**Reply to FDA Docket Number 02N-0204**

**Bar Code Label Requirement for Human Drug Products and Blood**

**The Uniform Code Council commends the FDA and its personnel for this
regulation. These regulations are a major first step to reduce
medication errors in American hospitals and eventually all hospitals
globally.**

**1. Whether we should require bar codes on prescription drug samples,
and the costs and benefits associated with such bar codes (see section
II.B.2.a of this document).**

The EAN.UCC System specifically requires bar codes on all promotional
items or samples. The citation from the EAN.UCC General Specifications
is listed below:

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|   | A new Global Trade Item Number™ (GTIN™) should be allocated when a  |   |   |
|   | product is introduced. This rule also applies to sample or test     |   |   |
|   | products, which are distributed in an open environment.             |   |   |
+---+---------------------------------------------------------------------+---+---+

The EAN.UCC System has been a globally recognized standard since the
1970's. The Global Trade Item Number (GTIN) is the most widely
recognized and implemented bar code standard in the world. The EAN.UCC
System provides detailed specifications for the symbol including height,
printing the symbol, verifying of the symbol, encoding the data within
the symbol, and placing the symbol on the package. Based on continuous
input via the EAN.UCC System's consensus-based standards process, these
product identification standards have been fine tuned over the past 3
decades.

The UCC recommends that the FDA adopt the EAN.UCC System, and not parts
of the system, such as a particular symbology. The EAN.UCC System is
best implemented in its entirety, it should not be cherry picked. The
FDA should adopt this global commercial standard; otherwise the FDA will
enter the standard setting arena, which is not within its core mission.
As a neutral, not-for-profit standards organization, the Uniform Code
Council is best suited to ensure standards are developed that reflect
the business needs of users and comply with government regulations.

The EAN.UCC System has a rigorous change process to set and revise
standards called the Global Standards Management Process (GSMP). The
GSMP is a user-led, consensus process that allows the standard to be
changed after proper evaluation and consideration by the global
community. Anyone can submit a change request to the EAN.UCC System,
including the FDA, as along as it is accompanied by a strong business
case. Global standards are not changed lightly.

**2. The risks and benefits of including vaccines in a bar code rule
(see**

**section II.B.2.a of this document).**

There are no risks with including vaccines in a bar code rule. The UCC
recommends that vaccines be included in the bar code rule. Vaccines are
contained in similar packages as other pharmaceutical items that are
already included in this rule. There would be a comparable amount of
work to encode the National Drug Code (NDC) in a bar code and place it
on a vaccine, as it would be on any other small healthcare product such
as ampoules or vials. Abbott Laboratories has already bar-coded the NDC
in a GTIN format on items as small as 1 ML vials and is 100% complete in
bar coding in its Hospital Care Division. Please refer to Appendix AA.

The Center for Disease Control and Prevention (CDC) VISI group has
recommended that all vaccines be bar coded. The VISI draft
recommendation requires the use of the EAN.UCC System standard in
bar-coding all vaccines. Please see the CDC website at:
<http://www.cdc.gov/nip/visi/prototypes.htm>

In addition, the rule could also be extended to medical/surgical items.
The Japanese Federation of Medical Device Trade Associations (JFMDA) has
already mandated the use of the EAN.UCC System on all medical/surgical
items in Japan. If American manufacturers can bar code all
medical/surgical items that are destined for the Japanese market, the
same items can be bar-coded in the United States.

The JFMDA was founded in 1984 and consists of nineteen associations
engaged in the development, production, and distribution of medical and
health care devices, equipment, instruments, and supplies. The four main
functions of JFMDA are government relations (close contact with
Ministries and other government agencies), information services (collect
information, organize conferences and carry out PR activities), study
and research activities, and international affairs. Contact details:
Hongo Ishiwata Building, 3-38-1 Hongo Bunkyo-Ku, Tokyo 113-0033, Japan,
Tel: (81 3) 38182310, Fax: (81 3) 38182448. Please refer to Appendix BB.

**3. What terms we should use to describe OTC drugs that should be
subject to the bar code requirement (see section II.B.2.b of this
document).**

While this question is not applicable to the EAN.UCC System, it is
believed that the most equitable course would be to have this rule
applied to only those OTC items that are directly marketed or sold to
the hospital by the manufacturer or its agent.

