AmerisourceBergen Corporation Serialization

AmerisourceBergen Corporation
Serialization Labeling
Guidelines and Requirements
AmerisourceBergen Corporation Serialization Labeling Guidelines and Requirements
V3
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Table of Contents
Purpose
3
Definitions, Acronyms & Abbreviations
3
References
5
Pharmaceutical (Rx) Serializations Labeling
5
What does the DSCSA require for a data carrier?
5
Three Key Definitions
6
Existing FDA Guidance (Example)
6
Converting a NDC (National Drug Code) to a GTIN (Global Trade Item Number)
6
GS1 Application Identifiers
6
AmerisourceBergen Pharmaceutical (Rx) Labeling Standards & Guidelines
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AmerisourceBergen Unit (Primary) Label Requirements
7
Unit Level Barcode & Label Examples
8
Homogeneous Case Label Requirements
10
Case Label Barcode & Label Examples
11
Pallet and Non-Homogeneous Case Label Requirements
13
Pallet and Non-Homogeneous Case Label Barcode & Label Examples
13
Summary Case Specifications (from HDMA Guidelines for Barcoding)
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Purpose
The purpose of the ABC (AmerisourceBergen Corporation) Labeling Requirement Specification
Document (LBRS) is to define, outline and communicate to all ABC suppliers and customers
the business requirements that AmerisourceBergen must meet in order to be compliant and
adhere to industry best practices with the Drug Supply Chain Security Act (DSCSA). The
AmerisourceBergen labeling requirements will be defined at each packaging level with clear
labeling guidance stemmed from the GS1 General Specification Guide and HDMA Bar Code
Guidelines.
DSCSA sets forth multiple phases of compliance starting November 27, 2013 through to
November 27th 2023 and impacts all members of the prescription drug supply chain. The
Labeling Requirement Specification Document will outline the affected AmerisourceBergen
business units as well as timing of compliance to the law. On November 27, 2017, each
manufacturer must comply with applying a Product Identifier (SNI) (Standard Numerical
Identifier) placed on all saleable packages and sealed homogenous cases. With requests
for verification, manufacturers must also reply with an indication of whether or not the
product identifier provided in the request for verification from trading partners corresponds
to the product identifier affixed or imprinted by the manufacturer within 24 hours.
AmerisourceBergen will ultimately utilize the manufacturer’s SNI within multiple business and
IT processes, thus communicating the labeling requirements to ALL suppliers will benefit the
organization greatly.
Definitions, Acronyms & Abbreviations
Acronym / Abbreviation
Definition
DQSA
Drug Quality and Security Act: US Federal law signed into law by President Obama on
November 27, 2013, that outlines critical steps to build an electronic, interoperable
system to identify and trace certain prescription drugs as they are distributed in the
United States.
DSCSA
The Drug Quality and Security Act (DQSA), was signed into law by President Obama
on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act1, outlines
critical steps to build an electronic, interoperable system to identify and trace certain
prescription drugs as they are distributed in the United States.
FDA
Food and Drug Administration: A government agency established in 1906 with the
passage of the Federal Food and Drugs Act. With the passage of DSCSA the FDA now
has expanded regulatory authority of wholesalers and dispensaries.
GS1
GS1 is a neutral, not-for-profit, international organization that develops and maintains
standards for supply and demand chains across multiple industry sectors.
AmerisourceBergen Corporation Serialization Labeling Guidelines and Requirements
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Definitions, Acronyms & Abbreviations
Acronym / Abbreviation
GS1 2D Data Matrix
Definition
GS1 DataMatrix is a two-dimensional (2D) barcode that holds large amounts of data in a
relatively small space.
GS1-128
GS1-128 is an application standard of the GS1 implementation using the Code 128
barcode specification. The former correct name was UCC/EAN-128.
GTIN
Global Trade Item Number (GTIN) is an identifier for trade items developed by GS1.
For the purposes of serialization the industry will be using a 14 digit GTIN which
contains he encoded 10 digit NDC.
Homogeneous Case
Non-Homogeneous Case
Product Case Label
Serial Number Verification
sGTIN
Shipper Label
SSCC(18)
A packaging container, often called a case or shipper, that contains all of the same NDC
or product.
