HDMA Guidelines for Bar Coding in the

Transcription

HDMA Guidelines for Bar Coding in the
Pharmaceutical Supply Chain
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Distributed by Cardinal Health, Inc. with permission from HDMA
HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain
HDMA Guidelines for Bar Coding
in the Pharmaceutical Supply Chain
Created by
Sponsored by
Product Identification & Processing Systems, Inc. (PIPS) has been a recognized leader in
healthcare bar code standards development and implementation solutions for more than 30
years. We specialize in precision AccuMaster™ digital bar code artwork; the OptiVal™ suite
of data validation solutions; and Webscan TruCheck and LVS Integra online and tabletop print
quality verifiers, the industry-standard bar code QA tools for healthcare manufacturers and
contract packagers. For distributors and providers (hospitals especially), our unique OptiScan/
AppAWARE™ middleware utility for Windows® automatically captures, parses, validates,
formats and delivers virtually any bar code data element, encoded in any bar code format to any
application or web-based interface, whether it was built “bar code ready” or not.
Product Identification & Processing Systems, Inc. (PIPS)
10 Midland Avenue, Suite M-02
Port Chester, New York 10573
Tel: (212) 996-6000 Fax: (212) 410-7795 Website: www.pips.com
Contact: George Wright IV, Vice-President, at (212) 996-6076 or gw4@pips.com
Revised December 2011
Although HDMA has prepared or compiled the information presented herein in an effort to inform
its members and the general public about the healthcare distribution industry, HDMA does not
warrant, either expressly or implicitly, the accuracy or completeness of this information and
assumes no responsibility for its use.
© Copyright 2011 Healthcare Distribution Management Association
All rights reserved. No part of this book may be reproduced or transmitted in any form or by any
means, electronic or mechanical, including photocopying, recording or by an information storage
and retrieval system, without permission in writing from the publisher.
ISBN: 978-0-9839043-3-5
HDMA is the national association representing primary healthcare distributors, the vital link
between the nation’s pharmaceutical manufacturers and healthcare providers. Each business day,
HDMA member companies ensure that nearly nine million prescription medicines and healthcare
products are delivered safely and efficiently to nearly 200,000 pharmacies, hospitals, long-term
care facilities, clinics and others nationwide. HDMA and its members work daily to provide value
and achieve cost savings, an estimated $42 billion each year to our nation’s healthcare system. For
more information, visit www.HealthcareDistribution.org.
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Table of Contents
v
Summary of Revisions
1
Introduction
4
The National Drug Code (NDC)
4
• Decoding the 10-Digit NDC
5
• NCPDP 11-Digit Format for NDCs
6
• Importance of Adherence to NDC Format Standards
7
• FDA Bar Code Regulation
8
Bar Codes and Data Structures
8
• Benefits of Bar Coded NDCs
9
• History of the Industry’s Bar Code Symbology Selection
10
• NDC and U.P.C.: Compatible All-Numeric Systems
10
• Department of Defense (DoD) Universal Product Number and NDC
13
SKU and Unit-Level Packaging
13
• Encoding the NDC in Bar Code According to GS1 Standards (SKU Level)
13
• U.P.C. Numbering Scheme, U.P.C. Symbology
14
• Bar Codes for Units Smaller Than the SKU Package Size
15
• Update: Bar Coding Vaccines
15
• GS1 DataBar Symbology/Linear Symbols
18
• Specifying Symbol Size: X-Dimension vs. Magnification
18
• GS1 DataBar Symbology and Composite Symbology
20
• Encoding Quantity, Expiration Date and Lot Number
21
• Data Matrix and GS1 DataMatrix
23
• Unit-Level Serialization
25
Bar Codes for Inner Packs and Shipping Cases
26
• Codes Above the Unit Level
27
• Product Identification Label Data Structures, Symbologies and
Human-Readable Text
28
• Expiration Date Formats
30
• HDMA Shipping Case Product Identification Label — Summary Specifications
31
• Product Identification Label Format 1 — GTIN+SERIAL NUMBER
33
• Product Identification Label Format 1 — GTIN+SERIAL NUMBER: Example Bar
Code Labels
36
• Product Identification Label Format 2 — GTIN
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Table of Contents (Continued)
39
Case Marking and Labeling
39
• Homogenous Cases — Product Identification Labeling
40
• Homogenous Cases — Product Identification Label Placement
42
• Non-Homogenous/Mixed Product Cases — Product Identification Labeling
42
• Individual Shipping Cases and Pallets — Logistics/Serial Shipping Container
Code (SSCC) Label Format
45
• Individual Shipping Cases and Pallets — Logistics/SSCC Label Placement
45
• Pallets and Unit Loads — Logistics/SSCC Label Placement
46
• Radio Frequency Identification (RFID)
47
• Electronic Product Code (EPC)
47
• Multiple Data Carriers on Salable Units/Trade Items
47
• Multiple Data Carriers on Logistical Containers
48
Technology Considerations
48
• Bar Code Scanner Selection
48
• Bar Code Symbol Generation for Primary Labels and Packaging
49
• Bar Code Symbol Print-Quality Verification
51
Application Software Design Issues — ISO/IEC Symbology Identifiers
52
Scanner and Data Collection Hardware Issues
53
HDMA Recommendations
55
Acknowledgements
56
References
58
Resources for Healthcare Distribution Standards
59
Frequently Asked Questions
63
Glossary of Terms
65
Appendix
65
• Fundamentals of ANSI/ISO Linear Bar Code Print Quality Verification
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Summary of Revisions
Below is a list of significant changes from the previous version of the HDMA bar code
guidelines. The following changes are presented in further detail throughout the document:
• Inclusion of final Guidance for Industry: Bar Code Label Requirements —
Questions and Answers (Question 12 Update);
• Addition of a unique serial number in the GS1-128 product identification bar code;
• Addition of an optional but recommended GS1 DataMatrix bar code symbol;
• Removal of ITF-14 as Primary Data Carrier (bar code) option;
• Removal of AI(22) as Secondary Data structure option;
• Removal of AI(30) QUANTITY from the primary GS1-128 bar code;
• Use of AI(30) QUANTITY in the secondary GS1-128 bar code only;
• Reduction in the minimum X-dimension for GS1-128 symbols;
• Reduction in the minimum height for GS1-128 symbols;
• Reduction in the minimum point size for human-readable interpretation of
GS1-128 symbols;
• Change in the position of the bar code human-readable interpretation on
secondary data (Upper) GS1-128 symbol;
• Addition of HDMA recommendations for adding GS1 serial numbers to units
and shipping containers; and,
• Includes information on standardized numerical identifiers (SNI).
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Introduction
With continuing and increasing pressure to reduce healthcare costs and improve patient safety,
there is a perpetual need to identify and refine how proven technologies are used to increase the
efficiency of supply chain procurement, replenishment and logistics processes — and enhance the
quality of patient care in the United States and around the world.
This revision of the previously titled HDMA Guidelines for Bar Coding in the Pharmaceutical
Products Supply Chain has been developed by the HDMA Bar Code Task Force based on
strong industry consensus across major stakeholder segments. It reflects changes in terminology
(especially relating to GS1 DataBar symbology, formerly Reduced Space Symbology or RSS) and
updated and expanded content, including references, frequently asked questions, instructions
for employing GS1 EPC Standards and a glossary of terms. More significantly, this edition
incorporates changes to the shipping container label bar code formats that the HDMA Bar Code
Task Force recommends for the industry going forward. Every effort has been made to maintain
the solid, logical foundation upon which the 2005 edition was built and make the required label
format changes straightforward to implement.
Other additions to these guidelines focus on serialization. In March 2010, the Food and Drug
Administration (FDA) published Standards for Securing the Drug Supply Chain – Standardized
Numerical Identification for Prescription Drug Packages, a final guidance on how the industry
might use a standardized numerical identifier (SNI) for prescription drug packages. A guidance
describes the agency’s current thinking on a topic; in its guidance on SNIs, FDA provides an
example of an SNI that contains a 10-digit National Drug Code (NDC) and a unique serial
number of up to 20 characters (numeric or alphanumeric). The FDA refers to the combination of
NDC and a unique serial number as sNDC (serialized National Drug Code). It is up to individual
companies if and how they adopt numerical identifiers. These HDMA guidelines are intended to
demonstrate how a company could implement SNIs. Manufacturers are beginning to use Data
Matrix bar codes (and presumably GS1 DataMatrix in accordance with the GS1 system) as the
carrier for SNIs at the item level.1
The guidelines also note that the cost of two-dimensional bar code scanners (also called 2D
imagers) has decreased significantly and the use of such two-dimensional symbologies as Data
Matrix is increasing rapidly throughout the global healthcare supply chain. It is critical, therefore,
that all organizations in the supply chain bear in mind the potential long-term benefits of investing
in 2D-capable scanners instead of traditional linear readers. From the manufacturer’s packaging
line to the label on the shipping container to the receiving dock, the hospital supply room, patient
bedside and beyond — 2D bar codes are becoming increasingly prevalent. Remember that 2D
scanners can read both linear and 2D bar codes such as Data Matrix (and Aztec Code, QR Code
and many others). Manufacturers are beginning to use GS1 DataMatrix bar codes at the item and
case level to encode serialization data.
HDMA Recommendation
HDMA recommends investing in and/or upgrading to imaging
scanners capable of reading Data Matrix and linear codes whenever
auto-id procurement needs are under consideration.
Food and Drug Administration, Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for
Prescription Drug Packages, (March 2010). Retreived from http://www.fda.gov/RegulatoryInformation/Guidances/ucm125505.htm
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Automatic identification technology — and in the U.S. market, the National Drug Code (NDC)
— coupled with the global GS1 (formerly EAN.UCC) system of globally standardized item and
attribute identification data structures and data carriers (e.g., linear and 2D bar codes and RFID
tags), represent critical tools for achieving these goals. While not new, the NDC product identifier
[and bar code scanning, electronic data interchange (EDI) or other e-messaging technologies
applicable within the GS1 System] continue to offer substantial opportunities for efficiency, cost
savings and patient safety if they are used more widely and effectively throughout the global
healthcare supply chain.
Since 1969, the FDA has required the clear identification of all drug products sold in the U.S. with
the NDC, a unique, all-numeric 10-digit code identifying the drug manufacturer/labeler, product
and package size. The U.S. pharmaceutical industry uses the NDC to order, track and report
on products. Scanning a standardized GS1 System bar code containing the NDC has proven to
be an essential element in achieving faster and more accurate movement of both products and
information — and in promoting patient safety when incorporated into bar code-based medication
administration applications.
As early as the 1970s, the benefits of representing the NDC in a standardized bar code format
were readily apparent to the FDA and to the Uniform Code Council (UCC), now known as
GS1 US, the developers of the Universal Product Code (U.P.C.). Thus, at the inception of U.P.C.
numbering in the early 1970s, a provision was made to allow every pharmaceutical and healthrelated item manufacturer/labeler to apply to GS1 US and obtain the “Company Prefix” that
coincides with their FDA labeler code. Since that time the 10-digit NDC has been embedded
within the 12-digit U.P.C. symbol, with the NDC preceded by the number “3” and followed by
a modulo-10 check digit. Today, the NDC is encoded in the full range of GS1 symbologies at all
levels of packaging, from unit dose and unit of use all the way through to the shipping level.
This implementation of the National Drug Code embedded within the GTIN-12 data structure
and represented in the U.P.C. bar code symbol became the de facto standard in the U.S. for
pharmaceutical products. (The item identification “key” within the global GS1 System is referred
to as the Global Trade Item Number or GTIN. There are four formats of GTIN: GTIN-8, GTIN12, GTIN-13 and GTIN-14. Refer to the GS1 General Specifications for more details.) In 1993
HDMA published Numerical and Automatic Identification of Drug Products as a guideline for
pharmaceutical bar coding from the basic unit of sale (also known as the stock keeping unit or
SKU) to higher packaging levels, including inner packs, shipping cases and pallet loads. This
publication has been revised and renamed over the years (in 2001, Bar Codes, HDMA Voluntary
Guidelines; and most recently 2005, HDMA Guidelines for Bar Coding in the Pharmaceutical
Products Supply Chain), and continues to evolve to stay current with policies, recommendations
and changes — both technical and regulatory — within the U.S. healthcare supply chain.
This revision serves as an industry-wide voluntary guideline on the use of the NDC and
its numbering scheme, and the various globally accepted GS1 System data structures and
symbologies that convey the NDC (and, where appropriate, such secondary data as quantity,
expiration date and lot number). This revision is part of a global, multilateral effort to more fully
standardize common data structures and data carriers and to capitalize on technological advances
to achieve the dual goals of enhanced patient safety and efficiency throughout the global
pharmaceutical supply chain.
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The information contained herein relating to printing an industry standard bar code on
pharmaceutical products at, above and below the trade item level (the smallest unit of product
that can be sold from inventory or purchased or added to inventory, for example, a folding carton
or bottle) — including secondary data such as quantity, expiration date and lot number (and,
going forward, a unique serial number specific to a single trade item package), is a compilation
of relevant guidance, regulations, technical specifications and application standards that are
applicable to the U.S. pharmaceutical supply chain. In addition, this publication also provides
detailed guidance on shipping case bar code label format, marking and placement, and serves as
a resource for more detailed primary and secondary sources of information on standards for bar
codes to be used in the U.S. pharmaceutical supply chain.
It is important to maintain at least the minimum X-dimension and symbol height specified in
the shipping case bar code label format table provided in this document. In general, the largest
possible X-dimension that will fit in the space available should be used. The use of bar code
symbols with an X-dimension below the specified minimum may result in substantially reduced
“scannability” and disruption to the supply chain.
Since the early 1990s, the pharmaceutical industry has explored the benefits of industry standard
bar codes at the unit-dose and unit-of-use level. In February 2004, FDA issued new regulations
requiring the NDC to be encoded in a standardized data structure and incorporated in a linear
bar code data carrier according to either GS1 or HIBCC standards on virtually every prescription
pharmaceutical and biological product label.2 Many over-the-counter (OTC) pharmaceuticals
also were included in the regulation. (The regulation also mandates standardized data structures
and bar codes on blood and blood products, but this application is beyond the scope of this
document.) According to the rule, the date for full compliance was April 26, 2006, by which time
all covered products were required to carry a standardized linear bar code in accordance with the
requirements of the regulation.
For a link to the FDA bar code rule as published in the Federal Register, a synopsis of the rule
and a link to The FDA Bar Code Rule Decoded, published by the Association for Automatic
Identification & Mobility (AIM), see the “References” section.
Finally, your company must obtain a GS1 Company Prefix through a GS1 member organization
(such as GS1 US) to guarantee that this prefix is authentic. This will ensure that your GS1 bar
codes are globally unique and that the data contained in them can be authenticated through the
Global GS1 Electronic Party Information Registry (GEPIR), Global Data Synchronization Network
(GDSN) and EPC Information Services (EPCIS). The direct link to apply for a GS1 Company Prefix
in the U.S. is http://barcode.gs1us.org/.
Food and Drug Administration, CFR - Code of Federal Regulations Title 21, Parts 201, 606 and 610 (April 2004).
Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
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The National Drug Code (NDC)
The 10-digit NDC is the single, basic identifier for all forms of pharmaceutical products in the U.S.
healthcare industry. Pharmacy computer systems, third-party prescription claims processing and
sales tracking, reporting and industry support services all use the NDC to identify, describe and
pay for pharmaceutical services. For pharmacy providers, legislation now mandates the use of the
NDC for all Medicaid claims.3
The Department of Justice and the Drug Enforcement Administration require monthly reporting of
all incoming and outgoing controlled substance transactions and inventories on a national system
known as the Automation of Reports and Consolidated Orders Systems (ARCOS), as described in
the ARCOS Registrant Handbook.4 Again, the NDC is the identification and reporting standard by
which the system operates.
From the manufacturer, to the healthcare distributor to the provider, computer systems depend on
the NDC to identify what is being ordered, paid, returned and credited. It is a proven method of
enhancing the efficiency and accuracy of U.S. pharmaceutical distribution.
Decoding the 10-Digit NDC
The NDC, by FDA regulation, is a 10-digit numeric code, often preceded when displayed in
human-readable form by the letter N or letters NDC. The letter or letters are not part of the NDC.
The NDC consists of three numeric fields of information. The FDA assigns the labeler portion of
the code (the first or left-most field), while the labeler (the organization controlling the product,
typically the manufacturer) assigns both the product identification portion of the code (second or
middle field) and trade package portion (third or right-most field) according to format standards
specified by FDA and adopted by the labeler.
The FDA originally developed and assigned the NDC labeler identification portion of the code as
a fixed-length, four-digit field, starting at 0002. The system was designed not to exceed a labeler
identification of 0999. When it became apparent to the FDA Drug Listing Branch that the number
of companies applying for labeler codes would exceed 999, they redefined the NDC to also
include five-digit manufacturer/labeler identification. The numbering for these labelers starts at
10000. To avoid ambiguity with NDC labeler identification codes in this higher range, labeler
identification codes in the range of 1000-9999 are not assigned.
The FDA-prescribed NDC is presented in one of three hyphenated, human-readable formats:
these are referred to as “4-4-2,” “5-3-2” or “5-4-1.”
The first field of four or five digits identifies the manufacturer/labeler of the product. The next field
of three or four digits identifies the product, dosage form and strength. The final field of one or two
digits identifies the individual trade package size or stock-keeping unit (SKU). Labelers assigned a
five-digit identifier can choose either a “3-2” or a “4-1” product and package size code structure.
That is, the labeler can have up to 1,000 products with 100 trade package sizes for each one; or
10,000 products with 10 trade package sizes for each one. Once selected, labelers must maintain
the selected “5-3-2” or “5-4-1” structure for all products using this labeler code.
H.R. 5835 Omnibus Budget Reconciliation Act of 1990 (1990).
Retrieved from http://thomas.loc.gov/cgi-bin/query/z?c101:H.R.5835:
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Drug Enforcement Administration, ARCOS Registrant Handbook (Revised August 1997).
Retrieved from http://www.deadiversion.usdoj.gov/arcos/handbook/index.html
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Whenever an NDC is printed in human-readable form, all leading, embedded and trailing
zeros must be included and each of the three fields (labeler, product and package size) should
be separated by a hyphen. The hyphens appear in the human-readable text only and are never
encoded in any of the allowed bar code or other standardized data structures.