4\. Information on the costs and benefits associated with putting lot
number and expiration date information in the bar code (see section
II.C.2 of this Document).

The UCC recommends the use of lot number and expiry date on all
pharmaceuticals and biologicals at all packaging levels. EAN.UCC System
global healthcare guidelines have recommended this for the past three
years.

The UCC cannot speak to the cost of encoding this information on
healthcare products. There is definitely an added expense and
requirement for due diligence in encoding this information. GTINs
(encoding NDCs within) with lot and expiry date can be pre-printed and
then placed on healthcare items. The application of pre-printed labels
containing the GTIN on healthcare products would need to be done within
good manufacturing practices (GMP) to ensure the right label on the
right product.

Pfizer has placed lot number and expiration date successfully on
healthcare product (Dilation) as early as December 2002. Please refer to
Appendix DD. According to an January 15,2003 article in the Wall Street
Journal, it is Pfizer's corporate policy to place this information on at
least thirty products in Calendar Year 2003.

Baxter Healthcare, in its March 27, 2003 news release, believes its
customers have spoken, and the company has now begun placing lot and
expiration date on their products. Please refer to Appendix CC.

Adventis Behring in its March 27, 2003 press release announced a two
stage process to bar coding. The first step will be to ensure all its
smallest products are bar coded using RSS. The second phase is to bar
code lot and expiration date. Please refer to Appendix EE.

The marketplace will drive the implementation of lot and expiry, but
adoption will be slow. The FDA should have this as a requirement in
their rule. Such a requirement will drive the solution providers to have
this information utilized in all parts of the supply chain and the
healthcare providers would demand it.

**5. Whether the rule should refer instead to linear bar codes without**

**mentioning any particular standard or refer to UCC/EAN and HIBCC
standards (see section II.D.l of this document).**

The rule should refer to the EAN.UCC System as a whole, and not call out
any particular symbol. In that manner, the rule could evolve as the
marketplace and technology evolve, instead of being tied to potentially
obsolete symbols.

[The UCC strongly recommends that the rule not require bar coding
without stating a specific standard. This approach is as bad as not
having bar codes on products. A key premise of the EAN.UCC System is to
provide a standard that ensures that bar coded information is unique and
unambiguous. This is accomplished by using symbology that ties
specifically to the EAN.UCC System. Requiring bar codes without this
security will result in bar codes that cannot be processed
unambiguously. This approach would result in products using a huge
number of possible bar code symbologies, the bar coded data will not be
unique or secure, the scanned data will indeterminate -- is it a catalog
number, NDC, or a lot numbers, solutions providers will find it very
difficult to support such an environment, and finally wrong data will be
collected.]{.underline}

The UCC recommends that the rule exclusively require the EAN.UCC System
for pharmaceuticals and biologics. [The EAN.UCC System is the dominant
system for pharmaceuticals and biologics globally.]{.underline} Any
other approach would create numerous problems for the healthcare
industry, including:

-   Position U.S. regulation contrary to the global commercial
    marketplace

-   Cause confusion in the marketplace

-   Create technical and systems issues that would cause serious delay
    in implementation

-   Penalize the early adopters of Reduced Space Symbology (RSS)

-   Add substantial costs without corresponding benefit

-   Negatively affect U.S. manufacturers global competitive position

-   Delay and dilute the FDA's goal to reduce medication errors in a
    timely manner

The EAN.UCC System is implemented and dominant in many countries today.
A few examples include:

**Japan:**

-   The Japanese Federation of Medical Devices Associations (JFDMA) in
    their report titled "Guidelines for Standardizing Product Codes and
    Barcodes for Medical/Surgical Materials in Japan" (published in
    September 1999) concluded that *" Another reason why the Japanese
    industry has decided to adopt the UCC/EAN standards is that, judging
    from industry trends......barcode symbology applicable only to the
    medical care industry will not be accepted in the global market."*

-   In February 2001, the Japan Red Cross Society communicated to makers
    of pharmaceutical products and medical materials that it wanted them
    to adopt the Application Identifier (AI's) and UCC/EAN-128 system
    for the materials and reagents that are used to process blood for
    transfusion purposes.  The Japan Red Cross Society\'s 76 blood
    centers across Japan, receive about 19 million bags of blood for
    transfusion purposes from around 6 million donors every year. 