A packaging container that contains mixed products
This is the label that is applied to homogeneous cases. This typically contains the GTIN,
Quantity, Lot, Expire, and quantity encoded in both linear and 2D DataMatrix barcodes.
This is the process (systemic or manual) of ensuring that a serial number in ABC’s
possession is in fact a valid serial number per the manufacturer by the definition of
Product Verification as outlined in DSCSA.
For the US market, sGTIN is a serialized GTIN. When referring to a serial number, it is
in fact always referring to the GTIN + SN combination. A Serial Number by itself is not
unique until combined with a GTIN. Example: (01)0030456219999(21)1003451 is a
valid Serial Number, (21)1003451 is not because it is not with an associated GTIN.
This is a label that is applied to non-homogeneous cases, or totes and Pallets.
This label often contains logistics information and the SSCC (18).
The serial shipping container code (SSCC) is an 18-digit number used to identify logistics
units. In order to automate the reading process, the SSCC is often encoded in a barcode,
generally GS1-128.
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Definitions, Acronyms & Abbreviations
Acronym / Abbreviation
Definition
The term standardized numerical identifier refers to a set of numbers or characters used to
Standard Serialized Numerical uniquely identify each package or homogenous case. The SNI is composed of the National
Identifier (SNI)
Drug Code that corresponds to the specific product (including the particular package
configuration) combined with a unique alphanumeric serial number of up to 20 characters.
Product Verification
Bundle / Interpack
The term `verification’ or `verify’ means determining whether the product identifier
affixed to, or imprinted upon, a package or homogeneous case corresponds to the
standardized numerical identifier or lot number and expiration date assigned to the
product by the manufacturer or the re-packager.
Inner pack (s) of saleable units within a case.
References
GS1 General Specifications Version 1.4
http://www.gs1.org/docs/gsmp/barcodes/GS1_General_Specifications.pdf
HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain (2011)
http://www.healthcaredistribution.org/publications/hdma-guidelines-for-bar-coding-in-thepharmaceutical-supply-chain-quick-start-guide
H.R. 3024; Drug Quality and Security Act (DQSA), Title II –
Drug Supply Chain Security Act (DSCSA)
http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/
DrugSupplyChainSecurityAct/
Pharmacuetical (Rx) Serialization Labeling
What does the DSCSA require for a data carrier?
Unless the Secretary allows, through guidance, the use of other technologies for data instead
of or in addition to the technologies the applicable data:
• Shall be included in a 2-dimensional data matrix barcode when affixed to, or imprinted
upon, a package
• Shall be included in a linear or 2-dimensional data matrix barcode when affixed to, or
imprinted upon, a homogeneous case
The accepted ABC industry standard is to implement a GS1 2D data matrix ECC200
with different barcode sizes used where applicable.
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Pharmacuetical (Rx) Serialization Labeling
Three Key Definitions
• Standardized Numerical Identifier – The term ‘standardized numerical identifier’
means a set of numbers or characters used to uniquely identify each package or
homogenous case that is composed of the National Drug Code that corresponds to
the specific product (including the particular package configuration) combined with a
unique alphanumeric serial number of up to 20 characters.
• Package – a ‘package’ as smallest individual saleable unit of product for distribution by
a manufacturer or re-packager that is intended by the manufacturer for ultimate sale to
the dispenser of such product.
• Product Identifier – The term ‘product identifier’ means a standardized graphic that
includes, in both human readable form and on a machine-readable data carrier that
conforms to the standards developed by a widely recognized international standards
development organization, the standardized numerical identifier, lot number, and
expiration date of the product.
Existing FDA Guidance (Example)
According to GS1 and current best practices, this is NOT an
accepted SNI.
Converting and a NDC (National Drug Code) to a GTIN
(Global Trade Item Number)
GTIN, like the USA regional NDC, is a product identifier valid
and unique globally.
