There are different types of pharmacy permits, depending on the type of practice and the location of the
practice. Different rules apply to each type of practice site to prevent specialty practices from having to comply with general
rules that have no relevance to them.
465.018 Community pharmacies; permits.--Any person desiring a permit to operate a community pharmacy shall
apply to the department. If the board office certifies that the application complies with the laws of the state and the
rules of the board governing pharmacies, the department shall issue the permit. No permit shall be issued unless a
licensed pharmacist is designated as the prescription department manager responsible for maintaining all drug records, providing for the security of the prescription department, and following such other rules as relate to the prac159
tice of the profession of pharmacy. The permittee and the newly designated prescription department manager shall
notify the department within 10 days of any change in prescription department manager.
465.019 Institutional pharmacies; permits.-(1) Any institution desiring to operate an institutional pharmacy shall apply to the department. If the board certifies
that the application complies with the laws of the state and the rules of the board governing pharmacies, the department shall issue the permit.
(2) The following classes of institutional pharmacies are established:
(a)"Class I institutional pharmacies" are those institutional pharmacies in which all medicinal drugs are administered from individual prescription containers to the individual patient and in which medicinal drugs are not dispensed on the premises, except that nursing homes licensed under part II of chapter 400 may purchase medical
oxygen for administration to residents. No medicinal drugs may be dispensed in a Class I institutional pharmacy.
(b)"Class II institutional pharmacies" are those institutional pharmacies which employ the services of a registered
pharmacist or pharmacists who, in practicing institutional pharmacy, shall provide dispensing and consulting services on the premises to patients of that institution, for use on the premises of that institution. However, an institutional
pharmacy located in an area or county included in an emergency order or proclamation of a state of emergency declared by the Governor may provide dispensing and consulting services to individuals who are not patients of the institution. However, a single dose of a medicinal drug may be obtained and administered to a patient on a valid
physician's drug order under the supervision of a physician or charge nurse, consistent with good institutional practice procedures. The obtaining and administering of such single dose of a medicinal drug shall be pursuant to drughandling procedures established by a consultant pharmacist. Medicinal drugs may be dispensed in a Class II institutional pharmacy, but only in accordance with the provisions of this section.
(c)"Modified Class II institutional pharmacies" are those institutional pharmacies in short-term, primary care treatment centers that meet all the requirements for a Class II permit, except space and equipment requirements.
(3)Medicinal drugs shall be stocked, stored, compounded, dispensed, or administered in any health care institution
only when that institution has secured an institutional pharmacy permit from the department.
(4)Medicinal drugs shall be dispensed in an institutional pharmacy to outpatients only when that institution has secured a community pharmacy permit from the department. However, an individual licensed to prescribe medicinal
drugs in this state may dispense up to a 24-hour supply of a medicinal drug to any patient of an emergency department of a hospital that operates a Class II institutional pharmacy, provided that the physician treating the patient in
such hospital's emergency department determines that the medicinal drug is warranted and that community pharmacy services are not readily accessible, geographically or otherwise, to the patient. Such dispensing from the emergency department must be in accordance with the procedures of the hospital. For any such patient for whom a medicinal
drug is warranted for a period to exceed 24 hours, an individual licensed to prescribe such drug must dispense a 24hour supply of such drug to the patient and must provide the patient with a prescription for such drug for use after
the initial 24-hour period. The board may adopt rules necessary to carry out the provisions of this subsection.
(5)All institutional pharmacies shall be under the professional supervision of a consultant pharmacist, and the compounding and dispensing of medicinal drugs shall be done only by a licensed pharmacist. Every institutional pharmacy that employs or otherwise utilizes pharmacy technicians shall have a written policy and procedures manual
specifying those duties, tasks, and functions which a pharmacy technician is allowed to perform.
(6)In a Class II institutional pharmacy, an institutional formulary system may be adopted with approval of the medical staff for the purpose of identifying those medicinal drugs and proprietary preparations that may be dispensed by
the pharmacists employed in such institution. A facility with a Class II institutional permit which is operating under
the formulary system shall establish policies and procedures for the development of the system in accordance with
the joint standards of the American Hospital Association and American Society of Hospital Pharmacists for the utilization of a hospital formulary system, which formulary shall be approved by the medical staff.
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465.0193 Nuclear pharmacy permits.--Any person desiring a permit to operate a nuclear pharmacy shall apply to
the department. If the board certifies that the application complies with applicable law, the department shall issue
the permit. No permit shall be issued unless a duly licensed and qualified nuclear pharmacist is designated as being
responsible for activities described in s. 465.0126. The permittee shall notify the department within 10 days of any
change of the licensed pharmacist responsible for the compounding and dispensing of nuclear pharmaceuticals.
465.0196 Special pharmacy permits.--Any person desiring a permit to operate a special pharmacy shall apply to the
department for a special pharmacy permit. If the board certifies that the application complies with the applicable
laws and rules of the board governing the practice of the profession of pharmacy, the department shall issue the permit. No permit shall be issued unless a licensed pharmacist is designated to undertake the professional supervision of
the compounding and dispensing of all drugs dispensed by the pharmacy. The licensed pharmacist shall be responsible for maintaining all drug records and for providing for the security of the area in the facility in which the compounding, storing, and dispensing of medicinal drugs occurs. The permittee shall notify the department within 10
days of any change of the licensed pharmacist responsible for such duties. Every permittee that employs or otherwise
utilizes pharmacy technicians shall have a written policy and procedures manual specifying those duties, tasks, and
functions which a pharmacy technician is allowed to perform.
465.0156 Registration of nonresident pharmacies.-(1) Any pharmacy which is located outside this state and which ships, mails, or delivers, in any manner, a dispensed
medicinal drug into this state shall be considered a nonresident pharmacy, shall be registered with the board, shall
provide pharmacy services at a high level of protection and competence, and shall disclose to the board the following
specific information:
(a) That it maintains at all times a valid, unexpired license, permit, or registration to operate the pharmacy in compliance with the laws of the state in which the dispensing facility is located and from which the medicinal drugs shall
be dispensed;
(b) The location, names, and titles of all principal corporate officers and the pharmacist who serves as the prescription department manager for dispensing medicinal drugs to residents of this state. This disclosure shall be made
within 30 days after any change of location, corporate officer, or pharmacist serving as the prescription department
manager for dispensing medicinal drugs to residents of this state;
(c) That it complies with all lawful directions and requests for information from the regulatory or licensing agency of
all states in which it is licensed as well as with all requests for information made by the board pursuant to this section. It shall respond directly to all communications from the board concerning emergency circumstances arising
from errors in the dispensing of medicinal drugs to the residents of this state;
(d) That it maintains its records of medicinal drugs dispensed to patients in this state so that the records are readily
retrievable from the other business records of the pharmacy and from the records of other medicinal drugs dispensed; and
(e) That during its regular hours of operation but not less than 6 days per week, for a minimum of 40 hours per week,
a toll-free telephone service shall be provided to facilitate communication between patients in this state and a pharmacist at the pharmacy who has access to the patient's records. This toll-free number must be disclosed on the label
affixed to each container of dispensed medicinal drugs.
(2) Applications for nonresident pharmacy registration under this section shall be made on a form furnished by the
board. The board may require such information as the board deems reasonably necessary to carry out the purposes
of this section. The board may grant an exemption from the registration requirements of this section to any nonresident pharmacy which confines its dispensing activity to isolated transactions. The board may define by rule the term
isolated transactions.
(3) The registration fee and the biennial renewal fee shall be the fee specified in s. 465.022.
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(4) The board may deny, revoke, or suspend registration of, or fine or reprimand, a nonresident pharmacy for failure
to comply with s. 465.025 or with any requirement of this section in accordance with the provisions of this chapter.
(5) In addition to the prohibitions of subsection (4) the board may deny, revoke, or suspend registration of, or fine or
reprimand, a nonresident pharmacy in accordance with the provisions of this chapter for conduct which causes serious bodily injury or serious psychological injury to a resident of this state if the board has referred the matter to the
regulatory or licensing agency in the state in which the pharmacy is located and the regulatory or licensing agency
fails to investigate within 180 days of the referral.
(6) It is unlawful for any nonresident pharmacy which is not registered pursuant to this section to advertise its services in this state, or for any person who is a resident of this state to advertise the pharmacy services of a nonresident
pharmacy which has not registered with the board, with the knowledge that the advertisement will or is likely to induce members of the public in this state to use the pharmacy to fill prescriptions.
(7) This section does not apply to Internet pharmacies required to be permitted under s. 465.0197.
(8) Notwithstanding s. 465.003(10), for purposes of this section, the registered pharmacy and the pharmacist designated by the registered pharmacy as the prescription department manager or the equivalent must be licensed in the
state of location in order to dispense into this state.
465.0197 Internet pharmacy permits.-(1) Any person desiring a permit to operate an Internet pharmacy shall apply to the department for an Internet pharmacy permit. If the board certifies that the application complies with the applicable laws and rules of the board governing the practice of the profession of pharmacy, the department shall issue the permit. No permit shall be issued
unless a licensed pharmacist is designated as the prescription department manager for dispensing medicinal drugs to
persons in this state. The licensed pharmacist shall be responsible for maintaining all drug records and for providing
for the security of the area in the facility in which the compounding, storing, and dispensing of medicinal drugs to
persons in this state occurs. The permittee shall notify the department within 30 days of any change of the licensed
pharmacist responsible for such duties. Every permittee that employs or otherwise utilizes pharmacy technicians
shall have a written policy and procedures manual specifying those duties, tasks, and functions which a pharmacy
technician is allowed to perform.
(2) An Internet pharmacy must obtain a permit under this section to sell medicinal drugs to persons in this state.
(3) An Internet pharmacy shall provide pharmacy services at a high level of protection and competence and shall disclose to the board the following specific information:
(a) That it maintains at all times a valid, unexpired license, permit, or registration to operate the pharmacy in compliance with the laws of the state in which the dispensing facility is located and from which the medicinal drugs shall
be dispensed.
(b) The location, names, and titles of all principal corporate officers and the pharmacist who serves as the prescription department manager for dispensing medicinal drugs to persons in this state. This disclosure shall be made within 30 days after any change of location, principal corporate officer, or pharmacist serving as the prescription
department manager for dispensing medicinal drugs to persons in this state.
(c) That complies with all lawful directions and requests for information from the regulatory or licensing agency of
all states in which it is licensed as well as with all requests for information made by the board pursuant to this section. It shall respond directly to all communications from the board concerning emergency circumstances arising
from errors in the dispensing of medicinal drugs to persons in this state.
(d) That it maintains its records of medicinal drugs dispensed to patients in this state so that the records are readily
retrievable from the other business records of the pharmacy and from the records of other medicinal drugs dispensed.
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(e) That during its regular hours of operation but not less than 6 days per week, for a minimum of 40 hours per week,
a toll-free telephone service shall be provided to facilitate communication between patients in this state and a pharmacist at the pharmacy who has access to the patient's records. This toll-free number must be disclosed on the label
affixed to each container of dispensed medicinal drugs.
(4) Notwithstanding s. 465.003(10), for purposes of this section, the Internet pharmacy and the pharmacist designated by the Internet pharmacy as the prescription department manager or the equivalent must be licensed in the state
of location in order to dispense into this state.
465.0161 Distribution of medicinal drugs without a permit.--An Internet pharmacy that distributes a medicinal drug
to any person in this state without being permitted as a pharmacy under this chapter commits a felony of the second
degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
465.022 Pharmacies; general requirements; fees.-(1) The board shall adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of this chapter.
Such rules shall include, but shall not be limited to, rules relating to:
(a) General drug safety measures.
(b) Minimum standards for the physical facilities of pharmacies.
(c) Safe storage of floor-stock drugs.
(d) Functions of a pharmacist in an institutional pharmacy, consistent with the size and scope of the pharmacy.
(e) Procedures for the safe storage and handling of radioactive drugs.
(f) Procedures for the distribution and disposition of medicinal drugs distributed pursuant to s. 499.028.
(g) Procedures for transfer of prescription files and medicinal drugs upon the change of ownership or closing of a
pharmacy.
(h) Minimum equipment which a pharmacy shall at all times possess to fill prescriptions properly.
(2) A pharmacy permit shall be issued only to a person who is at least 18 years of age, a partnership whose partners
are all at least 18 years of age, or to a corporation that is registered pursuant to chapter 607 or chapter 617 whose
officers, directors, and shareholders are at least 18 years of age.
(3) Any person, partnership, or corporation before engaging in the operation of a pharmacy shall file with the board
a sworn application on forms provided by the department.
(a) An application for a pharmacy permit must include a set of fingerprints from each person having an ownership
interest of 5 percent or greater and from any person who, directly or indirectly, manages, oversees, or controls the
operation of the applicant, including officers and members of the board of directors of an applicant that is a corporation. The applicant must provide payment in the application for the cost of state and national criminal history records checks.
1. For corporations having more than $100 million of business taxable assets in this state, in lieu of these fingerprint
requirements, the department shall require the prescription department manager who will be directly involved in the
management and operation of the pharmacy to submit a set of fingerprints.
2. A representative of a corporation described in subparagraph 1. satisfies the requirement to submit a set of his or
her fingerprints if the fingerprints are on file with the department or the Agency for Health Care Administration,
meet the fingerprint specifications for submission by the Department of Law Enforcement, and are available to the
department.
(b) The department shall submit the fingerprints provided by the applicant to the Department of Law Enforcement for
a state criminal history records check. The Department of Law Enforcement shall forward the fingerprints to the
Federal Bureau of Investigation for a national criminal history records check.
(4) The department or board shall deny an application for a pharmacy permit if the applicant or an affiliated person,
partner, officer, director, or prescription department manager of the applicant has:
(a) Obtained a permit by misrepresentation or fraud;
(b) Attempted to procure, or has procured, a permit for any other person by making, or causing to be made, any false
representation;
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(c) Been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any
jurisdiction which relates to the practice of, or the ability to practice, the profession of pharmacy;
(d) Been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any
jurisdiction which relates to health care fraud;
(e) Been terminated for cause, pursuant to the appeals procedures established by the state or Federal Government,
from any state Medicaid program or the federal Medicare program, unless the applicant has been in good standing
with a state Medicaid program or the federal Medicare program for the most recent 5 years and the termination occurred at least 20 years ago; or
(f) Dispensed any medicinal drug based upon a communication that purports to be a prescription as defined by s.
based upon a valid practitioner-patient relationship that includes a documented patient evaluation, including history
and a physical examination adequate to establish the diagnosis for which any drug is prescribed and any other requirement established by board rule under chapter 458, chapter 459, chapter 461, chapter 463, chapter 464, or
chapter 466.
(5) After the application has been filed with the board and the permit fee provided in this section has been received,
the board shall cause the application to be fully investigated, both as to the qualifications of the applicant and the
prescription department manager or consultant pharmacist designated to be in charge and as to the premises and
location described in the application.
(6) The Board of Pharmacy shall have the authority to determine whether a bona fide transfer of ownership is present and that the sale of a pharmacy is not being accomplished for the purpose of avoiding an administrative prosecution.
(7) Upon the completion of the investigation of an application, the board shall approve or disapprove the application. If approved, the permit shall be issued by the department.
(8) Permits issued by the department are not transferable.
(9) The board shall set the fees for the following:
(a) Initial permit fee not to exceed $250.
(b) Biennial permit renewal not to exceed $250.
(c) Delinquent fee not to exceed $100.
(d) Change of location fee not to exceed $100.
Note that just as pharmacists can be disciplined, those who hold pharmacy permits can also be disciplined.
465.023 Pharmacy permittee; disciplinary action.-(1) The department or the board may revoke or suspend the permit of any pharmacy permittee, and may fine, place
on probation, or otherwise discipline any pharmacy permittee if the permittee, or any affiliated person, partner, officer, director, or agent of the permittee, including a person fingerprinted under s. 465.022(3), has:
(a) Obtained a permit by misrepresentation or fraud or through an error of the department or the board;
(b) Attempted to procure, or has procured, a permit for any other person by making, or causing to be made, any false
representation;
(c) Violated any of the requirements of this chapter or any of the rules of the Board of Pharmacy; of chapter 499,
known as the "Florida Drug and Cosmetic Act"; of 21 U.S.C. ss. 301-392, known as the "Federal Food, Drug, and
Cosmetic Act"; of 21 U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse Prevention and Control Act; or
of chapter 893;
(d) Been convicted or found guilty, regardless of adjudication, of a felony or any other crime involving moral turpitude in any of the courts of this state, of any other state, or of the United States;
(e) Been convicted or disciplined by a regulatory agency of the Federal Government or a regulatory agency of another state for any offense that would constitute a violation of this chapter;
(f) Been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any jurisdiction which relates to the practice of, or the ability to practice, the profession of pharmacy;
(g) Been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any
jurisdiction which relates to health care fraud; or
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(h) Dispensed any medicinal drug based upon a communication that purports to be a prescription as defined by s.
based upon a valid practitioner-patient relationship that includes a documented patient evaluation, including history
and a physical examination adequate to establish the diagnosis for which any drug is prescribed and any other requirement established by board rule under chapter 458, chapter 459, chapter 461, chapter 463, chapter 464, or
chapter 466.
(2) If a pharmacy permit is revoked or suspended, the owner, manager, or proprietor shall cease to operate the establishment as a pharmacy as of the effective date of such suspension or revocation. In the event of such revocation
or suspension, the owner, manager, or proprietor shall remove from the premises all signs and symbols identifying
the premises as a pharmacy. The period of such suspension shall be prescribed by the Board of Pharmacy, but in no
case shall it exceed 1 year. In the event that the permit is revoked, the person owning or operating the establishment
shall not be entitled to make application for a permit to operate a pharmacy for a period of 1 year from the date of
such revocation. Upon the effective date of such revocation, the permittee shall advise the Board of Pharmacy of the
disposition of the medicinal drugs located on the premises. Such disposition shall be subject to continuing supervision and approval by the Board of Pharmacy.
F.
Pharmacy Standards
A key aspect of the Pharmacy Act is the specification of expectations that apply to particular areas of pharmacy practice and drug distribution. These specific provisions constitute a road map for the Board of Pharmacy in the development of
rules that implement the standards.
Note that the mechanized dispensing of drugs, which is commonly done in hospitals, may also be done in long-term care institutions, hospices or state correctional institutions, even though a pharmacist is not directly present.
465.0235 Automated pharmacy systems used by long-term care facilities, hospices, or state correctional institutions.-(1) A pharmacy may provide pharmacy services to a long-term care facility or hospice licensed under chapter 400 or
chapter 429 or a state correctional institution operated under chapter 944 through the use of an automated pharmacy system that need not be located at the same location as the pharmacy.
(2) Medicinal drugs stored in bulk or unit of use in an automated pharmacy system servicing a long-term care facility, hospice, or correctional institution are part of the inventory of the pharmacy providing pharmacy services to that
facility, hospice, or institution, and drugs delivered by the automated pharmacy system are considered to have been
dispensed by that pharmacy.
(3) The operation of an automated pharmacy system must be under the supervision of a Florida-licensed pharmacist.
To qualify as a supervisor for an automated pharmacy system, the pharmacist need not be physically present at the
site of the automated pharmacy system and may supervise the system electronically. The Florida-licensed pharmacist
shall be required to develop and implement policies and procedures designed to verify that the medicinal drugs delivered by the automated dispensing system are accurate and valid and that the machine is properly restocked.
(4) The Legislature does not intend this section to limit the current practice of pharmacy in this state. This section is
intended to allow automated pharmacy systems to enhance the ability of a pharmacist to provide pharmacy services
in locations that do not employ a full-time pharmacist. This section does not limit or replace the use of a consultant
pharmacist.
(5) The board shall adopt rules governing the use of an automated pharmacy system by January 1, 2005, which must
specify:
(a) Recordkeeping requirements;
(b) Security requirements; and
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(c) Labeling requirements that permit the use of unit-dose medications if the facility, hospice, or institution maintains
medication-administration records that include directions for use of the medication and the automated pharmacy system identifies:
1. The dispensing pharmacy;
2. The prescription number;
3. The name of the patient; and
4. The name of the prescribing practitioner.
It is illegal for pharmacists or others associated with retail drug establishments to advertise controlled substances.
465.024 Promoting sale of certain drugs prohibited.-(1) It is declared that the unrestricted use of certain controlled substances, causing abnormal reactions that may interfere with the user's physical reflexes and judgments, may create hazardous circumstances which may cause accidents to the user and to others, thereby affecting the public health, safety, and welfare. It is further declared to be in
the public interest to limit the means of promoting the sale and use of these drugs. All provisions of this section shall
be liberally construed to carry out these objectives and purposes.
(2) No pharmacist, owner, or employee of a retail drug establishment shall use any communication media to promote
or advertise the use or sale of any controlled substance appearing in any schedule in chapter 893.
(3) This section shall not prohibit the advertising of any medicinal drugs, other than those controlled substances
specified in chapter 893, or any patent or proprietary preparation, provided the advertising is not false, misleading,
or deceptive.
465.0244 Information disclosure.--Every pharmacy shall make available on its Internet website a link to the performance outcome and financial data that is published by the Agency for Health Care Administration pursuant to s.
408.05(3)(k) and shall place in the area where customers receive filled prescriptions notice that such information is
available electronically and the address of its Internet website.
Note below that the Pharmacy Act provides for the substitution of generic products by a pharmacist for the purpose of saving
money. There are safeguards built in to this law to assure that the substituted drug will not cause harm to the patient.
465.025 Substitution of drugs.-(1) As used in this section:
(a)"Brand name" means the registered trademark name given to a drug product by its manufacturer, labeler, or distributor.
(b)"Generically equivalent drug product" means a drug product with the same active ingredient, finished dosage
form, and strength.
(c)"Prescriber" means any practitioner licensed to prescribe medicinal drugs.
(2) A pharmacist who receives a prescription for a brand name drug shall, unless requested otherwise by the purchaser, substitute a less expensive, generically equivalent drug product that is:
(a) Distributed by a business entity doing business, and subject to suit and service of legal process, in the United
States; and
(b) Listed in the formulary of generic and brand name drug products as provided in subsection (5) for the brand
name drug prescribed, unless the prescriber writes the words "MEDICALLY NECESSARY," in her or his own hand166
writing, on the face of a written prescription; unless, in the case of an oral prescription, the prescriber expressly indicates to the pharmacist that the brand name drug prescribed is medically necessary; or unless, in the case of a
prescription that is electronically generated and transmitted, the prescriber makes an overt act when transmitting the
prescription to indicate that the brand name drug prescribed is medically necessary. When done in conjunction with
the electronic transmission of the prescription, the prescriber's overt act indicates to the pharmacist that the brand
name drug prescribed is medically necessary.
(3)(a) Any pharmacist who substitutes any drug as provided in subsection (2) shall notify the person presenting the
prescription of such substitution, together with the existence and amount of the retail price difference between the
brand name drug and the drug substituted for it, and shall inform the person presenting the prescription that such
person may refuse the substitution as provided in subsection (2).
(b) Any pharmacist substituting a less expensive drug product shall pass on to the consumer the full amount of the
savings realized by such substitution.
(4) Each pharmacist shall maintain a record of any substitution of a generically equivalent drug product for a prescribed brand name drug as provided in this section.
(5) Each community pharmacy shall establish a formulary of generic and brand name drug products which, if selected as the drug product of choice, would not pose a threat to the health and safety of patients receiving prescription
medication. In compiling the list of generic and brand name drug products for inclusion in the formulary, the pharmacist shall rely on drug product research, testing, information, and formularies compiled by other pharmacies, by
states, by the United States Department of Health, Education, and Welfare, by the United States Department of
Health and Human Services, or by any other source which the pharmacist deems reliable. Each community pharmacy shall make such formulary available to the public, the Board of Pharmacy, or any physician requesting same. This
formulary shall be revised following each addition, deletion, or modification of said formulary.
(6) The Board of Pharmacy and the Board of Medicine shall establish by rule a formulary of generic drug type and
brand name drug products which are determined by the boards to demonstrate clinically significant biological or
therapeutic inequivalence and which, if substituted, would pose a threat to the health and safety of patients receiving
prescription medication.
(a) The formulary may be added to or deleted from as the Board of Pharmacy and the Board of Medicine deem appropriate. Any person who requests any inclusion, addition, or deletion of a generic drug type or brand name drug
product to the formulary shall have the burden of proof to show cause why such inclusion, addition, or deletion
should be made.
(b) Upon adoption of the formulary required by this subsection, and upon each addition, deletion, or modification to
the formulary, the Board of Pharmacy shall mail a copy to each manager of the prescription department of each
community pharmacy licensed by the state, each nonresident pharmacy registered in the state, and each board regulating practitioners licensed by the laws of the state to prescribe drugs shall incorporate such formulary into its
rules. No pharmacist shall substitute a generically equivalent drug product for a prescribed brand name drug product if the brand name drug product or the generic drug type drug product is included in the said formulary.
(7) Every community pharmacy shall display in a prominent place that is in clear and unobstructed public view, at or
near the place where prescriptions are dispensed, a sign in block letters not less than 1 inch in height which shall
read: "CONSULT YOUR PHARMACIST CONCERNING THE AVAILABILITY OF A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG AND THE REQUIREMENTS OF FLORIDA LAW."
(8) The standard of care to be applied to the acts of any pharmacist performing professional services in compliance
with this section when a substitution is made by said pharmacist shall be that which would apply to the performance
of professional services in the dispensing of a prescription order prescribing a drug by generic name. In no event
when a pharmacist substitutes a drug shall the prescriber be liable in any action for loss, damage, injury, or death to
any person occasioned by or arising from the use or nonuse of the substituted drug, unless the original drug was incorrectly prescribed.
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465.0251 Generic drugs; removal from formulary under specified circumstances.-(1) The Board of Pharmacy and the Board of Medicine shall remove any generic named drug product from the formulary established by s. 465.025(6), if every commercially marketed equivalent of that drug product is "A" rated as
therapeutically equivalent to a reference listed drug or is a reference listed drug as referred to in "Approved Drug
Products with Therapeutic Equivalence Evaluations" (Orange Book) published by the United States Food and Drug
Administration.
(2) Nothing in this act shall alter or amend s. 465.025 as to existing law providing for the authority of physicians to
prohibit generic drug substitution by writing "medically necessary" on the prescription.
Note that Florida law requires that an expiration date be placed on the label of all drugs dispensed by a pharmacist.
465.0255 Expiration date of medicinal drugs; display; related use and storage instructions.-(1) The manufacturer, repackager, or other distributor of any medicinal drug shall display the expiration date of
each drug in a readable fashion on the container and on its packaging. The term "readable" means conspicuous and
bold.
(2) Each pharmacist for a community pharmacy dispensing medicinal drugs and each practitioner dispensing medicinal drugs on an outpatient basis shall display on the outside of the container of each medicinal drug dispensed, or in
other written form delivered to the purchaser:
(a) The expiration date when provided by the manufacturer, repackager, or other distributor of the drug; or
(b) An earlier beyond-use date for expiration, which may be up to 1 year after the date of dispensing. The dispensing
pharmacist or practitioner must provide information concerning the expiration date to the purchaser upon request
and must provide appropriate instructions regarding the proper use and storage of the drug.
(3) This section does not impose liability on the dispensing pharmacist or practitioner for damages related to, or
caused by, a medicinal drug that loses its effectiveness prior to the expiration date displayed by the dispensing pharmacist or practitioner.
(4) The provisions of this section are intended to notify the patient receiving a medicinal drug of the information required by this section, and the dispensing pharmacist or practitioner shall not be liable for the patient's failure to
heed such notice or to follow the instructions for storage.
Prescriptions may be transferred from one pharmacy to another, as long as certain requirements are met.
465.026 Filling of certain prescriptions.--Nothing contained in this chapter shall be construed to prohibit a pharmacist licensed in this state from filling or refilling a valid prescription which is on file in a pharmacy located in this
state or in another state and has been transferred from one pharmacy to another by any means, including any electronic means, under the following conditions:
(1) Prior to dispensing any transferred prescription, the dispensing pharmacist must, either verbally or by any electronic means, do all of the following:
(a) Advise the patient that the prescription on file at the other pharmacy must be canceled before it may be filled or
refilled.
(b) Determine that the prescription is valid and on file at the other pharmacy and that the prescription may be filled
or refilled, as requested, in accordance with the prescriber's intent expressed on the prescription.
(c) Notify the pharmacist or pharmacy where the prescription is on file that the prescription must be canceled.
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(d) Record in writing, or by any electronic means, the prescription order, the name of the pharmacy at which the prescription was on file, the prescription number, the name of the drug and the original amount dispensed, the date of
original dispensing, and the number of remaining authorized refills.
(e) Obtain the consent of the prescriber to the refilling of the prescription when the prescription, in the dispensing
pharmacist's professional judgment, so requires. Any interference with the professional judgment of the dispensing
pharmacist by any pharmacist or pharmacy permittee, or its agents or employees, shall be grounds for discipline.
(2) Upon receipt of a prescription transfer request, if the pharmacist is satisfied in her or his professional judgment
that the request is valid, or if the request has been validated by any electronic means, the pharmacist or pharmacy
must do all of the following:
(a) Transfer the information required by paragraph (1)(d) accurately and completely.
(b) Record on the prescription, or by any electronic means, the requesting pharmacy and pharmacist and the date of
request.
(c) Cancel the prescription on file by electronic means or by recording the word "void" on the prescription record.
No further prescription information shall be given or medication dispensed pursuant to the original prescription.
(3) If a transferred prescription is not dispensed within a reasonable time, the pharmacist shall, by any means, so
notify the transferring pharmacy. Such notice shall serve to revalidate the canceled prescription. The pharmacist
who has served such notice shall then cancel the prescription in the same manner as set forth in paragraph (2)(c).
(4) In the case of a prescription to be transferred from or to a pharmacy located in another state, it shall be the responsibility of the pharmacist or pharmacy located in the State of Florida to verify, whether by electronic means or
otherwise, that the person or entity involved in the transfer is a licensed pharmacist or pharmacy in the other state.
(5) Electronic transfers of prescriptions are permitted regardless of whether the transferor or transferee pharmacy is
open for business.
(6) The transfer of a prescription for medicinal drugs listed in Schedules III, IV, and V appearing in chapter 893 for
the purpose of refill dispensing is permissible, subject to the requirements of this section and federal law. Compliance with federal law shall be deemed compliance with the requirements of this section.
465.0266 Common database.--Nothing contained in this chapter shall be construed to prohibit the dispensing by a
pharmacist licensed in this state or another state of a prescription contained in a common database, and such dispensing shall not constitute a transfer as defined in s. 465.026(1)-(6), provided that the following conditions are met:
(1) All pharmacies involved in the transactions pursuant to which the prescription is dispensed are under common
ownership and utilize a common database.
(2) All pharmacies involved in the transactions pursuant to which the prescription is dispensed and all pharmacists
engaging in dispensing functions are properly licensed, permitted, or registered in this state or another state.
(3) The common database maintains a record of all pharmacists involved in the process of dispensing a prescription.
(4) The owner of the common database maintains a policy and procedures manual that governs its participating
pharmacies, pharmacists, and pharmacy employees and that is available to the board or its agent upon request. The
policy and procedures manual shall include the following information:
(a) A best practices model detailing how each pharmacy and each pharmacist accessing the common database will
comply with applicable federal and state laws, rules, and regulations.
(b) The procedure for maintaining appropriate records for regulatory oversight for tracking a prescription during
each stage of the filling and dispensing process, identifying the pharmacists involved in filling and dispensing the
prescription and counseling the patient, and responding to any requests for information made by the board under s.
465.0156.
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(c) The policy and procedure for providing adequate security to protect the confidentiality and integrity of patient
information.
(d) A quality assurance program designed to objectively and systematically monitor, evaluate, and improve the quality and appropriateness of patient care through the use of the common database. Any pharmacist dispensing a prescription has at all times the right and obligation to exercise his or her independent professional judgment.
Notwithstanding other provisions in this section, no pharmacist licensed in this state participating in the dispensing
of a prescription pursuant to this section shall be responsible for the acts and omissions of another person participating in the dispensing process provided such person is not under the direct supervision and control of the pharmacist
licensed in this state.
Florida law allows the filling of prescriptions by a central fill facility, and the dispensing of those prescriptions by another
facility, as long as certain requirements are met.
465.0265 Centralized prescription filling.-(1) A pharmacy licensed under this chapter may perform centralized prescription filling for another pharmacy, provided that the pharmacies have the same owner or have a written contract specifying the services to be provided by
each pharmacy, the responsibilities of each pharmacy, and the manner in which the pharmacies will comply with federal and state laws, rules, and regulations.
(2) Each pharmacy performing or contracting for the performance of centralized prescription filling pursuant to this
section must maintain a policy and procedures manual, which shall be made available to the board or its agent upon
request. The policy and procedures manual shall include the following information:
(a) A description of how each pharmacy will comply with federal and state laws, rules, and regulations.
(b) The procedure for maintaining appropriate records to identify the pharmacist responsible for dispensing the prescription and counseling the patient.
(c) The procedure for tracking the prescription during each stage of the filling and dispensing process.
(d) The procedure for identifying on the prescription label all pharmacies involved in filling and dispensing the prescription.