    **Australia:**

```{=html}
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```
-   KPMG Report supporting EAN in pharmaceuticals and medical/surgical
    within 5 years.

-   Department of Health and Aging report supporting EAN for all
    medicines and use of EANnet as national data repository for
    medicines.

**Brazil:**

-   The Brazilian initiatives in the healthcare sector are divided into
    3 main projects: Hospital automation -- application of UCC/EAN-128
    on logistic units for receiving processes automation with the
    codification of complementary data on logistic labels. Also, the
    application of RSS and Composite Symbologies on the primary packages
    and the unit doses with restricted space.

-   EDI Messages -- EAN BRASIL is managing a work group that is
    reviewing and updating the EANCOM messages interchanged between the
    pharmaceutical manufacturers and the wholesalers, including the
    largest Brazilian drugstore chains.

-   More than 700 Brazilian companies from the healthcare sector are EAN
    BRASIL's members.

**6. Additional information regarding bar code scanning technology and
the ability of bar code scanners to read different symbologies (see
section II.D.lof this document).**

There are sufficient scanners in the healthcare marketplace to read all
the EAN.UCC symbologies. In addition, as the UCC stated in its July 26,
2002 testimony at the FDA, industry sources indicate there are several
million scanners in the marketplace that can read RSS symbols. These
scanner manufacturers have stated that many of their current products
can be easily upgraded to read RSS. There is a list (not all inclusive)
of solution providers on the UCC website whose products can support RSS
and the other UCC symbols. Many manufacturers are already producing
products that contain RSS on their smallest items, providing documented
examples of the symbol's success in real-world applications.

**7. Whether the rule should adopt a different format (whether that
format is a symbology, standard, or other technology), considering the
following issues:**

-   **What other symbol, standard, or technology should we consider,
    either in place of a linear bar code or in addition to it?**

-   **How accepted is that symbol, standard, or technology among firms
    that would have to affix or use that symbol, standard, or
    technology?**

-   **Will hospitals be able to read or use the symbol, standard, or
    technology, either with existing equipment or equipment under
    development? (see section II.D.l of this document).**

As stated in the UCC testimony given at the July 26, 2002 meeting, the
FDA should adopt the EAN.UCC System, not a particular symbol. The
symbols standardized by the EAN.UCC System were those selected by the
membership to have the greatest possible global use within each
industrial sector. Today, the standards of the EAN.UCC System are used
by nearly one million member companies conducting business in 140
countries around the world. These standards support 23 major industries
(including healthcare) and are the most widely used business standards
in the world. By selecting the EAN.UCC System, the FDA allows the global
healthcare market to evolve and select the data carriers in accordance
with industry, business, and technology advances.

The EAN.UCC Global Standards Management Process (GSMP) will provide the
structure for standards to evolve and meet the needs of the marketplace.
Any interested party can submit a change request to the GSMP as long as
it is supported by a documented business case. Change requests are
reviewed globally on three different levels, from a business
perspective, from a technology perspective, and from an implementation
perspective. The GSMP brings together users from four global regions
North America, Asia Pacific, South America, and EMEA (Europe, Middle
East and Africa)) to review and vote on all proposed changes. These
committees are balanced between industry sectors, manufacturers,
solution providers, and retailers / users. Currently, there are several
healthcare representatives on the North American committee (Proctor and
Gamble, 3M, and HDMA all are represented).

The GSMP process is very robust. In 2002, 209 change requests were
received and in 2003, to date, 121 change requests have been received.
In 2003, there were at least three change requests related to
healthcare. One healthcare change request supported adoption of data
matrix as a carrier for items where a RSS allegedly would not fit. The
second change request concerned the development of a global healthcare
application guideline, and the third request was to develop a hospital
model for the EAN.UCC keys in a healthcare environment.

The FDA does not have to be faced with the responsibility for
requirements of bar code label placement, the size and consistency of
the bar codes, or the data that they carry. These issues are within the