4-4-2 Format:
NDC 0001-4096-60
5-3-2 Format:
NDC 11111-569-73
5-4-1 Format:
NDC 22222-8395-5
Format
GS1-US
Prefix
Labeler
Identification
Product
Identification
SKU or Trade
Package Size
Mod-10 Check
Digit
4-4-2
3
0NNN
NNNN
NN
N
5-3-2
3
NNNNN
NNN
NN
N
5-4-1
3
NNNNN
NNNN
N
N
A common practice for prescription pharmaceuticals has been to assign the NDC to the level at
which the package insert is provided. It may also be appropriate according to FDA regulations
to assign a separate NDC (one with a different package code/”package size”) to a unit-dose or
unit-of-use package of the same drug. Some pharmaceutical labelers follow this practice; others
do not. For OTC products, the NDC generally has been assigned to the level that is intended to be
purchased by the retail customer. However, for those drugs packaged for institutional use, under
the FDA rule, it also may be appropriate to assign a distinct NDC to the unit-dose or unit-of-use
level if the drug is offered in that package configuration. As always, any new NDC number or
change to an existing one should be clearly and promptly communicated throughout the supply
channel, including to the compendia (database providers such as First Databank, Medi-Span,
Micromedex, etc.), so that the new numbers are included in the drug files made available by these
clinical support vendors.
NCPDP 11-Digit Format for NDCs
As stated above, the FDA requires assigning NDC numbers to “each drug product listed under
Section 510 of the Federal Food, Drug, and Cosmetic Act” to readily identify drug products.5 The
portions of the 10-digit, three-segment code and the configurations in which it may be represented
are detailed above. In addition, further information on the proper use of the NDC is available from
the FDA in the Drug Registration and Listing System Instructions. See the “References” section for
a link to this resource.
However, there is an important and prevalent practice in certain segments of the industry where
10-digit NDCs are converted into an 11-digit format to provide a consistent “5-4-2” hyphenated
representation of the NDC for certain data processing applications.
Food and Drug Administration, Federal Food, Drug and Cosmetic Act, Section 510, (Revised February 2008).
Retrieved from http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/
FDCActChapterVDrugsandDevices/ucm109201.htm
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When third-party billing of prescription drug claims became commonplace, a business case was
made for formatting the 10-digit NDC into an equivalent 11-digit format so the NDC could be
represented in a consistent “5-4-2” human-readable manner. To facilitate this third-party billing, first
on paper and eventually by electronic means, the National Council for Prescription Drug Programs
(NCPDP) developed a standard in which the manufacturer/labeler segment is always represented by
five digits, the product segment by four digits and the packaging segment by two digits.
Below are examples of the three FDA-prescribed NDC formats and the methods for re-formatting
them into 11 digits for use in accordance with NCPDP-based applications by the placement of
a zero in the proper position. In a “4-4-2” format the zero is placed in the first position of the
leading segment; in a “5-3-2” format the zero is placed in the first position of the middle (second)
segment (i.e., the sixth position of the unhyphenated code); and in a “5-4-1” format the zero is
placed in the first position of the last (third) segment (i.e., the tenth position of the unhyphenated
code). In all three cases the resulting format is “5-4-2.”
FDA-prescribed
NDC
NCPDP “5-4-2”
11‑digit format
4-4-2
(1234–5678-99)
01234-5678-99
5-3-2
(12345-678-99)
12345-0678-99
5-4-1
(12345-6789-9)
12345-6789-09
The NCPDP representation of the FDA-prescribed 10-digit NDC is not “the NDC.” Only the true
FDA-prescribed 10-digit NDC can be encoded in GS1 or HIBCC data formats in accordance with
the FDA bar code rule, always without the hyphens.6 Encoding the 11-digit NCPDP format does
not conform to the FDA bar code rule and in any event, it is not physically possible to embed an
11-digit number within the rules established for embedding the NDC within the GS1 GTIN-12
data structure.
Importance of Adherence to NDC Format Standards
The NDC has been an integral part of computer systems in the pharmaceutical distribution
channel for years. Strict adherence to FDA requirements should be maintained. The requirements
formerly laid out in FDA’s Drug Registration and Listing System Instruction Booklet can now
be found in FDA’s Guidance for Industry, Providing Regulatory Submissions in Electronic
Format – Drug Establishment Registration and Drug Listing. The regulations referenced in these
guidelines encompass all commercially marketed pharmaceuticals in the U.S., and HDMA urges
manufacturers and labelers to follow them closely.
In their catalogs and on price lists, manufacturers and labelers are encouraged to include the
complete 10-digit NDC for each listed item. Inclusion of the labeler code is especially important
for each listed item. Labelers are urged to discontinue use of internal or traditional list, order or
product numbers, as these identifiers are non-specific to trade package or SKU. Instead, these
numbers should be the full 10-digit NDC numbers used for EDI or other e-messaging transactions.
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Furthermore, manufacturers and labelers are encouraged to include the unique GS1 Global
Trade Item Number (GTIN) identifier associated with each drug at each packaging level in their
catalogs and on price lists. In most cases in the pharmaceutical supply chain, this number is
derived from the NDC and is the number represented in a GS1 bar code, whichever symbology
or data structure is used. Also note that under the GS1 system, depending on the data format and
symbology being used, in bar code format the GTIN may:
1. Be preceded and/or followed by additional digits;
2. Be exactly the encoded data; or,
3. Be a shortened but exactly equivalent form of the GTIN.
See the following section, “Bar Codes and Data Structures,” for more information about GTINs.
See the “References” section for a link to all of the relevant GS1 standards and guidelines
available on the GS1 US Solutions Center.
FDA Bar Code Regulation
In February 2004 the FDA culminated a two-year review process with the publication of a rule
requiring bar coding of the NDC (or in the case of blood products, other standardized identifiers)
on nearly all prescription pharmaceutical and biological packages, blood products and many OTC
items. The FDA came to appreciate the mounting evidence that patient safety could be enhanced
by scanning bar codes at the hospital bedside prior to medication administration, but found that
very few hospitals were investing in the technology, in part due to a lack of bar code availability at
the unit-dose or unit-of-use packaging level.
Thus, after a period of research and public discourse, the agency elected to require encoding
the NDC in a linear bar code on the FDA-required product label, using either the GS1 (formerly
EAN.UCC) or the HIBCC standard. This mandate is a requirement for virtually all human
pharmaceutical and biological products (with only a few exceptions) as well as for OTC products
“commonly used in a hospital and dispensed pursuant to a physician’s order.” Per the FDA rule,
blood products are required to encode “machine-readable information” in a format approved by
the director of the Center for Biologics Evaluation and Research (CBER).7
There are certainly a great many more details regarding this important regulation. According to the
rule, the date for full compliance was April 26, 2006. References are made throughout this publication
that will help to ensure that the rule’s mandates are clear and that compliance is achieved by all
HDMA members (and any other entities that must comply with or are otherwise affected by the rule).
For a link to the FDA bar code rule as published in the Federal Register and a synopsis of the rule,
see the “References” section. The FDA Bar Code Rule Decoded, published by the Association for
Automatic Identification & Mobility (AIM), may be purchased through the AIM website.
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Bar Codes and Data Structures
Benefits of Bar Coded NDCs
While including the NDC on the product label was previously sufficient to meet FDA requirements
and provides a unique numbering scheme for all products in the industry, the NDC must be bar
coded in a standardized manner to enable all users to automate their systems. Effective April 26,
2004, this longstanding U.S. pharmaceutical industry practice is now a requirement for nearly all
human prescription and some OTC drugs under federal FDA regulations.8 Systems automation using
bar code technology offers many efficiency benefits to members of the distribution channel. Bar
coded unit doses, SKUs, inner packs, shipping cases and pallets can be handled more accurately.
Additionally, bar coding unit doses and SKUs — in conjunction with appropriate pharmacy and
point-of-care medication administration clinical systems — has the significant added benefit of
contributing to increased patient safety.
For example, healthcare distributors and manufacturers can increase the product handling
efficiency of their distribution centers by using integrated computer systems with bar code data
entry in such areas as less-than-case quantities; bulk-order receiving and shipment; put-away
reporting; replenishment; order checking, picking and sorting; shipment staging; inventory control;
cycle counting; physical inventories; and, returned goods handling.
Managing and moving inventory from the manufacturer to healthcare distributor to retailer and/or
hospital pharmacy is more accurate when scanning bar-coded products. In the hospital pharmacy,
bar codes assist in drug routing and pharmaceutical dose administration monitoring. When used
in conjunction with electronic medical records and point-of-care medication administration
systems, bar codes can significantly increase patient safety. In the retail pharmacy sector, not
only are further advances still possible with point-of-sale checkout scanning systems, but there
are significant opportunities to improve patient safety by using bar codes and electronic patient
prescription records.
Scanning the bar code on pharmaceuticals and other dispensed items for third-party claims
loaded into electronic claims systems helps reduce possible delays from certain drug coverage
plans because of claims adjudication. Scanning bar codes is one factor in automating the input of
data. Eliminating handwritten documents and subsequent manual keystroke entries can result in
productivity gains and near 100 percent accuracy levels.
Bar coded products afford healthcare distributor prime vendor systems in both retail and
hospital pharmacy settings the potential for higher efficiencies. Replenishment and inventory
counts at the pharmacy and distribution levels can be entered easily by using bar codes on
products and shelf locations.
After scanning, the data can be used with an EDI or other e-messaging application, allowing for
quick and accurate sharing of product movement information among trading partners both up and
down the supply chain.
Food and Drug Administration, CFR - Code of Federal Regulations Title 21 (Parts 201, 606 and 610), (April 2004).
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History of the Industry’s Bar Code Symbology Selection
Because the NDC is the single basic means of product identification for all U.S. pharmaceutical
products, it is advantageous to encode the NDC in a bar code. It also is now required under FDA
regulations for most pharmaceuticals and biologics.9 (The FDA regulation also pertains to human
blood products, but the NDC is not part of the identification of such items.) Therefore, HDMA
urges manufacturers and labelers to identify their products with an NDC and to encode this
number in a standardized GS1 System bar code format. Moreover, it is important to differentiate
individual units-of-use and unit doses, trade packages or stock keeping units (SKUs), inner packs,
shipping cases and pallets according to the appropriate scheme, whether within the NDC or
otherwise as a part of the overall item identifier.
There are different bar code symbologies and a growing number of applications for each of them.
However, choosing the appropriate data structures and bar code symbologies for use in the U.S.
pharmaceutical industry is straightforward due to the widespread use and acceptance of the global
GS1 bar coding standards.
The GS1 standards have evolved over more than 35 years and are now strictly codified for global use
in the GS1 General Specifications, with more particular U.S. pharmaceutical industry application
guidance to be found in the GS1 US North American Guideline For Application of GS1 Bar Codes
To Very Small Healthcare Items. These documents are freely available to companies that are GS1
members in good standing and available for purchase by anyone else through its website.
For SKUs, in 1993 HDMA recommended using the GS1 GTIN-12 data structure (or code) to carry
the NDC on SKU-level packages. The Universal Product Code (U.P.C.) symbology is the singular
data carrier for this message format at this packaging level. It predominates at the point of sale and
in pharmacies — both in retail and in the hospital where pharmacy and other clinical software has
been developed based on this code and symbol combination.
For bar code marking on inner packs and shipping cases, the industry traditionally has followed
the guidelines set forth by GS1 specifying the GTIN-14 data structure carried by Interleaved 2
of 5 or GS1-128 symbologies. However, the Interleaved 2 of 5 (or ITF-14) symbology is limited
to carrying the 14-digit GTIN exclusively and cannot accommodate either a unique case serial
number or any secondary information (such as expiration date, lot number or quantity).
HDMA Recommendation
HDMA is no longer calling for the use of ITF-14. Instead, GS1-128
(with Application Identifiers) should be the linear symbology used
at the inner pack and shipping case levels.
The use of this symbology — and more importantly, the underlying globally recognized GTIN and
other secondary data structures — is critical for compatibility with the numbering and scanning
systems employed by the computerized applications and handheld devices that have been used
for electronic transmissions in pharmacies for years. Moreover, these globally standardized data
structures and the GS1-128 symbology are increasingly being adopted by the major international
trading partners throughout the global pharmaceutical supply chain, including the European
Union, Canada, Japan and elsewhere (including Turkey, Brazil and many other nations).
9
9
HDMA Recommendation
HDMA urges manufacturers and labelers to identify their products
with an NDC and to encode this number in a standardized GS1 bar
code format.
NDC and U.P.C.: Compatible All-Numeric Systems
The U.P.C. numbering system, administered by GS1 US, is an all-numeric, 12-digit, fixed-length
numbering system incorporating the U.P.C. symbology. The U.P.C. symbology is a proven and
reliable data carrier and best meets the needs of the healthcare supply chain for SKU-level
packaging. It should be noted that when discussing “U.P.C.” there is a difference between the
U.P.C. symbology (the bars and spaces) and the U.P.C. numbering scheme or GTIN-12 data
structure, which often is printed in a human-readable form that includes hyphens (especially
when it encodes the NDC). Hyphens, however, are neither part of the data structure, nor are they
encoded in the bar code.
Department of Defense (DoD) Universal Product Number and NDC
In the medical/surgical segment of the U.S. healthcare industry, there has been no federally
mandated, standardized code that uniquely identifies non-pharmaceutical healthcare items the
way that the NDC does for pharmaceutical items (although discussion of such an FDA-mandated
Unique Device Identifier (UDI) standard for medical devices currently is underway). To remedy
this situation (at least in part) the U.S. Department of Defense (DoD) coined the term “Universal
Product Number” (UPN) and designated and embraced two well-established standard identifiers
for medical/surgical and pharmaceutical products so that bar codes could be more widely
implemented throughout the U.S. DoD healthcare supply chain.
The UPN is an identifier that uniquely identifies a healthcare product, whether pharmaceutical
or medical/surgical, at a specific level of packaging. The UPN is either an all-numeric GS1 GTIN
(see the forthcoming sections) or an alpha-numeric HIBCC primary data structure. Both standards
offer a choice of bar-code symbologies in which to encode their standardized data structures,
depending on the level of packaging and the needs of the marketplace.
The NDC encoded in a GS1 GTIN format or the HIBC LIC Primary or HIBC Code 128 Small
Package format satisfies the requirement for a UPN identifier for pharmaceuticals. These data
structures have specific bar code symbologies associated with them as described below.
Examples of common DoD and FDA-compliant UPN data structures and their associated linear
bar code symbols are shown below.
UPC-A at X=13 mils encoding NDC 1234-5678-90 in GTIN-12 Data Format. The human-readable
format shown above conforms with GS1 General Specifications and includes the letter “N” to
denote the presence of the encoded 10-digit NDC, which is displayed in its properly hyphenated
format. The letter “N” is not encoded in the bar code.
10
GS1-128 at X=20 mils encoding
NDC 1234-5678-90 in GTIN-14 Data Format
GS1 DataBar Limited & GS1 DataBar
Stacked at X=13 mils encoding
NDC 1234-5678-90 in GTIN-14 Data Format
Code 128 at X=15 mils encoding NDC
1234-5678-90 in HIBC LIC Primary Data Format
Code 128 at X=10 mils encoding NDC
1234-5678-90 in HIBC Small Package Data Format
In addition, GS1 General Specifications now permit encoding the GTIN-14 data structure in the
two-dimensional symbology Data Matrix ECC200 under certain circumstances, where package
size is limited. (However, note that the 2004 FDA bar code rule requires the use of a linear bar
code on pharmaceutical products at the unit-dose or unit-of-use packaging level.) This version of
Data Matrix specified by GS1 is referred to as GS1 DataMatrix and (as with GS1-128) encodes the
special character FNC1 in the first position (and elsewhere as a field delimiter when needed). A
sample of this symbol is shown below at actual size typical for a unit-dose application and below
that at 200 percent of actual size. The matrix size is 16x16 overall.
0.24” x 0.24”
NDC 1234-5678-90 embedded in 14-digit GTIN
using Al(01) (0100312345678906) and encoded in
Data Matrix ECC200 with FNC1 in the first position
(aka GS1 DataMatrix) at X=15 mils
0.48” x 0.48”
NDC 1234-5678-90 embedded in 14-digit GTIN
using Al(01) (0100312345678906) and encoded in
Data Matrix ECC200 with FNC1 in the first position
(aka GS1 DataMatrix) at X=30 mils
It is important to note, however, that the FDA bar code rule specifically requires the NDC to be
encoded in a standardized linear bar code.10 Thus, the use of GS1 DataMatrix as shown above
does not meet the FDA current requirements. However, space permitting, it would be permissible
to include a GS1 DataMatrix, encoding GTIN+SERIAL NUMBER (or GTIN+EXP DATE and LOT) in
addition to the linear symbol as outlined below.
10
11
GS1 DataMatrix supports the concatenation of additional secondary data elements (i.e., item
attributes) following the GTIN. A typical example would be the addition of expiration date
(EXP) and lot number (LOT), or in a more contemporary mass serialization (e.g., track and
trace) environment, GTIN+Serial Number. The FDA bar code rule does not prohibit the use of
supplemental/additional machine-readable information, and some manufacturers are including
a GS1 DataMatrix symbol in addition to the linear symbol mandated by FDA. Examples of such
symbols are shown below.
NDC 1234-5678-90 embedded in 14-digit
GTIN with Al(01) followed by Al(17) for
EXP and Al(10) for LOT and encoded in
GS1 DataMatrix at X=15 mils
NDC 1234-5678-90 embedded in 14-digit
GTIN with Al(01) followed by Al(17) for
EXP and Al(10) for LOT and encoded in
GS1 DataMatrix at X=30 mils
Both symbols encode: (01) 00312345678906 (17) 051231 (10) 123ABC
Note that the inclusion of EXP and LOT only increases the size of the matrix by four cells to 20 x 20
from 16x16, for an overall symbol size of 0.30” square at X=15 mils or 0.60” at X=30 mils. Also, as
with all GS1 data structures, parentheses around Application Identifiers (AIs) and spaces between
data elements are displayed in human-readable form only and are not encoded.
12
SKU and Unit-Level Packaging
This section reviews common industry practice and is a synopsis of established guidance,
regulations, technical specifications and application standards that are applicable to the U.S.
pharmaceutical supply chain.
Encoding the NDC in Bar Code According to GS1 Standards (SKU Level)
As previously noted, the NDC is fully compatible with the all-numeric, 12-digit GTIN-12 data
structure and the U.P.C. symbology. Upon application to GS1 US, labelers with an FDA-assigned
NDC or National Health Related Item Code (NHRIC) labeler identifier are assigned a U.P.C.
Company Prefix that corresponds to their FDA-assigned labeler code. This U.P.C. Company Prefix
always begins with the number “3”. The use of this leading prefix of “3” is specifically reserved
for drug products using an NDC format and other healthcare products using a National Health
Related Item Code (NHRIC) format. The right to use this corresponding U.P.C Company Prefix is not
conferred by the FDA assignment of the manufacturer/labeler identifier. Labelers should apply to
GS1 US for assignment of the U.P.C. Company Prefix corresponding to their FDA labeler code.