(e) The policy and procedure for providing adequate security to protect the confidentiality and integrity of patient
information.
(f) The procedure to be used by the pharmacy in implementing and operating a quality assurance program designed
to objectively and systematically monitor, evaluate, and improve the quality and appropriateness of patient care.
(3) The filling, delivery, and return of a prescription by one pharmacy for another pursuant to this section shall not
be construed as the filling of a transferred prescription as set forth in s. 465.026 or as a wholesale distribution as set
forth in s. 499.012(1)(a).
(4) The board shall adopt rules pursuant to ss. 120.536(1) and 120.54 necessary to implement this section.
If a patient has run out of medication, and if the prescription has no remaining refills, and if the medication is essential to the
maintenance of life or to the continuation of therapy in a chronic condition, then the pharmacy may provide an emergency
refill of up to a 72 hour supply, as long as the prescription is not for a C-II medication.
465.0275 Emergency prescription refill.--In the event a pharmacist receives a request for a prescription refill and
the pharmacist is unable to readily obtain refill authorization from the prescriber, the pharmacist may dispense a
one-time emergency refill of up to a 72-hour supply of the prescribed medication, with the exception of those areas or
counties included in an emergency order or proclamation of a state of emergency declared by the Governor, in which
the executive order may authorize the pharmacist to dispense up to a 30-day supply, providing that:
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(1) The prescription is not for a medicinal drug listed in Schedule II appearing in chapter 893.
(2) The medication is essential to the maintenance of life or to the continuation of therapy in a chronic condition.
(3) In the pharmacist's professional judgment, the interruption of therapy might reasonably produce undesirable
health consequences or may cause physical or mental discomfort.
(4) The dispensing pharmacist creates a written order containing all of the prescription information required by this
chapter and chapters 499 and 893 and signs that order.
(5) The dispensing pharmacist notifies the prescriber of the emergency dispensing within a reasonable time after
such dispensing.
A facsimile of a prescription may serve as the original under specified circumstances.
465.035 Dispensing of medicinal drugs pursuant to facsimile of prescription.-(1) Notwithstanding any other provision of this chapter, it is lawful for a pharmacy to dispense medicinal drugs, including controlled substances authorized under subsection (2), based on reception of an electronic facsimile of the
original prescription if all of the following conditions are met:
(a) In the course of the transaction the pharmacy complies with laws and administrative rules relating to pharmacies
and pharmacists.
(b) Except in the case of the transmission of a prescription by a person authorized by law to prescribe medicinal
drugs:
1. The facsimile system making the transmission provides the pharmacy receiving the transmission with audio communication via telephonic, electronic, or similar means with the person presenting the prescription.
2. At the time of the delivery of the medicinal drugs, the pharmacy has in its possession the original prescription for
the medicinal drug involved.
3. The recipient of the prescription shall sign a log and shall indicate the name and address of both the recipient and
the patient for whom the medicinal drug was prescribed.
(2) Controlled substances listed in Schedule II as defined in s. 893.03(2) may be dispensed as provided in this section
to the extent allowed by 21 C.F.R. s. 1306.11.
To prevent collusion in relationships that might increase prices or otherwise be counterproductive to patients, Florida prevents rebates (sometimes referred to as “kickbacks”) for pharmacy referrals.
465.185 Rebates prohibited; penalties.-(1) It is unlawful for any person to pay or receive any commission, bonus, kickback, or rebate or engage in any splitfee arrangement in any form whatsoever with any physician, surgeon, organization, agency, or person, either directly
or indirectly, for patients referred to a pharmacy registered under this chapter.
(2) The department shall adopt rules which assess administrative penalties for acts prohibited by subsection (1). In
the case of an entity licensed by the department, such penalties may include any disciplinary action available to the
department under the appropriate licensing laws. In the case of an entity not licensed by the department, such penalties may include:
(a) A fine not to exceed $1,000.
(b) If applicable, a recommendation by the department to the appropriate regulatory agency that disciplinary action
be taken.
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Florida pharmacists are permitted to prescribe a very limited number of drugs completely under their own authority. This is
not to be confused with collaborative practice, which occurs within a relationship between a pharmacist and a professional
who has prescribing authority. The limited number of drugs that pharmacists are authorized to prescribe makes this authority of very limited value.
465.186 Pharmacist's order for medicinal drugs; dispensing procedure; development of formulary.-(1)There is hereby created a committee composed of two members of the Board of Medicine licensed under chapter
458 chosen by said board, one member of the Board of Osteopathic Medicine licensed under chapter 459 chosen by
said board, three members of the Board of Pharmacy licensed under this chapter and chosen by said board, and one
additional person with a background in health care or pharmacology chosen by the committee. The committee shall
establish a formulary of medicinal drug products and dispensing procedures which shall be used by a pharmacist
when ordering and dispensing such drug products to the public. Dispensing procedures may include matters related
to reception of patient, description of his or her condition, patient interview, patient physician referral, product selection, and dispensing and use limitations. In developing the formulary of medicinal drug products, the committee
may include products falling within the following categories:
(a) Any medicinal drug of single or multiple active ingredients in any strengths when such active ingredients have
been approved individually or in combination for over-the-counter sale by the United States Food and Drug Administration.
(b) Any medicinal drug recommended by the United States Food and Drug Administration Advisory Panel for transfer to over-the-counter status pending approval by the United States Food and Drug Administration.
(c) Any medicinal drug containing any antihistamine or decongestant as a single active ingredient or in combination.
(d) Any medicinal drug containing fluoride in any strength.
(e) Any medicinal drug containing lindane in any strength.
(f) Any over-the-counter proprietary drug under federal law that has been approved for reimbursement by the Florida Medicaid Program.
(g) Any topical anti-infectives excluding eye and ear topical anti-infectives. However, any drug which is sold as an
over-the-counter proprietary drug under federal law shall not be included in the formulary or otherwise affected by
this section.
(2)The Board of Pharmacy, the Board of Medicine, and the Board of Osteopathic Medicine shall adopt by rule a formulary of medicinal drugs and dispensing procedures as established by the committee. A pharmacist may order and
dispense a product from the formulary pursuant to the established dispensing procedure, as adopted by the boards,
for each drug in conjunction with its inclusion in the formulary. Any drug product ordered by a pharmacist shall be
selected and dispensed only by the pharmacist so ordering, and said order shall not be refilled, nor shall another medicinal drug be ordered for the same condition unless such act is consistent with dispensing procedures established
by the committee. Appropriate referral to another health care provider is indicated under such circumstances. On
each occasion of such dispensing, the pharmacist shall create and maintain a prescription record in the form required by law.
(3)Affixed to the container containing a medicinal drug dispensed pursuant to this section shall be a label bearing
the following information:
(a) The name of the pharmacist ordering the medication.
(b) The name and address of the pharmacy from which the medication was dispensed.
(c) The date of dispensing.
(d) The order number or other identification adequate to readily identify the order.
(e) The name of the patient for whom the medicinal drug was ordered.
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(f) The directions for use of the medicinal drug ordered.
(g) A clear, concise statement that the order may not be refilled.
(4) Any pharmacist performing the services authorized by this section shall be eligible for reimbursement by third
party prescription programs when so provided by contract or when otherwise provided by such program.
(5) Any person ordering or dispensing medicinal drugs in violation of this section shall be guilty of a misdemeanor of
the first degree, and such violation shall be punishable as provided in s. 775.082 or s. 775.083.
To avoid abuses in audits of pharmacies by state Medicaid, the Florida Legislature has established provisions that guard
against problems that have occurred in the past.
465.188 Medicaid audits of pharmacies.-(1) Notwithstanding any other law, when an audit of the Medicaid-related records of a pharmacy licensed under
chapter 465 is conducted, such audit must be conducted as provided in this section.
(a) The agency conducting the audit must give the pharmacist at least 1 week's prior notice of the initial audit for
each audit cycle.
(b) An audit must be conducted by a pharmacist licensed in this state.
(c) Any clerical or recordkeeping error, such as a typographical error, scrivener's error, or computer error regarding a document or record required under the Medicaid program does not constitute a willful violation and is not subject to criminal penalties without proof of intent to commit fraud.
(d) A pharmacist may use the physician's record or other order for drugs or medicinal supplies written or transmitted
by any means of communication for purposes of validating the pharmacy record with respect to orders or refills of a
legend or narcotic drug.
(e) A finding of an overpayment or underpayment must be based on the actual overpayment or underpayment and
may not be a projection based on the number of patients served having a similar diagnosis or on the number of similar orders or refills for similar drugs.
(f) Each pharmacy shall be audited under the same standards and parameters.
(g) A pharmacist must be allowed at least 10 days in which to produce documentation to address any discrepancy
found during an audit.
(h) The period covered by an audit may not exceed 1 calendar year.
(i) An audit may not be scheduled during the first 5 days of any month due to the high volume of prescriptions filled
during that time.
(j) The audit report must be delivered to the pharmacist within 90 days after conclusion of the audit. A final audit report shall be delivered to the pharmacist within 6 months after receipt of the preliminary audit report or final appeal,
as provided for in subsection (2), whichever is later.
(k) The audit criteria set forth in this section applies only to audits of claims submitted for payment subsequent to July 11, 2003. Notwithstanding any other provision in this section, the agency conducting the audit shall not use the
accounting practice of extrapolation in calculating penalties for Medicaid audits.
(2) The Agency for Health Care Administration shall establish a process under which a pharmacist may obtain a preliminary review of an audit report and may appeal an unfavorable audit report without the necessity of obtaining legal counsel. The preliminary review and appeal may be conducted by an ad hoc peer review panel, appointed by the
agency, which consists of pharmacists who maintain an active practice. If, following the preliminary review, the
agency or review panel finds that an unfavorable audit report is unsubstantiated, the agency shall dismiss the audit
report without the necessity of any further proceedings.
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(3) This section does not apply to investigative audits conducted by the Medicaid Fraud Control Unit of the Department of Legal Affairs.
(4) This section does not apply to any investigative audit conducted by the Agency for Health Care Administration
when the agency has reliable evidence that the claim that is the subject of the audit involves fraud, willful misrepresentation, or abuse under the Medicaid program.
Florida pharmacists may administer influenza immunizations, subject to specific requirements.
465.189 Administration of influenza virus immunizations.-(1)Pharmacists may administer influenza virus immunizations to adults within the framework of an established protocol under a supervisory practitioner who is a physician licensed under chapter 458 or chapter 459. Each protocol
shall contain specific procedures for addressing any unforeseen allergic reaction to influenza virus immunizations.
(2) A pharmacist may not enter into a protocol unless he or she maintains at least $200,000 of professional liability
insurance and has completed training in influenza virus immunizations as provided in this section.
(3) A pharmacist administering influenza virus immunizations shall maintain and make available patient records using the same standards for confidentiality and maintenance of such records as those that are imposed on health care
practitioners under s. 456.057. These records shall be maintained for a minimum of 5 years.
(4) The decision by a supervisory practitioner to enter into a protocol under this section is a professional decision on
the part of the practitioner, and a person may not interfere with a supervisory practitioner's decision as to entering
into such a protocol. A pharmacist may not enter into a protocol that is to be performed while acting as an employee
without the written approval of the owner of the pharmacy. Pharmacists shall forward immunization records to the
department for inclusion in the state registry of immunization information.
(5) Any pharmacist seeking to administer influenza virus immunizations to adults under this section must be certified
to administer influenza virus immunizations pursuant to a certification program approved by the Board of Pharmacy
in consultation with the Board of Medicine and the Board of Osteopathic Medicine. The certification program shall,
at a minimum, require that the pharmacist attend at least 20 hours of continuing education classes approved by the
board. The program shall have a curriculum of instruction concerning the safe and effective administration of influenza virus immunizations, including, but not limited to, potential allergic reactions to influenza virus immunizations.
(6) The written protocol between the pharmacist and supervising physician must include particular terms and conditions imposed by the supervising physician upon the pharmacist relating to the administration of influenza virus immunizations by the pharmacist. The written protocol shall include, at a minimum, specific categories and conditions
among patients for whom the supervising physician authorizes the pharmacist to administer influenza virus immunizations. The terms, scope, and conditions set forth in the written protocol between the pharmacist and the supervising
physician must be appropriate to the pharmacist's training and certification for immunization. Pharmacists who have
been delegated the authority to administer influenza virus immunizations by the supervising physician shall provide
evidence of current certification by the Board of Pharmacy to the supervising physician. Supervising physicians shall
review the administration of influenza virus immunizations by the pharmacists under such physician's supervision
pursuant to the written protocol, and this review shall take place as outlined in the written protocol. The process and
schedule for the review shall be outlined in the written protocol between the pharmacist and the supervising physician.
(7) The pharmacist shall submit to the Board of Pharmacy a copy of his or her protocol or written agreement to administer influenza virus immunizations.
465.1901 Practice of orthotics and pedorthics.--The provisions of chapter 468 relating to orthotics or pedorthics do
not apply to any licensed pharmacist or to any person acting under the supervision of a licensed pharmacist. The
practice of orthotics or pedorthics by a pharmacist or any of the pharmacist's employees acting under the supervision of a pharmacist shall be construed to be within the meaning of the term "practice of the profession of pharmacy"
as set forth in s. 465.003(13), and shall be subject to regulation in the same manner as any other pharmacy practice.
The Board of Pharmacy shall develop rules regarding the practice of orthotics and pedorthics by a pharmacist. Any
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pharmacist or person under the supervision of a pharmacist engaged in the practice of orthotics or pedorthics is not
precluded from continuing that practice pending adoption of these rules.
G.
Florida Controlled Substance Laws
Although the schedules of controlled substances under Florida law generally parallel those under federal law, Soma
(carisoprodol) is classified as C-IV in Florida. There are several other differences worth noting.
893.04 Pharmacist and practitioner.-(1) A pharmacist, in good faith and in the course of professional practice only, may dispense controlled substances
upon a written or oral prescription of a practitioner, under the following conditions:
(a) Oral prescriptions must be promptly reduced to writing by the pharmacist or recorded electronically if permitted
by federal law.
(b) The written prescription must be dated and signed by the prescribing practitioner on the day when issued.
(c) There shall appear on the face of the prescription or written record thereof for the controlled substance the following information:
1. The full name and address of the person for whom, or the owner of the animal for which, the controlled substance
is dispensed.
2. The full name and address of the prescribing practitioner and the practitioner's federal controlled substance registry number shall be printed thereon.
3. If the prescription is for an animal, the species of animal for which the controlled substance is prescribed.
4. The name of the controlled substance prescribed and the strength, quantity, and directions for use thereof.
5. The number of the prescription, as recorded in the prescription files of the pharmacy in which it is filled.
6. The initials of the pharmacist filling the prescription and the date filled.
(d) The prescription shall be retained on file by the proprietor of the pharmacy in which it is filled for a period of 2
years.
(e) Affixed to the original container in which a controlled substance is delivered upon a prescription or authorized
refill thereof, as hereinafter provided, there shall be a label bearing the following information:
1. The name and address of the pharmacy from which such controlled substance was dispensed.
2. The date on which the prescription for such controlled substance was filled.
3. The number of such prescription, as recorded in the prescription files of the pharmacy in which it is filled.
4. The name of the prescribing practitioner.
5. The name of the patient for whom, or of the owner and species of the animal for which, the controlled substance is
prescribed.
6. The directions for the use of the controlled substance prescribed in the prescription.
7. A clear, concise warning that it is a crime to transfer the controlled substance to any person other than the patient
for whom prescribed.
(f) A prescription for a controlled substance listed in Schedule II may be dispensed only upon a written prescription
of a practitioner, except that in an emergency situation, as defined by regulation of the Department of Health, such
controlled substance may be dispensed upon oral prescription but is limited to a 72-hour supply. A prescription for a
controlled substance listed in Schedule II may not be refilled.
(g) A prescription for a controlled substance listed in Schedule III, Schedule IV, or Schedule V may not be filled or
refilled more than five times within a period of 6 months after the date on which the prescription was written unless
the prescription is renewed by a practitioner.
(2)(a) A pharmacist may not dispense a controlled substance listed in Schedule II, Schedule III, or Schedule IV to any
patient or patient's agent without first determining, in the exercise of her or his professional judgment, that the order
is valid. The pharmacist may dispense the controlled substance, in the exercise of her or his professional judgment,
when the pharmacist or pharmacist's agent has obtained satisfactory patient information from the patient or the patient's agent.
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(b) Any pharmacist who dispenses by mail a controlled substance listed in Schedule II, Schedule III, or Schedule IV
is exempt from the requirement to obtain suitable identification for the prescription dispensed by mail if the pharmacist has obtained the patient's identification through the patient's prescription benefit plan.
(c) Any controlled substance listed in Schedule III or Schedule IV may be dispensed by a pharmacist upon an oral
prescription if, before filling the prescription, the pharmacist reduces it to writing or records the prescription electronically if permitted by federal law. Such prescriptions must contain the date of the oral authorization.
(d) Each written prescription prescribed by a practitioner in this state for a controlled substance listed in Schedule
II, Schedule III, or Schedule IV must include both a written and a numerical notation of the quantity of the controlled
substance prescribed on the face of the prescription and a notation of the date, with the abbreviated month written
out on the face of the prescription. A pharmacist may, upon verification by the prescriber, document any information
required by this paragraph. If the prescriber is not available to verify a prescription, the pharmacist may dispense
the controlled substance but may insist that the person to whom the controlled substance is dispensed provide valid
photographic identification. If a prescription includes a numerical notation of the quantity of the controlled substance or date, but does not include the quantity or date written out in textual format, the pharmacist may dispense
the controlled substance without verification by the prescriber of the quantity or date if the pharmacy previously dispensed another prescription for the person to whom the prescription was written.
Note that an oral prescription for a Schedule III substance can not be dispensed for more than a 30-day supply.
(e) A pharmacist may not dispense more than a 30-day supply of a controlled substance listed in Schedule III upon
an oral prescription issued in this state.
(f) A pharmacist may not knowingly fill a prescription that has been forged for a controlled substance listed in
Schedule II, Schedule III, or Schedule IV.
(3) Notwithstanding subsection (1), a pharmacist may dispense a one-time emergency refill of up to a 72-hour supply
of the prescribed medication for any medicinal drug other than a medicinal drug listed in Schedule II, in compliance
with the provisions of s. 465.0275.
(4) The legal owner of any stock of controlled substances in a pharmacy, upon discontinuance of dealing in controlled substances, may sell said stock to a manufacturer, wholesaler, or pharmacy. Such controlled substances may
be sold only upon an order form, when such an order form is required for sale by the drug abuse laws of the United
States or this state, or regulations pursuant thereto.
1893.055
Prescription drug monitoring program.-(1) As used in this section, the term:
(a) "Patient advisory report" or "advisory report" means information provided by the department in writing, or as
determined by the department, to a prescriber, dispenser, pharmacy, or patient concerning the dispensing of controlled substances. All advisory reports are for informational purposes only and impose no obligations of any nature
or any legal duty on a prescriber, dispenser, pharmacy, or patient. The patient advisory report shall be provided in
accordance with s. 893.13(7)(a)8. The advisory reports issued by the department are not subject to discovery or introduction into evidence in any civil or administrative action against a prescriber, dispenser, pharmacy, or patient
arising out of matters that are the subject of the report; and a person who participates in preparing, reviewing, issuing, or any other activity related to an advisory report may not be permitted or required to testify in any such civil
action as to any findings, recommendations, evaluations, opinions, or other actions taken in connection with preparing, reviewing, or issuing such a report.
(b) "Controlled substance" means a controlled substance listed in Schedule II, Schedule III, or Schedule IV in s.
893.03.
(c) "Dispenser" means a pharmacy, dispensing pharmacist, or dispensing health care practitioner.
(d) "Health care practitioner" or "practitioner" means any practitioner who is subject to licensure or regulation by
the department under chapter 458, chapter 459, chapter 461, chapter 462, chapter 464, chapter 465, or chapter 466.
(e) "Health care regulatory board" means any board for a practitioner or health care practitioner who is licensed or
regulated by the department.
(f) "Pharmacy" means any pharmacy that is subject to licensure or regulation by the department under chapter 465
and that dispenses or delivers a controlled substance to an individual or address in this state.
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(g) "Prescriber" means a prescribing physician, prescribing practitioner, or other prescribing health care practitioner.
(h) "Active investigation" means an investigation that is being conducted with a reasonable, good faith belief that it
could lead to the filing of administrative, civil, or criminal proceedings, or that is ongoing and continuing and for
which there is a reasonable, good faith anticipation of securing an arrest or prosecution in the foreseeable future.
(i) "Law enforcement agency" means the Department of Law Enforcement, a Florida sheriff's department, a Florida
police department, or a law enforcement agency of the Federal Government which enforces the laws of this state or
the United States relating to controlled substances, and which its agents and officers are empowered by law to conduct criminal investigations and make arrests.
(2)(a) By December 1, 2010, the department shall design and establish a comprehensive electronic database system
that has controlled substance prescriptions provided to it and that provides prescription information to a patient's
health care practitioner and pharmacist who inform the department that they wish the patient advisory report provided to them. Otherwise, the patient advisory report will not be sent to the practitioner, pharmacy, or pharmacist. The
system shall be designed to provide information regarding dispensed prescriptions of controlled substances and shall
not infringe upon the legitimate prescribing or dispensing of a controlled substance by a prescriber or dispenser acting in good faith and in the course of professional practice. The system shall be consistent with standards of the
American Society for Automation in Pharmacy (ASAP). The electronic system shall also comply with the Health Insurance Portability and Accountability Act (HIPAA) as it pertains to protected health information (PHI), electronic
protected health information (EPHI), and all other relevant state and federal privacy and security laws and regulations. The department shall establish policies and procedures as appropriate regarding the reporting, accessing the
database, evaluation, management, development, implementation, operation, storage, and security of information
within the system. The reporting of prescribed controlled substances shall include a dispensing transaction with a
dispenser pursuant to chapter 465 or through a dispensing transaction to an individual or address in this state with a
pharmacy that is not located in this state but that is otherwise subject to the jurisdiction of this state as to that dispensing transaction. The reporting of patient advisory reports refers only to reports to patients, pharmacies, and
practitioners. Separate reports that contain patient prescription history information and that are not patient advisory
reports are provided to persons and entities as authorized in paragraphs (7)(b) and (c) and s. 893.0551.
(b) The department, when the direct support organization receives at least $20,000 in nonstate moneys or the state
receives at least $20,000 in federal grants for the prescription drug monitoring program, and in consultation with the
Office of Drug Control, shall adopt rules as necessary concerning the reporting, accessing the database, evaluation,
management, development, implementation, operation, security, and storage of information within the system, including rules for when patient advisory reports are provided to pharmacies and prescribers. The patient advisory report
shall be provided in accordance with s. 893.13(7)(a)8. The department shall work with the professional health care
licensure boards, such as the Board of Medicine, the Board of Osteopathic Medicine, and the Board of Pharmacy;
other appropriate organizations, such as the Florida Pharmacy Association, the Office of Drug Control, the Florida
Medical Association, the Florida Retail Federation, and the Florida Osteopathic Medical Association, including
those relating to pain management; and the Attorney General, the Department of Law Enforcement, and the Agency
for Health Care Administration to develop rules appropriate for the prescription drug monitoring program.
(c) All dispensers and prescribers subject to these reporting requirements shall be notified by the department of the
implementation date for such reporting requirements.
(3) The pharmacy dispensing the controlled substance and each prescriber who directly dispenses a controlled substance shall submit to the electronic system, by a procedure and in a format established by the department and consistent with an ASAP-approved format, the following information for inclusion in the database:
(a) The name of the prescribing practitioner, the practitioner's federal Drug Enforcement Administration registration
number, the practitioner's National Provider Identification (NPI) or other appropriate identifier, and the date of the
prescription.
(b) The date the prescription was filled and the method of payment, such as cash by an individual, insurance coverage through a third party, or Medicaid payment. This paragraph does not authorize the department to include individual credit card numbers or other account numbers in the database.
(c) The full name, address, and date of birth of the person for whom the prescription was written.
(d) The name, national drug code, quantity, and strength of the controlled substance dispensed.
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(e) The full name, federal Drug Enforcement Administration registration number, and address of the pharmacy or
other location from which the controlled substance was dispensed. If the controlled substance was dispensed by a
practitioner other than a pharmacist, the practitioner's full name, federal Drug Enforcement Administration registration number, and address.
(f) The name of the pharmacy or practitioner, other than a pharmacist, dispensing the controlled substance and the
practitioner's National Provider Identification (NPI).
(g) Other appropriate identifying information as determined by department rule.
(4) Each time a controlled substance is dispensed to an individual, the controlled substance shall be reported to the
department through the system as soon thereafter as possible, but not more than 15 days after the date the controlled
substance is dispensed unless an extension is approved by the department for cause as determined by rule. A dispenser must meet the reporting requirements of this section by providing the required information concerning each controlled substance that it dispensed in a department-approved, secure methodology and format. Such approved
formats may include, but are not limited to, submission via the Internet, on a disc, or by use of regular mail.
(5) When the following acts of dispensing or administering occur, the following are exempt from reporting under this
section for that specific act of dispensing or administration:
(a) A health care practitioner when administering a controlled substance directly to a patient if the amount of the
controlled substance is adequate to treat the patient during that particular treatment session.
(b) A pharmacist or health care practitioner when administering a controlled substance to a patient or resident receiving care as a patient at a hospital, nursing home, ambulatory surgical center, hospice, or intermediate care facility for the developmentally disabled which is licensed in this state.
(c) A practitioner when administering or dispensing a controlled substance in the health care system of the Department of Corrections.
(d) A practitioner when administering a controlled substance in the emergency room of a licensed hospital.
(e) A health care practitioner when administering or dispensing a controlled substance to a person under the age of
16.
(f) A pharmacist or a dispensing practitioner when dispensing a one-time, 72-hour emergency resupply of a controlled substance to a patient.
(6) The department may establish when to suspend and when to resume reporting information during a state-declared or nationally declared disaster.
(7)(a) A practitioner or pharmacist who dispenses a controlled substance must submit the information required by
this section in an electronic or other method in an ASAP format approved by rule of the department unless otherwise
provided in this section. The cost to the dispenser in submitting the information required by this section may not be
material or extraordinary. Costs not considered to be material or extraordinary include, but are not limited to, regular postage, electronic media, regular electronic mail, and facsimile charges.
(b) A pharmacy, prescriber, or dispenser shall have access to information in the prescription drug monitoring program's database which relates to a patient of that pharmacy, prescriber, or dispenser in a manner established by the
department as needed for the purpose of reviewing the patient's controlled substance prescription history. Other access to the program's database shall be limited to the program's manager and to the designated program and support
staff, who may act only at the direction of the program manager or, in the absence of the program manager, as authorized. Access by the program manager or such designated staff is for prescription drug program management only or for management of the program's database and its system in support of the requirements of this section and in
furtherance of the prescription drug monitoring program. Confidential and exempt information in the database shall
be released only as provided in paragraph (c) and s. 893.0551.
(c) The following entities shall not be allowed direct access to information in the prescription drug monitoring program database but may request from the program manager and, when authorized by the program manager, the program manager's program and support staff, information that is confidential and exempt under s. 893.0551. Prior to
release, the request shall be verified as authentic and authorized with the requesting organization by the program
manager, the program manager's program and support staff, or as determined in rules by the department as being
authentic and as having been authorized by the requesting entity:
1. The department or its relevant health care regulatory boards responsible for the licensure, regulation, or discipline of practitioners, pharmacists, or other persons who are authorized to prescribe, administer, or dispense con-
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trolled substances and who are involved in a specific controlled substance investigation involving a designated
person for one or more prescribed controlled substances.
2. The Attorney General for Medicaid fraud cases involving prescribed controlled substances.
3. A law enforcement agency during active investigations regarding potential criminal activity, fraud, or theft regarding prescribed controlled substances.
4. A patient or the legal guardian or designated health care surrogate of an incapacitated patient as described in s.
893.0551 who, for the purpose of verifying the accuracy of the database information, submits a written and notarized
request that includes the patient's full name, address, and date of birth, and includes the same information if the legal
guardian or health care surrogate submits the request. The request shall be validated by the department to verify the
identity of the patient and the legal guardian or health care surrogate, if the patient's legal guardian or health care
surrogate is the requestor. Such verification is also required for any request to change a patient's prescription history or other information related to his or her information in the electronic database.
Information in the database for the electronic prescription drug monitoring system is not discoverable or admissible
in any civil or administrative action, except in an investigation and disciplinary proceeding by the department or the
appropriate regulatory board.
(d) The following entities shall not be allowed direct access to information in the prescription drug monitoring program database but may request from the program manager and, when authorized by the program manager, the program manager's program and support staff, information that contains no identifying information of any patient,
physician, health care practitioner, prescriber, or dispenser and that is not confidential and exempt:
1. Department staff for the purpose of calculating performance measures pursuant to subsection (8).
2. The Program Implementation and Oversight Task Force for its reporting to the Governor, the President of the
Senate, and the Speaker of the House of Representatives regarding the prescription drug monitoring program. This
subparagraph expires July 1, 2012.
(e) All transmissions of data required by this section must comply with relevant state and federal privacy and security
laws and regulations. However, any authorized agency or person under s. 893.0551 receiving such information as
allowed by s. 893.0551 may maintain the information received for up to 24 months before purging it from his or her
records or maintain it for longer than 24 months if the information is pertinent to ongoing health care or an active
law enforcement investigation or prosecution.
(8) To assist in fulfilling program responsibilities, performance measures shall be reported annually to the Governor,
the President of the Senate, and the Speaker of the House of Representatives by the department each December 1,
beginning in 2011. Data that does not contain patient, physician, health care practitioner, prescriber, or dispenser
identifying information may be requested during the year by department employees so that the department may undertake public health care and safety initiatives that take advantage of observed trends. Performance measures may
include, but are not limited to, efforts to achieve the following outcomes:
(a) Reduction of the rate of inappropriate use of prescription drugs through department education and safety efforts.
(b) Reduction of the quantity of pharmaceutical controlled substances obtained by individuals attempting to engage
in fraud and deceit.
(c) Increased coordination among partners participating in the prescription drug monitoring program.
(d) Involvement of stakeholders in achieving improved patient health care and safety and reduction of prescription
drug abuse and prescription drug diversion.
(9) Any person who willfully and knowingly fails to report the dispensing of a controlled substance as required by
this section commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.
(10) All costs incurred by the department in administering the prescription drug monitoring program shall be funded
through federal grants or private funding applied for or received by the state. The department may not commit funds
for the monitoring program without ensuring funding is available. The prescription drug monitoring program and
the implementation thereof are contingent upon receipt of the nonstate funding. The department and state government shall cooperate with the direct-support organization established pursuant to subsection (11) in seeking federal
grant funds, other nonstate grant funds, gifts, donations, or other private moneys for the department so long as the
costs of doing so are not considered material. Nonmaterial costs for this purpose include, but are not limited to, the
costs of mailing and personnel assigned to research or apply for a grant. Notwithstanding the exemptions to competi-
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tive-solicitation requirements under s. 287.057(5)(f), the department shall comply with the competitive-solicitation
requirements under s. 287.057 for the procurement of any goods or services required by this section.
(11) The Office of Drug Control, in coordination with the department, may establish a direct-support organization
that has a board consisting of at least five members to provide assistance, funding, and promotional support for the
activities authorized for the prescription drug monitoring program.
(a) As used in this subsection, the term "direct-support organization" means an organization that is:
1. A Florida corporation not for profit incorporated under chapter 617, exempted from filing fees, and approved by
the Department of State.
2. Organized and operated to conduct programs and activities; raise funds; request and receive grants, gifts, and
bequests of money; acquire, receive, hold, and invest, in its own name, securities, funds, objects of value, or other
property, either real or personal; and make expenditures or provide funding to or for the direct or indirect benefit of
the department in the furtherance of the prescription drug monitoring program.
(b) The direct-support organization is not considered a lobbying firm within the meaning of s. 11.045.
(c) The director of the Office of Drug Control shall appoint a board of directors for the direct-support organization.
The director may designate employees of the Office of Drug Control, state employees other than state employees
from the department, and any other nonstate employees as appropriate, to serve on the board. Members of the board
shall serve at the pleasure of the director of the Office of Drug Control. The director shall provide guidance to members of the board to ensure that moneys received by the direct-support organization are not received from inappropriate sources. Inappropriate sources include, but are not limited to, donors, grantors, persons, or organizations that
may monetarily or substantively benefit from the purchase of goods or services by the department in furtherance of
the prescription drug monitoring program.
(d) The direct-support organization shall operate under written contract with the Office of Drug Control. The contract must, at a minimum, provide for:
1. Approval of the articles of incorporation and bylaws of the direct-support organization by the Office of Drug Control.
2. Submission of an annual budget for the approval of the Office of Drug Control.
3. Certification by the Office of Drug Control in consultation with the department that the direct-support organization is complying with the terms of the contract in a manner consistent with and in furtherance of the goals and purposes of the prescription drug monitoring program and in the best interests of the state. Such certification must be
made annually and reported in the official minutes of a meeting of the direct-support organization.