core mission of the UCC and have been administrated by the UCC for the
last thirty years. The UCC as a not-for-profit entity provides this
essential standards administration support. The UCC with 98 other EAN
International Member Organizations are the largest promoters of product
and process identification globally.

If the FDA selects just one symbology or several, it will face the real
possibility that these symbols will become obsolete as the marketplace
changes. For instance, Radio Frequency Identification (RFID) tags and a
new technology called the Electronic Product Code (EPC) are being tested
in prototype today. Acceptance in the marketplace will come in the next
ten years or sooner. If the FDA selects a symbol instead of the system
it will be faced with another selection process within the next decade.
During the mandatory review process, the U.S. healthcare could lag
behind as this emerging technology matures.

8\. **Whether any specific product or class of products should be exempt
from a bar code requirement and the reasons why an exemption is
considered be necessary (see section 1I.F of this document). In
addition, how could we create a waiver provision that would minimize the
potential for misusing the waiver?**

No EAN.UCC pharmaceutical member has presented the UCC with a healthcare
product too small for an RSS symbol. There may be some that exist.

**9. Whether the implementation period for a final rule can and should
be shortened from 3 years to some other specific time period (see
section 1I.G of this document).**

The UCC believes that three years is an adequate amount of time to
implement this regulation. It provides sufficient time for manufacturers
to convert and barcode all their items in a reasoned and disciplined
manner. It is also believed that competition will drive implementation
of this regulation, as there are a dozen manufacturers already beginning
to encode their smallest healthcare items using the EAN.UCC standard.
These manufacturers represent more than 30 percent of the global
pharmaceutical market.

**10. Whether we should require the use of ISBT 128 for blood products,
a specific symbology that is consistent with that required for drugs in
proposed 1175 201.25, or "machine-readable symbols" as approved by the
Director of CBER (see section I1.H of this document).**

Currently, the U.S. marketplace uses ISBT on the blood products, but
uses EAN.UCC standards on the commercial packages for shipment and
receiving.

If requested by the blood products community, the UCC would support the
creation of bar coding guidelines for blood products based on the
EAN.UCC System.

Please note that the EAN.UCC System is used for blood products in Japan.
In February 2001, the Japan Red Cross Society communicated to makers of
pharmaceutical products and medical materials that it wanted them to
adopt the Application Identifier (AIs) and UCC/EAN-128 system for the
materials and reagents that are used to process blood for transfusion
purposes.  The Japan Red Cross Society\'s 76 blood centers across Japan
receive about 19 million bags of blood for transfusion purposes from
approximately 6 million donors every year. 

11\. How the proposed rule might affect hospitals where patients receive
Blood or blood components, particularly with respect to a hospital' s
decision to purchase a machine reader (e.g., scanner) that can properly
identify the intended recipient of the blood or blood component, the
machine readable information encoded on the blood or blood component
label, and perhaps the linear bar codes appearing on drugs and OTC drugs
that are dispensed pursuant to an order and commonly used in the
hospital (see section 1I.H of this document).

The rule should have little or no effect on hospitals. The scanners are
able to read multiple codes. The focal point of the issue is the
software support within the hospitals themselves. There is very little
software support existing in hospitals today. The use of the EAN.UCC
System on all products would simplify the software development and
maintenance.

What the FDA needs to discover is the cost of maintaining two standards
whether the ISBT standard is robust and fully implemented within the
global marketplace. And finally what disruption would it cause to the
healthcare market if the ISBT standard were abandoned in favor of the
EAN.UCC System.

12\. Whether any of the alternatives discussed in the economic analysis
have merit (see section VII.0 of this document).

No comment.

Bar Code Label Requirement for Human Drug and Blood

Page 21 COMMENT: The rule for bar coding could be extended to the
medical device marketplace in the United States. Such a rule will not
affect the larger and more important initiative to bar code
pharmaceuticals. The EAN.UCC system should then be selected for
medical/surgical products as it was for the pharmaceutical sector.