To encode an NDC number in U.P.C. symbology, the prefix 3 is encoded first, followed by
the NDC and a modulo-10 check digit, thus creating the complete GTIN-12 code. The check
digit is calculated on all 11 leading digits, including the leading prefix “3”. See GS1 General
Specifications, Version 11, Figure 5.2.4.6 – 3 for detailed dimensions associated with the
formats shown below.
U.P.C. prefix “3”
N 3 0001-4096-60 1
NDC
N 3 11111-569-73 8
Check Digit
N 3 22222-8395-5 9
U.P.C. Numbering Scheme, U.P.C. Symbology
By comparison, non-NDC or NHRIC items coded with the U.P.C. numbering system and U.P.C.
symbology can have a variable-length U.P.C. Company Prefix beginning with 0, 1, 6, 7, 8 or
9, followed by the manufacturer-assigned item number and the calculated mod-10 check digit.
Some OTC products and most all general merchandise products have a U.P.C. bar code symbol
with the traditional “1-5-5-1” U.P.C. human-readable format, regardless of the relative length of
the respective U.P.C. Company Prefix and item code. However, the arrangement of the humanreadable numbers does not imply any particular length of U.P.C. Company Prefix or manufacturerassigned product identification code. Once combined, the complete GTIN-12 data structure
comprises a globally unique pointer to a database record. Once constructed by the labeler, the
GTIN cannot be parsed or broken down into parts since the length of the U.P.C. Company Prefix
generally is not known.
13
The GS1 System distinguishes between a U.P.C. Company Prefix and a GS1 Company Prefix. The
U.P.C. Company Prefix is that number to which a company adds its item identification to generate
a GTIN-12 data structure and the U.P.C. symbol. The GS1 Company Prefix is one digit longer and,
in North America, includes a leading zero before the U.P.C. Company Prefix.
Bar Codes for Units Smaller Than the SKU Package Size
For packaging below the SKU level, such as for unit-dose and unit-of-use packaging,
manufacturers have two possible technical options to uniquely identify or differentiate unit-of-use
and unit-dose packaging.
One option is to assign a unique NDC by changing the package size code segment (the third
segment) of the NDC. This practice allows the unique NDC to be encoded using the GTIN-12
data structure (and usually represented in the U.P.C. symbology), where the NDC is preceded
by the GS1 US prefix “3” and followed by the modulo-10 check digit. The second option for
differentiating one package size from another is to maintain the same NDC for the stock keeping
unit and unit-of-use, then use the leading Indicator digit in the 14-digit GS1 GTIN to differentiate
the items. Both schemes produce a unique GTIN and so are equally acceptable from a supply
chain perspective. Different companies may interpret FDA requirements for unique NDC
assignments differently and so both schemes are found in the supply chain.
If the NDC is unique to a package size — and the package size supports the relatively larger
U.P.C. symbol, then U.P.C. is the preferred data carrier because virtually every bar code scanner
can read it. If the package is destined for retail sale, then use of the U.P.C. symbology is a
requirement. For non-retail packages where space does not permit the use of U.P.C., then GS1
DataBar Symbology must be used if the labeler is to remain compliant with GS1 US standards and
FDA regulations specifying a linear symbology. It should be noted that the 10-digit HIBCC Small
Package Symbol — as defined in ANSI/HIBC 2.3-2009, The Health Industry Bar Code (HIBC)
Supplier Labeling Standard — also is slightly smaller than a U.P.C. symbol of the same X-dimension,
and would be compliant with the FDA regulation, although not with GS1 Standards.11
Pursuant to FDA regulations, HDMA recommends that all labelers (including manufacturers,
repackagers, etc.) apply bar codes to unit-dose, unit-of-use and very small packaging, if they offer
such packaging configurations. In addition, there are several healthcare organizations urging
pharmaceutical manufacturers to offer all products in unit-of-use and/or unit-dose packaging
configurations, and to provide a standardized bar code at these packaging levels. According to
these organizations, a standardized bar code should appear on the labels of drug products at all
levels of use, from the largest bulk to the smallest single-unit containers.
Applying a standard GS1 bar code at the unit-of-use and unit-dose level packaging provides such
benefits as:
1. Ensuring that medication is accurately identified and administered;
2. Enhancing efficiencies within the medication-use process;
3. Improving overall public health and patient safety;
4. Improving monitoring of drug-use trends within a population of patients to aid in research
and develop disease management; and,
5. Developing overall efficiencies in the supply system, including the purchasing, storage
and distribution of drug products.
11
14
However, FDA’s 2004 bar code rule does not require manufacturers to offer any particular packaging
configurations, including unit dose or unit of use. Each package level requires a unique GTIN to
differentiate it from other levels of packaging.12
Update: Bar Coding Vaccines
In August 2011, FDA revised its Guidance for Industry: Bar Code Label Requirements—Questions
and Answers, originally published in October 2006. The revised document references a change to
the agency’s answer to question 12 in the Q-and-A section. The FDA will now consider requests from
vaccine manufacturers to use alternate encoding technologies such as two-dimensional bar codes.13
GS1 DataBar Symbology/Linear Symbols
Linear bar code symbologies have been in use since the early 1970s. Over time, there has
been a demand across industries for more compact symbologies to carry not only primary item
identification (GTIN) but secondary attribute data as well (e.g., expiration date, lot number,
serial number). Encoding this secondary attribute data indicated that the new symbology would
have to encode alphabetic characters in addition to the numeric characters used for GTIN.
Uses varying from non-retail small packages, such as blister packs, to the need to facilitate
transportation and logistics by identifying content and the capture of customer-specific and
hazardous material data were specified.
The first of these new symbologies, Code 128 — and its special GS1 format called GS1-128 —
was introduced in the 1980s and has become an indispensable addition to the global GS1 System.
For additional information on the use of GS1-128 in the U.S. pharmaceutical supply chain, see
the “Inner Packs and Shipping Cases” section.
In the late 1990s GS1 convened a multi-industry task group to address the requirements for an
even more compact symbology for GTINs and for the full array of secondary data elements as
well. The goal of this team was to identify and recommend an actionable, multi-industry, globalGS1-system business solution to enable automatic data capture for space-constrained products
and packages across the widest range of supply chain applications (where current solutions could
not be leveraged). The result of that effort was the development and introduction of the GS1
DataBar Symbology and 2D Composite Symbology families.
HDMA Recommendation
In accordance with FDA regulations, HDMA urges all labelers
(including manufacturers, repackagers, etc.) to incorporate bar
code to unit-dose, unit-of-use and very small packaging, if they
offer such packaging configurations.
GS1, Healthcare GTIN Allocation Rules (January 2011).
Retrieved from http://www.gs1.org/docs/gsmp/healthcare/GS1_Healthcare_GTIN_Allocation_Rules.pdf
13
Food and Drug Administration, Guidance for Industry: Bar Code Label Requirements – Questions and Answers
(August 2011). Retrieved from
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM267392.pdf
12
15
GS1 DataBar Symbology (formerly Reduced Space Symbology or RSS) is a family of linear symbols
that will accommodate very small items and primary and secondary item identification within an
extremely compact linear symbol. There are three distinct branches of the GS1 DataBar family,
comprising a total of seven GS1 DataBar versions. Of those seven versions, only GS1 DataBar
Stacked and GS1 DataBar Limited have been approved by GS1 US for use on unit-dose and
other space-constrained pharmaceuticals in accordance with the North American Guideline For
Application of GS1 Bar Codes To Very Small Healthcare Items. At the time of publication, no other
GS1 DataBar versions are authorized by GS1 US for use in the U.S. healthcare supply chain.
GS1 DataBar Stacked encodes the full 14-digit GS1 Global Trade Item Number with a leading
digit of zero through eight in a linear symbol for use on small items that will not be scanned at
the point of sale. It is truncated to a predefined minimum height of 13X and stacked in two rows,
making it much shorter in height and about half as wide as regular GS1 DataBar Omnidirectional
(formerly RSS-14 and referred to as GS1 DataBar). Though stacked in two rows, GS1 DataBar
Stacked is considered a linear symbol and is specifically acknowledged as such by the FDA; (see
Comment 40 and the associated response in the FDA’s final rule, a link to which is provided in the
“References” section at the end of this publication.)
NDC/GTIN encoded in GS1 DataBar Stacked on unit-of-use cup lid.
Photo courtesy of Boehringer Ingelheim Roxane Inc.
16
GS1 DataBar Limited encodes a 14-digit GS1 item identifier (GTIN) with an indicator digit of one
or zero only, in a linear symbol for use on small items that will not be scanned at the point of sale.
Other than zero and one, no other digits are supported by GS1 DataBar Limited. GS1 DataBar
Limited also is a highly truncated form of GS1 DataBar that is fixed at 10X tall and not suitable for
omni-directional point-of sale scanning.
NDC/GTIN encoded in GS1 DataBar Limited on safety syringe barrel.
Photo courtesy of PIPS, Inc. (courtesy of Pfizer, Inc.)
NDC/GTIN encoded in GS1 DataBar Limited on Hospital Unit Dose (HUD) blister.
Photo courtesy of Boehringer Ingelheim Pharmaceuticals, Inc.
The following illustration depicts the relative size (from bottom to top) of GS1-128, UPC-A, HIBC
Code 128 Small Package Symbol, GS1 DataBar Limited and GS1 DataBar Stacked all at the same
X-dimension of 13 mils (0.013 inches), which corresponds to the nominal size of U.P.C. (at 100
percent magnification).
17
1.43 > 2.00 >
0.97 >
0.65 >
Dimensions in inches, including any required Quiet Zone. All
symbols at X=13 mils (U.P.C. nominal size). RSS (unit dose) may
be printed smaller; UCC/EAN-128 (multi-packs/shippers) must be
printed larger.
GS1-RSS-14 Stacked
Unit Dose
GS1-RSS Limited
Unit Dose
HIBC-Code 128 Small Package Symbol
Unit Dose
GS1-UPC-A
Carton/SKU
GS1-UCC/EAN-128
Multi-pack, Shipper
Specifying Symbol Size: X-Dimension vs. Magnification
Among all GS1 and HIBCC symbologies, when referring to symbol size, the term “magnification”
or “magnification factor” is used correctly only with respect to the U.P.C. symbology (and, in
the past, ITF-14, the use of which is no longer endorsed by these HDMA guidelines). This is true,
though some bar code symbol generation software incorrectly refers to “magnification” when
specifying the size or narrow element width (“X-dimension”) of other symbologies.
When referring to size of a bar code symbol’s narrow element width, the correct term to use
is “X-dimension,” which can be equated to a “magnification” only in EAN/UPC symbology.
Specifically, the U.P.C. (or EAN) “nominal” size symbol of 100 percent magnification has an
X-dimension of 13 mils (0.013 inches) or 330 microns for metric-based systems.
In EAN/UPC this nominal X-dimension is specified in the symbology standard and provides a fixed
dimensional reference for the relative reference of magnification. No such nominal X-dimension is
currently specified for any other GS1 or HIBCC symbology that is currently endorsed by HDMA.
Therefore, any use of a reference to magnification in bar code symbol generation software for
any other symbology must be in relation to some arbitrary X-dimension selected by the software
provider. This practice causes considerable confusion and should be avoided.
Fortunately, most of this type of software also allows the user to specify symbol size using
X-dimension. Users should choose this method and ignore any derived expression of
magnification, which is not a recognized or appropriate term in reference to any symbology other
than U.P.C. (or EAN).
GS1 DataBar Symbology and Composite Symbology
According to the International Symbology Specification for EAN.UCC Composite Symbology™
(which references the outdated EAN.UCC name instead of GS1):
A EAN.UCC Composite symbol consists of a linear component (encoding the item’s
primary identification) associated with an adjacent 2D Composite Component (encoding
supplementary data, such as a batch number or expiration date). The Composite symbol
always includes a linear component so that the primary identification is readable by all
18
scanning technologies, and so that bar code scanners can use the linear component as a
finder pattern for the adjacent 2D Composite Component. The Composite symbol always
includes a multi-row 2D Composite Component, for compatibility with both linear- and
area-CCD scanners, and with linear and rastering laser scanners.
EAN.UCC Composite bar code symbols are intended for encoding identification numbers
and data supplementary to the identification in accordance with EAN.UCC application
guidelines. The administration of the numbering system by EAN.UCC ensures that
identification codes assigned to particular items are unique world-wide and that they and
the associated supplementary data are defined in a consistent way. The major benefit for the
users of the EAN.UCC system is the availability of uniquely defined identification codes and
supplementary data formats for use in their trading transactions.14
It is important to note that 2D Composite Symbology symbols cannot stand alone. GS1 DataBar
and GS1-128 symbologies have a structural linkage mechanism specified to alert suitably
programmed scanners to the presence of additional 2D Composite Symbology data. Because of
its design, the EAN/UPC symbology does not have such a linkage mechanism, although it does
support 2D Composite Symbology. Samples of GS1 DataBar Composite, GS1-128 Composite and
U.P.C. Composite are shown below.
GS1 DataBar Limited Composite
GS1 DataBar Stacked Composite
GS1-128 Composite
19
UPC-A Composite
Note: These symbols are presented at various X-dimensions and with a variety of 2D Composite
Component data; they are not meant to be compared for relative size or judged for accuracy of
data content.
Association for Automatic Identification and Mobility, ISS EAN.UCC Composite Symbology.
Available from https://www.aimglobal.org/estore/ProductDetails.aspx?ProductID=36
14
The new Composite Symbologies have the strongest performance for their size while providing
the smallest solution allowing users to scan while leveraging lower-cost laser or linear CCD
technology. They can be printed using common commercial processes and provide the coexistence of current and future supply chain scanning and data processing alternatives.
The 2D Composite Component has three different sizes:
• Composite Component A (CC-A) can include up to 56 digits;
• Composite Component B (CC-B) can include up to 338 digits; and,
• Composite Component C (CC-C) can include up to 2,361 digits, but only can be used
with the GS1-128 linear symbology.
The data capacity of all three Composite Components is reduced from these maximums based on
the mix of alphabetic and numeric characters.
Encoding Quantity, Expiration Date and Lot Number
In most supply chains information must be encoded beyond simple item identification. Within the
GS1 System, Application Identifiers, or AIs, have been developed to precisely define what type
of data is encoded in the bar code. AIs are numeric two-digit, three-digit or four-digit prefixes or
flags (sometimes referred to as “metadata” or “data about the data”) used to uniquely identify the
meaning and the format of the data field that follows the AI. In the pharmaceutical supply chain,
a handful of AIs have proven to be particularly useful: AI(17) for expiration date, AI(10) for lot or
batch number and AI(30) for count/quantity.
HDMA Recommendation
AI(22), which can combine quantity, expiration date, lot number and a link
character into one compact code also has been widely (and often, incorrectly)
used, but it is no longer endorsed by HDMA. With the publication of its GS1
General Specifications, Issue 10 (January 2010), GS1 formally announced the
withdrawal of Application Identifier AI(22), effective January 1, 2013. HDMA
recommends eliminating all uses of AI(22), with the affected package labels
revised to use AI(17), AI(10) and AI(30), as appropriate.
When encoding Expiration Date AI(17) and Lot Number AI(10) (whether in 2D Composite
Component for use on unit doses) or GS1-128 for use on multi-packs (e.g., inner packs or
shipping case labels), it is important to remember that GS1 encoding rules call for fixed-length
AIs to precede variable-length AIs. Since AI(17) for expiration date is defined as a single, fixedlength format (“YYMMDD”), it must come before AI(10). Following this rule will generally yield
a smaller, more compact linear or 2D Composite bar code symbol than the alternative. At the
same time, GS1 encoding rules require that consecutively used variable-length AIs [such as AI(10)
followed by AI(30), for example] are separated from each other by the special bar code character
Function 1 (FNC1). For additional information refer to the GS1 General Specifications.
Although the FDA bar code rule does not require encoding the expiration date and lot number
in a bar code, the agency specifically allowed additional bar code markings at the labeler’s
discretion and many pharmaceutical manufacturers have chosen voluntarily to include this
information in 2D Composite Symbology when printing GS1 DataBar on unit-dose labeling.15
15
20
Most often this has been on hospital unit-dose blisters because there is generally space available
and the inline printing process lends itself readily to the inclusion of this information. Most
linear scanners available today (whether laser or linear CCD) are equipped to read GS1 DataBar
Symbology. Some of these units can be ordered with special optics to allow them also to read the
2D Composite Component. 2D scanners or area imagers also read mostly all linear symbologies
(including GS1 DataBar), the 2D Composite Components, postal bar codes and such 2D matrix
symbologies as Data Matrix, GS1 DataMatrix, Aztec Code, QR Code and others. In addition, area
imagers can perform signature capture and take still photographs.
NDC/GTIN encoded in GS1 DataBar Stacked w/CC-A encoding expiration date and lot number
on Hospital Unit Dose (HUD) blister.
Photo courtesy of PIPS, Inc. (courtesy of Pfizer, Inc.)
Another scenario that would be allowed under the FDA bar code rule would be the addition of,
for example, a GS1 DataMatrix symbol (ECC200 with FNC1 in the first position) to a label that
already carries an FDA-compliant “NDC bar code.” Some pharmaceutical labelers have expressed
an interest in adding such a 2D symbol, possibly using in-line laser engraving, laser ablation, ink
jet or thermal transfer printing.
Such a symbol would typically encode the complete GTIN, expiration date and lot number using
AI(01)+AI(17)+AI(10). Although redundant with respect to the GTIN, the addition of this GS1
DataMatrix symbol would provide complete primary and secondary data in a very small space
that could be captured using an area imaging scanner. This complete “information packet” would
otherwise not be available if only the linear bar code encoding NDC were present.
Data Matrix and GS1 DataMatrix
Data Matrix is a two-dimensional matrix or checkerboard symbology as compared to the linear,
one-dimensional (left-to-right) codes such as U.P.C., GS1-128, GS1 DataBar, etc. described above.
Originally developed as a proprietary symbology with various capacities and properties (versions
ECC80-ECC140), an advanced version of Data Matrix (ECC200) was developed with the support
of the Association for Automatic Identification and Mobility (AIM) and introduced into the public
domain. Data Matrix ECC200 is described here, including the GS1 System version with the
special character FNC1 in the first position, known as GS1 DataMatrix.