4. The reversion, without penalty, to the Office of Drug Control, or to the state if the Office of Drug Control ceases to
exist, of all moneys and property held in trust by the direct-support organization for the benefit of the prescription
drug monitoring program if the direct-support organization ceases to exist or if the contract is terminated.
5. The fiscal year of the direct-support organization, which must begin July 1 of each year and end June 30 of the
following year.
6. The disclosure of the material provisions of the contract to donors of gifts, contributions, or bequests, including
such disclosure on all promotional and fundraising publications, and an explanation to such donors of the distinction
between the Office of Drug Control and the direct-support organization.
7. The direct-support organization's collecting, expending, and providing of funds to the department for the development, implementation, and operation of the prescription drug monitoring program as described in this section and s.
2, chapter 2009-198, Laws of Florida, as long as the task force is authorized. The direct-support organization may
collect and expend funds to be used for the functions of the direct-support organization's board of directors, as necessary and approved by the director of the Office of Drug Control. In addition, the direct-support organization may
collect and provide funding to the department in furtherance of the prescription drug monitoring program by:
a. Establishing and administering the prescription drug monitoring program's electronic database, including hardware and software.
b. Conducting studies on the efficiency and effectiveness of the program to include feasibility studies as described in
subsection (13).
c. Providing funds for future enhancements of the program within the intent of this section.
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d. Providing user training of the prescription drug monitoring program, including distribution of materials to promote public awareness and education and conducting workshops or other meetings, for health care practitioners,
pharmacists, and others as appropriate.
e. Providing funds for travel expenses.
f. Providing funds for administrative costs, including personnel, audits, facilities, and equipment.
g. Fulfilling all other requirements necessary to implement and operate the program as outlined in this section.
(e) The activities of the direct-support organization must be consistent with the goals and mission of the Office of
Drug Control, as determined by the office in consultation with the department, and in the best interests of the state.
The direct-support organization must obtain a written approval from the director of the Office of Drug Control for
any activities in support of the prescription drug monitoring program before undertaking those activities.
(f) The Office of Drug Control, in consultation with the department, may permit, without charge, appropriate use of
administrative services, property, and facilities of the Office of Drug Control and the department by the direct-support organization, subject to this section. The use must be directly in keeping with the approved purposes of the direct-support organization and may not be made at times or places that would unreasonably interfere with
opportunities for the public to use such facilities for established purposes. Any moneys received from rentals of facilities and properties managed by the Office of Drug Control and the department may be held by the Office of Drug
Control or in a separate depository account in the name of the direct-support organization and subject to the provisions of the letter of agreement with the Office of Drug Control. The letter of agreement must provide that any funds
held in the separate depository account in the name of the direct-support organization must revert to the Office of
Drug Control if the direct-support organization is no longer approved by the Office of Drug Control to operate in the
best interests of the state.
(g) The Office of Drug Control, in consultation with the department, may adopt rules under s. 120.54 to govern the
use of administrative services, property, or facilities of the department or office by the direct-support organization.
(h) The Office of Drug Control may not permit the use of any administrative services, property, or facilities of the
state by a direct-support organization if that organization does not provide equal membership and employment opportunities to all persons regardless of race, color, religion, gender, age, or national origin.
(i) The direct-support organization shall provide for an independent annual financial audit in accordance with s.
215.981. Copies of the audit shall be provided to the Office of Drug Control and the Office of Policy and Budget in
the Executive Office of the Governor.
(j) The direct-support organization may not exercise any power under s. 617.0302(12) or (16).
(12) A prescriber or dispenser may have access to the information under this section which relates to a patient of that
prescriber or dispenser as needed for the purpose of reviewing the patient's controlled drug prescription history. A
prescriber or dispenser acting in good faith is immune from any civil, criminal, or administrative liability that might
otherwise be incurred or imposed for receiving or using information from the prescription drug monitoring program.
This subsection does not create a private cause of action, and a person may not recover damages against a prescriber or dispenser authorized to access information under this subsection for accessing or failing to access such information.
(13) To the extent that funding is provided for such purpose through federal or private grants or gifts and other types
of available moneys, the department, in collaboration with the Office of Drug Control, shall study the feasibility of
enhancing the prescription drug monitoring program for the purposes of public health initiatives and statistical reporting that respects the privacy of the patient, the prescriber, and the dispenser. Such a study shall be conducted in
order to further improve the quality of health care services and safety by improving the prescribing and dispensing
practices for prescription drugs, taking advantage of advances in technology, reducing duplicative prescriptions and
the overprescribing of prescription drugs, and reducing drug abuse. The requirements of the National All Schedules
Prescription Electronic Reporting (NASPER) Act are authorized in order to apply for federal NASPER funding. In
addition, the direct-support organization shall provide funding for the department, in collaboration with the Office of
Drug Control, to conduct training for health care practitioners and other appropriate persons in using the monitoring program to support the program enhancements.
(14) A pharmacist, pharmacy, or dispensing health care practitioner or his or her agent, before releasing a controlled substance to any person not known to such dispenser, shall require the person purchasing, receiving, or otherwise acquiring the controlled substance to present valid photographic identification or other verification of his or
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her identity to the dispenser. If the person does not have proper identification, the dispenser may verify the validity of
the prescription and the identity of the patient with the prescriber or his or her authorized agent. Verification of
health plan eligibility through a real-time inquiry or adjudication system will be considered to be proper identification. This subsection does not apply in an institutional setting or to a long-term care facility, including, but not limited to, an assisted living facility or a hospital to which patients are admitted. As used in this subsection, the term
"proper identification" means an identification that is issued by a state or the Federal Government containing the
person's photograph, printed name, and signature or a document considered acceptable under 8 C.F.R. s.
274a.2(b)(1)(v)(A) and (B).
(15) The Agency for Health Care Administration shall continue the promotion of electronic prescribing by health
care practitioners, health care facilities, and pharmacies under s. 408.0611.
(16) By October 1, 2010, the department shall adopt rules pursuant to ss. 120.536(1) and 120.54 to administer the
provisions of this section, which shall include as necessary the reporting, accessing, evaluation, management, development, implementation, operation, and storage of information within the monitoring program's system.
1Note:
"(1) The Program Implementation and Oversight Task Force is created within the Executive Office of the
Governor. The director of the Office of Drug Control shall be a nonvoting, ex officio member of the task
force and shall act as chair. The Office of Drug Control and the Department of Health shall provide staff
support for the task force.
"(a) The following state officials shall serve on the task force:
"1. The Attorney General or his or her designee.
"2. The Secretary of Children and Family Services or his or her designee.
"3. The Secretary of Health Care Administration or his or her designee.
"4. The State Surgeon General or his or her designee.
"(b) In addition, the Governor shall appoint 12 members of the public to serve on the task force. Of these 12
appointed members, one member must have professional or occupational expertise in computer security; one
member must be a Florida-licensed, board-certified oncologist; two members must be Florida-licensed, fellowship-trained, pain-medicine physicians; one member must be a Florida-licensed primary care physician
who has experience in prescribing scheduled prescription drugs; one member must have professional or occupational expertise in e-Prescribing or prescription drug monitoring programs; two members must be . . .
Florida-licensed pharmacists; one member must have professional or occupational expertise in the area of
law enforcement and have experience in prescription drug investigations; one member must have professional or occupational expertise as an epidemiologist and have a background in tracking and analyzing drug
trends; and two members must have professional or occupational expertise as providers of substance abuse
treatment, with priority given to a member who is a former substance abuser.
"(c) Members appointed by the Governor shall be appointed to a term of 3 years each. Any vacancy on the
task force shall be filled in the same manner as the original appointment, and any member appointed to fill a
vacancy shall serve only for the unexpired term of the member's predecessor.
"(d) Members of the task force and members of subcommittees appointed under subsection (4) shall serve
without compensation, but are entitled to reimbursement for per diem and travel expenses as provided in s.
112.061, Florida Statutes.
"(e) The task force shall meet at least quarterly or upon the call of the chair.
"(2) The purpose of the task force is to monitor the implementation and safeguarding of the electronic system
established for the prescription drug monitoring program under s. 893.055, Florida Statutes, and to ensure
privacy, protection of individual medication history, and the electronic system's appropriate use by physicians, dispensers, pharmacies, law enforcement agencies, and those authorized to request information from
the electronic system.
"(3) The Office of Drug Control shall submit a report to the Governor, the President of the Senate, and the
Speaker of the House of Representatives by December 1 of each year which contains a summary of the work
of the task force during that year and the recommendations developed in accordance with the task force's
purpose as provided in subsection (2). Interim reports may be submitted at the discretion of the chair.
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"(4) The chair of the task force may appoint subcommittees that include members of state agencies that are
not represented on the task force for the purpose of soliciting input and recommendations from those state
agencies as needed by the task force to accomplish its purpose as provided in subsection (2). In addition, the
chair may appoint subcommittees as necessary from among the members of the task force in order to efficiently address specific issues. If a state agency is to be represented on any subcommittee, the representative
shall be the head of the agency or his or her designee. The chair may designate lead and contributing agencies within a subcommittee.
"(5) The direct-support organization created in s. 893.055, Florida Statutes, may collect, expend, and provide funds and other assistance to the department for the development, implementation, and operation of the
task force.
"(6) The task force shall provide a final report in accordance with the task force's purpose as provided in
subsection (2) on July 1, 2012, to the Governor, the President of the Senate, and the Speaker of the House of
Representatives. Such report shall be prepared using only data that does not identify a patient, a prescriber,
or a dispenser. The task force shall expire and this section is repealed on that date unless reenacted by the
Legislature."
893.06 Distribution of controlled substances; order forms; labeling and packaging requirements.-(1)Controlled substances in Schedules I and II shall be distributed by a duly licensed manufacturer, distributor, or
wholesaler to a duly licensed manufacturer, wholesaler, distributor, practitioner, pharmacy, as defined in chapter
465, hospital, or laboratory only pursuant to an order form. It shall be deemed a compliance with this subsection if
the parties to the transaction have complied with federal law respecting the use of order forms.
(2)Possession or control of controlled substances obtained as authorized by this section shall be lawful if in the regular course of business, occupation, profession, employment, or duty.
(3) A person in charge of a hospital or laboratory or in the employ of this state or of any other state, or of any political subdivision thereof, and a master or other proper officer of a ship or aircraft, who obtains controlled substances
under the provisions of this section or otherwise, shall not administer, dispense, or otherwise use such controlled
substances within this state, except within the scope of her or his employment or official duty, and then only for scientific or medicinal purposes and subject to the provisions of this chapter.
(4) It shall be unlawful to distribute a controlled substance in a commercial container unless such container bears a
label showing the name and address of the manufacturer, the quantity, kind, and form of controlled substance contained therein, and the identifying symbol for such substance, as required by federal law. No person except a pharmacist, for the purpose of dispensing a prescription, or a practitioner, for the purpose of dispensing a controlled
substance to a patient, shall alter, deface, or remove any labels so affixed.
893.065 Counterfeit-resistant prescription blanks for controlled substances listed in Schedule II, Schedule III, or
Schedule IV.--The Department of Health shall develop and adopt by rule the form and content for a counterfeit-resistant prescription blank which may be used by practitioners for the purpose of prescribing a controlled substance
listed in Schedule II, Schedule III, or Schedule IV. The Department of Health may require the prescription blanks to
be printed on distinctive, watermarked paper and to bear the preprinted name, address, and category of professional
licensure of the practitioner and that practitioner's federal registry number for controlled substances. The prescription blanks may not be transferred.
893.08 Exceptions.-(1) The following may be distributed at retail without a prescription, but only by a registered pharmacist:
(a) Any compound, mixture, or preparation described in Schedule V.
(b) Any compound, mixture, or preparation containing any depressant or stimulant substance described in
s.893.03(2)(a) or (c) except any amphetamine drug or sympathomimetic amine drug or compound designated as a
Schedule II controlled substance pursuant to this chapter; in s. 893.03(3)(a); or in Schedule IV, if:
1.The compound, mixture, or preparation contains one or more active medicinal ingredients not having depressant
or stimulant effect on the central nervous system, and
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2. Such ingredients are included therein in such combinations, quantity, proportion, or concentration as to vitiate the
potential for abuse of the controlled substances which do have a depressant or stimulant effect on the central nervous
system.
(2) No compound, mixture, or preparation may be dispensed under subsection (1) unless such substance may, under
the Federal Food, Drug, and Cosmetic Act, be lawfully sold at retail without a prescription.
(3) The exemptions authorized by this section shall be subject to the following conditions:
(a) The compounds, mixtures, and preparations referred to in subsection (1) may be dispensed to persons under age
18 only on prescription. A bound volume must be maintained as a record of sale at retail of excepted compounds,
mixtures, and preparations, and the pharmacist must require suitable identification from every unknown purchaser.
(b) Such compounds, mixtures, and preparations shall be sold by the pharmacist in good faith as a medicine and not
for the purpose of evading the provisions of this chapter. The pharmacist may, in his or her discretion, withhold sale
to any person whom the pharmacist reasonably believes is attempting to purchase excepted compounds, mixtures, or
preparations for the purpose of abuse.
Note that the quantity limits for non-prescription sale of cough syrups and anti-diarrheals in Florida are half those
under federal law.
(c) The total quantity of controlled substance listed in Schedule V which may be sold to any one purchaser within a
given 48-hour period shall not exceed 120 milligrams of codeine, 60 milligrams dihydrocodeine, 30 milligrams of
ethyl morphine, or 240 milligrams of opium.
(d) Nothing in this section shall be construed to limit the kind and quantity of any controlled substance that may be
prescribed, administered, or dispensed to any person, or for the use of any person or animal, when it is prescribed,
administered, or dispensed in compliance with the general provisions of this chapter.
(4) The dextrorotatory isomer of 3-methoxy-n-methylmorphinan and its salts (dextromethorphan) shall not be
deemed to be included in any schedule by reason of enactment of this chapter.
H.
General Requirements Applicable to Drugs and Health Care
In addition to the Florida Pharmacy Act, there are provisions of other Florida laws that directly impact the practice of
pharmacy. These laws are enforceable by the Board of Pharmacy.
In Florida, nurse practitioners and physician assistants may prescribe drugs that are not controlled substances. When dispensing prescriptions from these prescribers, the prescriber’s identity should be on the label, and not the identity of a supervising
physician.
456.0392 Prescription labeling.-(1) A prescription written by a practitioner who is authorized under the laws of this state to write prescriptions for
drugs that are not listed as controlled substances in chapter 893 but who is not eligible for a federal Drug Enforcement Administration number shall include that practitioner's name and professional license number. The pharmacist
or dispensing practitioner must include the practitioner's name on the container of the drug that is dispensed. A
pharmacist shall be permitted, upon verification by the prescriber, to document any information required by this section.
(2) A prescription for a drug that is not listed as a controlled substance in chapter 893 which is written by an advanced registered nurse practitioner certified under s. 464.012 is presumed, subject to rebuttal, to be valid and within the parameters of the prescriptive authority delegated by a practitioner licensed under chapter 458, chapter 459,
or chapter 466.
(3) A prescription for a drug that is not listed as a controlled substance in chapter 893 which is written by a physician assistant licensed under chapter 458 or chapter 459 is presumed, subject to rebuttal, to be valid and within the
parameters of the prescriptive authority delegated by the physician assistant's supervising physician.
All health care providers in Florida who aware of adverse incidents that result in serious harm to a patient must inform the
patient that the incident occurred.
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456.0575 Duty to notify patients.--Every licensed health care practitioner shall inform each patient, or an individual
identified pursuant to s. 765.401(1), in person about adverse incidents that result in serious harm to the patient. Notification of outcomes of care that result in harm to the patient under this section shall not constitute an acknowledgment of admission of liability, nor can such notifications be introduced as evidence.
To reduce errors caused by the misinterpretation of a written prescription, Florida law requires that prescriptions be either
legibly printed or typed, and that the quantity and date be specified in textual and numerical format.
456.42 Written prescriptions for medicinal drugs.--A written prescription for a medicinal drug issued by a health
care practitioner licensed by law to prescribe such drug must be legibly printed or typed so as to be capable of being
understood by the pharmacist filling the prescription; must contain the name of the prescribing practitioner, the
name and strength of the drug prescribed, the quantity of the drug prescribed, and the directions for use of the drug;
must be dated; and must be signed by the prescribing practitioner on the day when issued. A written prescription for
a controlled substance listed in chapter 893 must have the quantity of the drug prescribed in both textual and numerical formats and must be dated with the abbreviated month written out on the face of the prescription. However, a
prescription that is electronically generated and transmitted must contain the name of the prescribing practitioner,
the name and strength of the drug prescribed, the quantity of the drug prescribed in numerical format, and the directions for use of the drug and must be dated and signed by the prescribing practitioner only on the day issued, which
signature may be in an electronic format as defined in s. 668.003(4).
Note the acts that could lead to discipline for health care professionals, including pharmacists.
456.072 Grounds for discipline; penalties; enforcement.-(1) The following acts shall constitute grounds for which the disciplinary actions specified in subsection (2) may be
taken:
(a) Making misleading, deceptive, or fraudulent representations in or related to the practice of the licensee's profession.
(b) Intentionally violating any rule adopted by the board or the department, as appropriate.
(c) Being convicted or found guilty of, or entering a plea of guilty or nolo contendere to, regardless of adjudication,
a crime in any jurisdiction which relates to the practice of, or the ability to practice, a licensee's profession.
(d) Using a Class III or a Class IV laser device or product, as defined by federal regulations, without having complied with the rules adopted under s. 501.122(2) governing the registration of the devices.
(e) Failing to comply with the educational course requirements for human immunodeficiency virus and acquired immune deficiency syndrome.
(f) Having a license or the authority to practice any regulated profession revoked, suspended, or otherwise acted
against, including the denial of licensure, by the licensing authority of any jurisdiction, including its agencies or subdivisions, for a violation that would constitute a violation under Florida law. The licensing authority's acceptance of
a relinquishment of licensure, stipulation, consent order, or other settlement, offered in response to or in anticipation
of the filing of charges against the license, shall be construed as action against the license.
(g) Having been found liable in a civil proceeding for knowingly filing a false report or complaint with the department against another licensee.
(h) Attempting to obtain, obtaining, or renewing a license to practice a profession by bribery, by fraudulent misrepresentation, or through an error of the department or the board.
(i) Except as provided in s. 465.016, failing to report to the department any person who the licensee knows is in violation of this chapter, the chapter regulating the alleged violator, or the rules of the department or the board.
(j) Aiding, assisting, procuring, employing, or advising any unlicensed person or entity to practice a profession contrary to this chapter, the chapter regulating the profession, or the rules of the department or the board.
(k) Failing to perform any statutory or legal obligation placed upon a licensee. For purposes of this section, failing
to repay a student loan issued or guaranteed by the state or the Federal Government in accordance with the terms of
the loan or failing to comply with service scholarship obligations shall be considered a failure to perform a statutory
or legal obligation, and the minimum disciplinary action imposed shall be a suspension of the license until new pay185
ment terms are agreed upon or the scholarship obligation is resumed, followed by probation for the duration of the
student loan or remaining scholarship obligation period, and a fine equal to 10 percent of the defaulted loan amount.
Fines collected shall be deposited into the Medical Quality Assurance Trust Fund.
(l) Making or filing a report which the licensee knows to be false, intentionally or negligently failing to file a report
or record required by state or federal law, or willfully impeding or obstructing another person to do so. Such reports
or records shall include only those that are signed in the capacity of a licensee.
(m) Making deceptive, untrue, or fraudulent representations in or related to the practice of a profession or employing
a trick or scheme in or related to the practice of a profession.
(n) Exercising influence on the patient or client for the purpose of financial gain of the licensee or a third party.
(o) Practicing or offering to practice beyond the scope permitted by law or accepting and performing professional
responsibilities the licensee knows, or has reason to know, the licensee is not competent to perform.
(p) Delegating or contracting for the performance of professional responsibilities by a person when the licensee delegating or contracting for performance of the responsibilities knows, or has reason to know, the person is not qualified by training, experience, and authorization when required to perform them.
(q) Violating a lawful order of the department or the board, or failing to comply with a lawfully issued subpoena of
the department.
(r) Improperly interfering with an investigation or inspection authorized by statute, or with any disciplinary proceeding.
(s) Failing to comply with the educational course requirements for domestic violence.
(t) Failing to identify through written notice, which may include the wearing of a name tag, or orally to a patient the
type of license under which the practitioner is practicing. Any advertisement for health care services naming the
practitioner must identify the type of license the practitioner holds. This paragraph does not apply to a practitioner
while the practitioner is providing services in a facility licensed under chapter 394, chapter 395, chapter 400, or
chapter 429. Each board, or the department where there is no board, is authorized by rule to determine how its practitioners may comply with this disclosure requirement.
(u) Failing to comply with the requirements of ss. 381.026 and 381.0261 to provide patients with information about
their patient rights and how to file a patient complaint.
(v) Engaging or attempting to engage in sexual misconduct as defined and prohibited in s. 456.063(1).
(w) Failing to comply with the requirements for profiling and credentialing, including, but not limited to, failing to
provide initial information, failing to timely provide updated information, or making misleading, untrue, deceptive,
or fraudulent representations on a profile, credentialing, or initial or renewal licensure application.
(x) Failing to report to the board, or the department if there is no board, in writing within 30 days after the licensee
has been convicted or found guilty of, or entered a plea of nolo contendere to, regardless of adjudication, a crime in
any jurisdiction. Convictions, findings, adjudications, and pleas entered into prior to the enactment of this paragraph
must be reported in writing to the board, or department if there is no board, on or before October 1, 1999.
(y) Using information about people involved in motor vehicle accidents which has been derived from accident reports
made by law enforcement officers or persons involved in accidents under s. 316.066, or using information published
in a newspaper or other news publication or through a radio or television broadcast that has used information
gained from such reports, for the purposes of commercial or any other solicitation whatsoever of the people involved
in the accidents.
(z) Being unable to practice with reasonable skill and safety to patients by reason of illness or use of alcohol, drugs,
narcotics, chemicals, or any other type of material or as a result of any mental or physical condition. In enforcing
this paragraph, the department shall have, upon a finding of the State Surgeon General or the State Surgeon General's designee that probable cause exists to believe that the licensee is unable to practice because of the reasons stated
in this paragraph, the authority to issue an order to compel a licensee to submit to a mental or physical examination
by physicians designated by the department. If the licensee refuses to comply with the order, the department's order
directing the examination may be enforced by filing a petition for enforcement in the circuit court where the licensee
resides or does business. The department shall be entitled to the summary procedure provided in s. 51.011. A licensee or certificateholder affected under this paragraph shall at reasonable intervals be afforded an opportunity to demonstrate that he or she can resume the competent practice of his or her profession with reasonable skill and safety to
patients.
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(aa) Testing positive for any drug, as defined in s. 112.0455, on any confirmed preemployment or employer-ordered
drug screening when the practitioner does not have a lawful prescription and legitimate medical reason for using the
drug.
(bb) Performing or attempting to perform health care services on the wrong patient, a wrong-site procedure, a
wrong procedure, or an unauthorized procedure or a procedure that is medically unnecessary or otherwise unrelated
to the patient's diagnosis or medical condition. For the purposes of this paragraph, performing or attempting to perform health care services includes the preparation of the patient.
(cc) Leaving a foreign body in a patient, such as a sponge, clamp, forceps, surgical needle, or other paraphernalia
commonly used in surgical, examination, or other diagnostic procedures. For the purposes of this paragraph, it shall
be legally presumed that retention of a foreign body is not in the best interest of the patient and is not within the standard of care of the profession, regardless of the intent of the professional.
(dd) Violating any provision of this chapter, the applicable practice act, or any rules adopted pursuant thereto.
(ee) With respect to making a personal injury protection claim as required by s. 627.736, intentionally submitting a
claim, statement, or bill that has been "upcoded" as defined in s. 627.732.
(ff) With respect to making a personal injury protection claim as required by s. 627.736, intentionally submitting a
claim, statement, or bill for payment of services that were not rendered.
(gg) Engaging in a pattern of practice when prescribing medicinal drugs or controlled substances which demonstrates a lack of reasonable skill or safety to patients, a violation of any provision of this chapter, a violation of the
applicable practice act, or a violation of any rules adopted under this chapter or the applicable practice act of the
prescribing practitioner. Notwithstanding s. 456.073(13), the department may initiate an investigation and establish
such a pattern from billing records, data, or any other information obtained by the department.
(hh) Being terminated from a treatment program for impaired practitioners, which is overseen by an impaired practitioner consultant as described in s. 456.076, for failure to comply, without good cause, with the terms of the monitoring or treatment contract entered into by the licensee, or for not successfully completing any drug treatment or
alcohol treatment program.
(ii) Being convicted of, or entering a plea of guilty or nolo contendere to, any misdemeanor or felony, regardless of
adjudication, under 18 U.S.C. s. 669, ss. 285-287, s. 371, s. 1001, s. 1035, s. 1341, s. 1343, s. 1347, s. 1349, or s.
1518, or 42 U.S.C. ss. 1320a-7b, relating to the Medicaid program.
(jj) Failing to remit the sum owed to the state for an overpayment from the Medicaid program pursuant to a final order, judgment, or stipulation or settlement.
(kk) Being terminated from the state Medicaid program pursuant to s. 409.913, any other state Medicaid program, or
the federal Medicare program, unless eligibility to participate in the program from which the practitioner was terminated has been restored.
(ll) Being convicted of, or entering a plea of guilty or nolo contendere to, any misdemeanor or felony, regardless of
adjudication, a crime in any jurisdiction which relates to health care fraud.
(2) When the board, or the department when there is no board, finds any person guilty of the grounds set forth in
subsection (1) or of any grounds set forth in the applicable practice act, including conduct constituting a substantial
violation of subsection (1) or a violation of the applicable practice act which occurred prior to obtaining a license, it
may enter an order imposing one or more of the following penalties:
(a) Refusal to certify, or to certify with restrictions, an application for a license.
(b) Suspension or permanent revocation of a license.
(c) Restriction of practice or license, including, but not limited to, restricting the licensee from practicing in certain
settings, restricting the licensee to work only under designated conditions or in certain settings, restricting the licensee from performing or providing designated clinical and administrative services, restricting the licensee from practicing more than a designated number of hours, or any other restriction found to be necessary for the protection of
the public health, safety, and welfare.
(d) Imposition of an administrative fine not to exceed $10,000 for each count or separate offense. If the violation is
for fraud or making a false or fraudulent representation, the board, or the department if there is no board, must impose a fine of $10,000 per count or offense.
(e) Issuance of a reprimand or letter of concern.
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(f) Placement of the licensee on probation for a period of time and subject to such conditions as the board, or the department when there is no board, may specify. Those conditions may include, but are not limited to, requiring the licensee to undergo treatment, attend continuing education courses, submit to be reexamined, work under the
supervision of another licensee, or satisfy any terms which are reasonably tailored to the violations found.
(g) Corrective action.
(h) Imposition of an administrative fine in accordance with s. 381.0261 for violations regarding patient rights.
(i) Refund of fees billed and collected from the patient or a third party on behalf of the patient.
(j) Requirement that the practitioner undergo remedial education.
In determining what action is appropriate, the board, or department when there is no board, must first consider what
sanctions are necessary to protect the public or to compensate the patient. Only after those sanctions have been imposed may the disciplining authority consider and include in the order requirements designed to rehabilitate the
practitioner. All costs associated with compliance with orders issued under this subsection are the obligation of the
practitioner.
(3)(a) Notwithstanding subsection (2), if the ground for disciplinary action is the first-time failure of the licensee to
satisfy continuing education requirements established by the board, or by the department if there is no board, the
board or department, as applicable, shall issue a citation in accordance with s. 456.077 and assess a fine, as determined by the board or department by rule. In addition, for each hour of continuing education not completed or completed late, the board or department, as applicable, may require the licensee to take 1 additional hour of continuing
education for each hour not completed or completed late.
(b) Notwithstanding subsection (2), if the ground for disciplinary action is the first-time violation of a practice act for
unprofessional conduct, as used in ss. 464.018(1)(h), 467.203(1)(f), 468.365(1)(f), and 478.52(1)(f), and no actual
harm to the patient occurred, the board or department, as applicable, shall issue a citation in accordance with s.
456.077 and assess a penalty as determined by rule of the board or department.
(4) In addition to any other discipline imposed through final order, or citation, entered on or after July 1, 2001, under this section or discipline imposed through final order, or citation, entered on or after July 1, 2001, for a violation
of any practice act, the board, or the department when there is no board, shall assess costs related to the investigation and prosecution of the case. The costs related to the investigation and prosecution include, but are not limited to,
salaries and benefits of personnel, costs related to the time spent by the attorney and other personnel working on the
case, and any other expenses incurred by the department for the case. The board, or the department when there is no
board, shall determine the amount of costs to be assessed after its consideration of an affidavit of itemized costs and
any written objections thereto. In any case where the board or the department imposes a fine or assessment and the
fine or assessment is not paid within a reasonable time, the reasonable time to be prescribed in the rules of the
board, or the department when there is no board, or in the order assessing the fines or costs, the department or the
Department of Legal Affairs may contract for the collection of, or bring a civil action to recover, the fine or assessment.
(5) In addition to, or in lieu of, any other remedy or criminal prosecution, the department may file a proceeding in
the name of the state seeking issuance of an injunction or a writ of mandamus against any person who violates any of
the provisions of this chapter, or any provision of law with respect to professions regulated by the department, or any
board therein, or the rules adopted pursuant thereto.
(6) If the board, or the department when there is no board, determines that revocation of a license is the appropriate
penalty, the revocation shall be permanent. However, the board may establish by rule requirements for reapplication
by applicants whose licenses have been permanently revoked. The requirements may include, but are not limited to,
satisfying current requirements for an initial license.
(7) The purpose of this section is to facilitate uniform discipline for those actions made punishable under this section
and, to this end, a reference to this section constitutes a general reference under the doctrine of incorporation by reference.
456.074 Certain health care practitioners; immediate suspension of license.-(1) The department shall issue an emergency order suspending the license of any person licensed under chapter 458,
chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, chapter 464, chapter 465, chapter 466, or chapter
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484 who pleads guilty to, is convicted or found guilty of, or who enters a plea of nolo contendere to, regardless of
adjudication, to:
(a) A felony under chapter 409, chapter 817, or chapter 893 or under 21 U.S.C. ss. 801-970 or under 42 U.S.C. ss.
1395-1396; or
(b) A misdemeanor or felony under 18 U.S.C. s. 669, ss. 285-287, s. 371, s. 1001, s. 1035, s. 1341, s. 1343, s. 1347, s.
1349, or s. 1518 or 42 U.S.C. ss. 1320a-7b, relating to the Medicaid program.
(2) If the board has previously found any physician or osteopathic physician in violation of the provisions of s.
458.331(1)(t) or s. 459.015(1)(x), in regard to her or his treatment of three or more patients, and the probable cause
panel of the board finds probable cause of an additional violation of that section, then the State Surgeon General
shall review the matter to determine if an emergency suspension or restriction order is warranted. Nothing in this
section shall be construed so as to limit the authority of the State Surgeon General to issue an emergency order.
(3) The department may issue an emergency order suspending or restricting the license of any health care practitioner as defined in s. 456.001(4) who tests positive for any drug on any government or private sector preemployment
or employer-ordered confirmed drug test, as defined in s. 112.0455, when the practitioner does not have a lawful
prescription and legitimate medical reason for using such drug. The practitioner shall be given 48 hours from the
time of notification to the practitioner of the confirmed test result to produce a lawful prescription for the drug before
an emergency order is issued.
(4) Upon receipt of information that a Florida-licensed health care practitioner has defaulted on a student loan issued or guaranteed by the state or the Federal Government, the department shall notify the licensee by certified mail
that he or she shall be subject to immediate suspension of license unless, within 45 days after the date of mailing, the
licensee provides proof that new payment terms have been agreed upon by all parties to the loan. The department
shall issue an emergency order suspending the license of any licensee who, after 45 days following the date of mailing from the department, has failed to provide such proof. Production of such proof shall not prohibit the department
from proceeding with disciplinary action against the licensee pursuant to s. 456.073.
456.076 Treatment programs for impaired practitioners.-(1) For professions that do not have impaired practitioner programs provided for in their practice acts, the department shall, by rule, designate approved impaired practitioner programs under this section. The department may
adopt rules setting forth appropriate criteria for approval of treatment providers. The rules may specify the manner
in which the consultant, retained as set forth in subsection (2), works with the department in intervention, requirements for evaluating and treating a professional, requirements for continued care of impaired professionals by approved treatment providers, continued monitoring by the consultant of the care provided by approved treatment
providers regarding the professionals under their care, and requirements related to the consultant's expulsion of professionals from the program. .....
Under Florida law, there are specific requirements related to the provision of complementary and alternative medicine
(CAM).
456.41 Complementary or alternative health care treatments.-(1)LEGISLATIVE INTENT.--It is the intent of the Legislature that citizens be able to make informed choices for any
type of health care they deem to be an effective option for treating human disease, pain, injury, deformity, or other
physical or mental condition. It is the intent of the Legislature that citizens be able to choose from all health care options, including the prevailing or conventional treatment methods as well as other treatments designed to complement or substitute for the prevailing or conventional treatment methods. It is the intent of the Legislature that health
care practitioners be able to offer complementary or alternative health care treatments with the same requirements,
provisions, and liabilities as those associated with the prevailing or conventional treatment methods.