GS1 Application Identifiers
Data Field
Application Identifier
Data Field Length
GTIN
(01)
Fixed length, 14 numeric digits
Expiration Date
(17)
Fixed length, 6 numeric digits – YYMMDD format
Lot Number
(10)
Variable length, up to 20 alphanumeric characters
Serial Number
(21)
Variable length, up to 20 alphanumeric characters
Quantity
(30)
Variable length, up to 8 numeric digits
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AmerisourceBergen Pharmaceutical (Rx)
Labeling Standards and Guidelines
With the 2017 DQSA (Serialization) compliance date approaching, AmerisourceBergen
Corporation has now defined business requirements and IT system capabilites for Rx labeling
upon receipt from all suppliers.
AmerisourceBergen Corporation has adopted GS1 standards and follows, and expects
our trading partners to follow, HDMA Bar Code Implemetation Guidelines for labeling
requirements within the Life Sciences Industry. In order to ensure uninterupted flow of
serialized product, the following sections of this document will describe AmerisourceBergen’s
requirements and examples to assist manufacturers as they implement serialization packaging
and logistics capabilities.
AmerisourceBergen Unit (Primary)
Label Requirements
ABC requires all Manufacturer’s to comply with the requirements based on HDMA Barcode
Guidlelines and GS1 standards listed below:
Requirement Number
Requirement Description
SN_VEN_0010
The manufacturer shall label their primary, lowest unit of sale in accordance with the
HDMA Guidelines for Barcoding (Published 2011)
SN_VEN_0020
The manufacturer shall encode the GTIN in the 2D GS1 DataMatrix AI(01)
SN_VEN_0030
The manufacturer shall encode the Serial Number in the 2D GS1 DataMatrix AI(21)
SN_VEN_0040
The manufacturer shall encode the Lot Number in the 2D GS1 DataMatrix AI(10)
SN_VEN_0050
The manufacturer shall encode the Expiration Date in the 2D GS1 DataMatrix AI(17)
SN_VEN_0060
The manufacturer shall label their lowest unit of sale with the GTIN in Human Readable
format
SN_VEN_0070
The manufacturer shall label their lowest unit of sale with the Serial Number in Human
Readable format
SN_VEN_0080
The manufacturer shall label their lowest unit of sale with the Lot Number in Human
Readable format
SN_VEN_0090
The manufacturer shall label their lowest unit of sale with the Expiration Date in Human
Readable format
SN_VEN_0100
The manufacturer shall verify the readability of the 2D GS1 DataMatrix, containing
serialization information, to a minimum of a ISO Grade C
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Unit Level Barcode & Label Examples
1. (GS1 ECC 200 2 D Data Matrix with HRI
(Human Readable Information))
2. (GS1 ECC 200 2 D Data Matrix with HRI
(Human Readbale Information))
3. (GS1 ECC 200 2 D Data Matrix with HRI
(Human Readbale Information))
4. Sample Serialized Unit Label. (It is recommended that
only ONE 2D DataMatrix be place on each side of
the label)
AmerisourceBergen Corporation Serialization Labeling Guidelines and Requirements
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Unit Level Barcode & Label Examples
“In accordance with the DSCSA Product Identifier required for the smallest individual salable
unit of product, ABC requires encoding NDC [AI(01)+14 digit GTIN], unit-level serial number
[AI(21)+1-20 digit serial number],expiration date [AI(17)+6 digit date in YYMMDD format]
and lot number [AI(10)+1-20 alphanumeric lot number] using the 2D GS1 DataMatrix –
ECC200 (referred to in this document as GS1 DataMatrix) Bar Code. The combination of GTIN
+ Serial Number MUST be unique! (Use an indicator digit of zero in the GTIN for the lowest
saleable unit! This will ensure that product codes (NDC vs. GTIN 14) will not change between
the linear bar code and the 2D data matrix.)