The Japanese have mandated the use of the EAN.UCC standard on all
medical/surgical products shipped into their country. United States
medical device manufacturers that do not barcode for the U.S. market
either label at the factory or re-label at the distribution point in
Japan.

**APPENDIX AA ABBOTT**

**ABBOTT LABORATORIES COMPLETES INITIATIVE TO BAR CODE 100 PERCENT OF
ITS HOSPITAL INJECTABLE PHARMACEUTICALS AND IV SOLUTIONS**

*--- INDUSTRY-LEADING INITIATIVE INCLUDES MORE THAN 1,000 PRODUCTS AND
ALIGNS WITH FDA\'S RECENTLY PROPOSED GUIDANCE ---*

Abbott Park, Illinois, March 27, 2003 --- Abbott Laboratories announced
today that it has completed its initiative to affix unit-of-use bar
codes to 100 percent of its hospital injectable pharmaceuticals and IV
solutions. The achievement, which encompasses more than 1,000 products,
is part of Abbott's comprehensive, industry-leading initiative to help
reduce medication errors and enhance patient safety in hospitals.

In addition to the breadth of products, two other factors underscore the
positive and significant impact Abbott\'s action should make at the
hospital bedside. First, administration by injection is the most
frequently used drug-delivery method in hospitals. Second, Abbott is the
leading supplier of injectable pharmaceuticals and infusion therapy
products to the U.S. hospital market.

Abbott has worked for several years on this initiative and announced its
commitment last July, in advance of U.S. Food and Drug Administration
(FDA) hearings about the possibility of requiring bar codes on
pharmaceutical products. At that time, Abbott had already bar coded
about 45 percent of its expansive hospital injectable pharmaceuticals
and IV solutions portfolio. Additionally, virtually all of Abbott\'s
oral pharmaceuticals distributed in bottles in the United States already
include bar codes. Throughout the past year, Abbott also has been
working to develop bar coding technology across hospital unit-dose
packaging of these oral medications. Abbott\'s program is consistent
with the preliminary guidance issued in the FDA\'s March 13 proposed
rule to require bar code labeling on all prescription and some
over-the-counter drugs and vaccines.

\"Preventing medication errors is a critical part of ensuring patient
safety and improving the quality of medical care in this country,\" said
Tommy G. Thompson, Secretary of the U.S. Department of Health and Human
Services. \"Bar code initiatives, such as the one recently completed by
Abbott, are exactly what the FDA\'s proposed rule is designed to
achieve. I congratulate them on their efforts.\"

Bar coding systems can scan a patient\'s wristband, the nurse\'s ID
badge and the drug to be administered -- and then match them with a
computerized list, cross-checking what health care professionals call
the \"five rights\": right patient, right drug, right dose, right route
of administration, and right time.

A 1999 Institute of Medicine report, \"*To Err is Human: Building a
Safer Health System*,\" said medical errors contribute to as many as
98,000 deaths in the United States each year -- including 7,000
attributed to medication errors. The report also noted that medication
errors account for one out of every 131-outpatient death, and one out of
every 854-inpatient death.

Studies have shown that bar codes can dramatically reduce the risks
associated with one type of medical error, medication errors, which
involve the improper dosing and/or administration of drugs. For example,
one New Hampshire hospital reduced its medication error rate by 80
percent after it adopted a bar coding program. A medical center in
Colorado lowered its medication error rate by 71 percent.

\"Abbott\'s completion of its bar code effort is a triumph for millions
of hospital patients -- and should have a significant impact at the
hospital bedside,\" said James C. McAllister III, M.S., director of
pharmacy, University of North Carolina (UNC) Hospitals and Clinics, and
assistant dean for clinical affairs, UNC School of Pharmacy. \"While
other pharmaceutical companies have followed Abbott\'s lead in
implementing bar code technology, the breadth of Abbott's accomplishment
stands alone.\"

Also of note, about one-quarter of Abbott\'s hospital injectables and IV
solutions use a new technology -- Reduced Space Symbology^®^ (RSS) --
which allows for a miniaturized bar code to be applied to single-unit
containers as small as a pen cap. Previous technologies did not allow
for smaller or odd-shaped containers to be effectively bar coded. Abbott
is the first company to introduce RSS bar code technology commercially
on its hospital injectable pharmaceuticals and IV solutions.

\"We\'re pleased to have completed our bar code initiative, which
underscores Abbott's commitment to enhancing patient safety through
continued innovation in products, programs and processes,\" said
Christopher B. Begley, senior vice president, Hospital Products, Abbott