(2).DEFINITIONS--As used in this section, the term:
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(a)"Complementary or alternative health care treatment" means any treatment that is designed to provide patients
with an effective option to the prevailing or conventional treatment methods associated with the services provided by
a health care practitioner. Such a treatment may be provided in addition to or in place of other treatment options.
(b)"Health care practitioner" means any health care practitioner as defined in s. 456.001(4).
(3)COMMUNICATION OF TREATMENT ALTERNATIVES.--A health care practitioner who offers to provide a patient with a complementary or alternative health care treatment must inform the patient of the nature of the treatment
and must explain the benefits and risks associated with the treatment to the extent necessary for the patient to make
an informed and prudent decision regarding such treatment option. In compliance with this subsection:
(a) The health care practitioner must inform the patient of the practitioner's education, experience, and credentials in
relation to the complementary or alternative health care treatment option.
(b) The health care practitioner may, in his or her discretion, communicate the information orally or in written form
directly to the patient or to the patient's legal representative.
(c) The health care practitioner may, in his or her discretion and without restriction, recommend any mode of treatment that is, in his or her judgment, in the best interests of the patient, including complementary or alternative health
care treatments, in accordance with the provisions of his or her license.
(4) RECORDS.--Every health care practitioner providing a patient with a complementary or alternative health care
treatment must indicate in the patient's care record the method by which the requirements of subsection (3) were met.
(5). EFFECT--This section does not modify or change the scope of practice of any licensees of the department, nor
does it alter in any way the provisions of the individual practice acts for those licensees, which require licensees to
practice within their respective standards of care and which prohibit fraud and exploitation of patients.
Electronic prescription in Florida must meet particular requirements. Otherwise the electronic order is not a prescription and
cannot be filled.
456.43 Electronic prescribing for medicinal drugs.-(1) Electronic prescribing shall not interfere with a patient's freedom to choose a pharmacy.
(2) Electronic prescribing software shall not use any means or permit any other person to use any means, including,
but not limited to, advertising, instant messaging, and pop-up ads, to influence or attempt to influence, through economic incentives or otherwise, the prescribing decision of a prescribing practitioner at the point of care. Such means
shall not be triggered or in specific response to the input, selection, or act of a prescribing practitioner or his or her
agent in prescribing a certain pharmaceutical or directing a patient to a certain pharmacy.
(a) The term "prescribing decision" means a prescribing practitioner's decision to prescribe a certain pharmaceutical.
(b) The term "point of care" means the time that a prescribing practitioner or his or her agent is in the act of prescribing a certain pharmaceutical.
(3) Electronic prescribing software may show information regarding a payor's formulary as long as nothing is designed to preclude or make more difficult the act of a prescribing practitioner or patient selecting any particular
pharmacy or pharmaceutical.
Various health care providers, including pharmacists, are required to complete a course on HIV and AIDS.
456.033 Requirement for instruction for certain licensees on HIV and AIDS.--The following requirements apply to
each person licensed or certified under chapter 457; chapter 458; chapter 459; chapter 460; chapter 461; chapter
463; part I of chapter 464; chapter 465; chapter 466; part II, part III, part V, or part X of chapter 468; or chapter
486:
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(1) Each person shall be required by the appropriate board to complete no later than upon first renewal a continuing
educational course, approved by the board, on human immunodeficiency virus and acquired immune deficiency syndrome as part of biennial relicensure or recertification. The course shall consist of education on the modes of transmission, infection control procedures, clinical management, and prevention of human immunodeficiency virus and
acquired immune deficiency syndrome. Such course shall include information on current Florida law on acquired
immune deficiency syndrome and its impact on testing, confidentiality of test results, treatment of patients, and any
protocols and procedures applicable to human immunodeficiency virus counseling and testing, reporting, the offering of HIV testing to pregnant women, and partner notification issues pursuant to ss. 381.004 and 384.25.
(2) Each person shall submit confirmation of having completed the course required under subsection (1), on a form
as provided by the board, when submitting fees for first renewal.
(3) The board shall have the authority to approve additional equivalent courses that may be used to satisfy the requirements in subsection (1). Each licensing board that requires a licensee to complete an educational course pursuant to this section may count the hours required for completion of the course included in the total continuing
educational requirements as required by law.
(4) Any person holding two or more licenses subject to the provisions of this section shall be permitted to show proof
of having taken one board-approved course on human immunodeficiency virus and acquired immune deficiency syndrome, for purposes of relicensure or recertification for additional licenses.
(5) Failure to comply with the above requirements shall constitute grounds for disciplinary action under each respective licensing chapter and s. 456.072(1)(e). In addition to discipline by the board, the licensee shall be required to
complete the course.
Florida law prevents insurance companies, prescription benefits management firms and other third party payors from employing rules that will impede access by patients to medications if a hurricane or other state of emergency has occurred.
252.358 Emergency-preparedness prescription medication refills.--All health insurers, managed care organizations,
and other entities that are licensed by the Office of Insurance Regulation and provide prescription medication coverage as part of a policy or contract shall waive time restrictions on prescription medication refills, which include suspension of electronic "refill too soon" edits to pharmacies, to enable insureds or subscribers to refill prescriptions in
advance, if there are authorized refills remaining, and shall authorize payment to pharmacies for at least a 30-day
supply of any prescription medication, regardless of the date upon which the prescription had most recently been
filled by a pharmacist, when the following conditions occur:
(1) The person seeking the prescription medication refill resides in a county that:
(a) Is under a hurricane warning issued by the National Weather Service;
(b) Is declared to be under a state of emergency in an executive order issued by the Governor; or
(c) Has activated its emergency operations center and its emergency management plan.
(2) The prescription medication refill is requested within 30 days after the origination date of the conditions stated in
this section or until such conditions are terminated by the issuing authority or no longer exist. The time period for the
waiver of prescription medication refills may be extended in 15- or 30-day increments by emergency orders issued by
the Office of Insurance Regulation.
This section does not excuse or exempt an insured or subscriber from compliance with all other terms of the policy or
contract providing prescription medication coverage.
I.
Florida Drug and Cosmetic Act
The laws regulating drug distribution in Florida generally parallel those of the federal Food, Drug and Cosmetic Act,
and the regulations promulgated by the FDA. However, there are several sections that warrant particular attention.
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Florida has provisions that require pedigree papers for certain drugs to prevent the sale of drugs that are adulterated, misbranded, or otherwise of poor quality. These regulations have been widely cited as a productive approach to assuring drug
product integrity.
499.0121 Storage and handling of prescription drugs; recordkeeping.--The department shall adopt rules to implement this section as necessary to protect the public health, safety, and welfare. Such rules shall include, but not be
limited to, requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records.
(1) ESTABLISHMENTS.--An establishment at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed must:
(a) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;
(b) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space,
equipment, and security conditions;
(c) Have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded,
or adulterated, or that are in immediate or sealed, secondary containers that have been opened;
(d) Be maintained in a clean and orderly condition; and
(e) Be free from infestation by insects, rodents, birds, or vermin of any kind.
(2) SECURITY.-(a) An establishment that is used for wholesale drug distribution must be secure from unauthorized entry.
1. Access from outside the premises must be kept to a minimum and be well-controlled.
2. The outside perimeter of the premises must be well-lighted.
3. Entry into areas where prescription drugs are held must be limited to authorized personnel.
(b) An establishment that is used for wholesale drug distribution must be equipped with:
1. An alarm system to detect entry after hours; however, the department may exempt by rule establishments that only
hold a permit as prescription drug wholesale distributor-brokers and establishments that only handle medical oxygen; and
2. A security system that will provide suitable protection against theft and diversion. When appropriate, the security
system must provide protection against theft or diversion that is facilitated or hidden by tampering with computers or
electronic records.
(c) Any vehicle that contains prescription drugs must be secure from unauthorized access to the prescription drugs in
the vehicle.
(3) STORAGE.--All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions
in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the official compendium.
(a) If no storage requirements are established for a prescription drug, the drug may be held at "controlled" room
temperature, as defined in the official compendium, to help ensure that its identity, strength, quality, and purity are
not adversely affected.
(b) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, or
logs must be used to document proper storage of prescription drugs.
(c) The recordkeeping requirements in subsection (6) must be followed for all stored prescription drugs.
(4) EXAMINATION OF MATERIALS AND RECORDS.-(a) Upon receipt, each outside shipping container must be visually examined for identity and to prevent the acceptance of contaminated prescription drugs that are otherwise unfit for distribution. This examination must be adequate
to reveal container damage that would suggest possible contamination or other damage to the contents.
(b) Each outgoing shipment must be carefully inspected for identity of the prescription drug products and to ensure
that there is no delivery of prescription drugs that have expired or been damaged in storage or held under improper
conditions.
(c) The recordkeeping requirements in subsection (6) must be followed for all incoming and outgoing prescription
drugs.
(d) Upon receipt, a wholesale distributor must review records required under this section for the acquisition of prescription drugs for accuracy and completeness, considering the total facts and circumstances surrounding the trans-
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actions and the wholesale distributors involved. This includes authenticating each transaction listed on a pedigree
paper, as defined in 1s. 499.003(36).
(5) RETURNED, DAMAGED, OR OUTDATED PRESCRIPTION DRUGS.-(a)1. Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated must be quarantined
and physically separated from other prescription drugs until they are destroyed or returned to their supplier. A quarantine section must be separate and apart from other sections where prescription drugs are stored so that prescription drugs in this section are not confused with usable prescription drugs.
2. Prescription drugs must be examined at least every 12 months, and drugs for which the expiration date has passed
must be removed and quarantined.
(b) Any prescription drugs of which the immediate or sealed outer containers or sealed secondary containers have
been opened or used must be identified as such and must be quarantined and physically separated from other prescription drugs until they are destroyed or returned to the supplier.
(c) If the conditions under which a prescription drug has been returned cast doubt on the drug's safety, identity,
strength, quality, or purity, the drug must be destroyed or returned to the supplier, unless examination, testing, or
other investigation proves that the drug meets appropriate standards of safety, identity, strength, quality, and purity.
In determining whether the conditions under which a drug has been returned cast doubt on the drug's safety, identity,
strength, quality, or purity, the wholesale distributor must consider, among other things, the conditions under which
the drug has been held, stored, or shipped before or during its return and the conditions of the drug and its container, carton, or labeling, as a result of storage or shipping.
(d) The recordkeeping requirements in subsection (6) must be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs.
(6) RECORDKEEPING.--The department shall adopt rules that require keeping such records of prescription drugs
as are necessary for the protection of the public health.
(a) Wholesale distributors must establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs. These records must provide a complete audit trail
from receipt to sale or other disposition, be readily retrievable for inspection, and include, at a minimum, the following information:
1. The source of the drugs, including the name and principal address of the seller or transferor, and the address of
the location from which the drugs were shipped;
2. The name, principal address, and state license permit or registration number of the person authorized to purchase
prescription drugs;
3. The name, strength, dosage form, and quantity of the drugs received and distributed or disposed of;
4. The dates of receipt and distribution or other disposition of the drugs; and
5. Any financial documentation supporting the transaction.
(b) Inventories and records must be made available for inspection and photocopying by authorized federal, state, or
local officials for a period of 2 years following disposition of the drugs or 3 years after the creation of the records,
whichever period is longer.
(c) Records described in this section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means must be readily available for authorized inspection during the retention period. Records that are kept at a central location outside of this state and that are not electronically retrievable must be made
available for inspection within 2 working days after a request by an authorized official of a federal, state, or local
law enforcement agency. Records that are maintained at a central location within this state must be maintained at an
establishment that is permitted pursuant to this part and must be readily available.
(d) Each manufacturer or repackager of medical devices, over-the-counter drugs, or cosmetics must maintain records that include the name and principal address of the seller or transferor of the product, the address of the location from which the product was shipped, the date of the transaction, the name and quantity of the product involved,
and the name and principal address of the person who purchased the product.
(e) A wholesale distributor must maintain pedigree papers separate and distinct from other records required under
this chapter.
(7) PRESCRIPTION DRUG PURCHASE LIST.--Each wholesale distributor, except for a manufacturer, shall annually provide the department with a written list of all wholesale distributors and manufacturers from whom the whole-
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sale distributor purchases prescription drugs. A wholesale distributor, except a manufacturer, shall notify the
department not later than 10 days after any change to either list. Such portions of the information required pursuant
to this subsection which are a trade secret, as defined in s. 812.081, shall be maintained by the department as trade
secret information is required to be maintained under s. 499.051.
(8) WRITTEN POLICIES AND PROCEDURES.--Wholesale distributors must establish, maintain, and adhere to
written policies and procedures, which must be followed for the receipt, security, storage, inventory, and distribution
of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts,
and for correcting all errors and inaccuracies in inventories. Wholesale distributors must include in their written
policies and procedures:
(a) A procedure whereby the oldest approved stock of a prescription drug product is distributed first. The procedure
may permit deviation from this requirement, if the deviation is temporary and appropriate.
(b) A procedure to be followed for handling recalls and withdrawals of prescription drugs. Such procedure must be
adequate to deal with recalls and withdrawals due to:
1. Any action initiated at the request of the Food and Drug Administration or any other federal, state, or local law
enforcement or other government agency, including the department.
2. Any voluntary action by the manufacturer or repackager to remove defective or potentially defective drugs from
the market; or
3. Any action undertaken to promote public health and safety by replacing existing merchandise with an improved
product or new package design.
(c) A procedure to ensure that wholesale distributors prepare for, protect against, and handle any crisis that affects
security or operation of any facility if a strike, fire, flood, or other natural disaster, or a local, state, or national
emergency, occurs.
(d) A procedure to ensure that any outdated prescription drugs are segregated from other drugs and returned to the
manufacturer or repackager or destroyed. This procedure must provide for written documentation of the disposition
of outdated prescription drugs. This documentation must be maintained for 2 years after disposition of the outdated
drugs.
(9) RESPONSIBLE PERSONS.--Wholesale distributors must establish and maintain lists of officers, directors, managers, designated representatives, and other persons in charge of wholesale drug distribution, storage, and handling,
including a description of their duties and a summary of their qualifications.
(10) COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAW.--A wholesale distributor must operate in compliance with applicable federal, state, and local laws and regulations.
(a) A wholesale distributor must allow the department and authorized federal, state, and local officials to enter and
inspect its premises and delivery vehicles, and to audit its records and written operating procedures, at reasonable
times and in a reasonable manner, to the extent authorized by law.
(b) A wholesale distributor that deals in controlled substances must register with the Drug Enforcement Administration and must comply with all applicable state, local, and federal laws. A wholesale distributor that distributes any
substance controlled under chapter 893 must notify the department when registering with the Drug Enforcement Administration pursuant to that chapter and must provide the department with its DEA number.
(11) SALVAGING AND REPROCESSING.--A wholesale distributor is subject to any applicable federal, state, or local laws or regulations that relate to prescription drug product salvaging or reprocessing.
(12) SHIPPING AND TRANSPORTATION.--The person responsible for shipment and transportation of a prescription drug in a wholesale distribution may use a common carrier; its own vehicle or employee acting within the scope
of employment if authorized under s. 499.03 for the possession of prescription drugs in this state; or, in the case of a
prescription drug intended for domestic distribution, an independent contractor who must be the agent of the authorized seller or recipient responsible for shipping and transportation as set forth in a written contract between the
parties. A person selling a prescription drug for export must obtain documentation, such as a validated airway bill,
bill of lading, or other appropriate documentation that the prescription drug was exported. A person responsible for
shipping or transporting prescription drugs is not required to maintain documentation from a common carrier that
the designated recipient received the prescription drugs; however, the person must obtain such documentation from
the common carrier and make it available to the department upon request of the department.
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(13) DUE DILIGENCE OF SUPPLIERS.--Prior to purchasing any prescription drugs from another wholesale distributor, a prescription drug wholesale distributor, an out-of-state prescription drug wholesale distributor, or a prescription drug repackager must:
(a) Enter an agreement with the selling wholesale distributor by which the selling wholesale distributor will indemnify the purchasing wholesale distributor for any loss caused to the purchasing wholesale distributor related to the
purchase of drugs from the selling wholesale distributor which are determined to be counterfeit or to have been distributed in violation of any federal or state law governing the distribution of drugs.
(b) Determine that the selling wholesale distributor has insurance coverage of not less than the greater of 1 percent
of the amount of total dollar volume of the prescription drug sales reported to the department under s. 499.012(8)(g)
or $500,000; however the coverage need not exceed $2 million.
(c) Obtain information from the selling wholesale distributor, including the length of time the selling wholesale distributor has been licensed in this state, a copy of the selling wholesale distributor's licenses or permits, and background information concerning the ownership of the selling wholesale distributor, including the experience of the
wholesale distributor in the wholesale distribution of prescription drugs.
(d) Verify that the selling wholesale distributor's Florida permit is valid.
(e) Inspect the selling wholesale distributor's licensed establishment to document that it has a policies and procedures manual relating to the distribution of drugs, the appropriate temperature controlled environment for drugs requiring temperature control, an alarm system, appropriate access restrictions, and procedures to ensure that records
related to the wholesale distribution of prescription drugs are maintained as required by law:
1. Before purchasing any drug from the wholesale distributor, and at least once each subsequent year; or
2. Before purchasing any drug from the wholesale distributor, and each subsequent year obtain a complete copy of
the most recent inspection report for the establishment which was prepared by the department or the regulatory authority responsible for wholesale distributors in the state in which the establishment is located.
Florida now permits the donation of certain drugs that have been approved to treat cancer as long as specific requirements
have been met.
499.029 Cancer Drug Donation Program.-(1) This section may be cited as the "Cancer Drug Donation Program Act."
(2) There is created a Cancer Drug Donation Program within the department for the purpose of authorizing and facilitating the donation of cancer drugs and supplies to eligible patients.
1(3) As used in this section:
(a) "Cancer drug" means a prescription drug that has been approved under s. 505 of the federal Food, Drug, and
Cosmetic Act and is used to treat cancer or its side effects or is used to treat the side effects of a prescription drug
used to treat cancer or its side effects. "Cancer drug" does not include a substance listed in Schedule II, Schedule III,
Schedule IV, or Schedule V of s. 893.03.
(b) "Closed drug delivery system" means a system in which the actual control of the unit-dose medication package is
maintained by the facility rather than by the individual patient.
(c) "Donor" means a patient or patient representative who donates cancer drugs or supplies needed to administer
cancer drugs that have been maintained within a closed drug delivery system; health care facilities, nursing homes,
hospices, or hospitals with closed drug delivery systems; or pharmacies, drug manufacturers, medical device manufacturers or suppliers, or wholesalers of drugs or supplies, in accordance with this section. "Donor" includes a physician licensed under chapter 458 or chapter 459 who receives cancer drugs or supplies directly from a drug
manufacturer, wholesale distributor, or pharmacy.
(d) "Eligible patient" means a person who the department determines is eligible to receive cancer drugs from the
program.
(e) "Participant facility" means a class II hospital pharmacy that has elected to participate in the program and that
accepts donated cancer drugs and supplies under the rules adopted by the department for the program.
(f) "Prescribing practitioner" means a physician licensed under chapter 458 or chapter 459 or any other medical
professional with authority under state law to prescribe cancer medication.
(g) "Program" means the Cancer Drug Donation Program created by this section.
(h) "Supplies" means any supplies used in the administration of a cancer drug.
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(4) Any donor may donate cancer drugs or supplies to a participant facility that elects to participate in the program
and meets criteria established by the department for such participation. Cancer drugs or supplies may not be donated to a specific cancer patient, and donated drugs or supplies may not be resold by the program. Cancer drugs billed
to and paid for by Medicaid in long-term care facilities that are eligible for return to stock under federal Medicaid
regulations shall be credited to Medicaid and are not eligible for donation under the program. A participant facility
may provide dispensing and consulting services to individuals who are not patients of the hospital.
(5) The cancer drugs or supplies donated to the program may be prescribed only by a prescribing practitioner for
use by an eligible patient and may be dispensed only by a pharmacist.
(6)(a) A cancer drug may only be accepted or dispensed under the program if the drug is in its original, unopened,
sealed container, or in a tamper-evident unit-dose packaging, except that a cancer drug packaged in single-unit doses may be accepted and dispensed if the outside packaging is opened but the single-unit-dose packaging is unopened
with tamper-resistant packaging intact.
(b) A cancer drug may not be accepted or dispensed under the program if the drug bears an expiration date that is
less than 6 months after the date the drug was donated or if the drug appears to have been tampered with or mislabeled as determined in paragraph (c).
(c) Prior to being dispensed to an eligible patient, the cancer drug or supplies donated under the program shall be
inspected by a pharmacist to determine that the drug and supplies do not appear to have been tampered with or mislabeled.
(d) A dispenser of donated cancer drugs or supplies may not submit a claim or otherwise seek reimbursement from
any public or private third-party payor for donated cancer drugs or supplies dispensed to any patient under the program, and a public or private third-party payor is not required to provide reimbursement to a dispenser for donated
cancer drugs or supplies dispensed to any patient under the program.
(7)(a) A donation of cancer drugs or supplies shall be made only at a participant facility. A participant facility may
decline to accept a donation. A participant facility that accepts donated cancer drugs or supplies under the program
shall comply with all applicable provisions of state and federal law relating to the storage and dispensing of the donated cancer drugs or supplies.
(b) A participant facility that voluntarily takes part in the program may charge a handling fee sufficient to cover the
cost of preparation and dispensing of cancer drugs or supplies under the program. The fee shall be established in
rules adopted by the department.
(8) The department, upon the recommendation of the Board of Pharmacy, shall adopt rules to carry out the provisions of this section. Initial rules under this section shall be adopted no later than 90 days after the effective date of
this act. The rules shall include, but not be limited to:
(a) Eligibility criteria, including a method to determine priority of eligible patients under the program.
(b) Standards and procedures for participant facilities that accept, store, distribute, or dispense donated cancer
drugs or supplies.
(c) Necessary forms for administration of the program, including, but not limited to, forms for use by entities that donate, accept, distribute, or dispense cancer drugs or supplies under the program.
(d) The maximum handling fee that may be charged by a participant facility that accepts and distributes or dispenses
donated cancer drugs or supplies.
(e) Categories of cancer drugs and supplies that the program will accept for dispensing; however, the department
may exclude any drug based on its therapeutic effectiveness or high potential for abuse or diversion.
(f) Maintenance and distribution of the participant facility registry established in subsection (10).
(9) A person who is eligible to receive cancer drugs or supplies under the state Medicaid program or under any other
prescription drug program funded in whole or in part by the state, by any other prescription drug program funded in
whole or in part by the Federal Government, or by any other prescription drug program offered by a third-party insurer, unless benefits have been exhausted, or a certain cancer drug or supply is not covered by the prescription drug
program, is ineligible to participate in the program created under this section.
(10) The department shall establish and maintain a participant facility registry for the program. The participant facility registry shall include the participant facility's name, address, and telephone number. The department shall
make the participant facility registry available on the department's website to any donor wishing to donate cancer
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drugs or supplies to the program. The department's website shall also contain links to cancer drug manufacturers
that offer drug assistance programs or free medication.
(11) Any donor of cancer drugs or supplies, or any participant in the program, who exercises reasonable care in donating, accepting, distributing, or dispensing cancer drugs or supplies under the program and the rules adopted under this section shall be immune from civil or criminal liability and from professional disciplinary action of any kind
for any injury, death, or loss to person or property relating to such activities.
(12) A pharmaceutical manufacturer is not liable for any claim or injury arising from the transfer of any cancer drug
under this section, including, but not limited to, liability for failure to transfer or communicate product or consumer
information regarding the transferred drug, as well as the expiration date of the transferred drug.
(13) If any conflict exists between the provisions in this section and the provisions in this chapter or chapter 465, the
provisions in this section shall control the operation of the Cancer Drug Donation Program.
States have the right to classify as prescription-only drugs that under federal law may be classified as non-prescription drugs.
Florida has chosen to exercise that right.
499.032 Phenylalanine; prescription required.--Phenylalanine restricted formula is declared to be a prescription
drug and may be dispensed only upon the prescription of a practitioner authorized by law to prescribe prescription
drugs.
499.033 Ephedrine; prescription required.--Ephedrine is declared to be a prescription drug.
(1) Except as provided in subsection (2), any product that contains any quantity of ephedrine, a salt of ephedrine, an
optical isomer of ephedrine, or a salt of an optical isomer of ephedrine may be dispensed only upon the prescription
of a duly licensed practitioner authorized by the laws of the state to prescribe prescription drugs.
(2) A product containing ephedrine described in paragraphs (a)-(e) is exempt from subsection (1) if it may lawfully
be sold over the counter without a prescription under the federal act; is labeled and marketed in a manner consistent
with the pertinent United States Food and Drug Administration Over-the-Counter Tentative Final or Final Monograph; and is manufactured and distributed for legitimate medicinal use in a manner that reduces or eliminates the
likelihood of abuse, when considered in the context with: the package sizes and the manner of packaging of the drug
product; the name and labeling of the product; the manner of distribution, advertising, and promotion of the product;
the duration, scope, health significance, and societal cost of abuse of the particular product; the need to provide
medically important ephedrine-containing therapies to the public for United States Food and Drug Administration
approved indications on an unrestricted, over-the-counter basis; and other facts as may be relevant to and consistent
with public health and safety.
(a) Solid oral dosage forms that combine active ingredients in the following ranges for each dosage unit:
1. Theophylline (100-130mg), ephedrine (12.5-24mg).
2. Theophylline (60-100mg), ephedrine (12.5-24mg), guaifenesin (200-400mg).
3. Ephedrine (12.5-25mg), guaifenesin (200-400mg).
4. Phenobarbital (not greater than 8mg) in combination with the ingredients of subparagraph 1. or subparagraph 2.
(b) Liquid oral dosage forms that combine active ingredients in the following ranges for each (5ml) dose:
1. Theophylline (not greater than 45mg), ephedrine (not greater than 36mg), guaifenesin (not greater than 100mg),
phenobarbital (not greater than 12mg).
2. Phenylephrine (not greater than 5mg), ephedrine (not greater than 5mg), chlorpheniramine (not greater than
2mg), dextromethorphan (not greater than 10mg), ammonium chloride (not greater than 40mg), ipecac fluid extract
(not greater than 0.005ml).
(c) Anorectal preparations containing less than 5 percent ephedrine.
(d) Nasal decongestant compounds, mixtures, or preparations containing 0.5 percent or less ephedrine.
(e) Any drug product containing ephedrine that is marketed pursuant to an approved new drug application or legal
equivalent under the federal act.
(3) The department may implement this section by rule.
Disclaimer: This is a review only. For a complete listing of all state laws, refer to the Florida Board of Pharmacy website at
http://www.doh.state.fl.us/mqa/pharmacy/. The state portion of this guide was last updated: 3/10.
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Chapter 6: Florida Administrative Rules
Pharmacy law in Florida is contained primarily within the rules of the Florida Board of Pharmacy. While the Florida
Pharmacy Act, passed by the Florida Legislature, establishes general principles for pharmacists and pharmacies, it is the
Board of Pharmacy that provides specific requirements for implementing the principles. The Board promulgates rules that
have the force and effect of law. Failure to adhere to a Board rule exposes the violator to administrative penalties. All discipline administered by the Board must follow prescribed steps. A probable cause panel first determines whether there is probable cause to believe that a violation of the law has occurred. Only if there is probable cause to continue will the Board then
proceed with disciplinary actions against an alleged violator. Investigators are employed by the Board to assist it in disciplinary matters. Investigators need not be pharmacists, but preference is given to applicants who have a degree in pharmacy.
The organization of the Board of Pharmacy is set out as follows:
64B16-25.130 Executive Director.
The Executive Director is hereby designated as the agent of the Board for the service of legal process upon the Board.
64B16-25.170 Probable Cause Panel.
(1) The determination as to whether probable cause exists to believe that a violation of Chapter 456, Part II, 465, 499, or 893,
F.S., or of the rules promulgated thereunder, has occurred shall be made by the probable cause panel. The panel shall meet as
necessary.
(2) The probable cause panel shall be composed of two (2) persons, either current or former board members appointed by the
chairman of the Board. One appointee must be a current board member. The panel must include a former or current board
member who is a licensed pharmacist. An appointee may be a former board member.
64B16-25.340 Meetings and Workshops.
The following are considered to be official meetings of the Board:
(1) Board Meetings.
(2) Examination Committee Meetings.
(3) Tripartite Continuing Education Committee Meeting.
(4) Meetings of committees set out in the official minutes of the Board where statutory authority is given by the practice act.
(5) Meetings of a Board member with Department staff or contractors of the Department at the Department’s or Board’s request. Any participation or meeting of members noticed or unnoticed will be on file in the Board office.
(6) Where a Board member has been requested by the State Surgeon General to participate in a meeting.
(7) Probable Cause Panel meetings.
(8) All activity of Board members, if authorized by the Board, when grading, proctoring or reviewing examinations given by
the Department.
(9) All participation in Board authorized meetings with professional associations of which the Board is a member or invitee.
This would include all meetings of the National Association of Boards of Pharmacy of which the Board is a member as well
as Board authorized participation in meetings of national or professional associations or organizations involved in educating, regulating and reviewing the profession over which the Board has statutory authority.
(10) Any and all other activities which are Board approved and which are necessary for Board members to attend in order to
further protect the public health, safety and welfare, through the regulation of which the Board has statutory authority.
A.
Licensure Issues
The Florida Board of Pharmacy has adopted rules that impose requirements on those who wish to become licensed as
pharmacists in Florida. These rules reflect the requirements of the Florida Pharmacy Act, but they impose additional requirements also.
64B16-26.1001 Examination and Application Fees.
(1) The non-refundable examination fee for licensure by examination shall be $100, payable to the Board. Examination fees
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for the National Practice Examination and jurisprudence examination are payable to the examination vendor.
(2) The non-refundable application fee licensure by endorsement shall be $100, payable to the Board.
(3) The non-refundable application fee for a continuing education provider seeking approved provider status shall be $150,
payable to the Board.
(4) The non-refundable application fee for registered pharmacy technicians shall be $50, payable to the Board.
64B16-26.1002 Initial License Fees.
(1) The initial license fee for a pharmacist license shall be $190 plus a $5 unlicensed activity fee pursuant to Section
456.065(3), F.S.
(2) The initial license fee for a consultant pharmacist license shall be $50 plus a $5 unlicensed activity fee pursuant to Section
456.065(3), F.S.
(3) The initial license fee for a nuclear pharmacist license shall be $50 plus a $5 unlicensed activity fee pursuant to Section
456.065(3), F.S.
(4) The initial registration fee for a registered pharmacy technician shall be $50 plus a $5 unlicensed activity fee pursuant to
Section 456.065(3), F.S.
64B16-26.1003 Active License Renewal Fees.
(1) The biennial license renewal fee for an active pharmacist license shall be $250 plus a $5 unlicensed activity fee pursuant
to Section 456.065(3), F.S.
(2) The biennial license renewal fee for a consultant pharmacist active license shall be $100 plus a $5 unlicensed activity fee
pursuant to Section 456.065(3), F.S.
(3) The biennial license renewal fee for a nuclear pharmacist active license shall be $100 plus a $5 unlicensed activity fee
(4) The biennial registration renewal fee for a registered pharmacy technician shall be $50 plus $5 unlicensed activity fee
64B16-26.1004 Inactive License Election; Renewal; Fees.
(1) A pharmacist licensee may elect:
(a) At the time of license renewal to place the license on inactive status by submitting a written request with the board for
inactive status and submitting the inactive status renewal fee of $245 plus a $5 unlicensed activity fee pursuant to Section
456.065(3), F.S.
(b) At the time of license renewal, if the license is inactive, to continue the license on inactive status by submitting a written
request with the board for inactive status and submitting the inactive status renewal fee of $245 plus a $5 unlicensed activity
fee pursuant to Section 456.065(3), F.S.
(c) At the time of license renewal to change the inactive status license to active status, provided the licensee meets the
continuing education requirements of Rule 64B16-26.103, F.A.C., for each biennium the license was on inactive status, submits
the reactivation fee of $70, and the current active renewal fee set forth in Rule 64B16-26.1001, F.A.C.
(d) At a time other than license renewal to change the inactive status license to active status, provided the licensee meets the
continuing education requirements of Rule 64B16-26.103, F.A.C., for each biennium the license was on inactive status and
submits the reactivation fee of $70, a change of status fee of $25 and the difference between the inactive status renewal fee and
the active status renewal fee, if any exists.
(2) A consultant pharmacist licensee may elect:
(a) At the time of license renewal to place the license on inactive status by submitting a written request with the board for
inactive status and submitting the inactive status renewal fee of $100 plus a $5 unlicensed activity fee pursuant to Section
456.065(3), F.S.
(b) At the time of license renewal, if the consultant pharmacist license is inactive, to continue the license on inactive status by
submitting a written request with the board for inactive status and submitting the inactive status renewal fee of $100 plus a $5
unlicensed activity fee pursuant to Section 456.065(3), F.S.