Recommended Minimum Unit Size
GS1 Data Matrix Specifications
GS1 Data Matrix X Dimension
Mil Size
10 Mil
Quite Zone
10 Mil
The encoded data should appear as:
< FNC1>+AI (01) + GTIN+AI (21) + Serial Number + <FNC1> + AI (17) + Expiration Date + AI
(10) + Lot Number
The first FNC1 is used to indicate that this is a GS1 Data Matrix. The second FNC1 (also
known as a Group Separator) is used to terminate the variable length serial number prior to
starting the next AI. Since the lot number is last data element encoded in the bar code, there
is no need to terminate using FNC1. The parentheses are not encoded in the bar code — they
are only shown as human-readable. (HDMA Guidelines for Barcoding)
AmerisourceBergen Corporation Serialization Labeling Guidelines and Requirements
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Homogenous Case Label Requirements
ABC requires all Manufacturer’s to comply with the requirements based on HDMA Barcode
Guidlelines and GS1 standards listed below:
Requirement Number
Requirement Description
SN_VEN_0130
The manufacturer shall label their cases with a 2D GS1 DataMatrix ECC200
SN_VEN_0140
The manufacturer shall encode the GTIN in the 2D GS1 DataMatrix AI(01)
SN_VEN_0160
The manufacturer shall encode the Serial Number in the 2D GS1 DataMatrix AI(21)
SN_VEN_0170
The manufacturer shall encode the Lot Number in the 2D GS1 DataMatrix AI(10)
SN_VEN_0180
The manufacturer shall encode the Expiration Date in the 2D GS1 DataMatrix AI(17)
SN_VEN_0190
The manufacturer shall encode the GTIN in a 1D GS1-128 Linear Barcode AI(01)
SN_VEN_0200
The manufacturer shall encode the Serial Number in a 1D GS1-128 Linear Barcode AI(21)
SN_VEN_0210
The manufacturer shall encode the Lot Number in a 1D GS1-128 Linear Barcode AI(17)
SN_VEN_0220
The manufacturer shall encode the Expiration Date in a 1D GS1-128 Linear Barcode
AI(10)
SN_VEN_0250
The manufacturer shall label their product case with the GTIN in Human
Readable format
SN_VEN_0260
The manufacturer shall label their product case with the Serial Number in Human
Readable format
SN_VEN_0270
The manufacturer shall label their product case with the Lot Number in Human
Readable format
SN_VEN_0280
The manufacturer shall label their product case with the Expiration Date in
Human Readable format
SN_VEN_0300
The manufacturer shall verify that the 2D GS1 DataMatrix, which contains the
serialized information, is to a minimum quality of a ISO Grade C
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Case Label Barcode and Label Examples
HDMA Recommended Corner Wrap Case Label
Product identification labels are recommended on two
adjacent sides of the case. This can be achieved by using
the HDMA Recommended Corner Wrap Case Label shown
at right. A 4” by 10” Corner Wrap label is the industry
standard for a standard case size. Case labels should be
placed with the bar codes oriented in the “picket fence”
orientation relating to the bottom of the case. That is, the
bars should be perpendicular to the bottom edge of the
case. Also, the GS1 Data Matrix should be placed away from
the corner of the case as shown above.
Non-Corner Wrap Case Label
If the manufacturer is unable to comply with the required
Corner Wrap Case Label, the case label requirement can also
be achieved by placing Non-Corner Wrap 4” by 5” labels on
two adjacent sides of the case.
Non-Corner Wrap Case Label Placement
When using a Non-Corner Wrap Case Label, the labels
should be placed .75” from the shared corner and 1.25”
from the bottom of the case as shown at right (on two
adjacent sides).
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Case Label Barcode and Label Examples
“In accordance with the DSCSA, HDMA recommends encoding NDC [AI (01) + 14 digit
GTIN], serial number [AI (21) + 1-20 digit serial number], expiration date [AI (17) +6 digit
date in YYMMDD format] and lot number [AI (10) + 1-20 alphanumeric lot number] and
case quantity [AI (30) + 1-8 digit case quantity] using two GS1-128 bar codes and one GS1
DataMatrix – ECC200.
The combination of GTIN + Serial Number MUST be unique!
The HDMA-recommended case label format MUST include two distinct GS1-128 bar codes
on the label (one placed directly above the other) and one GS1 DataMatrix. The primary case
GS1- 128 bar code (bottom bar code) encodes the GTIN and the case serial number. The
secondary case bar code (top bar code) encodes the expiration date, lot number and quantity.
The GS1 DataMatrix barcode combines all data elements from both primary and secondary
GS1-128 bar codes. For case label size specifications, see Appendix.
