[Combating Counterfeiting and Enabling Traceability in the Global
Healthcare Supply Chain by using the EAN.UCC System]{.underline}

UCC comments to Docket Number #2003N0361

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October 2003

**[EXECUTIVE SUMMARY]{.underline}**

The Food and Drug Administration (FDA) has announced a task force to
examine and combat counterfeiting of pharmaceuticals. Earlier this year
the FDA announced a proposed rule mandating bar coding of all
pharmaceuticals and biologics. This proposed rule required the use of
EAN.UCC system linear symbols. Many healthcare associations suggested to
the FDA adoption of the entire EAN.UCC system for auto identification of
healthcare products.

The EAN.UCC System already has the tools available to combat
counterfeiting using bar-coded GTIN and serial numbers. Manufacturers
can greatly reduce counterfeiting by assigning a specific serial number
to every item they produce. Any item without a serial number is
immediately spotted as a fake. And even if a counterfeiter managed to
produce phony serial numbers for counterfeit goods, retailers, police
and customs officials could refer to the manufacturer\'s database to
find that the GTINs in question are bogus, or are duplicates of existing
codes.

-   The first method to combat counterfeiting is the Global Trade Item
    Number (GTIN). The GTIN is a unique identifier for a trade item and
    is recognized in over 104 countries. The GTIN, combined with a
    serial number and / or lot number, can identify packages from
    individual unit of use through intermediate and up to cases with
    precision (coupled with databases). This information (GTIN, serial
    and lot number) can be bar coded now with available commercial
    equipment and can be mapped to EPC.

-   The second method to combat counterfeiting is the SSCC (Serialized
    Shipping Container Code). The SSCC acts as an individual license
    plate for logistics units. The SSCC is widely used in the retail
    supply chain today. As with individual packages, pallets can be
    serialized and tracked across the supply chain globally. (Appendix
    C)

-   The third method to combat counterfeiting is the Global Individual
    Asset Identifier (GIAI). The GIAI identifies individual assets to
    provide tracking and tracing capabilities, facilitate maintenance,
    and provide equipment management and control. The GIAI has been
    adopted by the United States Department of Defense to identify their
    assets.

The EAN.UCC system data structures will be apart of the EPC structure,
insuring that an anti-counterfeiting effort started with bar codes will
be able to migrate to RFID chips.

UCC comments to Docket Number #2003N0361

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**[BACKGROUND]{.underline}**

"On July 16, 2003, FDA launched a major initiative to more aggressively
protect American consumers from counterfeit drugs. Counterfeit
prescription drugs are not only illegal but also are also inherently
unsafe. The initiative is designed to:

Better identify the risks and threats from counterfeit drugs, establish
a public and private coalition to fight drug counterfeiting and
distribution, and develop new tools to aid in identifying, deterring and
combating counterfeiting.

As part of the initiative, FDA will create an internal task force to
explore the use of modern technologies and other measures, such as
stronger enforcement, to make it more difficult to distribute
counterfeit drugs. The task force will submit its initial findings and
recommendations in 60 days and will issue a final report in six months,
after public comment."[^1]

**[PURPOSE OF THIS]{.underline}** **[PAPER]{.underline}**

This paper explains the power of the EAN.UCC System to combat
counterfeiting with current bar codes and data structures. It also
explains how these data structures will be migrated to the Electronic
Product Code (EPC). There is no need for the FDA to wait for EPC.
Counterfeiting can be combated today with the use of the EAN.UCC System
barcodes (appendix A) and data structures (Appendix B and C) and then
when applicable use the complementary technology of RFID.