(c) At the time of license renewal to change the inactive status consultant pharmacist license to active status, provided the
consultant pharmacist licensee meets the continuing education requirements of subsection 64B16-26.103(2), F.A.C., for each
biennium the license was on inactive status and by submitting a reactivation fee of $25, and the active consultant pharmacist
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renewal fee set forth in Rule 64B16-26.1003, F.A.C.
(d) At a time other than license renewal to change the inactive status license to active status, provided the licensee meets the
continuing education requirements of Rule 64B16-26.103, F.A.C., for each biennium the license was on inactive status, and
submits the reactivation fee of $25, a change of status fee of $25 and the difference between the inactive status renewal fee and
the active status renewal fee, if any exists.
(3) A nuclear pharmacist licensee may elect:
(a) At the time of license renewal to place the nuclear pharmacist license on inactive status by submitting a written request with
the board for inactive status and submitting the inactive status renewal fee of $100 plus a $5 unlicensed activity fee pursuant
to Section 456.065(3), F.S.
(b) At the time of license renewal, if the nuclear pharmacist license is inactive, to continue the license on inactive status by
submitting a written request with the board for inactive status and submitting the inactive status renewal fee of $100 plus a $5
unlicensed activity fee pursuant to Section 456.065(3), F.S.
(c) At the time of license renewal to change the inactive status license to active status, provided the nuclear pharmacist meets
the continuing education requirements of Rule 64B16-26.304, F.A.C., for each biennium the license was on inactive status, and
by submitting a reactivation fee of $50, and the active nuclear license renewal fee set forth in Rule 64B16-26.1003, F.A.C.
(d) At a time other than license renewal to change the inactive status license to active status, provided the nuclear pharmacist
licensee meets the continuing education requirements of Rule 64B16-26.304, F.A.C., for each biennium the license was on
inactive status and by submitting a reactivation fee of $50, a change of status fee of $25 and the difference between the inactive
status renewal fee and the active status renewal fee, if any exists.
(4) A registered pharmacy technician may elect:
(a) At the time of renewal to place the registered pharmacy technician registration on inactive status by submitting a written
request with the board for inactive status and submitting the inactive status renewal fee of $50 plus a $5 unlicensed activity fee
(b) At the time of renewal, if the registered pharmacy technician registration is inactive, to continue the registration on inactive
status by submitting a written request with the board for inactive status and submitting the inactive status renewal fee of $50
plus a $5 unlicensed activity fee pursuant to Section 456.065(3), F.S.
(c) At the time of renewal to change the inactive status registration to active status, provided the registered pharmacy
technician meets the continuing education requirements of Rule 64B16-26.103, F.A.C., for each biennium the registration was
on inactive status, and by submitting a reactivation fee of $50, and the active registration fee set forth in Rule 64B16-26.1003,
F.A.C.
(d) At a time other than renewal to change the inactive status registration to active status, provided the registered pharmacy
technician meets the continuing education requirements of Rule 64B16-26.103, F.A.C., for each biennium the registration was
on inactive status and by submitting a reactivation fee of $50, a change of status fee of $25 and the difference between the
inactive status renewal fee and the active status renewal fee, if any exists.
64B16-26.1005 Retired License Election; Renewal; Fees.
(1) A licensee may elect to place his or her license on retired status.
(a) At the time of license renewal, to place the license on retired status, the licensee must submit a written request with the board
for retired status and submit the retired status fee of $50.00 pursuant to Section 456.036(4)(b), F.S., and the current unlicensed
activity fee.
(b) At a time other than license renewal, to place the license on retired status, the licensee must submit a written request to the
Board for the retired status plus submit the retired status fee of $50.00 pursuant to Section 456.036(4)(b), F.S., plus a change
of status fee of $25.00, plus the current unlicensed activity fee.
(c) Before the license of a retired status licensee is reactivated, the licensee must meet the continuing education requirements
in Rule 64B16-26.103, F.A.C., and pay any renewal fees imposed on an active status licensee for all biennial licensure periods,
plus the current unlicensed activity fee during which the licensee was on retired status.
(2) Any pharmacist applying for an active status license who has been on retired status for 5 years or more, or if licensed
elsewhere, has not been active during the past 5 years, shall as a condition of licensure, demonstrate that he or she is able to
practice with the care and skill sufficient to protect the health, safety, and welfare of the public by:
(a) If inactive for less than 5 years, the licensee must pass a jurisprudence examination;
(b) If inactive for 5 or more years, in addition to paragraph (a), the licensee must pass the NAPLEX.
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64B16-26.1012 Approved Continuing Education Provider Renewal Fee.
The biennial fee to renew as an approved continuing education provider shall be $150.
64B16-26.1021 Delinquent License Reversion; Reinstatement; Fees.
(1) An active or inactive license that is not renewed by midnight of the expiration date of the license shall automatically revert
to delinquent status.
(2) A pharmacist may request that a delinquent license be reinstated to active or inactive status, provided the licensee meets
the continuing education requirements of Rule 64B16-26.103, F.A.C., for each biennium the license was on inactive status, and
by submitting a reactivation fee of $100 plus the current fee for an active status or inactive status license set forth in Rule
64B16-26.1003 or 64B16-26.1004, F.A.C.
(3) A consultant pharmacist may request that a delinquent consultant pharmacist license be reinstated to an active or inactive
status by submitting a delinquent fee of $100 plus the current fee for an active or inactive status consultant pharmacist license
set forth in Rule 64B16-26.1003 or 64B16-26.1004, F.A.C.
(4) A nuclear pharmacist may request that a delinquent nuclear pharmacist license be reinstated to an active or inactive license
status by submitting a delinquent fee of $100 plus the current fee for an active or inactive nuclear pharmacist license set forth
in Rule 64B16-26.1003 or 64B16-26.1004, F.A.C.
(5) A registered pharmacy technician may request that a delinquent registered pharmacy technician registration be reinstated
to an active or inactive status provided the registered pharmacy technician meets the continuing education requirements of
Rule 64B16-26.103, F.A.C., for each biennium the registration was on inactive status, and by submitting a reactivation fee of
$25 plus the current fee for an active or inactive status registered pharmacy technician registration set forth in Rule
64B16-26.1003 or 64B16-26.1004, F.A.C.
(6) A license in delinquent status that is not renewed prior to midnight of the expiration date of the current licensure cycle
shall be rendered null without any further action by the Department. Any subsequent license shall be the result of applying
for and meeting all requirements imposed on an applicant for new licensure.
64B16-26.1022 Permit Fees.
(1) The initial permit fee for a pharmacy, as provided by Section 465.022(8)(a), F.S., shall be $250.
(2) The biennial permit renewal fee for a pharmacy, as provided by Section 465.022(8)(b), F.S., shall be $250.
(3) The change of location fee for a pharmacy, as provided by Section 465.022(8)(d), F.S., shall be $100.
(4) The delinquent fee for a pharmacy permit, as provided by Section 465.022(8)(c), F.S., shall be $100.
64B16-26.103 Continuing Education Credits; License Renewal; Consultant Pharmacist License Renewal; Nuclear Pharmacist License Renewal. (1) Prior to biennal renewal of pharmacist licensure, a licensee shall complete no less than 30
hours of approved courses of continued professional pharmaceutical education within the 24 month period prior to the
expiration date of the license. The following conditions shall apply.
(a) Upon a licensee’s first renewal of licensure, the licensee must document the completion of one (1) hour of board
approved continuing education which includes the topics of Human Immunodeficiency Virus and Acquired Immune
Deficiency Syndrome; the modes of transmission, including transmission from a healthcare worker to a patient and the
patient to the healthcare worker; infection control procedures, including universal precautions; epidemiology of the disease;
related infections including tuberculosis (TB); clinical management; prevention; and current Florida law on AIDS and its
impact on testing, confidentiality of test results, and treatment of patients. In order to meet this requirement, licensees must
demonstrate that the course includes information on the State of Florida law on HIV/AIDS and its impact on testing,
reporting, the offering of HIV testing to pregnant women, and partner notification issues pursuant to Sections 381.004 and
384.25, F.S. Any HIV/AIDS continuing education course taken during the second or subsequent renewal of licensure may be
applied to satisfy the general continuing education hours requirement.
(b) The initial renewal of a pharmacist license will not require completion of courses of continued professional
pharmaceutical education hours if the license was issued less than 12 months prior to the expiration date of the license. If the
initial renewal occurs 12 months or more after the initial licensure, then 15 hours of continued professional pharmaceutical
education hours shall be completed prior to the renewal of the license but no earlier than the date of initial licensure.
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(c) Prior to renewal a licensee must complete, within the 24 month period prior to the expiration date of the license, a twohour continuing education course approved in advance by the Board or the Accreditation Council for Pharmacy Education
(ACPE) on medication errors that covers the study of root-cause analysis, error reduction and prevention, and patient safety.
Hours obtained pursuant to this section may be applied by the licensee to the requirements of subsection (1).
(d) Five hours of continuing education in the subject area of risk management may be obtained by attending one full day or
eight (8) hours of a board meeting at which disciplinary hearings are conducted by the Board of Pharmacy in compliance
with the following:
1. The licensee must sign in with the Executive Director or designee of the Board before the meeting day begins;
2. The licensee must remain in continuous attendance;
3. The licensee cannot receive continuing education credit for attendance at a board meeting if required to appear before the
board; and
4. The maximum continuing education hours allowable per biennium under this paragraph shall be ten (10).
(e) A member of the Board of Pharmacy may obtain five (5) hours of continuing education in the subject area of risk
management for attendance at one Board meeting at which disciplinary hearings are conducted. The maximum continuing
education hours allowable per biennium under this paragraph shall be ten (10).
(f) Up to five hours per biennium of continuing education credit may be fulfilled by the performance of volunteer services to
the indigent as provided in Section 456.013(9), F.S., or to underserved populations, or in areas of critical need within the
state where the licensee practices. In order to receive credit, the licensee must make application to and receive approval in
advance from the Board. Application shall be made on form DH-MQA 1170 (Rev. 02/09), Individual Request for Continuing
Education for Volunteers, which is hereby incorporated by reference. The form can be obtained from the Board of Pharmacy,
4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254. One hour credit shall be given for each two hours
volunteered in the 24 months prior to the expiration date of the license. In the application for approval, the licensee shall
disclose the type, nature and extent of services to be rendered, the facility where the services will be rendered, the number of
patients expected to be serviced, and a statement indicating that the patients to be served are indigent. If the licensee intends
to provide services in underserved or critical need areas, the application shall provide a brief explanation as to those facts. A
licensee who is completing community service as a condition of discipline imposed by the board cannot use such service to
complete continuing education requirements.
(g) Continuing education credit shall be granted for completion of post professional degree programs provided by accredited
colleges or schools of pharmacy. Credit shall be awarded at the rate of 5 hours of continuing education credit per semester
hour completed within the 24 months prior to the expiration date of the license.
(h) Continuing education may consist of post-graduate studies, institutes, seminars, lectures, conferences, workshops,
correspondence courses, or other educational opportunities which advance the practice of the profession of pharmacy if
approved by the Board. A course shall be approved prior to completion.
(i) In addition to the continuing education credits authorized above, any volunteer expert witness who is providing expert
witness opinions for cases being reviewed by the Department of Health pursuant to Chapter 465, F.S., shall receive five (5)
hours of credit in the area of risk management for each case reviewed in the 24 months prior to the expiration date of the
license, up to a maximum of ten (10) hours per biennium.
(j) At least ten (10) of the required 30 hours must be obtained either at a live seminar, a live video teleconference, or through
an interactive computer-based application.
(k) All programs approved by the ACPE for continuing education for pharmacists are deemed approved by the Board for
general continuing education hours for pharmacists. Any course necessary to meet the continuing education requirement for
HIV/AIDS, consultant pharmacist license renewal or nuclear pharmacist license renewal shall be Board approved.
(l) General continuing education earned by a non-resident pharmacist in another state that is not ACPE approved, but is
approved by the board of pharmacy in the state of residence can be applied to meet the requirements of license renewal in
subsection (1) above.
(2)(a) Prior to renewal a consultant pharmacist shall complete no less than 24 hours of Board approved continuing
education in the course work specified in Rule 64B16-26.302, F.A.C., within the 24 month period prior to the expiration date
of the consultant license. The hours earned to satisfy this requirement cannot be used to apply toward the 30 hours required
in subsection (1) above. However, if consultant recertification hours are earned and not used to meet the requirements of this
paragraph, they may be applied by the licensee to the 30 hours required in subsection (1).
(b) If the initial renewal of a consultant pharmacist license occurs less than 12 months after the initial licensure, then
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completion of consultant courses of continuing education hours will not be required.
(c) If the initial renewal of a consultant pharmacist license occurs 12 months or more after the initial licensure, then 12 hours
of consultant continuing education hours must be completed prior to the renewal date of the license but no earlier than the
date of initial licensure.
(3)(a) Prior to renewal a nuclear pharmacist shall complete no less than 24 hours of Board approved continuing education
in the course work specified in Rule 64B16-26.304, F.A.C., within the 24 month period prior to the expiration date of the
nuclear pharmacist license. The hours earned to satisfy this requirement cannot be used to apply toward the 30 hours
required in subsection (1) above. However, if nuclear pharmacist license renewal hours are earned and not used to meet the
requirements of this paragraph, they may be applied by the licensee to the 30 hours required in subsection (1).
(b) If the initial renewal of a nuclear pharmacist license occurs less than 12 months after the initial licensure, then
completion of courses of nuclear pharmacy continuing education hours will not be required.
(c) If the initial renewal of a nuclear pharmacist license occurs 12 months or more after the initial licensure, then 12 hours of
nuclear pharmacy continuing education hours must be completed prior to the renewal date of the license but no earlier than
the date of initial licensure.
64B16-26.1031 Influenza Immunization Certification Program.
The Board shall approve for initial certification of pharmacist administration of influenza immunizations, programs of study
not less than 20 hours that includes coursework covering all of the following;
(1) Mechanisms of action for vaccines, contraindications, drug interactions, and monitoring after vaccine administration;
(2) Immunization Schedules;
(3) Immunization screening questions, provision of risk/benefit information, informed consent, recordkeeping, and electronic
reporting into the statewide immunization registry through enrollment application DH Form 1997 (effective 10/07) herein
incorporated by reference and may be obtained from the Board office by writing to the Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254 or by telephoning 1(877)888-7468 ;
(4) Vaccine storage and handling;
(5) Bio-Hazardous waste disposal and sterile techniques;
(6) Entering, negotiating and performing pursuant to physician oversight protocols;
(7) Community immunization resources and programs;
(8) Identifying, managing and responding to adverse incidents including but not limited to potential allergic reactions associated with vaccine administration;
(9) Procedures and policies for reporting adverse events to the Vaccine Adverse Event Reporting System (VAERS);
(10) Reimbursement procedures and vaccine coverage by federal, state and local governmental jurisdictions and private
third party payors;
(11) Administration techniques;
(12) The current influenza immunization guidelines and recommendations of the United States Department of Health Centers
for Disease Control and Prevention published in the Morbidity Weekly Report (MMWR) December 1, 2006, Vol. 55 No. RR15 and updated MMWR July 13, 2007, Vol. 56, No. RR-6;
(13) Review of Section 465.189, F.S.; and
(14) Cardiopulmonary Resuscitation (CPR) training. Successful completion of the certification program must include a successful demonstration of competency in the administration technique and a cognitive examination.
64B16-26.104 Exemptions for Members of the Armed Forces; Spouses.
(1) Any pharmacist or registered pharmacy technician on active duty with the Armed Forces of the United States who at the
time of becoming a member of the Armed Forces of the United States was in good standing with the Board and was entitled
to practice the profession of pharmacy or registered as a pharmacy technician in Florida shall be exempt from all license
renewal provisions so long as the licensee is on active duty with the Armed Forces and for a period of six months after
discharge so long as the licensee is not engaged in the practice of pharmacy in the private sector for profit.
(2) A pharmacist or registered pharmacy technician who is a spouse of a member of the Armed Forces of the United States
and who was caused to be absent from the State of Florida because of the spouse’s duties with the Armed Forces shall be
exempt from all license renewal provisions.
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64B16-26.200 Examination Requirements.
(1) The examination provided in Section 465.007, F.S., shall be as follows:
(a) Part A – North American Pharmacist Licensure Examination (NAPLEX).
(b) Part B – Multistate Pharmacy Jurisprudence Examination – Florida Version.
64B16-26.203 Licensure by Examination; Application.
Applicants who are at least 18 years of age and a recipient of a degree from a school or college of pharmacy accredited by an
accrediting agency recognized and approved by the United States Office of Education may apply to take the licensure
examination.
(1) All applications for licensure by examination must be made on board approved form DOH/MQA/PH101 (Rev 7/08),
Application for Pharmacist Examination, which is hereby incorporated by reference, and which can be obtained from the
Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254, and must be accompanied with a
non-refundable examination fee and an initial license fee as set forth in Rules 64B16-26.1001 and 64B16-26.1002, F.A.C.
(2) The applicant must submit proof of having met the following requirements:
(a) Completion of an internship program provided by either an accredited school or college of pharmacy or a state board of
pharmacy or jointly by both provided that the program meets requirements of Rule 64B16-26.2032, F.A.C.
(b) Completion of a course not less than 2 hours on medication errors that covers the study of root-cause analysis, error
reduction and prevention, and patient safety. For those applicants who apply within one year following receipt of their
pharmacy degree, completed academic course work on medication errors will be accepted by the Board as an educational
course under this section, provided such course work is no less than 2 contact hours and that it covers the study of root-cause
analysis, error reduction and prevention, and patient safety, as evidenced by a letter attesting to subject matter covered from
the Dean of the University.
(3) An applicant must reapply if all requirements for licensure are not met within one year of the receipt of the application.
(4) Passing examination scores may be used upon reapplication only if the examination was completed within 3 years of the
reapplication.
64B16-26.2031 Licensure by Examination; Foreign Pharmacy Graduates.
In order for a foreign pharmacy graduate to be admitted to the professional licensure examination, the applicant must:
(1) Submit an application for licensure by examination on form DOH-MQA PH103 (Rev. 02/09), Foreign Graduate
Pharmacist Examination Application and Instructions, which is hereby incorporated by reference, and which can be obtained
from the Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254, and must be
accompanied with a non-refundable examination fee and an initial license fee set forth in Rules 64B16-26.1001 and 64B1626.1002, F.A.C.
(2) Be a graduate of a four year undergraduate pharmacy program at a school or college outside the United States and have
completed an internship program approved by the board.
(3) For applications received at the Board of Pharmacy on or before June 30, 2009, the applicant must:
(a) Successfully pass the foreign pharmacy graduate equivalency examination which is given by the Foreign Pharmacy Graduate Equivalency Commission.
(b) Demonstrate proficiency in the use of English by passing the Test of English as a Foreign Language (TOEFL), which is
administered by the Educational Testing Service, Inc., with a score of at least 500 for the pencil and paper test or 173 for the
computer version and by passing the Test of Spoken English (TSE) with a score of 45 on the recalibrated TSE; or
(c) Demonstrate proficiency in the use of English by passing the Test of English as a Foreign Language Internet-based test
(TOEFL ibt) with scores of: Listening – 18; Reading – 21; Speaking – 26; and Writing – 24.
(4) For applications received at the Board of Pharmacy on or after July 1, 2009, the applicant must:
(a) Successfully pass the foreign pharmacy graduate equivalency examination which is given by the Foreign Pharmacy Graduate Equivalency Commission;
(b) Demonstrate proficiency in the use of English by passing the Test of English as a Foreign Language (TOEFL), which is
administered by the Educational Testing Service, Inc., with a score of at least 550 for the pencil and paper test or 213 for the
computer version and by passing the Test of Spoken English (TSE) with a score of 50 on the recalibrated TSE; or
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(c) Demonstrate proficiency in the use of English by passing the Test of English as a Foreign Language Internet-based test
(TOEFL ibt) with scores of: Listening – 18; Reading – 21; Speaking – 26; and Writing – 24.
(5) Complete 2080 hours of supervised work activity, of which a minimum of 500 hours must be completed within the State of
Florida. Such experience must be equivalent to that required in the internship program as set forth in Rule 64B16-26.2032,
F.A.C. The work experience program including both the preceptor and the permittee must be approved by the Board of
Pharmacy. The work experience shall be documented on form DOH-MQA PH1153 (Rev. 03/09), Foreign Graduate Intern
Work Activity Manual, which is hereby incorporated by reference, and which can be obtained from the Board of Pharmacy,
4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254. Further, no program of supervised work activity shall
be approved for any applicant until said applicant has obtained the specified passing scores on the TOEFL or the TOEFL ibt.
64B16-26.2032 Licensure by Examination; Internship Requirements.
(1) All internship experience for the purpose of qualifying for the examination pursuant to Section 465.007(1)(c), F.S., shall
be obtained in a community pharmacy, institutional pharmacy or any Florida Board of Pharmacy approved pharmacy practice, which includes significant aspects of the practice of pharmacy as defined in Section 465.003(13), F.S.
(2) An internship program at an accredited college or school of pharmacy shall assure that community or institutional pharmacies utilized for the obtaining of internship experience meet the following minimum requirements:
(a) The pharmacy shall hold a current license or permit issued by the state in which they are operating and shall have available all necessary equipment for professional services, necessary reference works, in addition to the official standards and
current professional journals.
(b) The pharmacy shall be operated at all times under the supervision of a pharmacist and shall be willing to train persons
desiring to obtain professional experience.
(c) The pharmacy shall establish to the program’s satisfaction that the pharmacy fills, compounds and dispenses a sufficient
number, kind and variety of prescriptions during the course of a year so as to afford to an intern a broad experience in the
filling, compounding and dispensing of prescription drugs.
(d) The pharmacy shall have a clear record as to observance of federal, state and municipal laws and ordinances covering
any phase of activity in which it is engaged.
(e) No pharmacist may be responsible for the supervision of more than one intern at any one time.
(3) The program shall assure that all preceptors meet the following requirements:
(a) The pharmacist shall willingly accept the responsibility for professional guidance and training of the intern and be able
to devote time to preceptor training sessions and to instruction of the intern.
(b) The pharmacist shall hold current licensure in the state in which pharmacy is practiced.
(c) The pharmacist shall be ineligible to serve as a preceptor during any period in which the pharmacist’s license to practice
pharmacy is revoked, suspended, on probation, or subject to payment of an unpaid fine levied by lawful Board order, or during any period in which the pharmacist’s license is the subject of ongoing disciplinary proceedings.
(d) The pharmacist shall agree to assist the school or college of pharmacy in the achievement of the educational objectives
set forth and to provide a professional environment for the training of the intern.
(e) Evidence shall be provided of the pharmacist’s desire to continue broadening professional education and of an active involvement in a patient-oriented practice.
(4) In the event a program meets all the requirements set forth in subsection (2) of this rule, except for prior approval by the
Florida Board of Pharmacy, any applicant submitting it for the purpose of qualifying for licensure by examination must show
in addition to successful completion of the internship:
(a) Approval of the program by a state board of pharmacy; and
(b) Sufficient hours to total 2080 hours; or
(c) Licensure in another state and work performed as a pharmacist for a sufficient number of hours to total 2080 hours when
combined with the internship hours.
(5) All internship hours may be obtained prior to the applicant’s graduation.
(6) Proof of completion of an internship program shall consist of a certification that the applicant has completed the program. If additional hours are required to total 2080 hours, satisfactory proof of the additional hours shall be constituted by
the program’s certification of completion of the additional hours.
(7) Hours worked in excess of 50 hours per week prior to the applicant’s graduation or in excess of 60 hours per week after
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an applicant’s graduation, will not be credited toward meeting the required internship hours.
(8) The Board approves all internships that are required to obtain the doctor of pharmacy degree from institutions which are
accredited as provided by Section 465.007(1)(b)1., F.S. Applicants graduating after January 1, 2001 with the doctor of pharmacy degree from such institutions shall be deemed to have met the requirements of this section with documentation of graduation.
(9) The Board may conduct periodic review of programs to assure compliance with these rules.
(10) Proof of current licensure in another state and work as a pharmacist for up to 2080 hours may substitute for all or part
of the internship requirement.
(11) Governmental and private radiopharmacy internship programs shall not apply to the pharmacy internship required under subsection (1) of this rule.
64B16-26.204 Licensure by Endorsement.
An applicant for licensure by endorsement must be at least 18 years of age and a recipient of a degree from a school or
college of pharmacy accredited by an accrediting agency recognized and approved by the United States Office of Education.
(1) All applications for licensure by endorsement shall be made on board approved form DOH/MQA/PH100 (Rev. 01/2009).
The instructions and application form, entitled Florida Pharmacist Licensure by Endorsement Application and Instructions,
which is hereby incorporated by reference, can be obtained from the Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04,
Tallahassee, Florida 32399-3254, and shall be accompanied with a non-refundable endorsement application fee and initial
licensure fee as set forth in Rules 64B16-26.1001 and 64B16-26.1002, F.A.C.
(2) The applicant must submit satisfactory proof that one of the following requirements has been met:
(a) Two (2) years of active practice, as defined in Section 465.0075(1)(c), F.S., within the immediately preceding five (5)
years. If the applicant meets the requirements of this section, proof of completion of 30 hours of Florida Board of Pharmacy,
ACPE, or other state board of pharmacy approved continuing education obtained in the two years immediately preceding
application, must also be submitted.
(b) Successful completion of an internship meeting the requirements of Section 465.007(1)(c), F.S., within the immediately
preceding two (2) years.
(3) The applicant must submit satisfactory proof of completion of the following:
A course of no less than two (2) hours on medication errors covering the subjects set forth in Rule 64B16-26.103, F.A.C. The
course shall be completed no earlier than 12 months prior to application.
(4) Applicants qualifying under the education requirements of Section 465.007(1)(b)2., F.S., (foreign graduates), must
complete the requirements of Rule 64B16-26.2031, F.A.C., prior to certification for the examination required in subsection (6)
of this rule.
(5) All requirements for licensure by endorsement must be met within one (1) year of the receipt of the application. Applicants
failing to meet this requirement must reapply.
(6) Applicants applying under the provisions of Section 465.0075, F.S., must have obtained a passing score on the licensure
examination as described in subsection 64B16-26.200(1), F.A.C.
(7) Applicants applying under the provisions of Section 465.0075, F.S., shall cause the National Association of Boards of
Pharmacy, or other similar organization to issue a Transfer of Pharmaceutical Licensure certificate showing examination date,
examination results, states of licensure, disciplinary actions, and licensure status.
(8) Applicants deemed qualified for licensure by endorsement shall be required to complete the Multistate Pharmacy
Jurisprudence Examination – Florida Version. Passing scores on this examination may be used upon reapplication only if the
examination was completed within three (3) years of the reapplication.
64B16-26.300 Consultant Pharmacist Licensure.
(1) No person shall serve as consultant pharmacist as defined in Section 465.003(3), F.S., unless that person holds a license
as a consultant pharmacist.
(2) Application for consultant pharmacist licensure shall be made on form DOH-MQA 1109, 02/09, Consultant Pharmacist
Application and Information, which is hereby incorporated by reference. Contact the Board of Pharmacy at 4052 Bald
Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254, or (850) 488-0595 to request an application or download the
application from the board’s website at www.doh.state.fl.us/mqa/pharmacy. The application shall be accompanied by a non-
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refundable application fee.
(3) In order to be licensed as a consultant pharmacist, a person must meet the following requirements:
(a) Hold a license as a pharmacist which is active and in good standing,
(b) Successfully complete a consultant pharmacist course of no fewer than twelve (12) hours, sponsored by an accredited
college of pharmacy located within the State of Florida, and approved by the Florida Board of Pharmacy Tripartite
Continuing Education Committee which is based on the Statement of the Competencies Required in Institutional Pharmacy
Practice and subject matter set forth in Rule 64B16-26.301, F.A.C. The course shall be instructionally designed to include a
cognitive test on which the applicant must score a passing grade for certification of successful completion of the course.
(c) Successfully complete a period of assessment and evaluation under the supervision of a preceptor within one (1) year of
completion of the course set forth in paragraph (b) above. This period of assessment and evaluation shall be completed over
no more than three (3) consecutive months and shall include at least 40 hours of training in the following practice areas,
60% of which shall occur on-site at an institution that holds a pharmacy permit. The training shall include:
Minimum Skills Required
Percent of Time
Hours
Minimum of 40 Hours in Maximum of Three Months
1. Regimen review, documentation and
60%
24
communication.
a. Demonstrate ability to carry out process
and understand documentation functions.
b. Understand and perform drug regimen
review. Communicate findings to
appropriate individuals or groups.
c. The applicant is responsible for
learning other skills needed to perform in his/her
type of facility where he/she is or will be the
consultant Pharmacist of Record.
2. Facility review.
20%
8
Demonstrate areas that should be evaluated,
documentation, and reporting procedures.
3. Committee and Reports.
5%
2
Review quarterly Quality of Care Committee
minutes and preparation and delivery of pharmacist
quarterly report.
4. Policy and Procedures.
5%
2
Preparation, review, updating Policy
and Methods.
5. Principles of formulary management.
5%
2
Demonstrate ability to manage formulary.
6. Professional Relationships.
5%
2
Knowledge and interaction of facility
administration and professional staff.
(4) In order to act as a preceptor, a person shall:
(a) Be a consultant pharmacist of record at an institutional pharmacy which is required to have a consultant pharmacist under
the provisions of Chapter 465, F.S., and these rules.
(b) Have a minimum of one (1) year of experience as a consultant pharmacist of record.
(c) Maintain all pharmacist licenses in good standing with the Board.
(d) Not act as a preceptor to more than two (2) applicants at the same time.
(5) Upon completion of the requirements set forth above, the applicant’s preceptor shall confirm that the applicant’s
assessment and evaluation have met the requirements and that the applicant has successfully completed all required
assignments under the preceptor’s guidance and supervision.
(6) After licensure a consultant pharmacist’s license shall be renewed biennially upon payment of the fee set forth in Rule
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64B16-26.1003, F.A.C., and upon completing twenty-four (24) hours of board approved continuing education based upon the
provisions of Rule 64B16-26.302, F.A.C.
(7) The number of hours earned in recertification programs by a consultant pharmacist, if applied to the twenty-four (24) hours
required for consultant pharmacist license renewal, may not be used toward the thirty (30) hours of continued professional
pharmaceutical education credits as set forth in Rule 64B16-26.103, F.A.C.
(8) An applicant who applies for a consultant pharmacist license after the effective date of this rule shall be required to
complete the assessment and evaluation required in paragraph (3)(c) prior to being licensed as a consultant pharmacist.
64B16-26.301 Subject Matter for Consultant Pharmacist Training Program.
(1) Jurisprudence.
(a) Laws and regulations, state and federal, pertaining to institutional pharmacy and health care facilities.
(b) Laws and regulations, state and federal, pertaining to the safe and controlled storage of alcohol and other related substances, and relating to fire and health-hazard control.
(2) Policy and Procedures.
(a) Written procedures for outlining the medication system in effect.
1. Traditional systems.
2. Unit-dose systems.
Centralized.
Decentralized.
Automated medication systems.
3. Routine and emergency use of drugs.
4. After hours procedure for medication dispensing.
5. Managing drug shortages.
(b) Record keeping and reports.
1. Controlled substance control and record-of-usage.
2. Alcohol inventory and record-of-usage.
3. Patient drug use control and records.
Recalls.
Medication use evaluation.
Medications errors.
4. Drug charges, methods, accountability, and reports.
5. Statistical reports of usage, volume, etc.
(3) Administrative Responsibilities.
(a) Fiscal Control.
1. Perpetual and traditional inventory systems.
2. Application of EDP techniques.
(b) Personnel Management, orientation and training.
(c) Intra-professional relations pertaining to medication use.
(d) Inter-professional relations with other members of the institutional health care team.
1. Pharmacy & Therapeutic Committee.
a. Rational drug therapy; review of medication use and prescribing.
b. Formulary development – evaluation, appraisal, selection, procurement, storage, distribution, medication safety, criteria
for use development.
Automatic stop orders on potent and dangerous drugs.
Controls on storage and use of investigational drugs.
2. In-service education of nurses and other health-related personnel.
3. Infectious Disease Committee.
(4) Professional Responsibilities.
(a) Drug information retrieval and methods of dispersal.
(b) Development of pharmacy practice.
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(c) Development of an IV Admixture service.
(d) Procedures to enhance medication safety.
1. Availability of equipment, technique, etc., to prepare special dosage forms for pediatric and geriatric patients.
2. Preparation of sterile dosage forms.
3. Proper writing, transcribing and initiating and/or transferring patient medication orders; development of physician’s
chart order copy system.
4. Safety of patient self-medication and control of drugs at bedside.
5. Reporting and trending adverse drug reactions.
6. Screening for potential drug interactions.
7. Development and maintenance of up-to-date emergency kits.
(e) Maintain drug quality and safe storage.
1. Procedures for eliminating out-dated drugs.
2. Requirements for safe and appropriate storage conditions.
(f) Maintain drug identity.
1. Procedures for labeling, transferring of bulk medications, etc.
2. Manufacturing and packaging procedures.
3. Pre-packaging control and supervision.
(5) The Institutional Environment.
(a) The institution’s pharmacy function and purpose.