21
Data Matrix ECC200 symbols have a number of beneficial features. The first of these is a high
data-carrying capacity in a very small “footprint.” For the pharmaceutical supply chain, the GS1
version of the symbology is capable of encoding primary item identification (NDC embedded
within GTIN) and secondary attribute information — such as the expiration date, lot number,
quantity and serial number — in a substantially smaller area than a linear symbol. Data Matrix
ECC200 also has the capability of encoding the Electronic Product Code (EPC), a potentially
valuable feature that could allow a Data Matrix or GS1 DataMatrix symbol to serve as a redundant
data carrier for RFID-enabled EPC applications.
Two other benefits of the Data Matrix design are the ability to perform direct-part marking with
Data Matrix (such as etching, peening or stamping a symbol into metal) and its error-correction
feature, which can allow a symbol to be read if it is damaged (up to 30 percent, depending on
where the damage occurs). These features were factors in the 2004 GS1 adoption of Data Matrix
ECC200 as an allowable symbology within the global GS1 System. Note, however, that the only
format of Data Matrix embraced by GS1 is ECC200. Also note that current FDA regulations require
labelers to use HIBCC or GS1 System linear bar codes for primary product identification, though
GS1 Data Matrix also may be used as a additional data carrier. (Note that using two GS1 symbols
for the same purpose is a deviation from the GS1 General Specifications.)
In Data Matrix, the outer perimeter of the code is used to establish the bounds and to determine the
size of the matrix. The left and bottom sides (called the finder pattern) are solid; the right and top
sides (called the timing or clock track) are an alternating pattern of black and white cells. Damage to
the finder pattern or clock track significantly reduces the ability of a scanner to read the symbol.
Using the grid pattern established from the finder pattern and the clock track, a Data Matrix
scanner looks to determine if an area in the center on an individual cell of the grid is black or
white. For example, a 20x20 matrix has 400 cells. When attempting to decode or read a Data
Matrix symbol, only the center of the cell is considered, whereas with a linear bar code it is the
placement of the edges and the width of the bars that is meaningful.
Because of this design, Data Matrix is generally much easier to print and read than a linear code.
Edge quality is much less important since the imaging scanner is only looking at the center of the
cell to see if it is black or white. The symbol can be printed via laser engraving, laser ablation, ink
jet, hot foil stamping and thermal transfer as well as by traditional wet ink processes — another
key benefit. In many industries (such as automobiles and computers) an embossed or dot peened
Data Matrix code is used to encode part numbers and/or unique serial numbers.
It is important to remember that Data Matrix requires a two-dimensional imager (scanner) to be read.
Linear laser or CCD scanners do not have the ability to read Data Matrix codes but 2D imaging
scanners can read both linear and 2D bar codes such as Data Matrix or Aztec Code or QR Code.
Since Data Matrix and other 2D codes are becoming popular, HDMA recommends upgrading to
imaging scanners capable of reading Data Matrix and linear codes whenever auto-id procurement
needs are under consideration. And, as the cost of 2D imagers has decreased in recent years, the
price differential between linear scanners and 2D imagers is no longer a barrier to implementation.
22
Data Matrix ECC200 can be printed in either a square or a rectangular format, although square is
by far the more common, and readers can generally read either format equally well. The symbols
below are reproduced at actual size.
Data Matrix symbols encoding “Healthcare Distribution
Management Association” at a cell size (“X-dimension”)
of 30 mils
Unit-Level Serialization
An emerging alternative to encoding GTIN+EXP+LOT – AI(01)+AI(17)+AI(10) – in a complementary
GS1 DataMatrix symbol on unit-level packages is to encode GTIN+Serial Number or GTIN+Serial
Number+EXP+LOT. Manufacturers seeking to apply unique serial numbers to their individual salable
unit packaging — for example, in a track and trace or pedigree environment — should include the
GS1 System serial number AI(21) within the set of AIs encoded in a GS1 DataMatrix code.
HDMA Recommendation
At minimum, the code should include the GTIN AI(01) followed by the serial
number AI(21).
If additional information is optionally included in the same code it should be added
after the serial number. For example, in this scenario the encoded data may appear as
AI(01)+AI(21)+AI(17)+AI(10). Note that a FNC1 must be encoded between AI(21) and AI(17).
The purpose of a FNC1 is to terminate a variable length field prior to starting another AI. (Note:
This sequence of data elements deviates from the GS1 General Specifications to encode all
fixed-length data elements before variable-length data elements.) However, given the practical
limits on the length of scanned data in many current automatic data capture systems — and the
priority to capture the Serial Number versus the EXP and LOT information, potential problems
will be avoided if the GTIN+Serial Number combination always is listed first in the encoded data.
In virtually every case, the resulting GS1 DataMatrix symbol will be no larger than it otherwise
would be and the essential GTIN+Serial Number data will always be captured, even if some of
the following EXP and LOT data are truncated or otherwise cut off.
23
Sample label graphic courtesy of TEVA Pharmaceuticals USA
A scan of the DataMatrix symbol above yields the following data elements: GTIN, serial number,
expiration and batch number. Note: There are no parentheses actually encoded in the bar code.
The parentheses are only in the human-readable information for readability purposes.
When designing a unit-package label (or carton) including multiple bar codes (i.e., a UPC
encoding NDC, a DataMatrix for GTIN+Serial Number plus optional data, a component control
bar code, etc.) care must be taken to maximize the separation between the various symbols to
eliminate — or at least minimize — the likelihood of the reader/imager picking up more than one
symbol at a time. This will render downstream business processes more efficient.
For downstream trading partners to make use of serial numbers applied at the unit level,
manufacturers should expect to provide the parent-child hierarchy of each serialized shipping
container to its serialized unit contents by means of an electronic message (ASN, ePedigree envelope
or EPCIS events, depending on the capabilities of your customer) at the time of shipment.
When employing RFID for unit-level serialization (alone, in combination with a GS1 DataMatrix code
or otherwise), refer to the related guidance in the “Radio Frequency Identification (RFID)” section.
24
Bar Codes for Inner Packs and
Shipping Cases
For clarity, the following definitions and illustration are offered. While these terms are broad and
general, they are used to refer to the various terms often used interchangeably to discuss these
packaging levels, all which are above the item and SKU level in the packaging hierarchy.
Inner Pack: Also known as intermediate pack or multi-pack, this is a wrap, box or bundle
containing two or more unit packs (that is, item and/or SKU level packages) of identical items, and
that is in turn enclosed by an outer shipping case.
Inner packs may or may not be marked with the bar codes and labeling shown below. However,
when packaged as a trade unit, an inner pack requires a unique item identifier (GTIN) and a
label and appropriate human-readable and machine-readable identification. When bundled for
convenience, a label is not required.
Shipping Case: Also known as a shipping container, packer, shipper or case, this is a container
that is strong enough for commercial use for packing, storing and shipping commodities, and may
contain inner packs or other lower packaging levels, including the item or SKU directly.
The above definitions are adapted from ASTM Standard Terminology of Packaging and Distribution
Environments (D 996 – 04).
The following graphic illustrates the definitions used in this section:
25 Labeled Vials Loaded
Into Inner Pack
(Bar Code Required)
Inner Pack
(Bar Code Optional
See Above)
25
Applying Bar Codes Above
the Unit Level or Product
Identification Bar
Shipping Case
Code Label
Required
Codes Above the Unit Level
Historically, there are four product identification data elements that have been represented in a
bar code on an inner pack (i.e., a multi-pack) or case pack/shipping case:
1. The NDC number to identify the product;
2. The expiration date;
3. The lot number; and,
4. The quantity of SKUs contained in the package (whether inner pack or shipping case).
The NDC is considered primary item identification. Data elements two, three and four are referred
to as secondary data elements. For non-serialized product, HDMA recommends all four of these
fields be bar coded according to the GS1 System standards on all homogenous inner packs (if
inner packs are labeled) and homogenous cases. A homogenous case is one that contains a
multiple of the same item, all with the same expiration date and lot number.
HDMA Recommendation
HDMA recommends encoding the quantity of trade items contained
in the case (as well as the lot number and expiration date) in a bar
code because this field provides immediate electronic interpretation
or “direct read” and avoids the need for trading partners to
communicate updated quantities for each pack size.
Although directly encoding quantity data is not in strict accordance with the GS1 General
Specifications, it is nevertheless a long-standing practice in the pharmaceutical supply chain and
remains essential for the efficient distribution of pharmaceutical products.
Increasingly, in addition to the secondary data elements mentioned above, a serial number may
be associated with these levels of packaging, especially at the case level. The serial number, when
present, is encoded immediately following the GTIN as described the “Product Identification
Label Format 1” section of the document.
Inner-pack and case-pack identification is built up from the 12-digit NDC/U.P.C. coding scheme
(also referred to in GS1 System nomenclature as the GTIN-12 format) and includes an additional
piece of information, a packaging-level indicator digit. The capability of the full 14-digit GS1
System GTIN (GTIN-14) format and a GS1 System bar code symbology capable of representing
varying levels of packaging are used in this application.
Historically, there have been two GS1 symbologies used on inner packs and shipping cases in
the pharmaceutical industry: the now-predominant GS1-128 (formerly called EAN/UCC-128) and
the less widely used ITF-14 (standing for Interleaved 2 of 5, 14 digits). Both of these symbologies
encode the GTIN-14, but the GTIN-14 is the only data element that can be encoded in ITF-14.
GS1-128, on the other hand, supports additional data elements and also encodes AIs, which allow
suitably programmed bar code data-collection systems to differentiate between different data
elements, such as GTIN, serial number, expiration date, lot number and quantity.
HDMA Recommendation
HDMA no longer endorses the use of ITF-14 and urges all labelers
to convert to GS1-128 as outlined below.
26
The GS1 System has the flexibility to identify levels of packaging above (and below) the GTIN12 (U.P.C.) bar code level (the primary packaging or SKU level to which typically the NDC is
assigned), using a product packaging hierarchy based on the core U.P.C. company prefix and
product code (essentially the NDC in the U.S. pharmaceutical industry) without having to assign
a separate NDC to each packaging level. Following GS1 guidelines, the labeler assigns a
packaging indicator digit, which is a number from one to eight for each packaging level above
(or below) the primary packaging level where the NDC is assigned. (Zero is not considered an
indicator digit, and nine is reserved for variable measure products.)
For more than 10 years HDMA has endorsed encoding multiple types of data on product
identification labels on shipping cases, not just the GTIN for primary item identification. In the
pharmaceutical industry, the data elements most commonly required by trading partners have
been the GTIN-14 (which conveys the packaging level and the NDC in a consistent 14-digit
format); and the secondary item attribute data elements like the expiration date, lot number and
quantity. Other secondary data elements, such as serial number, also can be encoded. As noted
later in these guidelines, if unique shipping case serial numbers are assigned by the manufacturer,
GTIN+Serial Number is the preferred combination of data elements for the primary bar code on
shipping case labels.
Although these primary and secondary data elements could be strung together (or concatenated)
and represented in one long GS1-128 symbol, practical scanning limitations have indicated that
this approach is impractical. Therefore, since 2005 these HDMA guidelines have called for these
data elements to be represented in two separate GS1-128 symbols.
Each data element is preceded by an AI, an all-numeric “flag” designated by GS1 to identify each
of the more than 100 distinct data elements in use throughout the global GS1 System. AIs are
shown in the human-readable text within parentheses. In accordance with GS1 specifications, the
parentheses shall not be encoded in the bar code.
A special bar code character known as Function 1 (FNC1) must be encoded in the first character
position in a GS1-128 or GS1 DataMatrix bar code to define it as a GS1 application. See the GS1
General Specifications for complete details about GS1 data structures and encoding FNC1 in GS1128 and GS1 DataMatrix.
Product Identification Label Data Structures, Symbologies and Human-Readable Text
The HDMA product identification label formats detailed below (Format 1 — GTIN+SERIAL
NUMBER; and Format 2 — GTIN) both depict two distinct GS1-128 symbols on the label, one
placed directly above the other. The bottom symbol encodes either the GTIN plus a unique
shipping case serial number or just the GTIN alone; the top symbol in both formats encodes the
secondary data elements of expiration date, lot number and quantity, using a combination of
AI(17), AI(10) and AI(30). The secondary data elements in both Format 1 (GTIN+SERIAL NUMBER)
and Format 2 (GTIN) may be encoded in either of the following orders: AI(17), AI(10), AI(30); or,
AI(17), AI(30), AI(10). (Note: Encoding quantity using AI(30) as described in the previous section
deviates from the GS1 General Specifications.)
Both formats convey the same basic information of GTIN, EXPIRATION DATE, LOT and
QUANTITY. However, in addition to the four basic data elements encoded in the second format,
the first format also encodes the unique shipping container serial number (as would be required in
27
a track-and-trace or pedigree application). As of the publication date of these guidelines, although
most suppliers are not yet uniquely serializing shipping cases, the industry fully expects this to
become the norm and so Format 1 – GTIN+SERIAL NUMBER is preferred when the supplier
begins to uniquely serialize shipping cases. Therefore Format 1 is recommended by HDMA when
the product is serialized.
Note that in both formats, the upper, secondary data GS1-128 bar code must contain the special
symbology character FNC1 as a separator character to delineate AI(10) from AI(30). Both formats
also show an optional but recommended GS1 DataMatrix symbol encoding all data elements
— in a prescribed order. Here, too, FNC1 is required as a separator character to delineate AI(10)
from AI(30). It also is required to delineate AI(21) from AI(17) when a serial number is encoded.
See the GS1 General Specifications for further details about the use of FNC1 in GS1-128 and GS1
DataMatrix symbologies.
Expiration Date Formats
In both the first and second formats, the human-readable expiration date is transcribed into an
equivalent bar code data format, as illustrated by the examples in the following table. Although
the human-readable and the encoded bar code formats are not identical, they are exactly
equivalent and the information conveyed is identical.
The application identifier for expiration date, AI(17), requires the “YYMMDD” (Year, Year, Month,
Month, Day, Day) format; no other expiration date format is supported or allowed in the GS1
System. Yet some suppliers do not designate a day of the month as part of their expiration date.
In this case “00” is used in the GS1 System as a place holder for the “DD” date segment when
no day of the month is specified, as shown in the table below. The last day of the month is
analogous to using 00 and is also perfectly acceptable. Whatever the human-readable format,
HDMA recommends that the human-readable year always be represented in its complete “CCYY”
(Century, Century, Year, Year) four-digit format.
HDMA Recommendation
HDMA recommends that the human-readable year always be
represented in its complete “CCYY” four-digit format.
Expiration Date
Human-Readable
YYMMDD Encodation
January 31, 2015
JAN 31, 2015
150131
January 31, 2015
31 JAN 2015
150131
December 2005
DEC 2005
051200
December 2005
12/2005
051200
It also is important to note that the lack of a specified day of the month in the expiration date
can cause confusion as to which day of the month is the expiration date. HDMA recognizes the
following excerpt from the United States Pharmacopeia (USP) as authoritative on the subject of
the date format. The USP is “a non-governmental, official public standards-setting authority for
prescription and over-the-counter medicines and other healthcare products manufactured or sold
in the United States.”
28
USP 34–NF 29 through Second Supplement
10.40.100. Expiration Date and Beyond-Use Date
The label of an official drug product or nutritional or dietary supplement product shall bear
an expiration date ... The expiration date identifies the time during which the article may be
expected to meet the requirements of the compendial monograph, provided it is kept under the
prescribed storage conditions. The expiration date limits the time during which the article may
be dispensed or used. Where an expiration date is stated only in terms of the month and the
year, it is a representation that the intended expiration date is the last day of the stated month.16
Table 1 on the following page outlines the essential characteristics of HDMA shipping case
product identification label requirements for Format 1 — GTIN+SERIAL NUMBER and Format
2 — GTIN. These same requirements also pertain to an inner pack label if one is used. It is
imperative to maintain at least the minimum X-dimension and symbol height specified in the
table. In general, the largest possible X-dimension that will fit in the space available should be
used. The use of bar code symbols with an X-dimension below the specified minimum may result
in substantially reduced “scannability” and disruption to the supply chain.
29
United States Pharmacopeia, Second Supplement to USP 34-NF 29, (Available December 2011).
Available from http://www.usp.org/products/USPNF/USPNFUSP34NF29.html
16
HDMA Shipping Case Product Identification Label — Summary Specifications
Adherence to all of the technical requirements outlined above is essential. Often overlooked is the
necessity of at least the minimum clear area or “quiet zone” to the left and right of the GS1-128 symbols
(and on all four sides of the GS1 DataMatrix symbol). A “perfectly printed” symbol without the necessary
minimum “quiet zones” can be just as unscannable as a symbol printed partially off the label.
Table 1
HDMA Shipping Case Product Identification Label – Summary Specifications
Bar Code Symbology, Encoded Data Element, Human-Readable Interpretation (HRI) & Print Quality
Important Parameters
Symbology
(see Note 1)
Encoded
Data Elements
(see Note 2)
GS1-128 Bar Code
Symbol X-dimension
Primary & Secondary
GS1-128 Bar Code
Symbol Height
Primary & Secondary
(Increased height can
improve scannability)
GS1 DataMatrix (2D)
Bar Code X-dimension
Format #1 – GTIN+SERIAL NUMBER
Format #2 – GTIN
Primary: GS1-128 (incl. FNC1 where req'd)
Secondary: GS1-128 (incl. FNC1 where req'd)
2D Prim+Sec.: GS1 DataMatrix (incl. FNC1 where req'd)
GS1-128 (incl. FNC1 where req'd)
GS1-128 (incl. FNC1 where req'd)
GS1 DataMatrix (incl. FNC1 where req'd)
Primary: GTIN-14 + SN: AI(01)+AI(21)
Secondary: EXP + LOT + QTY: AI(17)+AI(10)+AI(30)
2D Prim.+Sec. GTIN-14 + SN + EXP + LOT + QTY:
COMBINED:
AI(01)+AI(21)+AI(17)+AI(10)+AI(30)
GTIN-14: AI(01)
EXP + LOT + QTY: AI(17)+AI(10)+AI(30)
Preferred: 16.7-20.0 mils (0.0167-0.0200 in.)
Minimum: 13.3 mils (0.0133 in.)*
*Use largest X-dim that will fit on the label
PRIMARY GTIN-14 + SN: AI(01)+AI(21)
Preferred: 0.75 inches
Minimum: 0.5 inches
SECONDARY EXP + LOT + QTY: AI(17)+AI(10)+AI(30)
Preferred: 0.5 inches
Minimum: 0.4 inches
Preferred: 30.0 mils (0.0300 in.)
Minimum: 30.0 mils (0.0300 in.)
GTIN-14 + EXP + LOT + QTY:
AI(01)+AI(17)+AI(10)+AI(30)
16.7-20.0 mils (0.0167-0.0200 in.)