UCC comments to Docket Number #2003N0361

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**[DISCUSSION]{.underline}**

[2003 FDA Proposed Rule on Bar Coding]{.underline}

In a proposed rule announced March 14, 2003, the FDA mandated bar coding
of all pharmaceutical and biologic products using EAN.UCC linear
symbologies. The UCC responded to this rule applauding the FDA
initiative but suggesting that the entire system be adopted rather than
its linear symbologies. When the FDA selects the entire EAN.UCC the
healthcare industry can evolve with the entire global marketplace rather
than be attached to a potential obsolete technology. Several healthcare
associations, i.e. HDMA, NAHIT, and AIM, also urged this approach. The
wisdom of their advice is apparent with this new FDA initiative on
counterfeiting. The EAN.UCC System has had symbology and data structures
in place to serialize every pharmaceutical product with a unique serial
number. These data structures can be applied now on every level of
pharmaceutical packaging with the tradition linear code such as
UCC/EAN-128 or Composite with U.P.C., RSS or UCC/EAN-128. (Appendix A).
In addition to consumable items, logistics units and fixed assets can be
tracked using the EAN.UCC system

[EAN.UCC System]{.underline}

The EAN.UCC System is a universally accepted identification and
communication system that facilitates efficient global commerce and
business communication. This global language of business and healthcare
comprises a standard numbering system and identification carriers to
provide global users with the means to uniquely identify items, assets,
and physical locations for automatic data capture and processing in
electronic data processing applications. Most importantly, the system
includes a series of standard data structures; called Application
Identifiers (AIs), which allow companies to encode secondary information
about a product. In healthcare, AIs are employed for one of the most
important logistics tasks: the tracking and tracing of medical products.

The EAN.UCC System utilizes a wide variety of integrated data carrier
technologies to provide seamless communication throughout the supply
chain. These numbers (GTINs) are integrated into electronic commerce and
encoded in machine-readable carriers.  Thus, these numbers enable the
linking together of the information flow of business transactions to the
physical flow of trade items.   The identification standards are the
foundation of *The Global Language of Business^®^*

The first method to combat counterfeiting is the Global Trade Item
Number (GTIN). The GTIN is a unique identifier for a trade item and is
recognized in over 104 countries. The GTIN, combined with a serial
number and / or lot number, can identify packages from individual unit
of use through intermediate and up to cases with precision (coupled with
databases). This information (GTIN, serial and lot number) can be bar
coded now with available commercial equipment and can be mapped to EPC.

The second method to combat counterfeiting is the SSCC (Serialized
Shipping Container Code). The SSCC acts as an individual license plate
for logistics units. The SSCC is widely used in the retail supply chain
today. As with individual packages, pallets can be serialized and
tracked across the supply chain globally. Over 85 Million SSCCs are
utilized annually in only two of the largest retail chains in the United
States. For more complete information about SSCC please see attached
document titled "Serial Shipping Container Code."

The third method to combat counterfeiting is the Global Individual Asset
Identifier (GIAI). The GIAI identifies individual assets to provide
tracking and tracing capabilities, facilitate maintenance, and provide
equipment management and control. The GIAI has been adopted by the
United States Department of Defense to identify their assets. For more
complete information about GIAI please see attached document titled
"Global Individual Asset Identifier."

*^ ^*

The machine-readable carriers are approved bar code symbologies but
other technologies, such as radio frequency tags (EPC), will be added. 
Following the principles and design of the EAN.UCC System means that
users can design applications to process EAN.UCC data automatically. The
system logic guarantees that data captured from approved
machine-readable carriers produces unambiguous electronic messages.

[Global Trade Item Number]{.underline}

The GTIN (Global Trade Item Number) is the foundation of the EAN.UCC
System for uniquely identifying trade items (products and services)
sold, delivered, warehoused, and billed throughout the retail and
commercial distribution channels. It provides an accurate, efficient and
economical means of controlling the flow of products and information
through the use of an all-numeric identification system. The Global
Trade Item Number (GTIN) is the EAN.UCC System identifier for trade
items, which encompasses both products and services. GTINs provide the
capability to deliver unique identification worldwide. The most commonly
recognized and used GTINs are encoded in U.P.C. and EAN-13 symbols,
GTINs are utilized on products and cases and are a key component of
e-commerce transactions and communications. Users can be confident that
a GTIN, when used correctly, will uniquely identify their products as
they pass through the global supply chain to the ultimate end user. This
global identification system ensures that the corresponding electronic
communications will contain information unique to their company and
products.