(b) Interdepartmental relationships important to the institutional pharmacy.
(c) Understanding of scope of service and in-patient care mission of the institution.
(d) Special training with respect to the operation of nursing homes and Extended Care Facilities (ECF)/pharmacy relationship and special procurement procedures.
(6) Nuclear pharmacy.
(a) Procurement.
(b) Compounding.
(c) Quality control procedures.
(d) Dispensing.
(e) Distribution.
(f) Basic radiation protection and practices.
(g) Consultation and education to the nuclear medicine community; including patients, pharmacists, other health professionals, and the general public.
(h) Research and development of new formulations.
(i) Record keeping.
(j) Reporting adverse drug reactions and medication errors.
(k) Screening for potential drug interaction.
64B16-26.302 Subject Matter for Consultant Pharmacist Licensure Renewal Continuing Education.
A Consultant Pharmacist License Renewal Continuing Education Program must contain at least three (3) hours of training in
any of the subjects specified below. Duplicate courses are not acceptable.
(1) Drug Therapy – Disease State. Patient Drug Therapy – management and monitoring.
(a) Drug, Disease State Information – In-depth disclosure of the drug or therapeutic class of drugs or disease state including
pharmacology, side effects and interaction.
(b) New Therapeutic Modalities: Expansion of current drug therapy or treatment.
(c) Patient Assessment: Assessment techniques by consultant pharmacist to determine the need and effectiveness of indicated
drug therapy along with identification and assessment of side effects on patient’s well-being.
(d) Pertinent Laboratory Tests.
(e) Therapeutic Dosing.
(2) Administrative Responsibilities.
(a) Update on Administrative Responsibilities.
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1. Legal requirements including statutes, rules and regulation (Federal and State).
2. JCAHO Standards.
3. Personnel requirements.
4. HIPAA requirements.
(b) Focus on Consultant Pharmacist Practice Issues/Concerns.
1. How to get things accomplished in complex organizations.
2. Key contacts to be effective as a consultant pharmacist.
3. Considerations and preparation for site inspections.
(3) Consultant Pharmacist Facility Responsibilities. This segment details the requirements in one of the facility types for which
a consultant pharmacist is required. Only one practice setting may be included in each program.
(a) Pharmacist-Medication Responsibilities – Assessment mechanism for delivery system, review procedures and monitoring
processes.
(b) Pharmacist-Patient Responsibilities – Patient assessment, laboratory test monitoring and therapeutic dosing.
(c) Committee Responsibilities – Make-up and responsibilities for various facility committees.
(d) Reporting requirements.
64B16-26.303 Nuclear Pharmacist Licensure.
(1) A pharmacist licensed to practice pharmacy in this state who performs a radiopharmaceutical service shall, prior to engaging in such specialized practice, be actively licensed as a nuclear pharmacist.
(2) A pharmacist seeking licensure as a nuclear pharmacist in this state shall submit to the Board of Pharmacy a course outline from an accredited college of pharmacy or other program recognized by the Florida Department of Health and the Florida Board of Pharmacy (a program comparable to those offered by accredited colleges of pharmacy for the training of
nuclear pharmacists), and a certificate of training which provides a minimum of 200 clock hours of formal didactic training,
which includes:
(a) Radiation physics and instrumentation (eighty-five (85) hours).
(b) Radiation protection (forty-five (45) hours).
(c) Mathematics pertaining to the use and measurement of radioactivity (twenty (20) hours).
(d) Radiation biology (twenty (20) hours).
(e) Radiopharmaceutical chemistry (thirty (30) hours).
(3) Such academic training programs will be submitted to the Board of Pharmacy for approval by an accredited educational
institution which operates under the auspices of or in conjunction with an accredited college of pharmacy.
(4) The minimum on-the-job training which shall be included in a radiopharmacy internship is 500 hours of training and experience in the handling of unsealed radioactive material under the supervision of a licensed nuclear pharmacist. The training and experience shall include but shall not be limited to the following:
(a) Ordering, receiving and unpackaging in a safe manner, radioactive material, including the performance of related radiation surveys.
(b) Calibrating dose calibrators, scintillation detectors, and radiation monitoring equipment.
(c) Calculating, preparing and verifying patient doses, including the proper use of radiation shields.
(d) Following appropriate internal control procedures to prevent mislabeling.
(e) Learning emergency procedures to safely handle and contain spilled materials, including related decontamination procedures and surveys.
(f) Eluting technetium-99m from generator systems, assaying the eluate for technetium-99m and for molybdenum99 contamination, and processing the eluate with reagent kits to prepare technetium-99m labeled radiopharmaceuticals.
(g) Clinical practice concepts.
(5) If the didactic and experiential training required in this section have not been completed within the last seven
(7) years, the applicant must have been engaged in the lawful practice of nuclear pharmacy in another jurisdiction at least
1080 hours during the last seven (7) years.
64B16-26.304 Subject Matter for Nuclear Pharmacist License Renewal Continuing Education Programs.
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(1) A licensee completing the continuing education requirement for nuclear pharmacist license renewal pursuant to Rule
64B16-26.103, F.A.C., shall complete twenty-four (24) additional hours per biennium of coursework each two (2) year period by or through a Committee approved provider, instructionally designed to provide in-depth treatment of nuclear pharmacy practice with suggested subject matter set out in subsection (2) of this rule.
(2) Content of nuclear pharmacist continuing education program.
(a) Application of radiopharmaceutical theory in a practice or a research setting with respect to the drug products and their
clinical application. Provision of drug and radiopharmaceutical information as it pertains to optimal handling and use of
these products in a clinical setting.
(b) Effective communication skills in a multi-disciplinary environment with patients, nuclear medicine physicians, nuclear
medicine technologists, radiation safety personnel and other nuclear pharmacists. The multi-faceted regulatory environment
requires such skills in the preparation and maintenance of a radioactive by-product materials license, the identification and
reporting of adverse reactions and misadministration, instances of poor product performance, environmental and personnel
radiation safety.
(c) Application of the most rigorous and up-to-date principles of radiation safety and quality assurance in order to assure
regulatory compendia, and operational standards for drug and radiopharmaceutical products and equipment. Record-keeping and other documentation activities essential to procurement, storage, compounding, handling and use, distribution and
disposal should be emphasized.
(d) Management of a nuclear pharmacy unit in accordance with regulatory and administrative agencies’ requirements.
(e) Advances in drug, radiopharmaceutical or related technology (including, but not limited to: monoclonal antibodies, magnetic resonance imaging, computed tomography, positron-emission tomography, radioplaque and other contact enhancement
agents, radioimmunoassay) with emphasis on paragraphs (a)-(d) above for such new agents.
64B16-26.320 Subject Matter for Continuing Education to Order and Evaluate Laboratory Tests.
(1) Consultant pharmacists and pharmacists holding the Doctor of Pharmacy degree that wish to order and evaluate laboratory tests under the provisions of Section 465.0125, F.S., shall successfully complete the requirements of a continuing education course set forth herein prior to such practice. Successful completion of the course will certify the pharmacist for this
practice for two (2) years from date of completion.
(2) Providers of courses seeking approval under this section shall meet the procedures and standards provided for in Rule
64B16-26.601, F.A.C. Courses approved under this section shall be at least three (3) hours in duration for initial certification and at least one (1) hour for recertification, and shall cover the following subjects:
(a) Requirements for monitoring laboratory values,
(b) Interpretation of laboratory values,
(c) Use of laboratory data to monitor and improve drug therapy,
(d) Legal aspects, restrictions, and requirements for obtaining laboratory studies,
(e) Use of laboratory data and therapeutic outcomes,
(f) Documentation of interventions, and
(g) Laboratory studies as an element of complete patient care.
(3) A consultant pharmacist may apply the three (3) hour initial certification course and the one (1) hour recertification
course toward the continuing education requirement for renewal of a consultant pharmacist license under Rule 64B1626.300, F.A.C., or may apply such continuing education hours toward the continuing education requirement for renewal of a
pharmacist license under Rule 64B16-26.103, F.A.C., but may not use the same continuing education hours to satisfy both
requirements. A Doctor of Pharmacy who is not a consultant pharmacist may apply the three (3) hour initial certification
course and the one (1) hour recertification course toward the continuing education requirement for renewal of a pharmacist
license under Rule 64B16-26.103, F.A.C.
64B16-26.400 Pharmacy Interns; Registration; Employment.
(1) A pharmacy intern is required to be registered with the Department of Health as an intern before being employed as an
intern in a pharmacy in Florida.
(2) An applicant for pharmacy intern registration must submit proof of:
(a) Enrollment in an intern program at an accredited college or school of pharmacy or;
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(b) Graduation from an accredited college or school of pharmacy and not yet licensed in the state. For purposes of this rule
only, any individual who has been accepted by the Foreign Pharmacy Graduate Examination Commission to sit or the Foreign Pharmacy Graduate Equivalency Examination shall be considered a graduate of an accredited college or school of
pharmacy. The internship experience allowed under this provision shall not count toward the 500-hours internship required
subsequent to passage of the Foreign Pharmacy Graduate Equivalency Examination as mandated in Section 465.007(1)(b)2.,
F.S., and as defined in Rule 64B16-26.203, F.A.C.
(3) Upon the receipt of proof satisfactory to the Board that the intern applicant meets the requirements of either paragraph
(a) or (b) of subsection (2), and unless there exists good cause for the Board’s refusal to certify an applicant as set forth in
Section 465.013, F.S., the Board shall certify the applicant to the Department for registration as an intern.
(4) No intern shall perform any acts relating to the filling, compounding, or dispensing of medicinal drugs unless it is done
under the direct and immediate personal supervision of a person actively licensed to practice pharmacy in this state.
64B16-26.600 Tripartite Continuing Education Committee.
(1) The Tripartite Continuing Education Committee will be composed of equal representation from the Board of Pharmacy,
each College or School of Pharmacy in the State, and practicing pharmacists within the State. The members of the Committee
shall be selected by the Board of Pharmacy and shall serve for a period of two years. The chairman of the committee shall be
selected by the Chair of the Board.
(2) The Tripartite Continuing Education Committee shall perform the following duties pursuant to Rule 64B16-26.601,
F.A.C.:
(a) Review continuing education providers and make recommendations to the Board;
(b) Approve continuing education course or program for approved providers or individuals that are non-approved providers
for the following:
1. General;
2. Initial Consultant Pharmacist Certification;
3. Consultant Recertification;
4. Nuclear Recertification;
5. Medication Errors;
6. HIV/AIDS;
7. Laboratory Tests;
8. Laws and Rules;
9. Quality Related Events.
(3) The Tripartite Continuing Education Committee shall perform auditing and monitoring activities pursuant to Rule 64B1626.601, F.A.C. The Tripartite Committee shall perform an audit on each approved continuing education provider 90 days
prior to the end of the biennium. The approved provider shall submit the following information for one program of the
provider’s choosing and one program selected by the Board:
(a) Title, date and location of the program;
(b) Program Number;
(c) Any Co-sponsors;
(d) Total number of pharmacists attending;
(e) Rosters of attendees with appropriate license numbers;
(f) Brochures of program announcement;
(g) CV’s of each speaker;
(h) Handouts, Copy of CE Credit statement, educational materials distributed as part of the program; and
(i) Summary report of program evaluations.
(4) The Committee shall hold meetings as may be convened at the call of the Chairman of the Committee.
64B16-26.601 Standards for Approval of Courses and Providers.
(1) Each proposal for program or course approval submitted by a qualified provider must contain a detailed outline of the
content of said program or course on forms which will be provided by the Board of Pharmacy upon request, and must build
upon Standards of Practice and a basic course or courses offered in the curricula of accredited colleges or schools of phar212
macy. Continuing education may consist of post-baccalaureate degree programs offered by accredited colleges or schools of
pharmacy, post-graduate studies, institutes, seminars, lectures, conferences, workshops, correspondence courses, or other
such committee-approved educational methods.
(2) All offerings must meet the following standards:
(a) Education Content Development.
1. Continuing education offerings shall involve advance planning that includes a statement of measurable educational goals
and behavioral objectives.
2. Continuing education offerings shall be designed to reflect the educational needs of the pharmacist and build on the standards for practice and courses in the curricula of accredited colleges or schools of pharmacy.
3. Each continuing education offering shall be designed to explore one (1) subject or a group of closely related subjects or
standards.
(b) Methods of Delivery.
1. The method of delivery of a course shall be determined by giving appropriate consideration to such factors as educational
content, objectives, and composition of the audience.
2. The method of delivery must encourage active participation and involvement on the part of the pharmacist.
(c) Program Faculty Qualifications.
1. The program faculty for a particular continuing education offering shall be competent in the subject matter and qualified
by experience.
2. An appropriate number of program faculty for each activity shall be utilized.
3. There shall be adequate personnel to assist with administrative matters and personnel with competencies outside content
areas in cases where the method of delivery requires technical or other special expertise.
(d) Facilities. The facilities to be utilized shall be appropriate and adequate to the content, method of delivery, size of the audience and promote the attainment of the objectives of the offering.
(e) Evaluation.
1. The provider must make provision for evaluation of the participants’ attainment of the stated learner objectives through
in-process activities that provide a measurable demonstration of the learner’s achievement(s).
2. The provider must develop and employ an evaluation mechanism for the purpose of allowing the participant to assess
his/her achievement of personal objectives.
3. The provider shall develop and employ an evaluation mechanism that will assess the effectiveness of the learning experiences, instructional methods, facilities, and resources used for the offering.
(f) Contact Hour Criteria. The number of contact hours or Continuing Education Units shall be determined by the provider
in advance of the offering subject to approval by the committee and awarded upon the successful completion of the entire
planned education experience.
(g) Record Keeping.
1. Records of individual offerings shall be maintained by the provider for inspection by the Board. The records shall be adequate to serve the needs of the participants and to permit the Board to monitor for adherence to the standards for continuing
education offerings as outlined in the rules.
2. An individual certificate of attendance specifying title of offering, provider number, date of offering, and number of contact
hours earned shall be furnished to each participant by the provider.
3. Records shall be maintained by the provider for a minimum of three (3) years.
(3) Providers seeking board approval shall meet each of the standards outlined herein:
(a) All continuing education offerings conducted by the provider shall meet the standards for continuing education offerings
as outlined in these rules.
(b) There shall be a visible, continuous, and identifiable authority charged with administration of continuing education programs. The person or persons in whom the administrative function is vested shall be qualified by virtue of background and
experience and approval by the committee.
(4) All programs approved by the Accreditation Council for Pharmacy Education (ACPE) for continuing education for pharmacists may be deemed approved by this Board for general continuing education hours for pharmacists.
(5) Entities or individuals who wish to become approved providers of continuing education must submit an initial approval
fee of $150 and provide information to demonstrate compliance with the requirements of this rule. A provider seeking to re213
new approved provider status shall pay a renewal fee of $150.
(6) Entities or individuals applying for approval of an individual program shall submit a fee of $50 and provide information
to demonstrate compliance with this rule.
64B16-26.6012 Guidelines for Board Ordered Disciplinary Continuing Education Courses.
Any continuing education course being taken as part of a disciplinary order, unless otherwise ordered by the Board, may be
conducted by any method, including live, correspondence, or distant education.
(1) Laws and Rules courses shall be at least twelve (12) hours in length. The program shall include review and analysis of the
laws regulating the profession of pharmacy in the State of Florida with discussion of recent changes to Florida Statutes and
Board of Pharmacy rules. The remainder of the continuing education program shall be derived from the following areas:
(a) Federal laws related to:
1. Handling, management, and dispensing of controlled substances;
2. Protected patient information; and
3. Medicare.
(b) Chapters 456, 499 and 893, F.S;
(c) Florida Medicaid program;
(d) Nursing home and Assisted Living Facility regulations;
(e) Prescriber laws and regulations;
(f) Pharmacy ethics;
(g) The Joint Commission (TJC) standards;
(h) Food and Drug Administration policies and procedures;
(i) Implementation of disaster and emergency preparedness plans by Florida pharmacists and pharmacy services providers;
and
(j) Occupational Safety and Health Administration (OSHA) and National Institute for Occupational Safety and Health (NIOSH)
guidelines and requirements for pharmacy employers.
(2) Quality Related Event (QRE) courses shall be at least eight (8) hours in length.
(a) Course material shall include:
1. Pharmacy error detection;
2. Pharmacy error prevention; and
3. Case studies of pharmacists who have made dosing calculation, checking/interpreting prescriptions, or dispensing errors.
(b) Course material shall include the following specific subject areas:
1. Common error types and causes;
2. Root cause analysis;
3. Process mapping and management;
4. System analysis;
5. Failure mode and effects analysis;
6. Human factors, cognitive and personality impacts;
7. Practice management and effective delegation tools;
8. Stress management;
9. Effective communication;
10. Continuous Quality Improvement (CQI) rules;
11. CQI implementation tools;
12. Individual self assessment, planning, and goal setting. The individual self assessment shall include a requirement that the
pharmacist prepare a written report, in essay form, summarizing the impact of the course, what the pharmacist learned, and
the changes that the pharmacist will implement in practice as a result of the course.
64B16-26.603 Continuing Education Records Requirements. Each pharmacist shall retain documentation of participation
in continuing education programs required for license renewal for not less than two (2) years after the license is renewed for
audit purposes if and when such audit is undertaken by the Department of Health and the Board of Pharmacy. Such documentation shall consist of statements of credit for lecture attendance, certification forms from instructors, or course comple214
tion slips from correspondence courses.
B.
Pharmacy Practice Standards
The Board of Pharmacy has established standards applicable to the practice of pharmacy. These standards must be
adhered to by all licensees.
64B16-27.100 Display of Current License; Pharmacist and Intern Identification.
(1) The current license of each pharmacist engaged in the practice of the profession of pharmacy as defined by Section
465.003(13), F.S., in any pharmacy shall be displayed, when applicable, in a conspicuous place in or near the prescription
department, and in such manner that said license can be easily read by patrons of said establishment. Pharmacists employed
in secondary practice sites shall present a valid wallet license as evidence of licensure upon request.
(2) No pharmacist shall display, cause to be displayed or allow to be displayed, their license in any pharmacy where said
pharmacist is not engaged in the practice of the profession as defined in Section 465.003(13), F.S.
(3) A pharmacist and registered pharmacy intern must be clearly identified by a means such as an identification badge or
monogrammed smock showing their name and if they are a pharmacist or a registered pharmacy intern.
(4) The current registration of each registered pharmacy technician shall be displayed, when applicable, in a conspicuous
place in or near the prescription department, and in such a manner that can be easily read by patrons of said establishment.
Registered pharmacy technicians employed in a secondary practice site shall present a valid wallet registration as evidence
of registration upon request.
64B16-27.1001 Practice of Pharmacy.
Those functions within the definition of the practice of the profession of pharmacy, as defined by Section 465.003(13), F.S.,
are specifically reserved to a pharmacist or a duly registered pharmacy intern in this state acting under the direct and immediate personal supervision of a pharmacist. The following subjects come solely within the purview of the pharmacist.
(1) A pharmacist or registered pharmacy intern must:
(a) Supervise and be responsible for the controlled substance inventory.
(b) Receive verbal prescriptions from a practitioner.
(c) Interpret and identify prescription contents.
(d) Engage in consultation with a practitioner regarding interpretation of the prescription and date in patient profile.
(e) Engage in professional communication with practitioners, nurses or other health professionals.
(f) Advise or consult with a patient, both as to the prescription and the patient profile record.
(2) When parenteral and bulk solutions of all sizes are prepared, regardless of the route of administration, the pharmacist
must:
(a) Interpret and identify all incoming orders.
(b) Mix all extemporaneous compounding or be physically present and give direction to the registered pharmacy technician
for reconstitution, for addition of additives, or for bulk compounding of the parenteral solution.
(c) Physically examine, certify to the accuracy of the final preparation, thereby assuming responsibility for the final preparation.
(d) Systemize all records and documentation of processing in such a manner that professional responsibility can be easily
traced to a pharmacist.
(3) Only a pharmacist may make the final check of the completed prescription thereby assuming the complete responsibility
for its preparation and accuracy.
(4) The pharmacist, as an integral aspect of dispensing, shall be directly and immediately available to the patient or the
patient’s agent for consultation and shall not dispense to a third party. No prescription shall be deemed to be properly dispensed unless the pharmacist is personally available.
(5) The pharmacist performing in this state any of the acts defined as “the practice of the profession of pharmacy” in Section
465.003(13), F.S., shall be actively licensed as a pharmacist in this state, regardless of whether the practice occurs in a permitted location (facility) or other location.
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(6) The pharmacist may take a meal break, not to exceed 30 minutes in length, during which the pharmacy department of a
permittee shall not be considered closed, under the following conditions:
(a) The pharmacist shall be considered present and on duty during any such meal break if a sign has been prominently posted in the pharmacy indicating the specific hours of the day during which meal breaks may be taken by the pharmacist and
assuring patients that a pharmacist is available on the premises for consultation upon request during a meal break.
(b) The pharmacist shall be considered directly and immediately available to patients during such meal breaks if patients to
whom medications are delivered during meal breaks are verbally informed that they may request that a pharmacist contact
them at the pharmacist’s earliest convenience after the meal break, and if a pharmacist is available on the premises during
the meal break for consultation regarding emergency matters. Only prescriptions with the final certification by the pharmacist may be delivered.
(c) The activities of registered pharmacy technicians during such a meal break shall be considered to be under the direct and
immediate personal supervision of a pharmacist if the pharmacist is available on the premises during the meal break to respond to questions by the technicians, and if at the end of the meal break the pharmacist certifies all prescriptions prepared
by the registered pharmacy technicians during the meal break.
(7) The delegation of any duties, tasks or functions to registered pharmacy interns and registered pharmacy technicians must
be performed subject to a continuing review and ultimate supervision of the pharmacist who instigated the specific task, so
that a continuity of supervised activity is present between one pharmacist and one registered pharmacy technician. In every
pharmacy, the pharmacist shall retain the professional and personal responsibility for any delegated act performed by registered pharmacy interns and registered pharmacy technicians in the licensee’s employ or under the licensee’s supervision.
64B16-27.1003 Transmission of Prescription Orders.
Prescriptions may be transmitted from prescriber to dispenser in written form or by any means of communication. Prescriptions may be transmitted by facsimile systems as provided in Section 465.035, F.S., and federal law. Any direct transmission
of prescriptions, including verbal, facsimile, telephonic or electronic data transmission, shall only be with the approval of the
patient or patient’s agent. The pharmacist receiving any such transmitted prescription shall not participate in any system that
the pharmacist knows or should have reason to know restricts the patient’s choice of pharmacy. The pharmacist shall take
such measures necessary to ensure the validity of all prescriptions received.
64B16-27.101 Counterfeit Drugs.
No pharmacist or pharmacy employee or proprietor shall knowingly purchase, sell, possess or distribute drugs which are
commonly called counterfeit, or which are misbranded, or improperly labeled as described by the Florida Drug and Cosmetic Law.
64B16-27.103 Oral Prescriptions and Copies.
(1) Only a pharmacist or registered pharmacy intern acting under the supervision of a pharmacist may, in the State of Florida, accept an oral prescription of any nature.
(2) Only a pharmacist or registered pharmacy intern acting under the supervision of a pharmacist may, in the State of Florida, prepare a copy of a prescription or read a prescription to any person for purposes of providing reference concerning
treatment of the person or animal for whom the prescription was written, and when said copy is given a notation shall be
made upon the prescription that a copy has been given, the date given, and to whom given.
64B16-27.104 Conduct Governing Pharmacists and Pharmacy Permittees.
(1) A pharmacist or pharmacy shall be permitted to advertise medicinal drugs other than those controlled substances specified in Chapter 893, F.S., and patent and proprietary preparations so long as such advertising is not false, misleading or deceptive.
Note below that a pharmacist may not maintain a “dropoff” at which either unfilled prescriptions may be left by patients for
the pharmacist or filled prescriptions may be left by the pharmacist for patients.
(2) No pharmacist, employer or employee of a pharmacy shall maintain a location, other than a pharmacy for which a permit
has been issued by the Florida Board of Pharmacy, from which to solicit, accept or dispense prescriptions.
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(3) No pharmacist or pharmacy, or employee or agent thereof, shall enter into or engage in any agreement or arrangement
with any physician or other practitioner or nursing home or extended care facility for the payment or acceptance of compensation in any form or type for the recommending of the professional services of either; or enter into a rebate or percentage
rental agreement of any kind, whereby in any way a patient’s free choice of a pharmacist or pharmacy is or may be limited.
(4) No pharmacist, employer or employee of a pharmacy may knowingly place in stock of any pharmacy any part of any prescription compounded for, or dispensed to, any customer of any pharmacy and returned by said customer, unless otherwise
permitted by Rule 64B16-28.118, F.A.C.
Note below that every community pharmacy must have a pharmacist in charge of the pharmacy, and this pharmacist is responsible to the Board of Pharmacy for assuring that rules of the practice of the profession are followed. This person is called
the Prescription Department Manager. A similar position exists in institutional pharmacies, and it designated as the Consultant of Record.
(5) Pursuant to Section 465.018, F.S., a permit for a community pharmacy may not be issued unless a licensed pharmacist is
designated as the prescription department manager responsible for maintaining all drug records, providing for the security
of the prescription department and following such other rules as relate to the practice of the profession of pharmacy. The
Board shall not register a prescription department manager as the manager of more than one pharmacy. The Board shall
grant an exception to this requirement upon application by the permittee and the prescription department manager showing
circumstances such as proximity of permits and limited pharmacist workload that would allow the manager to carry out all
duties and responsibilities required of a prescription department manager.
64B16-27.1042 Rebates Prohibited; Violations Defined.
As provided in Section 465.185(1), F.S., acts which will be considered as falling within the range of activities which would
justify discipline against a pharmacist or permittee as provided in Section 465.016(1)(e) or Section 465.023(1)(c), F.S., shall
include:
(1) Offering or providing cash, or goods, or entertainment (including, money, food or decorations) to a health care facility (as
defined in Section 408.032(7), F.S.) or its representative in exchange for favorable consideration in obtaining or maintaining
the business of the facility;
(2) Offering or providing supplies or equipment to a health care facility (as defined in Section 408.032(7), F.S.) at no charge
or below market value when these items are not integral elements of the medication distribution system;
(3) Paying rent to a health care facility (as defined in Section 408.032(7), F.S.) for space that is not used or is unusable or
paying a rental rate for space that is significantly greater than the usual and customary rental rate for similar space;
(4) Offering or providing computers, FAX machines, or other electronic devices to a health care facility (as defined in Section
408.032(7), F.S.) when that equipment is not an integral element in providing pharmacy or consultant services;
(5) Offering or providing a health care facility (as defined in Section 408.032(7), F.S.) consultant pharmacist services, or
providing patient medical record systems, or any personnel services outside the practice of pharmacy, at no charge, below
market value, or below cost in exchange for obtaining or maintaining the business of the facility.
Note below that a pharmacist or a supervised intern may transfer a prescription, but a pharmacy technician may not perform
this function.
64B16-27.105 Transfer of Prescriptions.
(1) A pharmacist or registered pharmacy intern acting under the direct personal supervision of a Florida registered pharmacist
may transfer a valid prescription which is on file in another pharmacy in this state or any other state if such transfer is
consistent with the conditions set forth in Section 465.026, F.S. Prior to dispensing, the pharmacist or pharmacy where the
prescription is on file shall be notified verbally, or by any electronic means that the former prescription must be voided.
(2) In processing a transferred prescription pursuant to Section 465.026, F.S., the pharmacist has the option of substituting a
generically equivalent product if such substitution is consistent with the provisions of Section 465.025, F.S.
The Board of Pharmacy has recognized that consultant pharmacists and pharmacists with the PharmD degree may order and
evaluate lab tests allowed by 465.0125. Remember that this activity is limited to nursing home facilities and to home health
agencies, unless there is a prescriber care plan.
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64B16-27.120 Ordering and Evaluation of Laboratory Tests.
Those consultant pharmacists and pharmacists holding the Doctor of Pharmacy degree that meet the continuing education
requirements of Rule 64B16-26.320, F.A.C., may order and evaluate laboratory tests to the extent allowed by the provisions of
Section 465.0125, F.S. Evidence of such training and authorization to perform these tasks shall be furnished to the board, the
patient, or the patient’s physician upon request.
64B16-27.200 Purpose and Effect.
The purpose of this rule chapter is to set forth pursuant to the requirements of Section 465.186, F.S., the medicinal drug
products which may be ordered and dispensed by pharmacists to the public and to set forth the terms and conditions under
which such ordering and dispensing by the pharmacist may take place. The list of drugs set forth below and the conditions
under which said drugs may be ordered and dispensed have been determined pursuant to a joint committee of medical, osteopathic and pharmacy professionals as created by Section 465.186, F.S.
The rules for pharmacist prescribing promulgated by the Board of Pharmacy go well beyond those established by the Legislature in the Florida Pharmacy Act.
64B16-27.210 General Terms and Conditions to Be Followed by a Pharmacist When Ordering and Dispensing Approved
Medicinal Drug Products.
Pursuant to the authority of the Formulary Committee in Section 465.186, F.S., a pharmacist may order the medicinal drug
products listed in Rule 64B16-27.220, F.A.C., subject to the following terms and limitations:
(1) Injectable products shall not be ordered by the pharmacist.
(2) No oral medicinal drugs shall be ordered by a pharmacist for a pregnant patient or nursing mother.
(3) In any case of dispensing hereunder, the amount or quantity of drug dispensed shall not exceed a 34-day supply or standard course of treatment unless subject to the specific limitations in this rule. Patients shall be advised that they should seek
the advice of an appropriate health care provider if their present condition, symptom, or complaint does not improve upon
the completion of the drug regimen.
(4) The directions for use of all prescribed medicinal drugs shall not exceed the manufacturer’s recommended dosage.
(5) The pharmacist may only perform the acts of ordering and dispensing in a pharmacy which has been issued a permit by
the Board of Pharmacy.
(6) The pharmacist shall create a prescription when ordering and dispensing medicinal drug products which shall be maintained in the prescription files of the pharmacy. The pharmacist shall place the trade or generic name and the quantity dispensed on the prescription label, in addition to all other label requirements.
(7) The pharmacist shall maintain patient profiles, separate from the prescription order, for all patients for whom the pharmacist orders and dispenses medicinal drug products and shall initial and date each profile entry. Such profiles shall be
maintained at the pharmacy wherein the ordering and dispensing originated for a period of two (2) years.
(8) In the patient profiles, the pharmacist shall record as a minimum the following information if a medicinal drug product is
ordered and dispensed.
(a) Patient’s chief complaint or condition in the patient’s own words.
(b) A statement regarding the patient’s medical history.
(c) A statement regarding the patient’s current complaint which may include, onset, duration and frequency of the problem.
(d) The medicinal drug product ordered and dispensed.
(e) The pharmacist ordering and dispensing the medicinal drug product shall initial the profile.
(f) The prescription number shall be recorded in the patient’s profile.
(9) A medicinal drug product may be ordered, and dispensed only by the pharmacist so ordering.
(10) Only legend medicinal drugs may be prescribed by a pharmacist. Over-the-counter drugs are exempt from the requirements of this rule and shall be recommended as over-the-counter products.
(11) Pharmacy interns and technicians may not be involved in the ordering of the medicinal drugs permitted in this rule.
64B16-27.211 Prescription Refills.
No prescription may be filled or refilled in excess of one (1) year from the date of the original prescription was written. No
prescription for a controlled substance listed in Schedule II may be refilled. No prescription for a controlled substance listed
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in Schedules III, IV, or V may be filled or refilled more than five (5) times within a period of six (6) months after the date on
which the prescription was written.
64B16-27.220 Medicinal Drugs Which May Be Ordered by Pharmacists.
A Pharmacist may order and dispense from the following formulary, within their professional judgment, subject to the stated
conditions.
(1) Oral analgesics for mild to moderate pain. The pharmacist may order these drugs for minor pain and menstrual cramps
for patients with no history of peptic ulcer disease. The prescription shall be limited to a six (6) day supply for one treatment.
If appropriate, the prescription shall be labeled to be taken with food or milk.
(a) Magnesium salicylate/phenyltoloxamine citrate.
(b) Acetylsalicylic acid (Zero order release, long acting tablets).
(c) Choline salicylate and magnesium salicylate.
(d) Naproxen sodium.
(e) Naproxen.
(f) Ibuprofen.
(2) Urinary analgesics. Phenazopyridine, not exceeding a two (2) day supply. The prescriptions shall be labeled about the
tendency to discolor urine. If appropriate, the prescription shall be labeled to be taken after meals.
(3) Otic analgesics. Antipyrine 5.4%, benzocaine 1.4%, glycerin, if clinical signs or symptions of tympanic membrane perforation do not exist. The product shall be labeled for use in the ear only.
(4) Anti-nausea preparations.
(a) Meclizine up to 25 mg., except for a patient currently using a central nervous system (CNS) depressant. The prescription
shall be labeled to advise the patient of drowsiness and to caution against concomitant use with alcohol or other depressants.
(b) Scopolamine not exceeding 1.5 mg. per dermal patch. Patient shall be warned to seek appropriate medical attention if eye
pain, redness or decreased vision develops.