13.3 mils (0.0133 in.)*
*Use largest X-dim that will fit on the label
GTIN-14: AI(01)
0.75 inches
0.5 inches
EXP + LOT + QTY: AI(17)+AI(10)+AI(30)
0.5 inches
0.4 inches
30.0 mils (0.0300 in.)
30.0 mils (0.0300 in.)
GS1-128 10X (10 times X-dim; 0.20" recommended)
GS1 DataMatrix 3X (3 times X-dim; 0.10" recommended)
10X (10 times X-dim; 0.20" recommended)
3X (3 times X-dim; 0.10" recommended)
Bar Code Quality MINIMUM Grade
GS1-128 1.5/10/660 (per GS1 & ISO/IEC 15416)
GS1 DataMatrix 1.5/20/660 (per HDMA & ISO/IEC 15415)
1.5/10/660 (per GS1 & ISO/IEC 15416)
1.5/20/660 (per HDMA & ISO/IEC 15415)
Position of Bar Code
Symbols on Label
2D Prim.+Sec.: GS1 DataMatrix, Upper Right Corner
Secondary: GS1-128, Directly Above Primary Symbol
Primary: GS1-128, Bottom of Label
GS1 DataMatrix, Upper Right Corner
GS1-128, Directly Above Primary Symbol
GS1-128, Bottom of Label
Bar Code HumanReadable Interpretation
(HRI) Position & Size
2D Prim.+Sec.: None (Data is IDENTICAL to Prim. & Sec.)
Secondary: Below GS1-128, 10 Point (8 pt. min.)
Primary: Below GS1-128, 10 Point (8 pt. min.)
None (Data is IDENTICAL to Prim. & Sec.)
Below GS1-128, 10 Point (8 pt. min.)
Below GS1-128, 10 Point (8 pt. min.)
Secondary Data DESC.
Secondary: Above GS1-128, 12 Point (10 pt. min.)
Bar Code Quiet Zones MINIMUM Width
Printing Process
and Substrate
All Labels
Label Skew
All Labels
Thermal Transfer
Pressure-sensitive Label
Above GS1-128, 12 Point (10 pt. min.)
Thermal Transfer
Pressure-sensitive Label
+/- 2 Degrees from Horizontal**
+/- 2 Degrees from Horizontal**
**Approx. 0.15 inch Across a 4" Wide Label
**Approx. 0.15 inch Across a 4" Wide Label
Note 1: Primary and secondary data in separate GS1-128 symbols is required. In addition, it is strongly recommended that primary and
secondary data be combined as specified and encoded in a complimentary 2D GS1 DataMatrix symbol.
Note 2: GS1-128 & GS1 DataMatrix symbols encode FNC1 at the beginning of the symbol and as a variable-length field delimiter, as required.
GTIN: FNC1+AI(01)+GTIN
GTIN+SN: FNC1+AI(01)+GTIN+AI(21)+SN
EXP+LOT+QTY: FNC1+AI(17)+EXP+AI(10)+LOT+FNC1+AI(30)+QTY
GTIN+SN+EXP+LOT+QTY: FNC1+AI(01)+GTIN+AI(21)+SN+FNC1+AI(17)+EXP+AI(10)+LOT+FNC1+AI(30)+QTY
Rev 2E
30
Product Identification Label Format 1 — GTIN+SERIAL NUMBER
HDMA Recommendation
As companies begin to serialize product, HDMA recommends
product identification labels follow Format 1 — GTIN, Serial Number,
Expiration, Lot Number and Quantity as described in this section.
Product Identification Label Format I — GTIN+SERIAL NUMBER specifies two distinct GS1-128
symbols, which are both mandatory. One symbol is placed directly above the other, as has been
the HDMA standard since 2005. The bottom symbol contains the item identification (primary)
data and encodes the GTIN using AI(01), plus the unique case pack or shipping container serial
number (SN) using AI(21). [Note: Quantity using AI(30) is no longer encoded following the GTIN
in the primary bar code.] The top symbol contains item attribute (secondary) data and encodes
expiration date using AI(17), lot number using AI(10) and quantity using AI(30) — or alternatively,
AI(17) + AI(30) + AI(10). These same format options apply to Format 2 — GTIN.
Representative Format 1 — GTIN+SERIAL NUMBER sample label. See below for detailed examples.
Note that in addition to the FNC1 character required to be encoded in the first position of any
GS1-128 symbol, an FNC1 character must be encoded as a separator character to delineate the
end of the AI(10) data field from the subsequent AI(30) in the secondary bar code [or to delineate
the end of the AI(30) data field from the subsequent AI(10) if AI(30) comes before AI(10)]. The
FNC1 separator character will be automatically decoded, translated and transmitted by a scanner
as <GS> or Group Separator (ASCII 29), as indicated by the GS1-128 symbology specification. The
FNC1 character at the beginning of the symbol has another purpose and is never transmitted.
Format 1 — GTIN+SERIAL NUMBER shows an optional but recommended GS1 DataMatrix
symbol encoding the primary/item identification data (GTIN) plus unique serial number and their
associated AIs, followed by secondary/item attribute data elements and their associated AIs. They
are shown in the preferred order: AI(01) GTIN, AI(21) Serial Number, AI(17) EXP DATE, AI(10)
LOT and AI(30) QTY. However, GS1-128 secondary/item attribute data elements may optionally
be encoded as AI(17) + AI(30) + AI(10). If this is done then the order of these data elements in the
GS1 DataMatrix symbol must be the same.
31
The GS1 DataMatrix symbol does not replace the two linear bar codes, which are mandatory.
The DataMatrix symbol carries the same data in an alternative symbology.
The GS1 DataMatrix symbol can be scanned by trading partners equipped with appropriate
camera-based imagers (scanners) throughout the supply chain, from manufacturer to distributor
to the hospital receiving dock. It enables those who choose to scan it to capture all of the data
elements in a single scan. Note that a FNC1 symbol character must be encoded to delineate
the AI(21) data field from AI(17) and another FNC1 symbol character must be encoded to
delineate the AI(10) data field from AI(30), as noted above. The FNC1 separator characters will
be automatically decoded, translated and transmitted by a scanner as <GS> or Group Separator
(ASCII 29), as per the GS1 DataMatrix symbology specification. As with GS1-128, the FNC1
character at the beginning of the symbol has another purpose and is never transmitted.
HDMA Recommendation
The GS1-128 and GS1 DataMatrix symbols should be printed as
black bars on a white pressure-sensitive label using, for example, the
thermal-transfer printing process. Thermal transfer printing generally
provides the best contrast and overall bar code print quality.
Other printing techniques are possible. The key is to maintain the required print quality, whatever
the printing method. Care must always be taken to ensure that print speed and head temperature
are correctly set and that the thermal printhead is clean and free of “dead dots,” that is, thermal
printhead elements that do not work and cause blank streaks or voids along the length of the
printed label, which can cause symbols to be unreadable.
The nominal GS1-128 symbol X-dimension in this application is 16.7-20 mils. The lower GTIN
symbol is printed taller than the upper symbol to denote its primacy. The nominal height of the lower
symbol is 0.75 inches; the nominal height of the secondary bar code is 0.5 inches. The nominal (and
minimum) GS1 DataMatrix symbol X-dimension in this application is 30 mils. See Table 1 above.
The human-readable interpretation of the primary GTIN+SERIAL NUMBER bar code shall be
printed directly beneath the bar code. The preferred format includes the leading uppercase
character “N” to denote a pharmaceutical product that has an “NDC” assigned to it (if such is the
case; otherwise omit the “N”). This is followed by the GTIN Application Identifier in parentheses
“(01),” then the Indicator digit (“5” in the examples herein), the two-digit “03” GS1 prefix for an
NDC embedded within a GTIN, the hyphenated NDC itself, the GTIN mod-10 check digit; then
the serial number application identifier in parentheses “(21)” followed by the serial number data.
Each of these elements shall be separated by a single space. The nominal font size of this humanreadable string is 10 points. Space constraints on the label may dictate another human-readable
configuration but the format described above is the preferred arrangement as the “N” clearly
denotes the presence of a drug product and the hyphenated NDC is readily identifiable.
The human-readable interpretation of the secondary expiration date, lot number and quantity bar
code shall be printed directly beneath the bar code. (Note that this is a change from the 2005
edition of these guidelines.) In the preferred embodiment, this string includes the expiration date
AI in parentheses “(17)” followed by the expiration date data; the lot number AI in parentheses
“(10)” followed by the lot number data; and the quantity AI in parentheses “(30)” followed by the
quantity data. Each of these distinct elements should be printed in this precise order and separated
by a single space. The nominal font size of this human-readable string is 10 points. However, if GS1HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain
32
128 secondary/item attribute data elements are encoded as AI(17) + AI(30) + AI(10) then the order of
these human-readable data elements should be the same — that is, expiration date AI in parentheses
“(17)” followed by the expiration date data; the quantity AI in parentheses “(30)” followed by the
quantity data; and the lot number AI in parentheses “(10)” followed by the lot number data.
A more explicit representation of the data encoded in the secondary bar code is generally printed
directly above this bar code. This string typically begins with the field label “EXP:” followed by
a space and the expiration date with the year displayed as “CCYY” and the month and day, as
appropriate; then three spaces and the field label “LOT” followed by a space and the lot number;
then the field label “QTY:” followed by a space and the quantity data as encoded in the bar code,
including any leading zeros. The nominal font size of this human-readable string is 12 points.
A human-readable interpretation of the GS1 DataMatrix symbol is not required since the GS1
DataMatrix symbol encodes exactly the same data elements — in a precisely prescribed order —
as the two GS1-128 symbols.
Recognizing that there is a wide variety of shipping case sizes, these HDMA guidelines depict
three product identification label templates or sizes that represent the optimal arrangement of the
various data elements and maximization of bar code X-dimension, height and human-readable
interpretation. In every case the preferred embodiment is the largest of these three label templates
that is compatible with the shipping case. Labelers are urged to review their shipping case
labeling capabilities and to adhere to this recommendation as closely as possible.
Product Identification Label Format 1 — GTIN+SERIAL NUMBER: Example Bar Code Labels
Primary Data GS1-128 Symbol:
Global Trade Item Number (GTIN): 50312345678901
NDC Embedded within GTIN: 1234-5678-90
Serial Number: 123456789012
Note: This is a representative 12-digit all-numeric serial number, which is compatible with
GS1 serialized GTIN radio frequency identification (RFID) applications. Longer serial
numbers or those with alpha characters will produce a longer length GS1-128 symbol than
that shown. This may result in the necessity to use a wider label or a smaller X-dimension.
Before using a smaller X-dimension, be certain that your GS1-128 symbol is optimized to
produce the shortest possible symbol per the Code 128 symbology specification.
Secondary Data GS1-128 Symbol:
Expiration Date: December 2020
Lot Number: 123456L
Note: This is a representative lot number/code. Longer lot codes or those with more alpha
characters will produce a longer length GS1-128 symbol than that shown. This may result in
the necessity to use a wider label or smaller X-dimension. Before using a smaller X-dimension,
be certain that your GS1-128 symbol is optimized to produce the shortest possible symbol
per the Code 128 symbology specification.
Quantity: 144
Note: Quantity is often encoded with a single leading zero to create an even number of
digits in the bar code data (e.g., “144” becomes “0144”). This technique can produce a
shorter length GS1-128 symbol than encoding an odd-number quantity value directly.
33
Combined Primary and Secondary Data GS1 DataMatrix Symbol:
Note: The combined primary and secondary data string encoded in the 2D GS1 DataMatrix
symbol must be exactly the same AIs, data elements and FNC1 separator characters as are
encoded in the individual primary and secondary data GS1-128 symbols. See Note 2 in Table
1 for the precise encoding model.
GTIN with Embedded NDC: 50312345678901
Serial Number: 123456789012
Lot Number: 123456L
Quantity: 144
Format 1 — GTIN+SERIAL NUMBER, Example 1 — Preferred Minimum Label Size
34
Format 1 — GTIN+SERIAL NUMBER, Example 2 — Smallest Height Label
Format 1 — GTIN+SERIAL NUMBER, Example 3 — Smallest Width Label
35
A factor that may impact the placement of the data matrix symbol on the label could be if an RFID
tag is incorporated in the label. For example, if the placement of the RFID tag impacts the readability
of the data matrix symbol the symbol may need to be moved to the left side of the label.
Product Identification Label Format 2 — GTIN
Product Identification Label Format 2 — GTIN specifies two distinct GS1-128 symbols, both of
which are mandatory. One symbol is placed directly above the other, as has been the HDMA
standard since 2005. The bottom symbol contains the item identification (primary) data and
encodes the GTIN (only) using AI(01). [Note that Quantity using AI(30) is no longer encoded
following the GTIN in the primary bar code.] The top symbol contains item attribute (secondary)
data and encodes expiration date using AI(17), lot number using AI(10) and quantity using AI(30)
— or alternatively, AI(17) + AI(30) + AI(10). These same format options apply to Format 1 —
GTIN+SERIAL NUMBER.
Product Label Format 2 — GTIN sample label. See below for detailed examples.
Note that in addition to the FNC1 character required to be encoded in the first position of any
GS1-128 symbol, a FNC1 character must be encoded as a separator character to delineate the
end of the AI(10) data field from the subsequent AI(30) in the secondary bar code (or to delineate
the end of the AI(30) data field from the subsequent AI(10) if AI(30) comes before AI(10). The
FNC1 separator character will be automatically decoded, translated and transmitted by a scanner
as <GS> or Group Separator (ASCII 29), as per the GS1-128 symbology specification. The FNC1
character at the beginning of the symbol has another purpose and is never transmitted. Format
#2 – GTIN Format also shows an optional but recommended GS1 DataMatrix symbol encoding
the primary/item identification (GTIN) followed by secondary/item attribute data elements and
their associated AIs. They are shown in the preferred order: AI(01) GTIN, AI(17) EXP DATE, AI(10)
LOT and AI(30) QTY. However, GS1-128 secondary/item attribute data elements may optionally
be encoded as AI(17) + AI(30) + AI(10). If this is done then the order of these data elements in the
GS1 DataMatrix symbol must be the same.
Product Identification Label Format 2 — GTIN: Example Bar Code Labels
Primary Data GS1-128 Symbol:
Global Trade Item Number (GTIN): 50312345678901
NDC Embedded within GTIN: 1234-5678-90
36
Secondary Data GS1-128 Symbol:
Lot Number: 123456L
NOTE: This is a representative lot number/code. Longer lot codes or those with more alpha
characters will produce a longer length GS1-128 symbol than that shown. This may result in
the necessity to use a wider label or smaller X-dimension. Before using a smaller X-dimension,
be certain that your GS1-128 symbol is optimized to produce the shortest possible symbol
per the Code 128 symbology specification.
Quantity: 144
NOTE: Quantity is often encoded with a single leading zero to create an even number of
digits in the bar code data (e.g., “144” becomes “0144”). This technique can produce a
shorter length GS1-128 symbol than encoding an odd-number quantity value directly.
Combined Primary and Secondary Data GS1 DataMatrix Symbol:
NOTE: The combined primary and secondary data string encoded in the GS1 DataMatrix
symbol should use the same AIs, data elements and FNC1 separator characters as are
encoded in the individual primary and secondary data GS1-128 symbols. See Note 2 in Table
1 for the precise encoding model.
GTIN with Embedded NDC: 50312345678901
Lot Number: 123456L
Quantity: 144
Format 2 — GTIN, Example 1 — Preferred Minimum Label Size
37
Format 2 — GTIN, Example 2 — Smallest Height Label
Format 2 — GTIN, Example 3 — Smallest Width Label
38
Note: The sample symbols depicted in Format 1 — GTIN+SERIAL NUMBER and Format 2
— GTIN encode valid data and are reproduced at 100 percent of actual size. The examples
also conform with this standard with respect to the recommended GS1-128 symbol minimum
X-dimension for the available label width, GS1-128 symbol height for the available label height,
GS1 DataMatrix minimum X-dimension (30 mils) and the position and arrangement of the humanreadable interpretation.
Case Marking and Labeling
HDMA Recommendation
The preferred method of marking both product identification
and transportation/logistics information is to print the requested
information on a pressure-sensitive label. A pressure-sensitive label
can be applied to any and all cases, thereby reducing the number
of different cases a manufacturer must order and inventory. To
maximize human and machine readability, the preferred color
scheme is a white background with black printing.
Exceptions are possible, such as augmented human-readable information, where a color other
than black can be used to call attention to certain information that would improve handling
efficiency and reduce errors. The label and printing should be water, smear and scuff-resistant.
Homogenous Cases — Product Identification Labeling
Homogenous cases, or those cases containing a single product from the same lot, should be
clearly labeled with a product identification label (as outlined in following section) and should
unambiguously identify the product and the quantity of it contained in the case. Handling, storing
and picking require the ability for workers or automatic identification systems to determine case
contents quickly and accurately. Readability inside a truck trailer and warehouse environment is
crucial for efficiency and error prevention. Drug Enforcement Administration regulations must be
followed when labeling scheduled drugs. This may differ from the recommendations below.
HDMA recommends marking the following information on a product identification label (a
different label from the SSCC/logistics label), located on each trade-item case (a Standard Product
Grouping in GS1 terminology):
1. Trade name of the product (if applicable), printed 0.5 inch in height or larger if possible
(controlled substances may or may not be identified for security reasons in accordance
with the labeler’s policy and/or DEA regulations);
2. Product strength (augmentation with large print can be helpful;
3. NDC number in human-readable form;
4. Storage requirements, such as minimum and maximum temperature range;
5. Manufacturer and/or distributor name;
6. Expiration date, lot number and quantity in GS1-128 bar code with appropriate human
readable interpretation (HRI) per GS1 specifications;
7. NDC number encoded in GTIN-14 format plus concatenated case serial number in GS1128 bar code with appropriate human-readable interpretation per GS1 specifications; and,
8. NDC number encoded in GTIN-14 format, case serial number, expiration date, lot
number and quantity in GS1 DataMatrix bar code. No human-readable interpretation is
required provided the proper HRI accompanies the two GS1-128 bar codes.
39
Homogenous Cases — Product Identification Label Placement
HDMA Recommendation
Product identification labels are recommended on two adjacent sides
of the case. This can be achieved by using a wrap-around label or
using two separate but identical labels on adjacent sides.
Separate labels on adjacent sides should abut one another. When using wrap-around labels, care
must be taken to ensure that label placement is accurate and that no bar code or its minimum
required quiet zone is positioned bent around the corner of the case. The bar codes and their
associated quiet zones must not be obscured and must be readily scannable on each side of the
shipping case.