Laboratories. \"This accomplishment is a key component to Abbott's
larger medication management strategy.\"

Recently, Abbott launched the LifeCare^®^ PCA3 Infusion System, a new
patient-controlled analgesia (PCA) device -- the first of its kind to
incorporate a built-in bar code reader to identify and verify drug and
dose concentrations automatically. This advance adds to Abbott's long
list of proactive approaches to improving patient and health care worker
safety. Abbott pioneered the availability of premixed solutions and
prefilled syringes to minimize mixing and handling errors, and has been
at the forefront of providing products that protect against needlestick
injuries. Last year, Abbott launched a needlestick prevention Web site,
[www.abbottnps.com](http://www.abbottnps.com/), that offers health care
providers background on current needlestick prevention legislation, as
well as educational information about preventing needlestick injuries.

Abbott also has a long-running label enhancement program, and was the
first company to print on the backside of IV containers, allowing
clinicians to see critical information on both sides of the container.
Through continued funding and support, Abbott has made it possible for
hundreds of health care professionals to complete continuing medical
education programs on the subject of medication error reduction.

Abbott Laboratories is a global, broad-based health care company devoted
to the discovery, development, manufacture and marketing of
pharmaceuticals, nutritionals, and medical products, including devices
and diagnostics. The company employs approximately 70,000 people and
markets its products in more than 130 countries.

**APPENDIB BB JAPAN HEALTHCARE INDUSTRY GUIDELINES**

The answers to the questions below, reference the Japanese Federation of
Medical Devices Associations (JFMDA) document dated October 2000.
Versions before or after that date may not correspond to the pages
referenced below.

For detailed information please refer to the Standardization of Product
Codes and UCC/EAN-128 Bar Codes for Medical/Surgical Materials in Global
Supply Chain, Operational Manual, edited and published by the JFMDA,
Cooperation: Distribution Systems Research Institute (DCC-Japan; member
EAN International). For copies please contact JFMDA or DCC directly.

**What is the JFMDA?**

JFMDA was founded in Japan in 1984 as a federation of organizations in
Japan engaged in the development, production and distribution of devices
for healthcare and medical treatment. JFMDA strives to find solutions to
the concerns of its members and the overall enhancement of national
(Japan) healthcare and social welfare.

**What is the purpose of the JFMDA Manual?**

The manual aims for the widespread use of barcodes in the Japanese
healthcare industry.

**Does the JFMDA require specific Application Identifiers (AIs) on
healthcare Items?**

JFMDA has identified the basic AIs in the healthcare industry,
specifically, (01) GTIN, (10) Lot Number, (30) Quantity, and (17)
Expiration Date. Additional AIs can be used if more or different
information is required. Please refer to page 21 of the JFMDA manual
titled Items not displayed within the four standard items.

**APPENDIX CC BAXTER**

 **BAXTER LAUNCHES IV PRODUCTS WITH ENLIGHTENEDHRBC BAR CODING SYSTEM,
WHICH PROVIDES EXPANDED INFORMATION**

**Baxter Highlights Leadership in Patient Safety at Industry Meeting on
Bar Code Initiatives**

DEERFIELD, Ill., March 27, 2003 - Baxter Healthcare Corporation
reinforced its long-standing commitment to patient safety with the
launch of its innovative, high-resolution ENLIGHTENEDHRBC bar code
technology for its flexible IV containers, marking the next phase in the
company\'s ongoing plans to apply bar coding to its entire line of IV
fluids and medications.

At an industry meeting this week that will focus on strategies for
implementing bar code systems for patient safety, Baxter plans to voice
support for the U.S. Food and Drug Administration\'s (FDA) recent
proposal to require bar coding on medications. The company noted that
its next generation bar code technology, the ENLIGHTENEDHRBC bar code
system, exceeds anticipated industry requirements by providing
information that may be useful in enhancing patient safety beyond the
product identification.

On March 13, 2003, U.S. Department of Health and Human Services
Secretary Tommy Thompson proposed regulations for the Food and Drug
Administration (FDA) that would require a supermarket-style bar code on
every dispensed drug, including prescription drugs, and some
over-the-counter drugs and vaccines. Under this plan, all patients
admitted to hospitals would be given a bar coded identification linked
to the patient\'s medical records. Under the proposed guidelines, the
bar code would, at a minimum, contain the drug\'s National Drug Code
number, which uniquely identifies the drug, its strength, and its
dosage.