For more than 25 years the EAN.UCC System has incorporated the National
Drug Code, as well as the National Health Related Item Code (NHRIC).
Since the creation of the Universal Product Code (U.P.C.) in the early
1970's, a NDC can be embedded within a Global Trade Item Number (GTIN).
The National Drug Code (NDC) identifies pharmaceutical products and the
National Health Related Item Code (NHRIC) identifies medical/surgical
products. Furthermore, the EAN.UCC system provides identifiers for lot
number and expiration.

[Application Identifiers]{.underline}

Most of the bar codes that are used in the marketplace carry only the
GTIN. However, there is a need to provide other information in a bar
code that is specific to this particular item or set of similar items.
But, a difficulty then arises. With multiple information segments in one
bar code, it is difficult to tell where one information segment ends and
the next segment begin. For example, suppose you wanted to tell a
trading partner that product 30614141000869 was produced in batch number
43. Would you express this as 3061414100086943 or 4330614141000869?

How would the application software know which string of numbers is used
to identify the product and which is used to identify the batch? The
EAN•UCC system uses a bar code that can carry special identifier to
define and separate multiple data structures. These two-, three-, or
four-digit numbers, called Application Identifiers (AI). (Please refer
to Appendix A for abbreviated AI list)

The EAN•UCC system has established more than 100 Application
Identifiers. The heart of the AI system is the AI Table and the
associated AI definitions contained in the General EAN•UCC
Specifications. For example, (00) is the AI for Identification of
Logistics Unit (SSCC). The format for this AI is n2+n18 (two digits for
the 00 and 18 digits for the SSCC). The data title is SSCC.

**[Counterfeiting and Traceability]{.underline}**

[Premise]{.underline}

One of the best ways to combat counterfeiting is through a layering
approach. The EAN.UCC system allows for serialization for the consumable
unit at the unit dose, each packaging level and the logistics unit. For
fixed assets the Global Individual Assent Identifier can be used.

Manufacturers can greatly reduce counterfeiting by assigning a specific
ID number/ serial number to every item they produce. See Appendix A for
examples of GTIN and Serial number in EAN.UCC symbols. Any item without
a serial number is immediately spotted as a fake. And even if a
counterfeiter managed to produce phony serial numbers for counterfeit
goods, retailers, police and customs officials could refer to the
manufacturer\'s database to find that the GTINs in question are bogus,
or are duplicates of existing codes.

UCC comments to Docket Number #2003N0361

[Current Application]{.underline}

Today manufacturers can bar code serial numbers on all their products at
all levels of packaging. The technology and the printing capacity exist.
However, this is not an inexpensive task for the manufacturers, or for
the remainder of the healthcare supplies chain.

The manufacturers after assigning a GTIN to a product would have to
serialize each product. Each item would have to be bar-coded at the time
of production and the information stored in a database for future use
(See Table 1 below). As stated above the EAN.UCC System already has the
standards necessary to accomplish this

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TABLE 1

Serial Shipping Container Code (SSCC)

Another method to combat counterfeiting at the logistics level is the
SSCC (Serialized Shipping Container Code). The SSCC acts as an
individual license plate for logistics units. The SSCC is widely used in
the retail supply chain. As with individual packages, pallets can be
serialized and tracked across the supply chain globally. Two retail
chains use the SSCC to track 85 million packages yearly. For more
complete information about SSCC please see attached document titled
"Serial Shipping Container Code."

Global Individual Asset Identifier (GIAI)

The third method to combat counterfeiting is the Global Individual Asset
Identifier (GIAI). The GIAI identifies individual assets to provide
tracking and tracing capabilities, facilitate maintenance, and provide
equipment management and control. The GIAI has been adopted by the
United States Department of Defense to identify their assets under the
UID program. For more complete information about GIAI please see
attached document titled "Global Individual Asset Identifier"

UCC comments to Docket Number #2003N0361

**[AUTO-ID]{.underline}**

The Uniform Code Council (UCC) established EPCGlobal USA, a
not-for-profit organization, to develop and oversee commercialization
and technical standards for the Electronic Product Code™ (EPC) Network.
This is an important next step in the research effort initiated by the
Auto-ID Center at MIT and is critical to making the EPC Network *real*.