Note that a single product identification label on one side of a shipping case is not acceptable.
Product identification labels are recommended on two adjacent sides. Care should be taken when
packing cases on a pallet to ensure that at least one product identification label is visible on any
case with a side facing the exterior of the pallet load.
Product identification 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. The bottom edge of the label should be no closer than 1.25 inches from
the bottom of the case. If a wrap-around label is used the left half of the product identification
label should be affixed to the right-most side of the long side of the carton. Once wrapped around
the carton edge, the right half of the label will then be positioned at the left-most side of the short
side of the carton as shown in the illustration below. As previously noted, care must be taken
to ensure that there is a sufficient bar code quiet zone in the center of the label and that the bar
codes on both halves of the label are readily scannable once the label is affixed to the case. If the
labeler uses two separate product identification labels, they should be affixed to the carton so that
they mimic a wrap-around label.
Figure 1
40
Same Here
Healthcare distributors receive inquires regularly from their customers asking what company is the
labeler of a particular product. To ensure accurate and efficient disclosure, this information should
be included on the case label as “Produced by” or “Distributed by” names.
WRAP-AROUND PRODUCT IDENTIFICATION LABEL – HOMOGENOUS CASE, SERIALIZED
Label Size is 4.00” x 10.00”. The X-dimension of the GS1-128 symbols is 20.0 mils. GS1
DataMatrix symbol X-dimension is 30.0 mils. Primary GTIN+SN is 0.75” tall; Secondary
EXP+LOT+QTY is 0.75” tall. Bar code Human-Readable Interpretation (HRI) below the GS1-128
symbols is 12 point. EXP/LOT/QTY text above top secondary data symbol is also 12 point. GS1
DataMatrix is a 22x22 matrix, therefore 0.66” x 0.66”, plus mandatory quiet zone. All symbols
encode FNC1 in the first position and FNC1 as the mandatory field delimiter where required.
The wrap-around label shown above is reproduced at 50 percent of actual size. Below is one half
of the wrap-around label depicted above but reproduced at 100 percent size. The right half is
identical to the left. Actual size is 4.0” H x 5.0” W on each side or 4.0” x 10” overall.
41
Courtesy of TEVA Pharmaceuticals USA
Non-Homogenous/Mixed Product Cases — Product Identification Labeling
There should be no product identification labeling associated with non-homogenous (also
called mixed product) cases. Only a logistics/SSCC label should be used in accordance with the
following section.
Individual Shipping Cases and Pallets — Logistics/Serial Shipping Container Code (SSCC) Label Format
For transportation/logistics labels, HDMA encourages use of the GS1 Serial Shipping Container
Code (SSCC) and label format, substantially as set forth in the GS1 General Specifications. To
obtain a copy of this document, contact GS1 US.
The relevant sections (section 2.2 Logistics Units, Section 3.3.1 Identification of a Logistics Unit
AI00) of the GS1 General Specifications detail the structure and layout of GS1 logistics/SSCC
labels. Emphasis is given to the basic requirements for practical application in an open trade
environment. Primary topics include:
• The unambiguous identification of logistic units;
• The efficient presentation of text and machine readable data;
• The information requirements of the key partners in the supply chain: suppliers,
customers, and carriers; and,
• Technical parameters to ensure systematic and stable interpretation of labels.
However, this HDMA document describes a specific label design made up of individual modules
called “building blocks” with a height ranging from 0.75 inches to 2 inches and the width affected
by the creation of sub-blocks.
The label itself will measure not less than four inches wide and in the U.S. pharmaceutical supply
chain generally will be 6 inches tall. The building blocks are arranged to support three logically
grouped information segments based in substance on GS1 General Specifications and various
trading partners’ needs. These segments are stacked vertically and, from the top, include the
following (generally in this order), as depicted in the example on the following page:
Carrier Segment
• Carrier identification
• Ship-from address
• Shipment number
• Ship-to address
Customer Segment
• Purchase order number
• Case count
Supplier Segment
• Serial Shipping Container Code (SSCC)
Each block has a title that appears in the upper-left corner, printed in uppercase characters. It
contains a human-readable identification of the type of information in each field.
42
TITLE LINE: (Human-readable information)
Building block example for HDMA’s serialized shipping container label
Any information encoded in a bar code should conform to GS1 system data structure requirements
and use the GS1-128 symbology. Companies should follow the relevant GS1 standards, but due to
the size of the label and space considerations, there may be exceptions in certain situations. The
data encoded in the bar code symbol should be represented in the appropriate human-readable
interpretation above the bar code. The human-readable characters are uppercase and usually
left justified with the bar code, leaving room for the title line. AIs are considered part of the data
and should be included in the human-readable format, separated from the rest of the data within
parentheses. Consult the GS1 General Specifications for additional details.
43
package carriers) should be a 4” x “6, UCC-128 compliant label. Below is an example label. In this example
the supplier could be a manufacturer and the customer could be a distributor.
The following diagram is an example of the HDMA-recommended SSCC label with each of its
KEY
building blocks defined and described.
FROM:
XYZ SUPPLIER
1060 W ADDISON ST
CHICAGO, IL 60613
1
TO:
CUSTOMER #1234
143 BEALE ST.
MEMPHIS, TN 38103
SHIP TO POSTAL CODE:
(420) 38141
P.O.#
CARRIER: RDWY
1.) Ship From Information **
Enter in the origin address.
Rec’d Font Size 10-12pt
Area 1” x 1 ¾”
2
1
ROUTE: 4768
3 B/L#: 0083273642
2
(400) 8194696681
1
4
1
5
XYZ SUP6 81947
SSCC:
2.) Ship To Information **
Enter in the customer warehouse address
Area 1” x 2 ¼”
3.) Ship To Postal Code
Enter as shown, with bar code of zip code
below
Area 1” x 2”
4.) Shipper Information
Include four digit SCAC code of carrier, route
(opt), bill of lading or carrier/PRO number
Area 1” x 2”
5.) PO Number **
Enter the customer PO# with bar code of the
number below
Area 1”x 4”
6.) Expanded Supplier Name
Enter in the first seven characters of the
supplier’s name.
(00) 1 0003002 100000001 6
Area 1” x 2 ¾”
8
7.) Customer Warehouse ID
Enter the four digit Customer warehouse
number (first four digits from PO#).
Area 1” x 1 ¼”
8.) SSCC**
1. Ship-From Information
Enter the origin address
Rec’d Font Size 10-12pt; Area 1” x 1 ¾”
2. Ship-To Information
Enter the customer warehouse address
Rec’d Font Size 10-12pt; Area 1” x 2 ¼”
3. Ship-To Postal Code
Enter as shown, with bar code of zip code below
Rec’d Font Size 10-12pt; Area 1” x 2”
4. Shipper Information
Include four-digit SCAC code of carrier, route (opt), bill
of lading or carrier/PRO number
Enter the SSCC Identifier with large bar code
5. PO Number
below
Enter the customer
Rec’d FontPO
Sizenumber
18-22pt with bar code of the
Area 2” x 4”
number below
Rec’d Font**Size
20-24pt;mandatory
Area 1”x 4”
Indicates
field
6. Expanded Supplier Name
Enter the first seven characters of the supplier’s name
Rec’d Font Size 36-40pt; Area 1” x 2 ¾”
7. Customer Warehouse ID
Enter the four-digit Customer warehouse number (first
four digits from PO number)
Rec’d Font Size 36-40pt; Area 1” x 1 ¼”
8. SSCC
Enter the SSCC Identifier with large bar code below
44
Carrier Identification: This field’s information is carrier-assigned and for the internal use of the
carrier. The carrier and the supplier will agree on the contents of this field and include the SCAC
and perhaps the PRO number, if the necessary information can be provided to the labeler. This
building block is specified to be 4 inches wide (the width of the label) and 1.5 inches high.
Ship-From Address: This is the human-readable address of the origination point of shipment. This
building block is specified to be 1.33 inches wide and 0.75 inches high.
Shipment Number: The bill of lading number is located in this field. It can be bar coded if the
involved parties agree to accept an existing GS1 Application Identifier specifically for this purpose.
This building block is 2.67 inches wide and 0.75 inches high.
Ship-To Address: This is the human-readable address of the shipping destination point. This
building block is specified to be 4 inches wide and 1 inch high.
Purchase Order Number: The customer purchase order number is located in this field. It should
be encoded in GS1-128 symbology using GS1 Application identifier AI(400). This building block
is 2.67 inches wide and 0.75 inches high.
Case Count: This is the human-readable case count or number of cases in the shipment, typically
expressed as “xx OF yy”. This building block is specified to be 1.33 inches wide and 0.75 inches high.
Serial Shipping Container Code (SSCC): The 18-digit GS1 Serial Shipping Container Code
(SSCC) number is located in this field. It should be encoded in GS1-128 symbology using GS1
Application Identifier AI(00). This building block is 4 inches wide and 2 inches high.
Individual Shipping Cases and Pallets — Logistics/SSCC Label Placement
The logistics/SSCC label should be affixed to the long side of the shipping case, no closer than
1.25 inches (32 millimeters) from any package edge. Avoid placing the label toward the center of
the sides of rectangular corrugated packages to prevent undue exposure to abrasion damage.
For individual shipping cases up to 39 inches (1 meter) in height, the top and right edges of the
label should be within 1.25 to 3 inches (32 to 76 millimeters) of the top edge and within 1.25 to 3
inches (32 to 76 millimeters) of the right edge of the long side of the package (preferably the same
long side where the HDMA-recommended product identification case label is visible). (Fig. A)
For individual shipping cases greater than 39 inches (1 meter) in height, place the label so the
bottom edge of the label is within 30 to 33 inches (76.2 to 83.8 centimeters) of the natural bottom
of the case and the right side of the label is within 1.25 to 3 inches (32 to 76 millimeters) of
the right edge of the long side of the package (preferably the same long side where the HDMArecommended product identification case label is visible). (Fig. B)
Pallets and Unit Loads — Logistics/SSCC Label Placement
For pallets or unit loads up to 39 inches (1 meter) in height, the top of the label should be within
1.25 to 3 inches (32 to 76 millimeters) of the top edge of the pallet or unit load. Unit loads should
have the label on a minimum of two adjacent sides, although four sides are preferred. (Fig. C)
For pallets or unit loads greater than 39 inches (1 meter) in height, place the label so the bottom
edge of the label is within 30 to 33 inches (76.2 to 83.8 centimeters) of the natural bottom of the
pallet or unit load.
45
serialized shipping
container label
Fig. B
Fig. A
case label
Fig. C
HDMA Recommendation
HDMA encourages the use of the GS1 US Guidelines for Marking
Logistics Units Using the Serial Shipping Container Code with the
exception of the deviations noted in this document.
HDMA recommends bar coding the narrow side (or front) of the
case (one side minimum) for single case at receiving, on conveyors
and shelf storage.
HDMA recommends encoding the quantity of trade items
contained in a homogenous case (as well as the lot number and
expiration date) in a bar code symbology, because this field
provides immediate electronic interpretation, or “direct read,”
and avoids the need for trading partners to communicate updated
quantities for each pack size.
Radio Frequency Identification (RFID)
Radio Frequency Identification (RFID) is a technology that has existed for some time. There is
an increased interest in RFID because of the applications it enables, particularly from its use as
the enabling technology behind the Electronic Product Code (EPC). RFID technology employs
radio waves to “read” data. This allows automatic data capture without the need for line-of-sight
scanning, a significant advantage over bar coding.
RFID functionality requires a data storage medium, usually a silicon chip, as well as a power
source, an antenna and a receiver. With these components, data can be transferred wirelessly. The
functionality of the technology can be altered by various configurations and capabilities of the
components, as well as the frequency at which the RFID application is operating.
46
Electronic Product Code (EPC)
The innovation broadly referred to as EPC was first developed at the Massachusetts Institute
of Technology’s Auto-ID Center and is now housed within GS1, where the concept is being
commercialized into an industry-driven standard by EPCglobal, Inc. The EPC itself is simply a data
structure developed by industry participants at EPCglobal, where the EPC is being standardized
to allow for the unique, serialized identification of single items. EPCglobal is attempting to build
a communications network to facilitate the exchange of EPC data, which will drive supply chain
applications, trading partner collaboration and more effective and efficient business decisions.
The EPC Network uses RFID as a key component of its facilitating technology, with EPC numbers
encoded on RFID tags and wirelessly transmitted to RFID readers, which provide a gateway
to the EPC Network for the EPC data. For more information on the EPC, and to get involved in
developing the EPC Network standard, visit the EPCglobal website.
Multiple Data Carriers on Salable Units/Trade Items
Whenever serial numbers are affixed to salable units/trade items using two or more data carriers per
item — including two distinct bar code data carriers, the serial number encoded in all data carriers
must be identical. For example, if a manufacturer applies the minimally required GS1-128 linear bar
codes and/or a complimentary GS1 DataMatrix bar code as called for in these guidelines and/or an
RFID tag to a salable package of drugs, the GTIN+Serial Number encoded in the GS1 DataMatrix
symbol and/or the RFID tag must be identical to the GTIN+Serial Number encoded in the GS1 bar
code. If RFID tags are used, each salable unit should be uniquely identified by a single EPC whose
serial number is identical (strictly, functionally equivalent) to the serial number in the GS1 bar code.
This prevents ambiguity and confusion when the trade items are read.
Multiple Data Carriers on Logistical Containers
If a trading partner applies two different labels for the same purpose (e.g., an SSCC bar code label
and an SSCC encoded in an RFID tag), the serial numbers must be the same. The same would
hold true for product identification information encoded in a bar code label and an RFID tag.
A single container may contain a product ID label and an SSCC label with two different serial
numbers. These labels are intended for different purposes so two different serial numbers would
be acceptable. This prevents ambiguity and confusion when the containers are read.
Furthermore, and most importantly, all serial numbers applied should appear in all electronic
communications related to this shipment (ASN and/or pedigree) so that when the recipient reads
any one of the serial numbers they can find the proper information about the contents of the
container within the electronic communication.
47
Technology Considerations
Bar Code Scanner Selection
The cost of two-dimensional bar code scanners (also called 2D imagers) has decreased
significantly, and the use of two-dimensional symbologies such as Data Matrix is increasing
rapidly throughout the global healthcare supply chain. It is critical, therefore, that all organizations
in the supply chain bear in mind the long-term benefits of investing in 2D-capable scanners
instead of traditional linear readers. From the manufacturer’s packaging line to the label on the
shipping container to the receiving dock, the hospital supply room, patient bedside and beyond
— 2D bar codes are becoming increasingly prevalent. Remember that 2D scanners can read
both linear and 2D bar codes such as Data Matrix. Therefore, HDMA recommends upgrading to
imaging scanners capable of reading Data Matrix and linear codes whenever auto-id procurement
needs are under consideration.
HDMA Recommendation
HDMA recommends investing in and/or upgrading to imaging
scanners capable of reading Data Matrix and linear codes whenever
auto-id procurement needs are under consideration.
Bar Code Symbol Generation for Primary Labels and Packaging
Nothing is more critical to the ultimate success of every bar code scanning application than the
generation of a high-quality original bar code image. For traditional “wet ink” processes where
printing plates or engraved cylinders are used (as opposed to on-demand label or ink-jet printing,
for example), the first-generation bar code art is most often produced as a digital image file.
Historically, such files were supplied on a “service bureau” basis by companies specializing in
this area. The considerable expertise of these companies helped ensure that poor quality bar codes
were avoided (though certainly not completely) on packaging and labeling where the bar code
was incorporated and preprinted with other graphics.
More recently, with the advent of digital printing and the evolution toward digital bar codes
generated “in-house” by package graphics personnel using low-cost desktop software, the
proliferation of lower- quality bar codes has increased. This is due in some measure to the absence
of the experience and the knowledge previously brought to this market by the companies who
specialize in this area. And evidence suggests that the use of bar code images downloaded from
the Web is contributing to this decline in bar code symbol print quality, particularly in nonFDA regulated markets. To counter this trend, it is imperative that package design and graphics
personnel become well acquainted with bar code design, generation, printing and internationally
recognized print quality standards.
In addition to the expertise still available from qualified companies that continue to offer high
quality digital bar code images, print-quality verification solutions and consulting services in this
area, a number of organizations have developed documentation that cover this subject matter in
detail. One such organization is GS1 US.
GS1 US publishes the following, all of which offer valuable information on this topic:
• U.P.C. Printed Symbol & Quality Specifications; and,
• Guidelines for Supply Chain Identification.
48
Like other manufacturers, healthcare manufacturers must regularly print industry-standard bar
codes “on-demand” using a number of different technologies and substrates, ranging from thermal
transfer printing on paper labels, to laser ablation, to direct-to-plate flexo on blister foils to name a
few. Each of these technologies and applications has its own special considerations and care must
be taken to become well acquainted with the technical issues surrounding each.
Bar Code Symbol Print-Quality Verification
Whatever the printing process, bar codes must be verified to conform to relevant ISO/IEC print
quality standards for the distribution channel to work efficiently. Previously, this was a requirement
only to the extent that trading partners chose to enforce the minimum print quality requirements
set forth by the GS1 and HIBCC standards and guidelines.
Healthcare supply chain partners have become increasingly less accepting of poorly printed
bar codes; bar codes with incorrect or “bad” data; or the absence of standardized bar codes.
Moreover, when it comes to pharmaceutical labeling that falls under the purview of the FDA,
these requirements for correctly encoded and well-printed symbols have the full force and effect
of FDA regulations. This conclusion follows directly from the FDA’s directive that these covered
items are to be bar coded in accordance with GS1 or HIBCC standards.17 Moreover, in the
pharmaceutical supply chain, the final point of use of a bar coded product is very often the point
of care, where high quality, industry-standard bar code are essential to patient safety.
Bar code print quality verification is based on internationally accepted methodology and
conformance requirements detailed in ISO/IEC standards, specifically:
1. ISO/IEC 15416, Information technology — Automatic identification and data capture
techniques — Bar code print quality test specification — Linear symbols;
2. ISO/IEC 15426-1, Information technology — Automatic identification and data capture
techniques — Bar code verifier conformance specification — Part 1: Linear symbols;
3. ISO/IEC 15415, Information technology — Automatic identification and data capture
techniques — Bar code print quality test specification — Two-dimensional symbols; and,
4. ISO/IEC 15426-2, Information technology — Automatic identification and data capture
techniques — Bar code verifier conformance specification — Part 2: Two-dimensional symbols.
These standards are available for purchase from ISO at http://www.iso.org/.
