July 15, 2002

Documents Management Branch

Food and Drug Administration

<fdadockets@oc.fda.gov>

SUBJECT: DOCKET NO. 02N-0204

Department of Health and Human Services

Bar Code Label Requirements for Human Drug Products

Please consider this as the comments and input from the Center for
Automatic Identification at Ohio University for your consideration
regarding the above-referenced hearing and proceedings.

**Introduction and Credentials**

The Center for Automatic Identification at Ohio University is the
nation's first university-based, non-profit educational and research
facility dedicated to the understanding and implementation of Automatic
Identification and Data Capture (AIDC) technologies. We are in our
16^th^ year of educating both the academic and business communities on
the advantages of implementing AIDC solutions in support and improvement
of their business processes. Please note that when we reference AIDC, we
are identifying Bar Coding as the most-understood and most deeply
implemented of AIDC technologies. Other technologies include Radio
Frequency Identification, Magnetic Stripe, Smart Card and Biometrics.
[Of these, only Bar Coding is in the scope of the subject Docket
02N-0204.]{.underline} COMMENT: While our comments below are limited to
a direct response to the topic of "Bar Code Label Requirements for Human
Drug Products; Notice of Public Meeting" we do suggest that participants
and organizers of the public meeting and those who participate in any
resulting action must be aware of these other technologies. Depending on
the application, the best Data Carrier for the job may be a bar code --
and it very frequently is. Other Data Carriers such as Radio Frequency
Identification (RFID) may very well be suitable in some
Logistics-related (and some item-related) applications. The remainder of
our comments concentrates on bar codes as the Data Carrier of choice.

The Center for Automatic Identification at Ohio University is both
provider-independent and technology-independent. This allows us to
conduct research and provide instruction on AIDC solutions without being
"tied" to any individual or group of solution providers. Our Center
staff includes professionals from the manufacturing, academic, and AIDC
standards organization disciplines. Our Executive Director has 35 years
of experience in the engineering, business and academic sectors while
our Managing Director has 14 years of experience with AIDC standards
(primarily Bar Code) including 12 years with the Uniform Code Council in
both technical and educational capacities. We bring credentials of
professionalism, technical accuracy, and academic credibility to the
Docket Item currently facing the FDA.

**Comments on your Scope of Discussion**

**A. General Questions Related to Drugs and Biologics**

1\. All prescription and OTC drugs; all blood products and vaccines, and
all medical/surgical devices should carry bar codes. The need to match
the right {drug/process/device} to the right patient is present for all
of these categories. So is the need to identify inventories of all
subject categories in a TIMELY and ACCURATE manner, as is enabled by
appropriate implementation of bar coding technology.

2\. At a **minimum**, primary product identification shall always be
encoded in the appropriate bar code symbology (or symbologies. See 3.
below.) Primary Product information may be defined as Whose product is
it? Which of their products is it? And What level of packaging is it? In
the EAN.UCC system of standards (globally and jointly administered by
the Uniform Code Council in the U.S. and by EAN International based in
Brussels), this primary information is encoded -- at all levels of
packaging -- in the Global Trade Item Number (GTIN.) This is the same
information encoded for retail products, including all OTC drugs and
Health and Beauty Products. Desirable secondary or supplemental data
should include the product's Expiration Date where applicable as well as
the Batch/Lot identification for traceability, inventory freshness, and
potential recall purposes. The EAN.UCC system already has Application
Identifiers (AI) defined for all of the primary and secondary
attributes. They are:

. Primary product ID (GTIN AI(01) 2-digit AI plus 14-digit GTIN
(numeric)

. Expiration Date (Safety Date) AI(17) 2-digit AI plus 6-digit date
(YYMMDD)

. Batch/Lot Code AI(10) variable-length alphanumeric field

3\. Multiple symbologies should be defined [as the applications
dictate]{.underline}. Specific examples include, but are not limited,
to:

. UCC/EAN-128 for shipment, pallet, and shipping container
identification.

. Either EAN/UPC or UCC/EAN-128 for "consumer unit" identification.

-   EAN/UPC encodes only the "Primary" product identification and is the
    same symbology seen on OTC items sold at retail.

-   UCC/EAN-128 encodes both the primary product ID (GTIN) as well as
    all requisite secondary or supplementary ID such as Date and
    Batch/Lot. It is not used at retail Point Of Sale but is usable for
    all non-POS data capture.

. Depending on the space available, either UCC/EAN-128 or the newer,
more space-efficient Reduced Space Symbology (RSS) developed by the
Uniform Code Council are applicable at the unit dose/unit of use level.
Again, depending on space available and on the amount of
secondary/supplemental data to be encoded, either the RSS as a
standalone solution, or the Composite Symbology as an integrated
solution, should be considered. The Composite Symbology uses a linear
bar code to encode the GTIN and a linked Two Dimensional (2D) symbology
to encode the secondary/supplemental data. The reader should be aware of
substantive differences between linear (one-dimensional) bar code
symbologies and 2D or matrix symbologies. There are applications for
both of them, and their selection depends on the scanning environment,
the amount of data being encoded, and the space available in which to
print the bar code.