Automatic Identification is the umbrella term for technologies that
allow machines (typically computers) to automatically identify objects.
Radio Frequency Identification (RFID) is one type of automatic
identification technology. Objects are labeled with \"tags\" (a
microchip with a radio frequency antenna) that store data, which defines
that object in a structured manner. Using radio waves, the \"reader\"
wakes up the tags and automatically captures that data, which can then
be processed.

The EPC Network is comprised of five fundamental elements that enable
the automatic identification and tracking of physical objects in real
time:

1\) Electronic Product Code (EPC)

2\) ID System (Radio Frequency Readers and Tags)

3\) Object Name Service (ONS)

4\) Physical Markup Language (PML)

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height="0.7047244094488189in"}5) Savant (software that directs and
routes EPC and associated information)

The Auto-ID Center\'s research has focused on developing these five
critical elements of the EPC Network. The Center is also developing some
of the software that will help manage the flow of data. This will create
a global system that can revolutionize how products are manufactured,
tracked, sold, and recycled.

EPC Network technology enables the identification of unique objects.
That is, an individual package, container, or dose from a given
manufacturing lot can be identified within the Electronic Product Code.
Ubiquitous mass serialization, and the ability to identify each unique
primary package will be key to taking anti-counterfeiting solutions in
pharmaceuticals to the next level.  Authenticity of physical product and
authenticity of product identity can be verified to provide a more
robust solution.\
\
In addition, the EPC Network brings hardware and software solutions to
the problem.  Sophisticated tags could wrestle with the issues of
physical product tampering while the information technology backbone
could lend itself to EPC verification, Track (control and knowledge of
where the object is at any time) and Trace (pedigree - the building of
history behind the object).

Bar codes are well established and provide unprecedented benefits for
manufacturers and retailers. EPC will be complementary to the
symbologies currently used in the EAN.UCC System, which includes the
U.P.C., Reduced Space Symbology® (RSS), and UCC/EAN-128. The UCC and EAN
recommend that companies currently considering Reduced Space Symbology
(RSS) should implement it now because the increased ID capability
provided by RSS will provide immediate benefit and help prepare data
systems for EPC. GTIN is part of the data structure incorporated in the
EPC.

While EPC represents a potential new standard to uniquely identify
products, the UCC and EAN International are working with the Auto-ID
Center to ensure that a migration path exists between current bar code
standards and the new EPC. Development of standards for the EPC will
utilize existing standards development methodologies, such as the Global
Standards Management Process (GSMP).

**[CONCLUSION]{.underline}**

**DON'T WAIT, USE THE EAN.UCC SYSTEM NOW TO COMBAT** **COUNTERFEIT
DRUGS**. The healthcare industry does not have to wait for the EPC to
combat counterfeiting. The use of EAN.UCC System bar code symbologies
and data structure can be used immediately. As EPC matures the data
structures will be incorporated in the EPC.

**[About the Uniform Code Council]{.underline}**

The Uniform Code Council, Inc. (UCC) is a not-for-profit organization

dedicated to the development and implementation of standards-based,

global supply chain solutions. Under its auspices, the UCC operates two

wholly-owned subsidiaries, UCCnet and RosettaNet, and it co-manages

its global EAN•UCC System with EAN International. UCC-based

solutions, including business processes, XML standards, EDI transaction

sets, and the bar code identification standards of the EAN•UCC System

are currently used by nearly one million member companies worldwide.

Visit *www.uc-council.org* for more information.

**Contact** John Roberts at jroberts@uc-council.org

UCC comments to Docket Number #2003N0361

Appendix A

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**UCC/EAN-128 symbol with concatenated GTIN and Serial Number**

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**[UCC/EAN-128 with Composite containing GTIN in UCC/EAN-128 and Serial
Number in Composite]{.underline}**

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**U.P.C. and Composite with GTIN in UPC and Composite containing Serial
Number**

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height="0.7083333333333334in"}

**[Reduced Space Symbology with Composite containing GTIN (in RSS) and
Serial Number in Composite.]{.underline}**

![](media/image3.png){width="3.0in" height="0.6263888888888889in"}UCC
comments to Docket Number #2003N0361

[^1]: FDA website, http://www.fda.gov/oc/initiatives/counterfeit/