(5) Antihistamines and decongestants. The following, including their salts, either as a single ingredient product or in combination, including nasal decongestants, may be ordered for a patient above 6 years of age.
(a) Antihistamines. The pharmacist shall warn the patient that an antihistamine should not be used by patients with bronchial
asthma or other lower respiratory symptoms, glaucoma, cardiovascular disorders, hypertension, prostate conditions and urinary retention. An antihistamine shall be labeled to advise the patient of drowsiness and caution against the concomitant use
with alcohol or other depressants.
1. Diphenhydramine.
2. Carbinoxamine.
3. Pyrilamine.
4. Dexchlorpheniramine.
5. Brompheniramine.
(b) Decongestants. The pharmacist shall not order an oral decongestant for use by a patient with coronary artery disease,
angina, hyperthyroidism, diabetes, glaucoma, prostate conditions, hypertension, or a patient currently using a monoamine
oxidase inhibitor.
1. Phenylephrine.
2. Azatadine.
(6) Topical antifungal/antibacterials. The pharmacist shall warn the patient that any of the products should not be used near
deep or puncture wounds and contact with eyes or mucous membranes should be avoided. Iodochlorhydroxyquin preparations shall be labeled with staining potential.
(a) Iodochlorhydroxyquin with 0.5% Hydrocortisone (not exceeding 20 grams).
(b) Haloprogin 1%.
(c) Clotrimazole topical cream and lotion.
(d) Erythromycin topical.
(7) Topical anti-inflammatory. The pharmacist shall warn the patient that hydrocortisone should not be used on bacterial
infections, viral infections, fungal infections, or by patients with impaired circulation. The prescription shall be labeled to
advise the patient to avoid contact with eyes, mucous membranes or broken skin. Preparations containing hydrocortisone not
exceeding 2.5%.
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(8) Otic antifungal/antibacterial. Acetic acid 2% in aluminum acetate solution which shall be labeled for use in ears only.
(9) Keratolytics. Salicylic acid 16.7% and lactic acid 16.7% in flexible collodion, to be applied to warts, except for patients
under two (2) years of age, and those with diabetes or impaired circulation. Prescriptions shall be labeled to avoid contact
with normal skin, eyes and mucous membranes.
(10) Vitamins with fluoride. (This does not include vitamins with folic acid in excess of 0.9 mg.)
(11) Medicinal drug shampoos containing Lindane. The pharmacist shall:
(a) Limit the order to the treatment of head lice only;
(b) Order no more than four (4) ounces per person; and
(c) Provide the patient with the appropriate instructions and precautions for use.
(12) Ophthalmics. Naphazoline 0.1% ophthalmic solution.
(13) Histamine H2 antagonists. The pharrmacist shall advise the patient to seek medical attention if symptom persist longer
than 14 days while using the medication or if stools darken or contain blood.
(a) Cimetidine.
(b) Famotidine.
(c) Ranitidine HC1.
(14) Acne products. Benzoyl Peroxide. The prescription shall be labeled to advise the patient to avoid use on the eye, eyelid,
or mucous membranes.
(15) Topical Antiviral.
(a) Acyclovir ointment may be ordered for the treatment of herpes simplex infections of the lips.
(b) Penciclovir.
64B16-27.230 Fluoride Containing Products That May be Ordered by Pharmacists.
Oral medicinal drug products containing fluoride may be ordered by pharmacists for their patients who do not have fluoride
supplement in their drinking water, pursuant to the following limitations:
(1) The fluoride content of drinking water does not exceed 0.5 ppm.
(2) Once a fluoride treatment has been initiated with one specific fluoride medicinal drug product it should not be interchanged
with a product of a different manufacturer for the course of the treatment.
(3) If the fluoride content is less than 0.5 ppm then the following dosage schedule for oral usage shall be followed.
(a)1. For ages 0-6 months.
a. Less than 0.3 ppm in water – no supplementation,
b. 0.3-0.6 ppm in water – no supplementation,
c. 0.6 ppm in water – no supplementation,
2. For ages 6 months – 3 years,
a. Less than 0.3 ppm in water – supplement with 0.25 mg. F/day,
b. 0.3-0.6 ppm in water – no supplementation,
c. 0.6 ppm in water – no supplementation.
3. For ages 3-6 years.
b. 0.3-0.6 ppm in water – supplement with 0.25 mg. F/day,
4. For ages 6-16 years.
b. 0.3-0.6 ppm in water – supplement with 0.5 mg. F/day,
(b) No more than 264 mg. of sodium fluoride may be dispensed at any one time to a patient.
(c) Notwithstanding the provisions of subsection 64B16-27.210(3), F.A.C., a pharmacist may continue a course of therapy with
fluoride products until appropriate referral to another health care practitioner is indicated or in no event shall the course of
therapy be more than one (1) year.
64B16-27.300 Standards of Practice - Continuous Quality Improvement Program.
(1) “Continuous Quality Improvement Program” means a system of standards and procedures to identify and evaluate
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quality-related events and improve patient care.
(2) “Quality-Related Event” means the inappropriate dispensing or administration of a prescribed medication including:
(a) A variation from the prescriber’s prescription order, including, but not limited to:
1. Incorrect drug;
2. Incorrect drug strength;
3. Incorrect dosage form;
4. Incorrect patient; or
5. Inadequate or incorrect packaging, labeling, or directions.
(b) A failure to identify and manage:
1. Over-utilization or under-utilization;
2. Therapeutic duplication;
3. Drug-disease contraindications;
4. Drug-drug interactions;
5. Incorrect drug dosage or duration of drug treatment;
6. Drug-allergy interactions; or
7. Clinical abuse/misuse.
(3)(a) Each pharmacy shall establish a Continuous Quality Improvement Program which program shall be described in the
pharmacy’s policy and procedure manual and, at a minimum shall contain:
1. Provisions for a Continuous Quality Improvement Committee that may be comprised of staff members of the pharmacy,
including pharmacists, registered pharmacy interns, registered pharmacy technicians, clerical staff, and other personnel
deemed necessary by the prescription department manager or the consultant pharmacist of record;
2. Provisions for the prescription department manager or the consultant pharmacist of record to ensure that the committee
conducts a review of Quality Related Events at least every three months.
3. A planned process to record, measure, assess, and improve the quality of patient care; and
4. The procedure for reviewing Quality Related Events.
(b) As a component of its Continuous Quality Improvement Program, each pharmacy shall assure that, following a QualityRelated Event, all reasonably necessary steps have been taken to remedy any problem for the patient.
(c) At a minimum, the review shall consider the effects on quality of the pharmacy system due to staffing levels, workflow, and
technological support.
(4) Each Quality-Related Event that occurs, or is alleged to have occurred, as the result of activities in a pharmacy, shall be
documented in a written record or computer database created solely for that purpose. The Quality-Related Event shall be
initially documented by the pharmacist to whom it is described, and it shall be recorded on the same day of its having been
described to the pharmacist. Documentation of a Quality-Related Event shall include a description of the event that is sufficient
to permit categorization and analysis of the event. Pharmacists shall maintain such records at least until the event has been
considered by the committee and incorporated in the summary required in subsection (5) below.
(5) Records maintained as a component of a pharmacy Continuous Quality Improvement Program are confidential under the
provisions of Section 766.101, F.S. In order to determine compliance the Department may review the policy and procedures
and a Summarization of Quality-Related Events. The summarization document shall analyze remedial measures undertaken
following a Quality-Related Event. No patient name or employee name shall be included in this summarization. The
summarization shall be maintained for two years. Records are considered peer-review documents and are not subject to
discovery in civil litigation or administrative actions.
64B16-27.410 Registered Pharmacy Technician, to Pharmacist Ratio.
(1) Registered pharmacy technicians may assist a pharmacist in performing professional services within a pharmacy
environment provided that no pharmacist shall supervise more than one registered pharmacy technician unless otherwise
permitted by the Florida Board of Pharmacy. A pharmacist’s supervision of a registered pharmacy technician in a working
environment requires that a registered pharmacy technician be under the direct personal supervision of a pharmacist.
(2) The prescription department manager or consultant pharmacist of record is required to submit a written request and receive
approval prior to the pharmacy’s allowing a pharmacist to supervise more than one registered pharmacy technician as
permitted by law. Such requests shall be reviewed and pre-approved by Board staff according to the guidelines adopted herein,
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and submitted to the Board for ratification.
(3) The request to practice with a ratio greater than 1:1 shall include a brief description of the workflow needs that justify the
ratio request. The brief description of workflow needs shall include the operating hours of the pharmacy, number of
pharmacists, registered interns, and registered pharmacy technicians employed.
(4) A pharmacy that employs pharmacy technicians shall meet the following conditions:
(a) Establish written job descriptions, task protocols, and policies and procedures that pertain to duties performed by the
registered pharmacy technician and provide this information to the Board upon request;
(b) Establish that each registered pharmacy technician is knowledgeable in the established job descriptions, task protocols,
and policy and procedures in the pharmacy setting in which the technician is to perform his or her duties;
(c) Ensure that the duties assigned to any registered pharmacy technician do not exceed the established job descriptions, task
protocols, and policy and procedures, nor involve any of the prohibited tasks in Rule 64B16-27.420, F.A.C.; or
(d) Ensure that each registered pharmacy technician receives employer-based or on-the-job training in order for the registered
pharmacy technician to assume his or her responsibilities and maintain documentation of the training.
(5) The pharmacy shall maintain a policy and procedure manual with regard to registered pharmacy technicians which shall
include the following:
(a) Supervision by a pharmacist;
(b) Minimum qualifications as established by law;
(c) Documentation of in-service education and/or on-going training and demonstration of competency, specific to practice site
and job function;
(d) General duties and responsibilities of registered pharmacy technicians;
(e) Retrieval of prescription files, patient files, patient profile information and other records pertaining to the practice of
pharmacy;
(f) All functions related to prescription processing;
(g) All functions related to prescription legend drug and controlled substance ordering and inventory control, including
procedures for documentation and recordkeeping;
(h) rescription refill and renewal authorization;
(i) Registered pharmacy technician functions related to automated pharmacy systems; and
(j) Continuous quality improvement program.
64B16-27.420 Registered Pharmacy Technician Responsibilities.
(1) Registered pharmacy technicians may assist the pharmacist in performing the following tasks:
(a) Retrieval of prescription files, patient files and profiles and other such records pertaining to the practice of pharmacy;
(b) Data Entry;
(c) Label preparation;
(d) The counting, weighing, measuring, pouring and compounding of prescription medication or stock legend drugs and
controlled substances, including the filling of an automated medication system;
(e) Initiate communication to a prescribing practitioner or their medical staffs (or agents) regarding patient prescription refill
authorization requests. For the purposes of this section “prescription refill” means the dispensing of medications pursuant to
a prescriber’s authorization provided on the original prescription;
(f) Initiate communication to confirm the patient’s name, medication, strength, quantity, directions and date of last refill;
(g) Initiate communication to a prescribing practitioner or their medical staff (or agents) to obtain clarification on missing or
illegible dates, prescriber name, brand/generic preference, quantity, DEA registration number or license numbers; and
(h) May accept authorization for a prescription renewal. For the purposes of this section, “prescription renewal” means the
dispensing of medications pursuant to a practitioner’s authorization to fill an existing prescription that has no refill remaining.
(2) Registered Pharmacy technicians shall not:
(a) Receive new verbal prescriptions or any change in the medication, strength or directions;
(b) Interpret a prescription or medication order for therapeutic acceptability and appropriateness;
(c) Conduct a final verification of dosage and directions;
(d) Engage in prospective drug review;
(e) Provide patient counseling;
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(f) Monitor prescription usage; and
(g) Override clinical alerts without first notifying the pharmacist.
(3) Nuclear pharmacy permits allow the registered pharmacy technician to receive diagnostic orders only. The pharmacist
must receive therapy or blood product procedure orders.
(4)(a) All registered pharmacy technicians shall identify themselves as registered pharmacy technicians by wearing a type of
identification badge that is clearly visible which specifically identifies the employee by name and by status as a “registered
pharmacy technician”; and
(b) All registered pharmacy technicians shall state their names and verbally identify themselves as registered pharmacy
technicians in the context of telephone or other forms of communication.
64B16-27.430 Responsibilities of the Pharmacist.
The delegation of any duties, tasks or functions to registered pharmacy interns and registered pharmacy technicians must be
performed subject to a continuing review and ultimate supervision of the pharmacist who instigated the specific task, so that a
continuity of supervised activity is present between one (1) pharmacist and one (1) registered pharmacy technician. In every
pharmacy, the licensed pharmacist shall retain the professional and personal responsibility for any delegated act performed
by registered pharmacy interns and registered pharmacy technicians in his employ and under his supervision.
64B16-27.440 Policies and Procedures.
Any pharmacy utilizing registered pharmacy technicians shall be required to have written policies and procedures regarding
the number of positions and their utilization, including the specific scope of responsibilities of technicians, available for
inspection by the Florida Board of Pharmacy or its authorized agents and representatives.
Amplifying on the standards contained within the Florida Pharmacy Act, the Board has provided guidance to pharmacists on
the practice of generic substitution. Note that the negative formulary lists drugs for which no substitution is permitted. This
means that regardless of whether the prescriber wrote a prescription that would permit substitution, there can be no substitution of negative formulary drugs. If the prescription is written using a generic name, then no product has been specified and a
pharmacist may dispense any product, regardless of the negative formulary.
64B16-27.500 Negative Drug Formulary.
The negative drug formulary is composed of medicinal drugs which have been specifically determined by the Board of
Pharmacy and the Board of Medicine to demonstrate clinically significant biological or therapeutic inequivalence and which,
if substituted, could produce adverse clinical effects, or could otherwise pose a threat to the health and safety of patients
receiving such prescription medications. Except where certain dosage forms are included on the negative drug formulary as a
class, all medicinal drugs are listed by their official United States Pharmacopoeia Non-Proprietary (generic) name. The
generic name of a drug shall be applicable to and include all brand-name equivalents of such drug for which a prescriber may
write a prescription. Substitution by a dispensing pharmacist on a prescription written for any brand name equivalent of a
generic named drug product listed on the negative formulary or for a drug within the class of certain dosage forms as listed,
is strictly prohibited. In cases where the prescription is written for a drug listed on the negative drug formulary but a brand
name equivalent is not specified by the prescriber, the drug dispensed must be one obtained from a manufacturer or distributor
holding an approved new drug application or abbreviated new drug application issued by the Food and Drug Administration,
United States Department of Health and Welfare permitting that manufacturer or distributor to market those medicinal drugs
or when the former is non-applicable, those manufacturers or distributors supplying such medicinal drugs must show
compliance with other applicable Federal Food and Drug Administration marketing requirements. The following are included
on the negative drug formulary:
(1) Digitoxin.
(2) Conjugated Estrogen.
(3) Dicumarol.
(4) Chlorpromazine (Solid Oral Dosage Forms).
(5) Theophylline (Controlled Release).
(6) Pancrelipase (Oral Dosage Forms).
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4B16-27.510 Identification of Manufacturer.
Each formulary of generic and brand name drug products established by each community pharmacy pursuant to the provisions
of Section 465.025, F.S., shall include the name of the manufacturer of the generic drug listed in said formulary.
64B16-27.520 Positive Drug Formulary.
A positive formulary of generic and brand name drug products is required of each community pharmacy pursuant to subsection
465.025(5), F.S. Those medicinal drugs on the positive formulary shall be obtained from manufacturers or distributors holding
an approved new drug application or abbreviated new drug application issued by the Food and Drug Administration, U.S.
Department of Health, Education and Welfare permitting that manufacturer or distributor to market those medicinal drugs or
when the former is non-applicable, those manufacturers or distributors supplying those medicinal drugs must show compliance
with other applicable Federal Food and Drug Administration marketing requirements.
Note that for a generic substitution to occur in Florida, three parties must agree to it. First, the prescriber must issue the prescription in a way that does not forbid substitution. Second, the pharmacist must believe that there is available a suitable generic substitute. Third, the person presenting the prescription must agree to the substitution.
64B16-27.530 Duty of Pharmacist to Inform Regarding Drug Substitution.
Prior to the delivery of the prescription, a pharmacist must inform the person presenting a prescription of any substitution of
a generic drug product for a brand name drug product, of any retail price difference between the two, and of the person’s
right to refuse the substitution. This information must be communicated at a meaningful time such as to allow the person to
make an informed choice as to whether to exercise the option to refuse substitution without undue inconvenience to the presenter of the prescription or to the consumer of the drug. This information shall be communicated to the person presenting
the prescription in a manner determined to be appropriate by the pharmacist using professional discretion and judgment.
Community pharmacies in Florida may possess samples of medications only if the medication is one of the limited few that
can be prescribed by a pharmacist.
64B16-27.615 Possession and Disposition of Sample Medicinal Drugs.
(1) Pharmacies may not be in possession of sample medicinal drugs except:
(a) Pharmacies may possess the sample medicinal drugs that are listed within Rule 64B16-27.220, F.A.C., Medicinal Drugs
That May be Ordered by Pharmacists.
(b) Institutional pharmacies may possess sample medicinal drugs upon the written request of the prescribing practitioner.
Such possession must be in accordance with the provisions of Section 499.028(3)(e)2., F.S.
(c) Those community pharmacies that are pharmacies of health care entities, as defined by Sections 499.003(3) and (14),
F.S., may possess sample medicinal drugs upon the written request of the prescribing practitioner. Such possession must be
in accordance with the provisions of Section 499.028(3)(e)2., F.S.
(2) Sample packages of medicinal drugs that are found to be unsuitable for dispensing by reason of physical condition or
failure to meet requirements of state or federal law shall be returned to the company of origin in accordance with the requirements of Chapter 499, F.S.
Florida state law on extemporaneous compounding parallels the federal guidelines, but there are some differences. The basic
rule is the same. Filling a prescription for an extemporaneously prepared dosage form is compounding and not manufacturing, as long as the prescription is prepared by a physician for an individual patient who is known to the physician.
64B16-27.700 Definition of Compounding.
“Compounding” is the professional act by a pharmacist or other practitioner authorized by law, employing the science or art
of any branch of the profession of pharmacy, incorporating ingredients to create a finished product for dispensing to a patient or for administration by a practitioner or the practitioner’s agent; and shall specifically include the professional act of
preparing a unique finished product containing any ingredient or device defined by Sections 465.003(7) and (8), F.S. The
term also includes the preparation of nuclear pharmaceuticals and diagnostic kits incident to use of such nuclear pharmaceuticals. The term “commercially available products,” as used in this section, means any medicinal product as defined by
Sections 465.003(7) and (8), F.S., that are legally distributed in the State of Florida by a drug manufacturer or wholesaler.
(1) Compounding includes:
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(a) The preparation of drugs or devices in anticipation of prescriptions based on routine, regularly observed prescribing patterns.
(b) The preparation pursuant to a prescription of drugs or devices which are not commercially available.
(c) The preparation of commercially available products from bulk when the prescribing practitioner has prescribed the compounded product on a per prescription basis and the patient has been made aware that the compounded product will be prepared by the pharmacist. The reconstitution of commercially available products pursuant to the manufacturer’s guidelines is
permissible without notice to the practitioner.
(2) The preparation of drugs or devices for sale or transfer to pharmacies, practitioners, or entities for purposes of dispensing or distribution is not compounding and is not within the practice of the profession of pharmacy. Except that the supply of
patient specific compounded prescriptions to another pharmacy under the provisions of Section 465.0265, F.S., and Rule
64B16-28.450, F.A.C., is authorized.
(3) Office use compounding, “Office use” means the provision and administration of a compounded drug to a patient by a
practitioner in the practitioner’s office or by the practitioner in a health care facility or treatment setting, including a hospital, ambulatory surgical center, or pharmacy. A pharmacist may dispense and deliver a quantity of a compounded drug to a
practitioner for office use by the practitioner in accordance with this section provided:
(a) The quantity of compounded drug does not exceed the amount a practitioner anticipates may be used in the practitioner’s
office before the expiration date of the drug;
(b) The quantity of compounded drug is reasonable considering the intended use of the compounded drug and the nature of
the practitioner’s practice;
(c) The quantity of compounded drug for any practitioner and all practitioners as a whole, is not greater than an amount the
pharmacy is capable of compounding in compliance with pharmaceutical standards for identity, strength, quality, and purity
of the compounded drug that are consistent with United States Pharmacopoeia guidelines and accreditation practices.
64B16-27.797 Standards of Practice for Compounding Sterile Preparations (CSPs).
The purpose of this section is to assure positive patient outcomes through the provision of standards for 1) pharmaceutical
care; 2) the preparation, labeling, and distribution of sterile pharmaceuticals by pharmacies, pursuant to or in anticipation of
a prescription drug order, and 3) product quality and characteristics. These standards are intended to apply to all sterile
pharmaceuticals, notwithstanding the location of the patient (e.g., home, hospital, nursing home, hospice, doctor’s office).
(1) Definitions:
(a) “Anteroom” means an area where personnel perform hand hygiene and garbing procedures, staging of components, order
entry, CSP labeling, and other high-particulate generating activities. It is also a transition area that provides assurance that
pressure relationships are constantly maintained so that air flows from clean to dirty areas. The Anteroom area is to be
maintained within ISO Class 8 level of particulate contamination.
(b) “Antineoplastic” means a pharmaceutical agent that has the intent of causing cell death targeted to cancer cells, metastatic
cells, or other cells involved in a severe inflammatory or autoimmune response.
(c) “Beyond-use-date” means the date after which a compounded preparation should not be used and is determined from the
date the preparation was compounded.
(d) “Biological safety cabinet” means a containment unit suitable for the preparation of low, moderate, and high risk agents
where there is a need for protection of the product, personnel, and environment.
(e) “Bulk Compounding” means the compounding of CSPs in increments of twenty-five (25) or more doses from a single source.
(f) “Buffer area” (Clean room) is an area where the activities of CSP take place; it shall not contain sinks or drains. In
High-Risk compounding this must be a separate room. The Buffer area is to be maintained within ISO Class 7 level of
particulate contamination.
(g) “Class 100 environment” means an atmospheric environment which contains no more than one hundred particles of 0.5
microns in diameter or larger per cubic foot of air. A class 100 environment is equivalent to ISO Class 5 level of particulate
contamination.
(h) “Compounding Aseptic Isolator” (CAI) – is a form of barrier isolator specifically designed for compounding pharmaceutical ingredients or preparations. It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer process. Air exchange into the isolator from the surrounding environment should
not occur unless it is first passed through a microbially retentive filter (HEPA minimum 0.2 microns).
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(i) “High-Risk Level CSPs” – are products compounded under any of the following conditions are either non-sterile or at high
risk to become non-sterile with infectious microorganisms.
1. Non-sterile ingredients, including manufactured products for routes of administration other than sterile parenteral administration are incorporated or a non-sterile device is employed before terminal sterilization.
2. Sterile contents of commercially manufactured products, CSP that lack effective antimicrobial preservatives, sterile surfaces
of devices and containers for the preparation, transfer, sterilization, and packaging of CSPs are exposed to air quality worse
than ISO Class 5 for more than one (1) hour.
3. Before sterilization, non-sterile procedures such as weighing and mixing are conducted in air quality worse than ISO Class
7, compounding personnel are improperly garbed and gloved, or water-containing preparations are stored for more than 6
hours.
4. For properly stored sterilized high-risk preparation, in the absence of passing a sterility test, the storage periods cannot
exceed the following time periods: before administration, the CSPs are properly stored and exposed for not more than 24 hours
at controlled room temperature, and for not more than 3 days at a cold temperature (2-8 degrees Celsius) and for not more
than 45 days in solid frozen state at -20 degrees celsius or colder.
5. Examples of high-risk compounding include: (1) dissolving non-sterile bulk drug and nutrient powders to make solutions,
which will be terminally sterilized; (2) exposing the sterile ingredients and components used to prepare and package CSPs to
room air quality worse than ISO Class 5 for more than one (1) hour; (3) measuring and mixing sterile ingredients in non-sterile
devices before sterilization is performed; (4) assuming, without appropriate evidence or direct determination, that packages of
bulk ingredients contain at least 95% by weight of their active chemical moiety and have not been contaminated or adulterated
between uses.
6. All high risk category products must be rendered sterile by heat sterilization, gas sterilization, or filtration sterilization in
order to become a CSP.
7. Quality assurance practices for high-risk level CSPs include all those for low-risk level CSPs. In addition, each person
authorized to compound high-risk level CSPs demonstrates competency by completing a media-filled test that represents
high-level compounding semiannually.
(j) Immediate Use CSPs:
1. Requires only simple aseptic measuring and transfer manipulations are performed with not more than three (3) sterile
non-hazardous drug or diagnostic radiopharmaceutical drug preparations, including an infusion or dilution solution.
2. The preparation procedure occurs continuously without delays or interruptions and does not exceed 1 hour.
3. At no point during preparation and prior to administration are critical surfaces and ingredients of the CSP directly exposed
to contact contamination such as human touch, cosmetic flakes or particulates, blood, human body substances (excretions and
secretions, e.g., nasal or oral) and non-sterile inanimate sources.
4. Administration begins not later than one (1) hour following the start of preparing the CSP.
5. When the CSP is not administered by the person who prepared it, or its administration is not witnessed by the person who
prepared it, the CSP container shall bear a label listing patient identification information (name, identification numbers), and
the names and amounts of all active ingredients, and the name or identifiable initials of the person who prepared the CSP, and
one (1) hour beyond-use time and date.
6. If administration has not begun within one (1) hour following the start of preparing the CSP, the CSP is promptly and safely
discarded. Immediate use CSPs shall not be stored for later use.
(k) ISO Class 5 guidelines are met when particulate contamination is measured at “not more than 3,520 particles 0.5 micron
size or larger per cubic meter of air for any lamiar airflow workbench (LAWF), BSC, or CAI. (Also referred to as a “Class 100
environment.”)
(l) ISO Class 7 guidelines are met when particulate contamination is measured at “not more than 352,000 particles 0.5 micron
size or larger per cubic meter of air for any buffer area (room).”
(m) ISO Class 8 guidelines are met when particulate contamination is measured at “not more than 3,520,000 particles 0.5
micron size or larger per cubic meter of air for any anteroom (area).”
(n) Low-Risk Level CSPs compounded under all of the following are at a low risk of contamination:
1. The CSPs are compounded with aseptic manipulations entirely within ISO Class 5 (class 100) or better air quality using only
sterile ingredients, products, components, and devices.
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2. The compounding involves only transfer, measuring, and mixing manipulations using no more than three commercially
manufactured sterile products and entries into one container (e.g., bag, vial) of sterile product to make the CSP.
3. Manipulations are limited to aseptically opening ampoules, penetrating sterile stoppers on vials with sterile needles and
syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers for storage
and dispensing. The contents of ampoules shall be passed through a sterile filter to remove any particles.
4. For low-risk preparation, in the absence of passing a sterility test or a documented validated process, the storage periods
cannot exceed the following time periods; before administration, the CSPs are properly stored and exposed for not more than
48 hours at controlled room temperature, and for not more than 14 days at a cold temperature (2-8 degrees celsius) and for 45
days in solid frozen state at -20 degrees celsius or colder.
5. Quality Assurance practices include, but are not limited to, the following: (1) routine disinfection and air quality testing of
the direct compounding environment to minimize microbial surface contamination and maintain ISO Class 5 air quality; (2)
Visual confirmation that compounding personnel are properly donning and wearing appropriate items and types of protective
garments; (3) Review of all orders and packages of ingredients to ensure that the correct identity and amounts of ingredients
were compounded; (4) Visual inspection of CSPs to ensure the absence of particulate matter in solutions, the absence of
leakage from vials and bags, and accuracy and thoroughness of labeling.
6. All compounding personnel are required to demonstrate competency by completing a media-filled test that represents
low-level compounding annually. A media-filled test is a commercially available sterile fluid culture media that shall be able
to promote exponential colonization of bacteria that are both likely to be transmitted to CSP from the compounding personnel
and environment. Media filled vials are incubated at 25-35 degrees celsius for 14 days. Failure is indicated by visible turbidity
in the medium on or before 14 days.
(o) Medium-Risk Level CSPs – When CSPs are compounded aseptically under Low-Risk Conditions, and one or more of the
following conditions exist, such CSPs are at a medium risk of contamination:
1. CSPs containing more than three (3) commercial sterile drug products and those requiring complex manipulations and/or
preparation methods.
2. Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP that will be administered
either to multiple patients or to one patient on multiple occasions.
3. The compounding process requires unusually long duration, such as that required to complete dissolution or homogeneous
mixing.
4. For Medium-risk preparation, in the absence of passing a sterility test or a documented validated process, the storage
periods cannot exceed the following time periods; before administration, the CSPs are properly stored and exposed for not
more than 30 hours at controlled room temperature, and for not more than 9 days at a cold temperature and for 45 days in
solid frozen state at -20 degrees celsius or colder.
5. These include compounding of total parenteral nutrition (TPN) using either manual or automated devices during which there
are multiple injections, detachments, and attachments of nutrient source products to the device or machine to deliver all
nutritional components to a final sterile container.
6. Filling of reservoirs of injection and infusion devices with more than three (3) sterile drug products and evacuation of air
from those reservoirs before the filled devices are dispensed.
7. Transfer of volumes from multiple ampules or vials into one or more final sterile containers.
8. Quality assurance practices for medium-risk level CSPs include all those for low-risk level CSPs.
9. Demonstrates competency by completing a media-filled test that represents medium-level compounding annually.
(p) Parenteral means a sterile preparation of drugs for injection through one or more layers of the skin.
(q) Risk level of the sterile preparation means the level assigned to a sterile product by a pharmacist that represents the
probability that the sterile product will be contaminated with microbial organisms, spores, endotoxins, foreign chemicals or
other physical matter.
(r) Sterile preparation means any dosage form devoid of viable microorganisms, including but not limited to, parenterals,
injectables, ophthalmics, and aqueous inhalant solutions for respiratory treatments.
(2) Compounded sterile preparations include, but are not limited, to the following:
(a) Total Parenteral Nutrition (TPN) solutions;
(b) Parenteral analgesic drugs;
(c) Parenteral antibiotics;
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(d) Parenteral antineoplastic agents;
(e) Parenteral electrolytes;
(f) Parenteral vitamins;
(g) Irrigating fluids;
(h) Ophthalmic preparations; and
(i) Aqueous inhalant solutions for respiratory treatments.
(3) Sterile preparations shall not include commercially manufactured products that do not require compounding prior to
dispensing.
(4) Policy & Procedure Manual. A policy and procedure manual shall be prepared and maintained for the compounding,
dispensing, and delivery of sterile preparation prescriptions. The policy and procedure manual shall be available for inspection
by the Department and include at a minimum:
(a) Use of single dose and multiple dose containers not to exceed United States Pharmacopeia 797 guidelines.
(b) Verification of compounding accuracy and sterility.
(c) Personnel training and evaluation in aseptic manipulation skills.
(d) Environmental quality and control:
1. Air particle monitoring for hoods (or Barrier Isolator), clean room and buffer area (or anteroom) when applicable;
2. Unidirectional airflow (pressure differential monitoring);
3. Cleaning and disinfecting the sterile compounding areas;
4. Personnel cleansing and garbing;
5. Environmental monitoring (air and surfaces).
(e) Personnel monitoring and validation.
(f) Finished product checks and tests.
(g) Method to identify and verify ingredients used in compounding.
(h) Labeling requirements for bulk compounded products:
1. Contents;
2. Beyond-Use-Date; and
3. Storage requirements.
(i) Packing, storage, and transportation conditions.
(5) Physical Requirements.
(a) The pharmacy shall have a designated area with entry restricted to designated personnel for preparing parenteral products.
This area shall have a specified ante area and buffer area; in high risk compounding, this shall be separate rooms. This area
shall be structurally isolated from other areas with restricted entry or access, and must be designed to avoid unnecessary traffic
and interference with unidirectional airflow. It shall be used only for the preparation of these sterile preparations. It shall be
of sufficient size to accommodate a laminar airflow hood and to provide for the proper storage of drugs and supplies under
appropriate conditions of temperature, light, moisture, sanitation, ventilation, and security.
(b) The pharmacy compounding parenteral and sterile preparation shall have the following:
1. Appropriate environmental control devices capable of maintaining at least class 100 conditions in the work place where
critical objects are exposed and critical activities are performed; furthermore, these devices must be capable of maintaining
class 100 conditions during normal activity. Examples of appropriate devices include laminar airflow hoods and zonal laminar
flow of high efficiency particulate air (HEPA) filtered air;
2. Appropriate disposal containers for used needles, syringes, and if applicable, for antineoplastic waste from the preparation
of chemotherapy agents;
3. Appropriate environmental control including approved biohazard cabinetry when antineoplastic drug products are prepared;
4. Appropriate temperature and transport containers;
5. Infusion devices and equipment, if appropriate.
(c) The pharmacy shall maintain and use supplies adequate to preserve an environment suitable for the aseptic preparation of
sterile preparations, such as:
1. Gloves, masks, shoe covers, head and facial hair covers, and non-shedding gowns;
2. Needles and syringes of various standard sizes;
3. Disinfectant cleaning agents;
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4. Clean towels;
5. Hand washing materials with bactericidal properties;
6. Vacuum containers and various transfer sets;
7. “Spill kits” for antineoplastic agent spills.
