Roadrunner Express Summer 2015 Edition

Roadrunner ExpressSummer 2015
Roadrunner Pharmacy 711 E. Carefree Hwy. Suite 140, Phoenix, AZ 85085
877-518-4589
Is the FDA Attempting to Regulate Veterinary
Compounding Without Congressional Authority?
In May, the FDA released for public comment a draft guidance document entitled
“Compounding Animal Drugs from Bulk Substances”. This guidance will supercede
the 2003 CPG that has since been withdrawn. The 2003 CPG allowed for compounding
from bulk powders for your child but prohibited it for your pet! This document suggests
new guidelines for compounding pharmacists AND veterinarians. These are mandates not
supported by existing federal law or congressional intent AND contradict long-standing
state authority to govern veterinary medicine. We have included a summary page
with this newsletter from the International Academy of Compounding
Pharmacists for your review. They and others have requested an extension in
the deadline for public comment. (continued on page 4)
E X P A NS I ON
COMPLETE!
Veterinary practitioners have long looked to Roadrunner Pharmacy as
the leader in animal health compounding and innovation and we haven’t
disappointed. With the increased scrutiny of sterile compounding and the
inherently high costs associated with it, many compounders have made the
decision to discontinue making sterile products. Instead of downsizing,
we’ve spent the spring upgrading and expanding our sterile suites to
ensure compounding of the highest quality products and to broaden our
selection, especially in the ophthalmic area. (continued on page 3)
www.roadrunnerpharmacy.com
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Sterile Ophthalmic Treatments
The majority of these products will be compounded with 6 month Beyond Use Dating (BUD)
Compounded
Ophthalmic Ointments
Chloramphenicol 1% - (Releasing Soon)
Idoxuridine 0.1% - (Releasing Soon)
Oxypol 0.5% *
PNB Fortified - (Releasing Soon)
PNB Fortified + HC - (Releasing Soon)
Tacrolimus 0.02%
TacroliteTM Solution & Tacrolimus Ointment
This is our most commonly requested sterile ophthalmic medication
and is available in multiple formats.
The first is in mineral oil at a concentration of 0.02% in either
metered-drop tubes or bottles. It is also available as a drop in corn
oil at either 0.02% or 0.03% in bottles.
Compounded
Ophthalmic Solutions
Cidofovir 0.5%
Cyclosporine 2% **
Demecarium Bromide 0.125%
Demecarium Bromide 0.25%
Gentamicin 3/Betamethasone 1mg/ml
Idoxuridine 0.1%
Tacrolimus 0.02% in Corn oil
TacroliteTM 0.02% in Mineral oil
Tacrolimus 0.03% in Corn oil
Voriconazole 1%
TACROLITETM DROPPER TUBE
TACROLITETM MINERAL OIL
TACROLIMUS CORN OIL
** Cyclosporine is compounded in a
synthetic version of the major component
of coconut oil.
Compounded
Ophthalmic Suspensions
Itraconazole 1%
Prednisolone acetate 1.25%
TACROLIMUS OINTMENT
Back by popular demand… Tacrolimus ointment! This sterile
ointment is available at a concentration of 0.02% and is a great option
for veterinarians treating KCS and dry eye, just like all other forms of
Tacrolimus.
CidofaDropsTM
CidofadropsTM, a new name
and package for our Cidofovir
0.5% ophthalmic clear
solution, is gaining popularity
as veterinarians’ first choice in
Feline Ocular Herpes.
CIDOFADROPS
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Friendly pharmacists are standing by!
OXYPOL
877-518-4589
Expansion
Cyclosporine
YES! WE HAVE IT!
Available as a 2% sterile
ophthalmic solution,
this medication is used
by veterinarians as an
alternative adjunct to
Tacrolimus.
CYCLOSPORINE
Voriconazole
This sterile ophthalmic
solution is available in a
1% concentration and is
frequently requested for
use in fungal infections.