As important as it is to verify the printed bar code for proper date encodation and print quality,
it is equally essential to “verify the verifier”. That is, a verifier must be regularly challenged for
conformance and accuracy to ensure that the results it is reporting may be relied upon. The
principal tools used to establish such conformance (in accordance with ISO/IEC 15426-1 and ISO/
IEC 15426-2) are the GS1 US Calibrated Conformance Standard Test Cards (CCSTCs).
CCSTCs are application-specific, high-quality, mounted photographic prints with bar code
symbols of precisely known print quality parameter grades. Some have specifically engineered
flaws. Each symbol on the card is verified and if the verifier reports parameter grades conforming
to those for the symbols printed on the card, then the verifier is demonstrably in conformance. If
it does not agree (within the tolerances specified) then the verifier is not reporting accurately and
corrective action must be taken.
Food and Drug Administration, CFR - Code of Federal Regulations Title 21 (Parts 201, 606 and 610), (April 2004).
17
49
The subject of bar code print quality is complex; verification instrument offerings vary widely and
a comprehensive, well-developed program takes time to implement. Nevertheless, non-compliant
bar codes are detrimental to supply chain efficiency.
Again, GS1 US offers a number of documents pertaining to this topic, as do many other
organizations. By the very number of documents available, one can infer the importance of this
issue. GS1 offerings include the following:
• Bar Code Verification for Linear Symbologies;
• Guidelines for Producing Quality Symbols; and,
• Quality Control Practices for Bar Code Symbol Verification.
GS1 US documents are freely available from GS1 US to members in good standing or for purchase
by anyone. Members should contact their GS1 US administrator for online access. Others should
visit the GS1 US website or contact GS1 US directly for assistance.
In addition, the Association for Automatic identification and Mobility (AIM) offers the following
documents:
• The Layman’s Guide to ANSI, CEN and ISO Bar Code Print Quality Documents;
• Bar Code Quality Control: Why Verification?; and,
• The FDA Bar Code Rule Decoded.
Finally, a brief article titled Fundamentals of ANSI/ISO Bar Code Print Quality Verification (written
from a healthcare perspective) is reprinted in the Appendix. This article is adapted and reprinted
with permission and originally appeared in substantially identical form in the annual Bar Coding
Supplement of Pharmaceutical & Medical Packaging News (March 2004).
50
Application Software Design Issues —
ISO/IEC Symbology Identifiers
The GS1 General Specifications, other GS1 specifications and application guidelines and many
of the related bar code symbology specifications clearly stipulate that efficient data collection
in the global GS1 System depends on the use of standardized ISO/IEC Symbology Identifiers in
conjunction with GS1 AIs. To understand the implications of this critical requirement, one first has
to understand the purpose and role of these two critical “metadata” elements.
The ISO/IEC Symbology Identifier is a unique, globally standardized three-character code that
unambiguously identifies a specific bar code symbology. This element of metadata is not encoded
in the bar code but rather is provided by the scanner, which has a programmable setting to
transmit these three characters as a prefix to the data encoded in the symbol. For this reason it
is critical to ensure that the scanners one intends to purchase fully support this long-established,
industry-standard feature (as most certainly do).
Knowing which symbology has been scanned is a critical piece of information to have in most any
application but most necessary in an open, global supply chain where items from a wide variety
of sources bar coded according to different standards are commonplace. Such is the nature of the
healthcare supply chain.
Using the ISO/IEC Symbology Identifier, suitably programmed data-collection systems — from the
manufacturer’s shipping dock through the distribution channel, right down to the point of care can
perform their initial input data string evaluation and choose the correct branch in their logic for the
next step in data processing. Knowing, for example, that one has scanned a U.P.C. or GS1 DataBar
or GS1-128 symbol determines that the proper logic branch is the one that handles GS1 format data
processing according to Application Identifier rules. Thereafter, the system determines the length
of the data string and begins to evaluate it for the presence of AIs and, if necessary, to break it into
separate data elements (such as GTIN, quantity, expiration date, lot number, serial number, etc.)
GS1-128, GS1 DataBar, GS1 DataBar/Composite and GS1 DataMatrix all encode AIs, whereas
U.P.C, EAN and ITF-14 never do. These latter three data carriers can only encode a GTIN (12-,
13- or 14-digit formats, respectively), so knowing the symbology and the string length is sufficient
to understand how to process the data.
By the same token, if one knows by virtue of the ISO/IEC Symbology Identifier that one has
scanned a Code 39 symbol or a “plain” Code 128 symbol (as opposed to a GS1-128 symbol)
and the symbol starts with the plus character (“+”), then the proper logic branch is the one that
handles HIBCC format data processing.
The complete rules for such “front-end” logic are somewhat complex, depending on the diversity
of data elements encountered at any particular point in the supply chain. Expert resources should
be consulted for further details.
51
Scanner and Data Collection
Hardware Issues
A number of scanner and data collection hardware issues also must be taken into consideration
when designing and implementing any bar code scanning solution. The scanner form-factor
(hand-held, presentation, fixed-mount), its working range and focal length for a given symbol
X-dimension, optical properties (laser or imager; linear or 2D) and ergonomic design are just a
few important considerations. In addition, many of today’s scanners offer wireless Bluetooth®
connectivity along with the traditional cabled connections through RS-232, keyboard wedge
interface or, more typically today, USB. And as already pointed out, a scanner must be capable of
fully supporting the transmission of ISO/IEC Symbology Identifiers as a prefix to the scanned data.
There are certainly more than 100 hand-held and small form factor scanner models from a wide
range of manufacturers that scan traditional linear, GS1 DataBar, GS1 DataBar/Composite and 2D
matrix symbols, in some combination depending on the model.
Beyond scanners, are portable data-collection terminals (PDTs), most of which would normally
be equipped with an integrated scanner, not only for use at the point of care, but throughout the
healthcare supply chain. Such PDTs come in a vast array of form factors with widely different
feature sets, from small hand-held units such as the personal digital assistants (PDAs) to wireless
vehicle-mounted devices on fork-lift trucks in warehouses.
In addition to the scanner considerations already mentioned above, the evaluation of PDTs also must
include their operating system, display capabilities, keypad configuration, battery life and more.
52
HDMA Recommendations
HDMA recommends investing in and/or upgrading to imaging scanners capable of reading Data
Matrix and linear codes whenever auto-id procurement needs are under consideration (page 1).
HDMA is no longer calling for the use of ITF-14. Instead, GS1-128 (with Application Identifiers)
should be the linear symbology used at the inner pack and shipping case levels (page 9).
HDMA urges manufacturers and labelers to identify their products with an NDC and to encode
this number in a standardized GS1 bar code format (page 10).
In accordance with FDA regulations, HDMA urges all labelers (including manufacturers,
repackagers, etc.) to incorporate bar code to unit-dose, unit-of-use and very small packaging, if
they offer such packaging configurations (page 15).
AI(22), which can combine quantity, expiration date, lot number and a link character into one
compact code also has been widely (and often, incorrectly) used, but it is no longer endorsed
by HDMA. With the publication of its GS1 General Specifications, Issue 10 (January 2010), GS1
formally announced the withdrawal of Application Identifier AI(22), effective January 1, 2013.
Therefore HDMA recommends eliminating all uses of AI(22), with the affected package labels
revised to use AI(17), AI(10) and AI(30), as appropriate (page 20).
At a minimum, the unit-item bar code should include the GTIN AI(01) followed by the serial
number AI(21). If additional information, such as expiration and lot number, is optionally included
in the same code it should be added after the serial number (page 23).
HDMA recommends encoding the quantity of trade items contained in the case (as well as the
lot number and expiration date) in a bar code because this field provides immediate electronic
interpretation or “direct read” and avoids the need for trading partners to communicate updated
quantities for each pack size (page 26).
HDMA no longer endorses the use of ITF-14 and urges all labelers to convert to GS1-128 (page 26).
HDMA recommends that the human-readable year always be represented in its complete “CCYY”
four-digit format (page 28).
As companies begin to serialize product, HDMA recommends using product identification labels
on cases following Format 1, which includes GTIN, Serial Number, Expiration, Lot Number and
Quantity as described in this section (page 31).
The GS1-128 and GS1 DataMatrix symbols should be printed as black bars on a white pressuresensitive label using, for example, the thermal-transfer printing process. Thermal transfer printing
generally provides the best contrast and overall bar code print quality (page 32).
For case marking, the preferred method of marking both product identification and transportation/
logistics information is to print the requested information on a pressure-sensitive label. A pressuresensitive label can be applied to any and all cases, thereby reducing the number of different
cases a manufacturer must order and inventory. To maximize human and machine readability, the
preferred color scheme is a white background with black printing (page 39).
Product identification labels are recommended on two adjacent sides of the case. This can be
achieved by using a wrap around label or using two separate but identical labels on adjacent sides
(page 40).
53
HDMA encourages the use of the GS1 US Guidelines for Marking Logistics Units Using the Serial
Shipping Container Code with the exception of the deviations noted in this document (page 46).
HDMA recommends bar coding the narrow side (or front) of the case (one side minimum) for
single case at receiving, on conveyors and shelf storage (page 46).
HDMA recommends encoding the quantity of trade items contained in a homogenous case (as
well as the lot number and expiration date) in a bar code symbology, because this field provides
immediate electronic interpretation, or “direct read,” and avoids the need for trading partners to
communicate updated quantities for each pack size (page 46).
54
Acknowledgements
HDMA thanks the following individuals and their companies for giving their time and expertise to
the Bar Code Task Force to revise and complete this publication:
David J. Colombo
Lilly USA, LLC
Allan M. Mohn
Cardinal Health, Inc.
Ray Delnicki
GS1 Healthcare US
Harry Ramsey
Purdue Pharma L.P.
John Hammer
TEVA Pharmaceuticals USA
John J. Roberts
GS1 Healthcare US
John G. Howells
Healthcare Distribution Management Association
Dirk Rodgers
Cardinal Health, Inc.
Ravi Kannan
Michael Stecher
Apotex Corp.
Michelle L. Keller
Darin K. Thornburgh
AmerisourceBergen Drug Company
Gordon Kosovan
Johnson & Johnson
Michael Ventura
GlaxoSmithKline
Kevan MacKenzie
McKesson Corporation
George Wright IV
Product Identification & Processing Systems, Inc.
Del Mineard
Boehringer Ingelheim Pharmaceuticals, Inc.
Dave Yoder
55
References
Association for Automatic Identification and Mobility, Bar Code Quality Control: Why Verification
Available at http://www.aimglobal.org/technologies/barcode/verify/whyverify2002.pdf
Association for Automatic Identification and Mobility, ISS EAN.UCC Composite Symbology.
Available from https://www.aimglobal.org/estore/ProductDetails.aspx?ProductID=36
Association for Automatic Identification and Mobility, The FDA Bar Code Rule Decoded. Available
from https://www.aimglobal.org/estore/ProductDetails.aspx?productID=290
Association for Automatic Identification and Mobility, The Layman’s Guide to ANSI, CEN and ISO
Bar Code Print Quality Documents (Revised November 2002). Retrieved from https://www.barcode.com/LaymansGuidetoANSI.pdf
ASTM, ASTM D996 – 10A Standard Terminology of Packaging and Distribution Environments
(2004). Available from http://www.astm.org/Standards/D996.htm
Drug Enforcement Administration, ARCOS Registrant Handbook (Revised August 1997).
Retrieved from http://www.deadiversion.usdoj.gov/arcos/handbook/index.html
Food and Drug Administration, Bar Code Label Requirement for Human Drug Products
and Biological Products (February 2004). Retrieved from http://www.federalregister.gov/
articles/2004/02/26/04-4249/bar-code-label-requirement-for-human-drug-products-andbiological-products
Food and Drug Administration, CFR - Code of Federal Regulations Title 21, Parts 201, 606 and 610
(April 2004). Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
Food and Drug Administration, Federal Food, Drug and Cosmetic Act, Section 510, (Revised
February 2008). Retrieved from http://www.fda.gov/RegulatoryInformation/Legislation/
FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/ucm109201.htm
Food and Drug Administration, Guidance for Industry: Bar Code Label Requirements – Questions
and Answers (August 2011). Retrieved from http://www.fda.gov/downloads/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/UCM267392.pdf
Food and Drug Administration, Guidance for Industry, Providing Regulatory Submissions in
Electronic Format – Drug Establishment Registration and Drug Listing (May 2010). Retrieved from
http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM164053.pdf
Food and Drug Administration, Guidance for Industry: Standards for Securing the Drug Supply
Chain – Standardized Numerical Identification for Prescription Drug Packages, (March 2010).
Retrieved from http://www.fda.gov/RegulatoryInformation/Guidances/ucm125505.htm
GS1, Healthcare GTIN Allocation Rules (January 2011). Retrieved from http://www.gs1.org/docs/
gsmp/healthcare/GS1_Healthcare_GTIN_Allocation_Rules.pdf
GS1 US, Bar Code Verification for Linear Symbologies (Revised May 2007). Available from http://
productcatalog.gs1us.org/Store/tabid/86/CategoryID/2/List/1/Level/a/ProductID/6/Default.aspx
GS1 US, GS1 General Specifications (January 2010). Available from http://www.gs1.org/barcodes/
technical/genspecs
GS1 US, Guidelines for Producing Quality Symbols (Revised May 2007). Available from http://
productcatalog.gs1us.org/Store/tabid/86/CategoryID/2/List/1/Level/a/ProductID/5/Default.aspx
56
GS1 US, Guidelines for Supply Chain Identification (Revised May 2007). Available from
http://productcatalog.gs1us.org/Store/tabid/86/CategoryID/6/List/1/Level/a/ProductID/18/Default.aspx
GS1 US, North American Guideline For Application of GS1 Bar Codes To Very Small Healthcare
Items (Revised May 2007). Available from http://productcatalog.gs1us.org/Store/tabid/86/
CategoryID/12/List/1/Level/a/ProductID/29/Default.aspx
GS1 US, Quality Control Practices for Bar Code Symbol Verification (Revised May 2007). Available from
GS1 US, GS1 US Solutions Center, https://solutionscenter.gs1us.org/Login/tabid/86/Default.
aspx?returnurl=%2fdefault.aspx (login required)
GS1 US, U.P.C. Printed Symbol & Quality Specifications (Revised May 2007). Available from
H.R. 5835 Omnibus Budget Reconciliation Act of 1990 (1990). Retrieved from http://thomas.loc.
gov/cgi-bin/query/z?c101:H.R.5835:
ISO/IEC 15415:2004, Information technology — Automatic identification and data capture
techniques — Bar code print quality test specification — Two-dimensional symbols
techniques — Bar code print quality test specification — Linear symbols
ISO/IEC 15426-1:2006, Information technology — Automatic identification and data capture
techniques — Bar code verifier conformance specification — Part 1: Linear symbols
ISO/IEC 15426-2:2005, Information technology — Automatic identification and data capture
techniques — Bar code verifier conformance specification — Part 2: Two-dimensional symbols
techniques — Data Matrix bar code symbology specification
United States Pharmacopeia, Second Supplement to USP 34-NF 29, (Available December 2011).
Available from http://www.usp.org/products/USPNF/USPNFUSP34NF29.html
57
Resources for Healthcare Distribution
Standards
Health Industry Business Communications Council (HIBCC): http://www.hibcc.org
Healthcare Distribution Management Association (HDMA): http://www.HealthcareDistribution.org
Healthcare Information and Management Systems Society (HIMSS):
http://www.himss.org/ASP/index.asp
National Association of Chain Drug Stores (NACDS): http://www.nacds.org
The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP):
http://www.nccmerp.org
The National Council for Prescription Drug Programs (NCPDP): http://www.ncpdp.org
The Pharmaceutical Research and Manufacturers of America (PhRMA): http://www.phrma.org
58
Frequently Asked Questions
1
Q: Why should my company work to eliminate the Application Identifier (22) from our shipper
labels before the 1/1/2013 sunset date?
A: It is no longer supported by HDMA and its members. If labels are being redesigned, it would be
cost effective to make the change at that time.
2
Q: Why has the use of AI (22) been deleted from the Guidelines?
A: GS1 has decided to sunset the AI (22) by 1/1/2013.
3
Q: What is a GTIN?
A: GTIN stands for Global Trade Item Number. The GTIN is the GS1 System standard term
for product and process identification. The GTIN is used for the unique identification of trade
items worldwide. A trade item is any product or service upon which there is a need to retrieve
predefined information and that may be priced or ordered or invoiced at any point in the supply
chain. The GTIN is a globally unique 8-, 12-, 13- or 14-digit number assigned to each packaging
level of a product The GS1 System of GTIN identifiers is designed so that this uniqueness is
inherent and maintained in a database where all GTINs are represented as a 14-digit number
(when zero-padded on the left in accordance with GS1 System rules).
4
Q: What are Application Identifiers?
A: The GSI System uses bar code symbologies that can carry special prefixes to identify and
separate multiple primary and secondary data elements contained within a single bar code symbol.
These two-, three- or four-digit numbers called Application Identifiers (AIs) can only be “carried” by
GS1 symbols. When a suitably programmed application “sees” a GS1 System bar code with these
special prefixes, it “knows” how to properly separate and interpret the individual data elements. The
information that follows the AIs can contain numeric or alphanumeric data characters.
5
Q: How large is the GS1 DataBar quiet zone?
A: Unlike other linear symbols, GS1 DataBar originally required no quiet zone. However,
experience has shown that a quiet zone can enhance scannability and it is recommended that the
GS1 DataBar is printed with a 10X wide quiet zone similar to other linear symbologies.
6
Q: What is the minimum readable/scannable print size for GS1 DataBar and GS1 DataBar/
Composite on an item?
A: The recommended minimum X-dimension is 10 mils. The minimum allowed X-dimension for
North American healthcare applications is 6.7 mils and the maximum is 16 mils. As a practical
matter, an X-dimension of 8 mils is the absolute minimum. It is important to note, however, that
symbols of less than a 10-mil X-dimension may have difficulty being printed to the required ANSI/
ISO print quality minimum “c” grade of 1.5/06/660.
7
Q: What data is encoded in the GS1 DataBar Limited and Stacked Symbols?
A: GS1 DataBar Limited and GS1 DataBar Stacked contain the GTIN. However, GS1 DataBar
Limited only supports a leading indicator digit of zero or one. As with GS1-128, a scanner will
transmit 16 digits, including the “01” AI preceding the GTIN formatted in a 14 digit field.
59
8
Q: What data is encoded in the 2D Composite Component?
A: Composite component contains secondary attribute data. There are more than 100 globally
recognized AIs. The most common AIs found in 2D Composite symbols used in healthcare are lot
number, AI(10); expiration date, AI(17); serial number, AI(21) and quantity AI(30).