(d) The pharmacy should have current reference material in hard copy or readily available on line:
1. USP Pharmacist Pharmacopeia (optional) or Handbook of Injectable Drugs by American Society of Hospital Pharmacists;
or other nationally recognized standard reference; and
2. “Practice Guidelines for Personnel Dealing with Cytotoxic Drugs,” or other nationally recognized standard cytotoxic
reference if applicable.
(e) Barrier isolator is exempt from all physical requirements subject to manufacturer guidelines for proper placement.
(6) Antineoplastic Drugs. The following requirements are necessary for those pharmacies that prepare antineoplastic drugs to
ensure the protection of the personnel involved:
(a) All antineoplastic drugs shall be compounded in a vertical flow, Class II, biological safety cabinet placed in negative
pressure room unless using barrier isolators. Other preparations shall not be compounded in this cabinet.
(b) Protective apparel shall be worn by personnel compounding antineoplastic drugs. This shall include at least gloves and
gowns with tight cuffs.
(c) Appropriate safety and containment techniques for compounding antineoplastic drugs shall be used in conjunction with the
aseptic techniques required for preparing sterile products.
(d) Disposal of antineoplastic waste shall comply with all applicable local, state, and federal requirements.
(e) Written procedures for handling both major and minor spills of antineoplastic agents shall be developed and shall be
included in the policy and procedure manual.
(f) Prepared doses of antineoplastic drugs shall be dispensed, labeled with proper precautions inside and outside, and shipped
in a manner to minimize the risk of accidental rupture of the primary container.
(7) Quality Assurance:
(a) There shall be a documented, ongoing quality assurance control program that monitors personnel performance, equipment,
and preparations. Appropriate samples of finished preparations shall be examined to assure that the pharmacy is capable of
consistently preparing sterile preparations meeting specifications:
1. All clean rooms and laminar flow hoods shall be certified by an independent contractor or National Sanitation Foundation
Standard 49, for operational efficiency at least semiannually for high risk CSPs and annually for low and medium risk CSPs
or any time the hood is relocated or the structure is altered and records shall be maintained for two years.
2. There shall be written procedures developed requiring sampling if microbial contamination is suspected for batches greater
than 25 units.
3. High risk greater than 25 units have antimicrobial testing prior to dispensing.
4. There shall be referenced written justification of the chosen beyond-use-dates for compounded products.
5. There shall be documentation of quality assurance audits at regular planned intervals, including infection control and sterile
technique audits.
(b) Compounding personnel shall be adequately skilled, educated, instructed, and trained to correctly perform and document
the following activities in their sterile compounding duties:
1. Demonstrate by observation or test a functional understanding of USP Chapter 797 and definitions, to include Risk Category
assessment;
2. Understand the characteristics of touch contamination and airborne microbial contaminants;
3. Perform antiseptic hand cleaning and disinfections of non-sterile compounding surfaces;
4. Select and appropriately don protective garb;
5. Demonstrate aseptic techniques and requirements while handling medications;
6. Maintain and achieve sterility of CSPs in ISO Class 5 (Class 100) primary engineering devices and protect personnel and
compounding environments from contamination by antineoplastic and chemotoxic or other hazardous drugs or substances;
7. Manipulate sterile products aseptically, sterilize high-risk level CSPs (where applicable) and quality inspect CSPs;
8. Identify, weigh and measure ingredients;
9. Prepare product labeling requirements and “beyond use” requirements of product expiration;
10. Prepare equipment and barrier requirement work requirements to maintain sterility;
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11. Prepare end point testing and demonstrated competencies for relevant risk levels;
12. Prepare media fills to test aseptic technique.
(8) Radiopharmaceuticals as Compounded Sterile Products
(a) Upon release of a Positron Emission Tomography (PET) radiopharmaceutical as a finished drug product from a PET
production facility, the further manipulation, handling, or use of the product will be considered compounding and will be
subject to the rules of this section.
(b) Radiopharmaceuticals compounded from sterile components in closed, sterile containers and with a volume of 100 ml or
less for single dose injection or not more than 30 ml taken from a multiple dose container, shall be designated as, and conform
to, the standards for low risk compounding.
(c) Radiopharmaceuticals shall be compounded using appropriately shielded vials and syringes in a properly functioning ISO
Class 5 PEC (Primary Engineering Control), located in an ISO Class 8 or better buffer area environment in compliance with
special handling, shielding, air flow requirements, and radiation safety programs to maintain radiation exposure as low as
reasonably achievable.
(d) Radiopharmaceuticals designed for multi use, compounded with Tc-99m, exposed to an ISO Class 5 environment by
components with no direct contact contamination, may be used up until the time indicated by manufacturers recommendations.
(e) Technetium 99/Molybdnenum 99 generator systems shall be stored and eluted in an ISO Class 8 or cleaner environment to
permit special handling, shielding, and airflow requirements.
(f) Manipulation of blood or blood derived products (e.g. radiolabeling white blood cells) shall be conducted in an area that
is clearly separated from routine material handling areas and equipment, and shall be controlled by specific standard
operating procedures to avoid cross contamination of products. The buffer area for manipulation of blood or blood derived
products shall be maintained as an ISO 7 environment and direct manipulations shall occur in an ISO 5 PEC suitable for these
products (e.g. biological safety cabinet).
64B16-27.800 Requirement for Patient Records.
(1) A patient record system shall be maintained by all pharmacies for patients to whom new or refill prescriptions are
dispensed. The patient record system shall provide for the immediate retrieval of information necessary for the dispensing
pharmacist to identify previously dispensed drugs at the time a new or refill prescription is presented for dispensing. The
pharmacist shall ensure that a reasonable effort is made to obtain, record and maintain the following information:
(a) Full name of the patient for whom the drug is intended;
(b) Address and telephone number of the patient;
(c) Patient’s age or date of birth;
(d) Patient’s gender;
(e) A list of all new and refill prescriptions obtained by the patient at the pharmacy maintaining the patient record during the
two years immediately preceding the most recent entry showing the name of the drug or device, prescription number, name and
strength of the drug, the quantity and date received, and the name of the prescriber; and
(f) Pharmacist comments relevant to the individual’s drug therapy, including any other information peculiar to the specific
patient or drug.
Note that it is the pharmacist’s responsibility to ensure that a reasonable effort has been made to gather this information. The
passive voice is used, indicating that the pharmacist need not be the one who does this, and there is no definition of the phrase
“reasonable effort.”
(2) The pharmacist shall ensure that a reasonable effort is made to obtain from the patient or the patient’s agent and shall
record any known allergies, drug reactions, idiosyncrasies, and chronic conditions or disease states of the patient and the
identity of any other drugs, including over-the-counter drugs, or devices currently being used by the patient which may relate
to prospective drug review. The pharmacist shall record any related information indicated by a licensed health care practitioner.
(3) A patient record shall be maintained for a period of not less than two years from the date of the last entry in the profile
record. This record may be a hard copy or a computerized form.
(4) Patient records shall be maintained for prescriptions dispensed subsequent to the effective date of this regulation.
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Perhaps the most important requirement of the OBRA-90 mandate is the ProDUR requirement. There are no qualifiers on this
responsibility. It must be done by a pharmacist (active voice) and compliance is not done simply through a reasonable effort.
There is no provision for patient waiver of Pro-DUR.
64B16-27.810 Prospective Drug Use Review.
(1) A pharmacist shall review the patient record and each new and refill prescription presented for dispensing in order to
promote therapeutic appropriateness by identifying:
(a) Over-utilization or under-utilization;
(b) Therapeutic duplication;
(c) Drug-disease contraindications;
(d) Drug-drug interactions;
(e) Incorrect drug dosage or duration of drug treatment;
(f) Drug-allergy interactions;
(g) Clinical abuse/misuse.
(2) Upon recognizing any of the above, the pharmacist shall take appropriate steps to avoid or resolve the potential problems
which shall, if necessary, include consultation with the prescriber.
Note below that the pharmacist must ensure a offer of counseling is provided (need not do it personally), the offer must be
verbally and printed, and it is required for new and refill prescriptions.
64B16-27.820 Patient Counseling.
(1) Upon receipt of a new or refill prescription, the pharmacist shall ensure that a verbal and printed offer to counsel is made
to the patient or the patient’s agent when present. If the delivery of the drugs to the patient or the patient’s agent is not made
at the pharmacy the offer shall be in writing and shall provide for toll-free telephone access to the pharmacist. If the patient
does not refuse such counseling, the pharmacist, or the pharmacy intern, acting under the direct and immediate personal
supervision of a licensed pharmacist, shall review the patient’s record and personally discuss matters which will enhance or
optimize drug therapy with each patient or agent of such patient. Such discussion shall be in person, whenever practicable, or
by toll-free telephonic communication and shall include appropriate elements of patient counseling. Such elements may
include, in the professional judgment of the pharmacist, the following:
(a) The name and description of the drug;
(b) The dosage form, dose, route of administration, and duration of drug therapy;
(c) Intended use of the drug and expected action (if indicated by the prescribing health care practitioner);
(d) Special directions and precautions for preparation, administration, and use by the patient;
(e) Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered,
including their avoidance, and the action required if they occur;
(f) Techniques for self-monitoring drug therapy;
(g) Proper storage;
(h) Prescription refill information;
(i) Action to be taken in the event of a missed dose; and
(j) Pharmacist comments relevant to the individual’s drug therapy, including any other information peculiar to the specific
patient or drug.
(2) Patient counseling as described herein, shall not be required for inpatients of a hospital or institution where other licensed
health care practitioners are authorized to administer the drug(s).
A pharmacist shall not be required to counsel a patient or a patient’s agent when the patient or patient’s agent refuses such
consultation.
The Board of Pharmacy has recognized that pharmacists and physicians may collaborate for the benefit of the patients in an
activity known as “Drug Therapy Management.” A Prescriber Care Plan is necessary for this activity to occur. Other requirements have been imposed by the Board.
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64B16-27.830 Standards of Practice - Drug Therapy Management.
(1) “Prescriber Care Plan” means an individualized assessment of a patient and orders for specific drugs, laboratory tests,
and other pharmaceutical services intended to be dispensed or executed by a pharmacist. The Prescriber Care Plan shall be
written by a physician licensed pursuant to Chapter 458, 459, 461, or 466, F.S., or similar statutory provision in another
jurisdiction, and may be transmitted by any means of communication. The Prescriber Care Plan shall specify the conditions
under which a pharmacist shall order laboratory tests, interpret laboratory values ordered for a patient, execute drug therapy
orders for a patient, and notify the physician.
(2) “Drug Therapy Management” means any act or service by a pharmacist in compliance with orders in a Prescriber Care
Plan.
(3) A pharmacist may provide Drug Therapy Management services for a patient, incidental to the dispensing of medicinal drugs
or as a part of consulting concerning therapeutic values of medicinal drugs or as part of managing and monitoring the patient’s
drug therapy. A pharmacist who provides Drug Therapy Management services for a patient shall comply with orders in a
Prescriber Care Plan, insofar as they specify:
(a) Drug therapy to be initially dispensed to the patient by the pharmacist; or
(b) Laboratory values or tests to be ordered, monitored and interpreted by the pharmacist; or
(c) The conditions under which the duly licensed practitioner authorizes the execution of subsequent orders concerning the
drug therapy for the patient; or
(d) The conditions under which the pharmacist shall contact or notify the physician.
(4) A pharmacist who provides Drug Therapy Management services shall do so only under the auspices of a pharmacy permit
that provides the following:
(a) A transferable patient care record that includes:
1. A Prescriber Care Plan that includes a section noted as “orders” from a duly licensed physician for each patient for whom
a pharmacist provides Drug Therapy Management services;
2. Progress notes; and
(b) A pharmaceutical care area that is private, distinct, and partitioned from any area in which activities other than patient
care activities occur, and in which the pharmacist and patient may sit down during the provision of Drug Therapy Management
services; and
(c) A continuous quality improvement program that includes standards and procedures to identify, evaluate, and constantly
improve Drug Therapy Management services provided by a pharmacist.
The Board of Pharmacy has designed standards of practice for the dispensing of controlled substances for pain, and these
standards parallel those of the Board of Medicine that are aimed at the prescribing of controlled substances for the treatment of
pain. The goal is to allow access to necessary medications for patients who need them and to deny access for people who do
not need them.
64B16-27.831 Standards of Practice for the Dispensing of Controlled Substances for Treatment of Pain.
(1) An order purporting to be a prescription that is not issued for a legitimate medical purpose is not a prescription and the
pharmacist knowingly filling such a purported prescription shall be subject to penalties for violations of the law.
(2) The following criteria shall cause a pharmacist to question whether a prescription was issued for a legitimate medical
purpose:
(a) Frequent loss of controlled substance medications,
(b) Only controlled substance medications are prescribed for a patient,
(c) One person presents controlled substance prescriptions with different patient names,
(d) Same or similar controlled substance medication is prescribed by two or more prescribers at same time,
(e) Patient always pays cash and always insists on brand name product.
(3) If any of the criteria in (2) is met, the pharmacist shall:
(a) Require that the person to whom the medication is dispensed provide picture identification and the pharmacist should
photocopy such picture identification for the pharmacist’s records. If a photocopier is not available, the pharmacist should
document on the back of the prescription complete descriptive information from the picture identification. If the person to
whom medication is dispensed has no picture identification, the pharmacist should confirm the person’s identity and document on the back of the prescription complete information on which the confirmation is based.
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(b) Verify the prescription with the prescriber. A pharmacist who believes a prescription for a controlled substance medication to be valid, but who has not been able to verify it with the prescriber, may determine not to supply the full quantity and
may dispense a partial supply, not to exceed a 72 hour supply. After verification by the prescriber, the pharmacist may dispense the balance of the prescription within a 72 hour time period following the initial partial filling, unless otherwise prohibited by law.
(4) Every pharmacy permit holder shall maintain a computerized record of controlled substance prescriptions dispensed. A
hard copy printout summary of such record, covering the previous 60 day period, shall be made available within 72 hours
following a request for it by any law enforcement personnel entitled to request such summary under authority of Section
465.017(2), F.S. Such summary shall include information from which it is possible to determine the volume and identity of
controlled substance medications being dispensed under the prescription of a specific prescriber, and the volume and identity
of controlled substance medications being dispensed to a specific patient.
(5) Any pharmacist who has reason to believe that a prescriber of controlled substances is involved in the diversion of controlled substances shall report such prescriber to the Department of Health.
(6) Any pharmacist that dispenses a controlled substance subject to the requirements of this rule when dispensed by mail
shall be exempt from the requirements to obtain suitable identification.
64B16-27.850 Standards of Practice for Orthotics and Pedorthics.
(1) Definitions.
(a) “Orthosis” means a medical device used to provide support, correction, or alleviation of neuromuscular or musculoskeletal dysfunction, disease, injury, or deformity, but does not include the following assistive technology devices: upper extremity
adaptive equipment used to facilitate the activities of daily living, including specialized utensils, combs, and brushes; finger
splints; wheelchair seating and equipment that is an integral part of the wheelchair and not worn by the patient; elastic abdominal supports that do not have metal or plastic reinforcing stays; arch supports; nontherapeutic accommodative inlays
and nontherapeutic accommodative footwear, regardless of method of manufacture; unmodified, over-the-counter shoes; prefabricated foot care products; durable medical equipment such as canes, crutches, or walkers; dental appliances; or devices
implanted into the body by a physician. For purposes of this subsection, “accommodative” means designed with the primary
goal of conforming to the individual’s anatomy and “inlay” means any removable material upon which the foot directly rests
inside the shoe and which may be an integral design component of the shoe.
(b) “Orthotics” means the practice, pursuant to a licensed physician’s written prescription, of evaluating, treatment formulating, measuring, designing, fabricating, assembling, fitting, adjusting, servicing, or providing the initial training necessary
to accomplish the fitting of an orthosis or pedorthic device; however, the repair, replacement, adjustment, or servicing of any
existing orthosis may be performed without an additional prescription from the patient’s physician, unless the original prescription states otherwise. If a patient is under the care of a licensed occupational therapist or physical therapist, the pharmacist must consult with the therapist if the therapist has requested consultation regarding the fitting, design, or fabrication
of an orthosis or regarding treatment with an orthosis.
(c) “Pedorthic device” means therapeutic shoes, shoe modifications made for therapeutic purposes, prosthetic fillers of the
forefoot, and foot orthoses for use from the ankle and below, but does not include arch supports; nontherapeutic accommodative inlays and nontherapeutic accommodative footwear, regardless of method of manufacture; unmodified, over-the-counter shoes; or prefabricated foot care products. For purposes of this subsection, “accommodative” means designed with the
primary goal of conforming to the individual’s anatomy and “inlay” means any removable material upon which the foot directly rests inside the shoe and which may be an integral design component of the shoe.
(d) “Pedorthics” means the practice, pursuant to a licensed physician's written prescription, of evaluating, treatment formulating, measuring, designing, fabricating, assembling, fitting, adjusting, servicing, or providing the initial training necessary
to accomplish the fitting of a pedorthic device; however, the repair, replacement, adjustment, or servicing of any existing pedorthic device may be performed without an additional prescription from the patient’s physician, unless the original prescription states otherwise. If a patient is under the care of a licensed occupational therapist or physical therapist, the
pharmacist must consult with the therapist if the therapist has requested consultation regarding the fitting, design, or fabrication of a pedorthic device or regarding treatment with a pedorthic device.
(2) Pursuant to a licensed physician’s written prescription, the pharmacist shall assume the responsibility for assessing the
patient, planning the patient’s treatment program, and directing the program. No pharmacist shall implement a prescription
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that, in the pharmacist’s judgment, is contraindicated. No change shall be made in the prescription without the authorization
of the prescribing physician.
(3) The pharmacist’s professional responsibilities include:
(a) Ongoing consultation with the prescribing physician regarding information that will impact the patient's medical and
functional outcomes.
(b) Orthotic and/or pedorthic evaluation of the patient.
(c) Identification and documentation of precautions, special problems, or contraindications.
(d) Development of a treatment plan including the short and long terms goals.
(e) Implementation of a treatment plan.
(f) Periodic review and update of the treatment plan, including reassessment of the patient in reference to goals and, when
necessary, modification of the treatment plan.
(g) Collaboration with members of the health care team when appropriate.
(h) Advising the patient, in terms which the patient can understand, of the nature and purpose of the services to be rendered
and the techniques for use and care of an orthosis or pedorthic device.
(i) Determination of the appropriateness of proper fit and function of any orthosis or pedorthic device.
(4) A pharmacist may delegate duties to nonlicensed supportive personnel if those duties are performed under the supervision
of the pharmacist. In such instances the supervising pharmacist is responsible for all acts performed by such persons. It is
below the standard of practice and prohibited for a pharmacist to delegate or assign activities, tasks or procedures that fall
within the scope of any practice defined in Section 468.812(3), F.S., to support personnel, without providing supervision for
the performance of the activities, tasks or procedures.
64B16-27.851 Record-Keeping for Orthotics and Pedorthics.
(1) The pharmacist or supportive personnel shall prepare and maintain in a timely manner patient records which include, at
a minimum, the following:
(a) The patient name, address and telephone number;
(b) The location and dates of all treatment, evaluation or consultation;
(c) The name of the prescribing physician;
(d) All prescriptions pertaining to services provided to the patient;
(e) A treatment or service plan;
(f) Progress notes for each session;
(2) The licensee may charge a fee for the reproduction of records, which shall be no greater than $ 1.00 per page for the first
25 pages, and $0.50 per page for every page after 25. In addition, the actual cost of postage may be added. Reasonable costs
of reproducing radiographs and such other kinds of records shall be the actual costs. “Actual costs” means the cost of the
material and supplies used to duplicate the record and the labor and overhead costs associated with the duplication.
(3) The licensee shall retain the patient record for at least two years from the date of last entry, unless otherwise provided by
law.
C.
Standards for Pharmacy Permits
Just as the Board of Pharmacy has established standards for individuals who are licensed to practice the profession of
pharmacy, it has established standards for those who operate pharmacy practice sites.
64B16-28.101 Prescription Area Accessible to Inspection.
(1) The prescription department compounding room or any other place where prescriptions are compounded, filled, processed,
accepted, dispensed, or stored in each pharmacy shall be so situated and located that authorized agents and employees of the
Department or other persons authorized by law to enter and inspect, can observe and survey the confines of said department,
room or area and can enter into said department, room or area after identifying themselves, for the purpose of inspection at a
reasonable hour or when the practice of the profession of pharmacy is being carried on, as defined in Section 465.003, F.S.,
without having been previously detained or announced. Such inspection may be routinely conducted at any time by authorized
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agents of the Department to determine whether Chapter 465, F.S., or provisions of these rules have been violated or for other
lawful purposes, and need not be in response to a complaint filed with the Department. There shall be a minimum of one (1)
inspection per year except as otherwise directed by the Board.
(2) Authorized agents and employees of the Department or other persons authorized by law shall have the right to inspect
invoices, shipping tickets, or any other document pertaining to the transfer of drugs or drug preparations, from or to all
pharmacies and a reasonable amount of time shall be allowed for said information to be made available.
64B16-28.102 Sink and Running Water, Sufficient Space, Refrigeration, Sanitation, Equipment.
There shall be provided for the prescription department of each pharmacy:
(1) An adequate sink in workable condition and running water easily accessible to the prescription counter that shall be
available during the hours when the prescription department is normally open for the business related to prescriptions.
(2) Sufficient shelf, drawer or cabinet space for the neat and orderly storage of pharmaceutical stock, prescription containers,
prescription labels, the required equipment, and all other items, articles or equipment stored therein and there shall be
sufficient walking space and sufficient work counter space within each prescription department of said establishment so as to
allow employees or pharmacists employed therein to adequately, safely, and accurately fulfill their duties related to prescriptions.
(3) Adequate facilities for the proper storage of pharmaceuticals which require refrigeration, and such pharmaceuticals shall
be stored therein, and in such manner as to preserve their therapeutic activity.
(4) Adequate sanitation to insure the prescription department is operating under clean, sanitary, uncrowded, and healthy
conditions.
(5) The following items:
(a) A current pharmacy reference compendium such as the United States Pharmacopoeia/National Formulary, the U.S.
Dispensatory, USP DI, (United States Pharmacopoeial Drug Information), the Remington Practice of Pharmacy, Facts and
Comparisons or an equivalent thereof sufficient in scope to meet the professional practice needs of that pharmacy, and a
current copy of the laws and rules governing the practice of pharmacy in the State of Florida. It shall be acceptable, in lieu of
an actual hard copy, to maintain these materials in a readily available electronic data format.
(b) Such other equipment as is necessary to meet the needs of the professional practice of pharmacy.
Note that every pharmacy must have a private patient consultation area to respect the confidentiality of the pharmacist-patient
relationship.
64B16-28.1035 Patient Consultation Area.
A community pharmacy shall provide a private consultation area so all patients of the pharmacy will be able to obtain
counseling without being overheard by others in the prescription dispensing area of the pharmacy. The consultation area must
be accessible by the patient from the outside of the prescription dispensing area of the pharmacy without having to traverse a
stockroom or the prescription dispensing area. In determining whether the area is suitable, consideration shall be given to the
proximity of the counseling area to the check-out or cash register area, the volume of pedestrian traffic in and around the
consultation area, and the presence of walls or other barriers between the counseling area and the prescription dispensing area
of the pharmacy. The consultation area may consist of designated private counter space. The area shall be designated with a
sign bearing “Patient Consultation Area”, or words that are substantially similar.
Although federal law specifies a limited amount of information that must be included on the label of all drugs, with additional
information for controlled substances, the Florida Board of Pharmacy has added to the list. Note that the Board of Pharmacy
also has indicated the labeling that must appear on Customized Patient Medication packages.
64B16-28.108 All Permits - Labels and Labeling of Medicinal Drugs.
Each container of medicinal drugs dispensed shall have a label or shall be accompanied by labeling.
(1) Definitions.
(a) “Controlled substance” means any substance named or described in Schedules II-V of Section 893.03, F.S.
(b) “Customized medication package” means a package that:
1. Is prepared by a pharmacist for a specific patient.
2. Is a series of containers.
3. Contains two (2) or more solid oral dosage forms.
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(c) “Labeling” means a label or other written, printed, or graphic material upon an agent or product or any of its containers,
wrappers, drug carts, or compartments thereof, as well as a medication administration record (MAR) if a medication
administration record is an integral part of the unit dose system.
(d) “Radiopharmaceutical” means any substance defined as a drug in section 201(g)(1) of the Federal Food, Drug and
Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons
and includes any of those drugs intended to be made radioactive. This includes nonradioactive reagent kits and nuclide
generators which are intended to be used in the preparation of any such substance, but does not include drugs which are
carbon-containing compounds or potassium-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides.
(e) “Serial number” means a prescription number or other unique number by which a particular prescription or drug package
can be identified.
(2) The label affixed to each container dispensed to a patient shall include:
(a) Name and address of the pharmacy.
(b) Date of dispensing.
(c) Serial number.
(d) Name of the patient or, if the patient is an animal, the name of the owner and the species of animal.
(e) Name of the prescriber.
(f) Name of the drug dispensed (except where the prescribing practitioner specifically requests that the name is to be withheld).
(g) Directions for use.
(h) Expiration date.
(i) If the medicinal drug is a controlled substance, a warning that it is a crime to transfer the drug to another person.
(3) The label on the immediate container of a repackaged product or a multiple unit prepackaged drug product shall include:
(a) Brand or generic name.
(b) Strength.
(c) Dosage form.
(d) Name of the manufacturer.
(e) Expiration date.
(f) Lot number:
1. Manufacturer’s lot number, or
2. Number assigned by the dispenser or repackager which references the manufacturer’s lot number.
(4) A medicinal drug dispensed in a unit dose system by a pharmacist shall be accompanied by labeling. The requirement will
be satisfied if, to the extent not included on the label, the unit dose system indicates clearly the name of the resident or patient,
the prescription number or other means utilized for readily retrieving the medication order, the directions for use, and the
prescriber’s name.
(5) A unit dose system shall provide a method for the separation and identification of drugs for the individual resident or patient.
(6) A customized patient medication package may be utilized if:
(a) The consent of the patient or the patient’s agent has been secured, and
(b) The label includes:
1. Name, address and telephone number of the pharmacy.
2. Serial number for the customized medication package and a separate serial number for each medicinal drug dispensed.
3. Date of preparation of the customized patient medication package.
4. Patient’s name.
5. Name of each prescriber.
6. Directions for use and any cautionary statements required for each medicinal drug.
7. Storage instructions.
8. Name, strength, quantity and physical description of each drug product.
9. A beyond use date that is not more than 60 days from the date of preparation of the customized patient medication package
but shall not be later than any appropriate beyond use date for any medicinal drug included in the customized patient
medication package.
(c) The customized patient medication package can be separated into individual medicinal drug containers, then each
container shall identify the medicinal drug product contained.
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(7) The label affixed to the immediate outer container shield of a radiopharmaceutical shall include:
(a) Name and address of the pharmacy.
(b) Name of the prescriber.
(c) Date of the original dispensing.
(d) The standard radiation symbol.
(e) The words “Caution Radioactive Material.”
(f) Name of the procedure.
(g) Prescription order number.
(h) Radionuclide and chemical form.
(i) Amount of radioactivity and the calibration date and time.
(j) Expiration date and time.
(k) If a liquid, the volume.
(l) If a solid, the number of items or weight.
(m) If a gas, the number of ampules or vials.
(n) Molybdenum 99 content to the United States Pharmacopeia (UPS) limits.
(o) Name of the patient or the words “Physician’s Use Only.”
(8) The label affixed to the immediate inner container of a radiopharmaceutical to be distributed shall include:
(a) The standard radiation symbol.
(b) The words “Caution Radioactive Material.”
(c) Radionuclide and chemical form.
(d) Name of the procedure.
(e) Prescription order number of the radiopharmaceutical.
(f) Name of the pharmacy.
(9) The labeling on a carton or package containing a medicinal drug or product dispensed from an Extended Scope Renal
Dialysis (ESRD) pharmacy shall include:
(a) “Use as Directed” statement.
(b) The name and address of the person to whom the products will be delivered.
(c) Name of the prescriber.
(d) Name and address of the ESRD pharmacy location from which the products were shipped.
(e) Prescription number.
(f) Any special instructions regarding delivery dates or locations.
(g) Beyond use date or, if the medicinal drug or product is dispensed in an unopened sealed package, the manufacturer’s
expiration date.
Florida community pharmacies must be kept open to provide a full range of services to patients. The days per week that a
pharmacy must be kept open, and the hours per day are stipulated by the Board.
64B16-28.1081 Regulation of Daily Operating Hours.
Any person who receives a community pharmacy permit pursuant to Section 465.018, F.S., and commences to operate such an
establishment shall keep the prescription department of the establishment open for a minimum of forty (40) hours per week and
a minimum of five (5) days per week. The Board hereby approves exceptions to the requirements noted above and permits
closing of the prescription department for the following holidays: New Year’s Day, Memorial Day, Fourth of July
(Independence Day), Labor Day, Veterans’ Day, Thanksgiving, Christmas and any bona fide religious holiday provided that
notice of such closing is given in a sign as set forth herein. A sign in block letters not less than one inch in height stating the
hours the prescription department is open each day shall be displayed either at the main entrance of the establishment or at or
near the place where prescriptions are dispensed in a prominent place that is in clear and unobstructed view.
Note that a Florida pharmacy must be closed when a pharmacist is not present, except under certain circumstances.
Nonpharmacists cannot enter a pharmacy unless a pharmacist is present.
64B16-28.109 Prescription Department; Padlock; Sign: “Prescription Department Closed.”
(1) The prescription department of any community pharmacy permittee shall be considered closed whenever the establishment
is open and a pharmacist is not present and on duty. A sign with bold letters not less than two (2) inches in width and height,
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shall be displayed in a prominent place in the prescription department so that it may easily be read by patrons of that
establishment. The sign shall contain the following language: “Prescription Department Closed.”
(2) The term “not present and on duty” shall not be construed to prevent a pharmacist from exiting the prescription department
for the purpose of consulting or responding to inquiries or providing assistance to patients or customers, attending to personal
hygiene needs, taking a meal break pursuant to Rule 64B16-27.1001, F.A.C., or performing any other function for which the
pharmacist is responsible, provided that such activities are conducted in a manner consistent with the pharmacist’s responsibility to provide pharmacy services.
(3) At all times when the prescription department is closed, either because of the absence of a pharmacist or for any other
reason, it shall be separated from the remainder of the establishment by partition or other means of enclosure, thereby
preventing access to the prescription department by persons not licensed in Florida to practice the profession of pharmacy.
(4) The partition or other means of enclosure shall be securely locked or padlocked and only a pharmacist shall have the means
to gain access to the prescription department.
(5) Whenever the prescription department of any community pharmacy establishment is closed, no person other than a
pharmacist shall enter, be permitted to enter or remain in the prescription department.
Note that the stock of every pharmacy must be examined at least every 4 months to remove expired drugs. A pharmacist
need not be the one to do this.
64B16-28.110 Outdated Pharmaceuticals.
Persons qualified to do so shall examine the stock of the prescription department of each pharmacy at a minimum interval of
four months, and shall remove all deteriorated pharmaceuticals, or pharmaceuticals which bear upon the container an
expiration date which date has been reached, and under no circumstances will pharmaceuticals or devices which bear upon
the container an expiration date which has been reached be sold or dispensed to the public.
Note that in Florida every location at which pharmacy is practiced must have its own pharmacy permit.
64B16-28.113 Permits; Single Entity; Single Location.
A Board of Pharmacy permit shall be issued only to a single entity at a single location. The service provided by the permit shall
be consistent with the issued permit. A single location shall be defined as:
(1) A contiguous area under the control of the permit holder. For purposes of this section, a public thoroughfare will be
considered to have not broken the area of contiguity; and
(2) An area not more than one-half mile from the central location of the permit.
The Board of Pharmacy’s administrative rule reiterates the circumstances under which a patient may return drugs from a closed
delivery system into stock.
64B16-28.118 Unit Dose and Customized Patient Medication Package Returns by In-patients.
No pharmacist shall place into the stock of any pharmacy permittee any part of any prescription, compounded or dispensed,
which is returned by a patient except under the following conditions:
(1) In a closed drug delivery system in which unit dose or customized patient medication packages are dispensed to in-patients,
the unused medication may be returned to the pharmacy for redispensing only if each unit dose or customized patient
medication package is individually sealed and if each unit dose or the unit dose system, or the customized patient medication
package container or the customized patient medication package unit of which it is clearly a part is labeled with the name of
the drug, dosage strength, manufacturer’s control number, and expiration date, if any.
(2) In the case of controlled substances, as it is allowed by Federal Law.
(3) A “unit dose system” to which this rule applies means a system wherein all individually sealed unit doses are physically
connected as a unit. For purpose of this section, a product in an unopened, sealed, manufacture’s container is deemed to be a
unit dose package.
(4) A “customized patient medication package” to which this rule applies means a system wherein all USP approved multi-dose
units are physically connected and are referr

For Use in 2010 Federal and State Pharmacy Law Study Guide

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