The encoded case primary GS1-128 bar code should appear as:
< FNC1> +AI (01) + GTIN + AI (21) + Serial Number.
The FNC1 is used to indicate that this is a GS1-128 Linear Barcode. (For a partial cases, an
SSCC18 number will replace the GTIN and Serial Number, and the label will no longer have a
GS1 Data Matrix)
The encoded case secondary GS1-128 bar code should appear as:
<FNC1> + AI (17) + Expiration Date + AI (10) + Lot Number + <FNC1> + AI (30) + Case
Quantity
The first FNC1 is used to indicate that this is a GS1-128 Linear Barcode. The second FNC1
(also known as a Group Separator) is used to terminate the variable length Lot Number prior
to starting the next AI. Since the case quantity is last data element encoded in the bar code,
there is no need to terminate using FNC1. The parentheses are not encoded in the bar code
— they are only shown as human-readable.
The encoded GS1 DataMatrix data should appear as:
< FNC1> + AI (01) + GTIN + AI (21) + Serial Number + <FNC1> + AI (17) + Expiration Date +
AI (10) + Lot Number
The first FNC1 is used to indicate that this is a GS1 DataMatrix. The second FNC1 (also known
as a Group Separator) is used to terminate the variable length serial number prior to starting
the next AI. Since the Lot Number is last data element encoded in the bar code, there is no
need to terminate using FNC1. The parentheses are NOT encoded in the bar code — they are
only shown as human-readable. (HDMA Guidelines for Barcoding)
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Pallet and Non-Homogeneous Case Label
Requirements
ABC requires all Manufacturer’s to comply with the requirements based on HDMA Barcode
Guidlelines and GS1 standards listed below:
Requirement Number
Requirement Description
SN_VEN_0360
The manufacturer shall encode the SSCC in the GS1-128 Barcode AI(00) on their pallets
SN_VEN_0370
The manufacturer shall encode the SSCC in the GS1-128 Barcode AI(00) on their Partial
Case Labels
SN_VEN_0380
The manufacturer shall encode the SSCC in the GS1-128 Barcode AI(00) on their NonHomogenous/Mixed Case Labels
SN_VEN_0390
The manufacturer shall label their full product pallets, Mixed Cases, and Partial Cases
with the SSCC in Human Readable format
SN_VEN_0400
The manufacturer should include the word “Partial” on the Partial Case Label
SN_VEN_0410
The manufacturer shall verify that the GS1-128 barcodes, which contains the serialized
information, is to a minimum of a ISO Grade C
Pallet and Non-Homogeneous Case Label
Barcode and Label Examples
“A SSCC (Serial Shipping Container Code) label should be used for non-homogenous/mixed
product cases and partial cases. There should be no product label information applied to a
non-homogenous/mixed product case.
At a minimum, the partial case label should include the SSCC 18 encoded into a GS1-128
Linear Barcode and the word “partial.” It is also recommended that the label not include the
secondary linear barcode to avoid confusing this label with the Homogenous Case Label.
To support logistics, HDMA recommends either the Pallet label or Mixed Case Label
(Shown Below).
HDMA further recommends the SSCC Pallet label for pallets shipped by ground freight
carriers. A logistics unit could be a pallet, a case or a tote.” (HDMA Guidelines for Barcoding)
The encoded SSCC in a GS1-128 linear bar code should appear as:
< FNC1> +AI (00) + SSCC
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Pallet and Non-Homogeneous Case Label
Barcode and Label Examples
The following diagram is an example of the HDMA-recommended SSCC label, for pallets
and containers shipped by ground freight carriers, with each of its building blocks defined
and described:
SSCC 18 Product Code Break Down:
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Pallet and Non-Homogeneous Case Label
Barcode and Label Examples
The following pictures are examples of the HDMA-recommended Partial (A) and Mixed (B)
case label:
Sample Partial Case Label
Sample Mixed Case Label
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Appendix
Summary Case Specifications
(From HDMA Guidelines for Barcoding)
AmerisourceBergen Corporation Serialization Labeling Guidelines and Requirements
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www.amerisourcebergen.com