9
Q: Where are GS1 DataBar Limited and Stacked used?
A: GS1 DataBar Limited and GS1 DataBar Stacked as presented in these guidelines are for use on
very small items for healthcare. They are not to be used for scanning at point of sale.
10
Q: Why do I need human readable characters with a Data Matrix bar code when the Data Matrix
symbol is so robust?
A: The Data Matrix symbol can become illegible. The supply chain could use the human readable
in this situation.
11
Q: Is printing human-readable data mandatory for GS1 DataBar and Composite?
a. If space allows the human readable should be printed for both GS1 DataBar and 2D
Composite Component.
b. If there only is enough room to print human readable for either GS1 DataBar (GTIN) or
2D Composite Component, print the GS1 DataBar GTIN data. GS1 DataBar was developed
for items that were not currently bar coded. The information contained in the bar code
is frequently required by law, regulation or trade practice to be printed on the item. A
bar code without human readable is better than no bar code and no human readable.
As always, government regulations supersede GS1 application guidelines. The supplier is
required to do their due diligence to comply with all applicable laws and regulations.
12
Q: What are the alternatives when human-readable data is larger than the space above the 2D
Composite Component?
There are two alternatives if the application data cannot fit on a single line directly above the 2D
Composite Component:
a. If all the application data is meant for supply chain use (lot number and expiration date)
and cannot fit on a single line above the composite, do not print at all. The rationale is
that a human observer might surmise that the partially printed information is all that is
included in the composite component.
b. If some information encoded in the composite is meant or required for the supply chain
(e.g., lot number and expiration date), and other information is not required or meant
for the supply chain (e.g., serial number of product for diversion tracking), then print the
supply chain information.
13
Q: If there is a conflict between government rules and regulations and the GS1 standards and
application guidelines, which should the supplier follow?
A: Government laws and regulations supersede GS1 specifications.
60
14
Q: Why should my company apply bar codes to small items?
A: All healthcare items, down to the unit of use, should be bar coded to reduce error and
increase patient safety and efficiencies. This is a continuing demand from healthcare customers
today. Some companies see the product identification of all healthcare items as a manner of
reducing liability while gaining a competitive edge.
15
Q: Does this guideline address GS1 DataBar Limited or GS1 DataBar Stacked used in retail packages?
A: Yes, GS1 DataBar Limited and GS1 DataBar Stacked are not omni-directionally scannable and
are therefore not intended for retail packages in any supply chain.
16
Q: Are GS1 DataBar Limited and GS1 DataBar Stacked used at all small packaging levels?
A: GS1 DataBar Limited is restricted to leading digit zero or one.
17
Q: Are inner packs (multiple salable units in trays or bundled in film) required to contain a
Product Identification label? If so, what bar codes are required for inner packs?
A: No inner packs are not required to be labeled.
18
Q: Our small case labels do not have room for a GS1 DataMatrix bar code. Can we remove the
linear bar codes and go direct to Data Matrix bar codes?
A: No. HDMA guidelines call for GS1 DataMatrix symbols only as an additional symbol on
Product Identification labels. Many of your customers may not have the capability to read Data
Matrix bar codes so existing linear bar codes should NOT be removed. HDMA has determined
that data matrix symbology will be necessary in the future for use at the case level on the
product. identification label especially for small labels. We recommend that linear and data
matrix symbols be used for a transitional period.
19
Q: When will HDMA recommend that all product ID labels on cases contain a data matrix bar
code along with the linear bar codes?
A: HDMA guidelines are recommendations only. Trading partners agree on what is acceptable
to implement between the individual companies. To our knowledge most participants in the
pharmaceutical supply chain can read linear symbologies currently but can’t read Data Matrix
symbologies in a production environment. Therefore , HDMA recommends that the linear
symbology currently on transportation/logistics label be “required” and GS1 DataMatrix be
optional. The data encoded should be the same in both symbologies for a particular label.
HDMA recognizes the use of the GS1 DataMatrix on transportation/logistics labels is not
currently an approved by GS1.
20
Q: The examples in the Guidelines show that AI (30) should be a four-digit field, 0144. Why is
0144 preferred over a 3 digit number, 144?
A: It is often the case that encoding a four-digit number in GS1-128 symbology at the end of
(or even within) this string of secondary data elements results in a shorter symbol (less wide,
not less tall) than encoding a three-digit number. It is perfectly permissible to encode the 3-digit
quantity literally. However, in those cases where encoding a four-digit number does produce
a shorter symbol and where it may already be a challenge to fit the symbol on the label at the
recommended X-dimension, then it is worth the effort to design the bar code to use a zeropadded quantity value.
61
21
Q: Why is AI (30) no longer recommended in the primary bar code?
A: AI(30) represents QUANTITY, which is a secondary data element and so it rightly belongs in
the secondary symbol with EXP DATE and LOT. With the advent of serialization, it is necessary
to concatenate AI(21) Serial Number following the AI(01) GTIN. In the future, GTIN & Serial
Number could be used to access the secondary data that would be communicated in electronic
transactions. These transactions would be available before the shipment arrives. The data could
be used at the point of receiving.
22
Q: What is the HDMA recommendation for the print quality of GS1 DataMatrix bar codes? Is it a
recommendation or a requirement?
A: HDMA recommends the requirements set forth in the GS1 General Specifications, which
call for a minimum grade of “C” in accordance with ISO/IEC 15415, expressed as “1.5/10/660”,
where “1.5” is the minimum grade in the “C” range, 10 is the diameter of the measuring aperture
and 660 (+/-10) is the wavelength in nanometers of the (red) light source. HDMA recommends a
minimum of C with a target of a grade of B.
23
Q: How long do we have to convert from one case level product ID label to two labels on
adjacent panels or one wrap around label on two adjacent panels?
A: HDMA’s recommendation for a Product identification label on adjacent sides of a shipping
case is not a new one but has been explicitly called for since 2006. While this is an individual
company decision, in general labelers should not delay in implementing this requirement as the
lack of labels on adjacent sides — whether a single wrap-around label or two separate labels —
impedes the distribution supply chain.
24
Q: Is there a preferred length (number of characters) for the serialized number which follows AI (21)?
A: Yes, the preferred length is 12 digits (all numeric). This allows the same serial number to be
encoded in an SGTIN-96 RFID Tag. This standard is limited to 12 digits and seems to be sufficient
in length to allow for approximately 275 billion serial numbers.
25
Q: What is the minimum readable/scannable print size for GS1 DataBar and GS1 DataBar/Composite?
A: The recommended minimum X-dimension is 10 mils. The minimum allowed X-dimension for
North American healthcare applications is 6.7 mils and the maximum is 16 mils. It is important to
note, however, that symbols of less than a 10-mil X-dimension may have difficulty being printed to
the required ANSI/ISO print quality minimum grade of 1.5/06/660.
26
Q: Why should my company apply bar codes to small items?
A: All healthcare items, down to the unit of use, should be bar coded to reduce error and increase
both patient safety and efficiencies. This is a continuing demand from healthcare customers today.
Some companies see the product identification of all healthcare items as a manner of reducing
liability while gaining a competitive edge.
62
Glossary of Terms
1D — One dimensional; used to describe 1D bar codes (also called linear bar codes)
2D — Two dimensional; Used to describe 2D bar codes
AI — Application identifier; a set of codes developed by UCC for bar coding. The AI will indicate
the type, format, and permissible length of data that follows the AI in the bar code. Examples
include AIs that would indicate a GTIN, expiry date or quantity of product.
AI 00 — Application identifier for SSCC; see SSCC for further information
AI 01 — Application identifier for GTIN; see GTIN for further information
AI 10 — Application identifier for lot number
AI 17 — Application identifier for expiry date in the YYMMDD format
AI 21 — Application identifier for serial number; generally used in the same bar code with AI 01
to create an SGTIN (see SGTIN for further information)
AI 30 — Application identifier for quantity
ASN — Advance shipping notification; this is generally an EDI document, but can be paper based,
sent to a receiver specifying the contents of a shipment. The level of detail can vary depending on
the shipper and receiver’s needs.
CBoP — California Board of Pharmacy
Check digit — A digit, generally at the end of a string of numbers, that is calculated through a
mathematical formula. This can be used to ensure that the number has been entered properly on
a computer system, by having the computer perform the same calculation and checking that the
results match. Examples of items with check digits are UPCs, GTINs, credit cards, etc.
Code-128 — A variable length bar code symbology capable of encoding the full ASCII 128
character set and other special characters
Dangerous drug — A drug that requires a prescription or similar order from a qualified person for use
ePedigree — Electronic pedigree; an electronic document based protocol for recording ownership
history of a product.
EPC — Electronic Product Code; An identification scheme for universally identifying physical
objects via RFID tags and other means. Standardized Electronic Product Code data consists of
among other partitions of data, an EPC Manager Number, an object class identification, a filter
value, and a serial number used to uniquely identify the instance of the object.
EPCGlobal — A non-profit standards group working on the creation, ratification and adoption of
standards for EPC, ePedigree, RFID and EPCIS
EPCIS — Electronic Product Code Information Services; a component of the EPCglobal Network
that enables users to exchange Electronic Product Code-related data in a structured format with
trading partners through the Network.
63
FNC1 — Function Code 1; a symbology element used to form the double start pattern of a GS1128 bar code symbol. It is also used to separate certain concatenated element strings, dependent
on their positioning in the bar code symbol.
GPhA — Generic Pharmaceutical Association
GS1 — An international non-profit standards group working on the creation, ratification and
adoption of standards for bar coding and electronic commerce. Many previous national standards
groups performing the same function have been renamed and become country chapters of GS1.
GS1 128 Symbology — A subset of Code 128 used exclusively for GS1 System element strings;
code 128 symbols have a special start code pattern (consisting of a Start Character in the first
symbol character position followed by the Function Code 1 in the second character position) to
designate the data that follows will comply with GS1 System standards.
GTIN — Global Trade Identification Number; the GS1 Identification Key used to identify trade
items. The key comprises a GS1 Company Prefix, an Item Reference and Check Digit.
HDMA — Healthcare Distribution Management Association
Linear bar code — See 1D
Logistic Unit — An item of any composition established for transport and/or storage that must be
managed through the supply chain; it is identified with an SSCC
NDC — National Drug Code
RFID — Radio Frequency Identification
RxASN — See serialized ASN
Serialized ASN — An ASN that includes information on item, case and pallet serialization in
addition to the standard information found in the ASN
SGTIN — Serialized GTIN; a GTIN plus serialization information, making each SGTIN an unique
identifier
SGTIN-96 — A format of the SGTIN that is used for RFID tags
SNI — Standardized Numerical Identifier
sNDC — Serialized NDC
SSCC — Serial shipping container code; the GS1 Identification Key is used to identify logistics units.
The key comprises an Extension digit, GS1 Company Prefix, Serial Reference and Check Digit.
SSCC-96 — A format of the SSCC that is used for RFID tags
Trade Item — Any item (product or service) upon which there is a need to retrieve predefined
information and that may be priced ordered or invoiced at any point in any supply chain
UCC — Uniform Code Council; renamed to GS1 US, see GS1 entry
64
Appendix
Fundamentals of ANSI/ISO Linear Bar Code Print Quality Verification
George Wright IV, Vice-President
Product Identification & Processing Systems, Inc.
Healthcare bar code application guidelines from GS1 and HIBCC require a minimum overall symbol
print quality grade of 1.5 on the ISO/IEC 0.0 - 4.0 numeric scale. This is the equivalent of “C” on
the original ANSI scale. The grade is determined according to the globally accepted standard for
calculating linear bar code print quality: ISO/I EC 15416:2000, Information technology -Automatic
identification and data capture techniques - Bar code print quality test specification - Linear
symbols. This ISO standard supersedes ANSI X3.182-1990. Similar requirements are stipulated for
GS1 DataMatrix minimum print quality based on ISO/IEC 15415:2004.
Scanning is not verification. A bar code scanner is a data collection tool, whose purpose is only to
decode or “read” the data encoded in the symbol. Ideally, it should do this easily, accurately and
quickly, even on poorer quality bar codes. A bar code print quality verifier is a quality assessment
instrument. It is intended to evaluate, measure and report with accuracy and repeatability specific
physical characteristics of a bar code in order to quantify the likelihood that it will be readily
decoded—even when using a relatively unsophisticated, low-cost scanner. That a verifier should
perform in strict accordance with globally accepted ISO specifications is essential.
Not all scanners are created equal. Some scanners may rely only on the simplest optics and the
published reference decode algorithm (the recipe) for reading a given symbology. Such scanners
have limited abilities to read poorer quality bar codes and generally operate well only over a
limited range. Other scanners incorporate extra processing power, enhanced decode algorithms,
special optics and secret tricks of the trade to read even very low quality symbols at varying
depths of field.
Because scanners differ in their capabilities, bar codes must be printed to accommodate (within limits)
the lowest common denominator. Thus, it is essential to be able to accurately predict how readily a bar
code can be decoded—even by the least sophisticated scanners. Grading symbols according to the
ISO 15416 specification is the globally accepted method of quantifying this “scannability.”
ISO 15416 defines a rigorous methodology for print quality verification. Depending on the
symbology and application, it specifies as many as 9 or more parameters to be graded. Some are
Pass/Fail, while others are graded on an integer scale from 4 (highest) to 0 (failure). The lowest
grade for any parameter in a single scan is the grade for that scan. The overall symbol grade is the
arithmetic mean (average) to one decimal place of the individual scan grades for 10 scans taken
from top to bottom of the symbol in the “inspection band.”
1 0 Scans in the Inspection Band
65
It is this 10-scan average grading that gives ISO 15416 its robustness. The height of a linear bar
code gives it “vertical redundancy,” providing multiple possible scan paths, any one of which
might provide the decode necessary for data capture. By averaging 10 scans, the methodology
allows for a reasonable amount of non-uniformity in the printing process, while at the same time
assuring a final grade that is fairly determined and representative of overall symbol quality.
It should be noted that it is highly preferable to record and refer to the numeric overall grades
rather than the less precise letter grades. Whereas a 2.5 is a “B,” a 2.4 is a “C”. Yet there is virtually
no qualitative difference in these two grades. In addition, the standard is quite specific about
when a symbol is to be verified: “Whenever possible, measurements shall be made on the bar
code symbol in its final configuration, i.e., now the configuration is intended to be scanned.”
One “ANSI/ISO” verifier is not the same as another. Not all verifiers marketed as following
or compliant with the ANSI/ISO methodology are the same. Different models from different
manufacturers have different features and costs vary widely, from less than $2,000 to more
than $7,000. Some features may be important to one user but not another, such as whether
the optical scan head moves manually or automatically across the bar code and/or down the
inspection band. Some units are hand-held and portable, while others are laboratory-type desktop
instruments. And some verifiers perform additional application-specific data format checks beyond
what is required by ISO 15416.
In addition to understanding the feature differences between verifiers from different manufacturers
(or different models from the same manufacturer), it is essential to determine exactly how closely
any “ANSI/ISO” verifier conforms to the relevant ISO standards for verifier methodology and
accuracy. ISO 15416 specifies the methodology by which a symbol is to be graded. Equally
important, and arguably more so, is the accuracy and repeatability with which the verifier
performs these calculations.
It is essential to “verify the verifier.” ISO/IEC 15426-1, Information technology - Automatic
identification and data capture techniques - Bar code verifier conformance specification: Part 1:
Linear symbols specifies the accuracy with which a verifier must derive and report the specified
parameter grades under ISO 15416. In order to determine whether or not any verifier is accurate
in this regard, one needs to test the verifier’s performance against a set of “certified” symbols with
known values for the parameters being tested. Not only is it important to determine that a verifier
in which one might be planning to invest grades with the required level of accuracy, it is important
to test a verifier for conformance on a regular basis after putting the unit into use. This is not the
same as “calibrating” a verifier for high and low reference reflectance values, generally the only
“calibration” function over which the user has control and one which has been likened to the
process of “zeroing” a scale.
Although a verifier manufacturer may offer test symbols against which its instrument’s performance
may be judged, GS1 System Calibrated Conformance Standard Test Cards from GS1 US are
the globally accepted tools for this purpose. These precision-engineered “primary reference test
symbols” are manufactured to the strict specifications of GS1 US and the images are traceable to a
chrome on glass master image and a extra-high-precision bar code verifier known as “the Judge,”
both of which are recognized by the U.S. National Institute of Standards and Technology (NIST).
Key parameter grades from ISO 15416 have allowable verifier measurement tolerances specified
in Table 1 (below) of ISO 15426-1. Of particular interest are minimum reflectance (Rmin),
66
maximum reflectance (Rmax), symbol contract (SC), defects (DEF) and decodability (DEC). The
manufacturer specifies the allowable tolerance for modulation (MOD).
Table 1 —Tolerances for measured parameter values
Parameter
Tolerance
Rmax
± 5% reflectance
Rmin
± 3% reflectance
Decodability
± 0.08
Defects
± 0.08
Note: The tolerances are additional to any tolerances stated by the
supplier of the primary reference test symbols.
No one verification set-up does it all. Bar code print quality verification needs vary from
application to application, even when all the applications require grading according to the
methodology of ISO 15416 and verifier conformance to ISO 15426-1 requirements for accuracy.
At the most fundamental level, the verifier optical scanning unit’s aperture must be matched to
the narrow bar/space width (referred to as the “X-dimension”) of the symbol being verified, a
requirement generally specified by the governing industry or other application guideline.
Nor have verification manufacturers yet developed and proven all of the tools a manufacturer
might wish to have for a given production environment, such as high-speed, in-line verification
on a pharmaceutical packaging line. As with most technologies, bar code print quality verification
equipment evolves constantly, with different manufacturers emphasizing a variety of different
features and benefits. And although trade-offs between features and cost must always be made, the
essential performance characteristics to look for remain constant: adherence to the methodology
of ISO 15416 and conformance to the requirements for accuracy specified in ISO 15426-1.
ISO standards can be purchased online at http://www.iso.org. GS1 System Calibrated
Conformance Standard Test Cards, standards and application guidelines can be purchased online
at http://www.gs1us.org. HIBCC application standards are freely available at http://www.hibcc.org.
Helpful information about bar code print quality verification is available from the Association for
Automatic Identification and Mobility (AIM) at http://www.aimglobal.org. Questions or comments
to the author should be addressed to George Wright IV at gw4@pips.com.
Adapted and reprinted with permission from Pharmaceutical & Medical Packaging News,
“Fundamentals of ANSI/ISO Bar Code Print Quality Verification,” March 2004. Copyright
©2004 Canon Communications LLC
67
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HDMA Guidelines for Bar Coding in the

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