No single bar code symbology meets the size, space and data content
parameters for all these levels of packaging. A noted benefit of the
EAN.UCC solutions is that they are global in nature and are recognized
by national and international standards bodies. The Application
Identifiers discussed above (and nearly 100 others) are jointly
developed, defined, and assigned by EAN International and the Uniform
Code Council. If it is a point of consideration for the FDA, as it is
for those in retail and industrial/commercial supply chains, these are
indeed global solutions.

4\. Symbol Placement Guidelines should be developed for all types of
packaging at all levels of packaging. Such placement guidelines shall
take ergonomics, scanner type, symbol type, packaging type,
transportation and materials handling, and point-of-capture
configuration into consideration.

While unit of use marking provides the ultimate patient/medication
match, unique identification of [all levels of packaging]{.underline}
(unit of use, consumer, multipack, shipping container, pallet, shipment)
enables accurate inventory and accountability throughout the supply
channel from manufacturer to wholesaler/distributor to healthcare
provider facility to the end point of use. EAN.UCC standards already
specify symbol placement on a variety of packaging types.

5\. All OTC products in healthcare and other retail channels currently
utilize bar codes at all levels of packaging, using EAN.UCC standard
symbols and data structures.

**B. Medical Device Questions**

1\. Medical devices should carry bar codes as a standard part of their
product identification. Recognizing the many distinctions between drug
products and devices, and with all due respect for those distinctions,
let's look at the similarities: Products are manufactured. Products are
ordered, shipped and received. Products go through a distribution
network. Products are matched with a patient. In the case of drugs, the
association between patient and drug is temporary. In the case of
devices, the association may also be temporary, such as with a swab, a
bandage, or sutures; or permanent or semi-permanent, such as with an
implant or joint replacement. The need to identify products and track
their inventory supercedes the distinction between drug and device.
There may be the requirement on some devices to provide an additional
data element -- Serialization. WHICH device, among many identical or
similar ones, are we tracking? The EAN.UCC system again meets this need
with Application Identifier (21) for Serial Number, a variable-length
alphanumeric data structure supported by UCC/EAN-128, RSS and CS.

2\. Tongue depressors, syringes, and bandages should be identified with
bar codes as well. Not on the individual item (where it does not make
sense to do so) but at all levels of packaging above the unit of use
level. How else will their inventories be kept accurate? Receipt and use
of any of these levels of packaging (use being defined as removal from
stores) should be recorded by a scan of the bar code associated with the
item received or removed. Supplementary identification such as Batch/Lot
identification is also applicable to many products in the Device
category due to the need for traceability and selective recall.

3\. We have no input on this issue.

4\. Inventory levels of medical devices are much more easily and
accurately maintained with bar codes. The issue is not only one of
patient safety, but one of what makes economic sense for the Healthcare
Industry and its supply network. We would also suggest that great
benefit is derived from matching the right device (implant, joint,
pacemaker, insulin pump, etc.) with the right patient, just as clear
benefit is seen in matching the right drug product with the right
patient.

**C. General Questions and Economic Impact Questions**

As a University-based educational and research facility, we cannot
answer manufacturer-specific questions. We would like to comment on one
point under this section, however.

3\. We do not manufacture any bar code printing, scanning, or
verification equipment. However, we will express a strong opinion that
clearly defined standards for bar code symbol quality verification
should (shall) be an integral part of:

. Any FDA standard or guideline relating to the use of bar codes

. Any drug or device manufacturer's overall quality program

. Any customer or healthcare provider's requirements for bar coding that
they communicate to their supplier network.

Bad bar codes mean bad data or no data at all. In the case of a retail
product, significant inconvenience and some form of financial
repercussion (negative) are caused for both the retailer and the
supplier. (Sometimes for the customer as well.) In the case of a drug
product, misidentification of the product, or mismatch of product and
patient, may result in more severe negative repercussions. Holding
suppliers of printed bar codes to established, existing ANSI/ISO
standards and guidelines for bar code symbol quality should indeed be an
integral part of any statement on the use of bar codes published by the
FDA. We do not specify the use of any particular line of verification
devices, but we must emphasize the importance of a uniform set of
requirements (minimum as well as recommended) for any and all bar code
symbologies utilized. Quality bar code symbols help insure quality data
and quality service.

**Conclusion**

The Center for Automatic Identification at Ohio University stands ready
to participate in the FDA's efforts to discuss, define, research,
specify, educate, and implement the utilization of bar codes for the
identification of human drug products and medical/surgical devices. We
would ask to be considered by the responsible parties when the time
comes to solicit Requests for Proposals in the arena of bar code
printer, scanner, and verifier research and in the arena of
manufacturer/supplier/provider/user education on the resulting standards
and their implementation.

Thank you for your consideration

Bruce E. Philpot

Managing Director

Center for Automatic Identification

Russ College of Engineering and Technology

128A Stocker Center

Ohio University

Athens, OH 45701-2979

Phone 740.593.1453

Email [philpot@ohio.edu](mailto:Philpot@ohio.edu)

Website [www.ent.ohiou.edu/autoid](http://www.ent.ohiou.edu/autoid)