(continued from page 1)
We have DOUBLED the number of ISO 7
cleanrooms and ISO 5 work stations, allowing us
to increase our offerings, to include Tacrolimus
0.02% ophthalmic ointment, Oxypol 0.5%
ophthalmic ointment and Cyclosporine 2%
ophthalmic solution, just to name a few.
These rooms must adhere to specifications found
in USP 797. Our sterile processes and facility are
inspected annually by numerous state inspectors
as well as the National Association of Boards of
Pharmacy.
Sterilizing ophthalmic ointments is a huge and
complex undertaking. Unlike injectables that
can be filtered or autoclaved, neither process can
be utilized with finished ophthalmic ointments.
Just like injectables, they must be quarantined
and tested for sterility prior to dispensing.
In another industry leading move, Roadrunner
Pharmacy has acquired a state-of-the-art vial
washer dedicated to the decontamination of
injectable vials to improve the sterile process.
VORICONAZOLE
Prednisolone Acetate
This ophthalmic steroid is
available as a sterile 1.25%
suspension. This medication
is often prescribed to
aide in the treatment of
inflammation due to allergy
or trauma.
PREDNISOLONE ACETATE
For as long as there has been a Roadrunner
Pharmacy, patient safety has been JOB ONE.
This expansion project will greatly enhance our
ability to provide you and your patients with the
highest quality sterile products.
To learn more about our sterile process,
watch our brief video ”Commitment to Sterile
Compounding” on our website at:
www.roadrunnerpharmacy.com/vets/videos/
Oxypol
This sterile anti-biotic ointment is a combination of
Oxytetracycline and Polymyxin.
* Compounded based on TerramycinTM availability.
The information contained is intended for use as an informational aid. It does not cover all possible uses, actions, precautions, side effects, or interactions of the preparations shown,
nor is the information intended as medical advice or diagnosis for individual health problems or for making an evaluation as to the risks and benefits of using a particular preparation.
Information and statements have not been evaluated by the Food and Drug Administration (FDA), nor has the FDA approved the preparations to diagnose, cure or prevent disease.
Roadrunner Pharmacy compounded veterinary preparations are medications prepared at the direction of a veterinarian and are not intended for use in food and food-producing animals.
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Did you know?
EVERY package shipped to a
pet owner includes a free toy!
FDA continued
Please Join Us:
Veterinarian
Dinner Talks
(continued from page 1)
In this draft guidance, it is clear the FDA wants to apply the same
regulations designed for human compounders to veterinary
compounders. Additionally, they would require veterinarians to
include very specific and lengthy wording on each prescription, limit
anticipatory compounding to 14 days and severely control the use of
properly tested bulk powders.
Relative to veterinary medicine, we find the FDA’s suggestion to create
a ‘Never To Be Compounded’ list to be preposterous. Any therapeutic
agent may need to be compounded at some point—yes, even in the
absence of evidence-based studies.
August
10th - Ocean Springs, MS
11th - Baton Rouge, LA
12th - Lafayette, LA
13th - Mandeville, LA
September
21st - Latcham, NY
Plus, more to come!!
Roadrunner Pharmacy has ALWAYS proposed an exclusion for
veterinary compounding – the scope of practice for each practitioner
is vastly different. A recent study commissioned by Roadrunner
Pharmacy illustrated overwhelming support from veterinarians for
compounding, especially in this era of back-orders, hard-to-find and
discontinued items, that involves the use of bulk powders. Properly
tested bulk powders allow compounders the ability to have precise
control over the final drug – exact concentrations and no unwanted
excipients.
As ALWAYS, Roadrunner Pharmacy will continue to work closely with
state and national veterinary organizations to ensure your needs are
being considered in future regulations.
You can also download the International Academy of Compounding
Pharmacists summary here: http://goo.gl/ef6cXR
Call for more information
877-518-4589 ext. 7513
Should your association desire
a Roadrunner Pharmacy
sponsored Dinner Talk, please
contact Stephen Bishop at:
1-877-518-4589 ext. 7681
Please share
your experience
with us on Yelp!
Insert with EVERY
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518-4589