Baxter\'s ENLIGHTENEDHRBC bar code features a 14-character Uniform Code
Council/European Article Number (UCC/EAN), which is a globally
recognized identifier used for automated tracking of products. The
UCC/EAN also incorporates the National Drug Code registered with the
FDA. A secondary bar code of the ENLIGHTENEDHRBC bar code features the
lot number and expiration date, which is scanned to help hospitals
ensure that drugs subject to recall will not be delivered to patients,
and that patients will not receive medication that has expired.

\"Reducing medication errors is one of the largest challenges facing
hospitals today,\" said David Bonderud, president of Baxter\'s
Medication Delivery business in the United States. \"The FDA\'s vision
of using information technology, such as bar codes that link to
computer-based hospital information systems, to address a major health
concern is a reality that Baxter is helping to create.\"

Baxter anticipates that the vast majority of its IV containers will have
the ENLIGHTENEDHRBC bar code by the end of 2003, a timetable aimed at
accelerating the use of technology to help hospitals reduce the
potential for medication error and help promote safer health care
practices in hospitals.

\"We appreciate this important action by Baxter. It can only help to
facilitate adoption of bar-code-enabled point-of-care (BPOC) systems in
hospitals, improve medical product safety and help protect patients from
medical errors,\" said Michael R. Cohen, president of the nonprofit
Institute for Safe Medication Practices.

\"Our commitment to patient safety, built over the last 70 years, has
resulted in a number of innovative technologies, including bar coding,
that provide safeguards against the potential for medication error. Not
only are we among the first to make available our IV products with
enhanced bar coding technologies, we\'re also continuing to design our
products and delivery systems to work together to offer patient safety
enhancements throughout the entire continuum of patient care,\" said
Bonderud.

Another example of Baxter\'s commitment to the use of bar code
technology to help further patient safety is the [Baxter\'s Patient Care
System](http://www.baxterpatientcare.com/). [Baxter\'s Patient Care
System](http://www.baxterpatientcare.com/), formerly called the AUTROS
system, is a wireless patient information and medication management
system that uses hand-held computer devices. This system helps provide
caregivers with access to the real-time information they need to safely
and correctly administer medications. [Baxter\'s Patient Care
System](http://www.baxterpatientcare.com/) is being designed to receive
communication from the company\'s COLLEAGUE CX infusion pump. This
connectivity will allow access to infusion information at the bedside
and is designed to help enable the nurse to verify that the pump setting
matches the physician order before starting the IV infusion.\
\
Together, these innovative technologies provide a comprehensive,
integrated approach to the delivery of medication in a hospital
environment and is one example of the initiatives that exist across
several of its businesses aimed at creating a safer health-care
environment.

Baxter Healthcare Corporation is the principal U.S. operating subsidiary
of Baxter International Inc. (NYSE:BAX). Baxter International Inc.,
through its subsidiaries, assists health-care professionals and their
patients with treatment of complex medical conditions, including cancer,
hemophilia, immune disorders, kidney disease and trauma. The company
applies its expertise in medical devices, pharmaceuticals and
biotechnology to make a meaningful difference in patients\' lives.

More information about Baxter\'s ENLIGHTENEDHRBC bar code technology can
be accessed at [www.baxter.com](http://www.baxter.com/).

(ENLIGHTENEDHRBC, AUTROS, and COLLEAGUE CX are trademarks of Baxter
International Inc. and its affiliates.)

*This news release contains forward-looking statements that involve
risks and uncertainties, including technological advances in the medical
field, product demand and market acceptance, actions of regulatory
bodies, the impact of competitive products and pricing, and other risks
detailed in the company\'s filings with the Securities and Exchange
Commission. These forward-looking statements are based on estimates and
assumptions made by management of the company and are believed to be
reasonable, though are inherently uncertain and difficult to predict.
Actual results or experience could differ materially from the
forward-looking statements.*

**FOR ADDITIONAL INFORMATION**:

+---+--------------------------------------------------------------------+
|   | ![](media/image1.png){width="0.1875in" height="0.1875in"}View the  |
|   | [Technical Background / Fact                                       |
|   | Sheet](http://ww                                                   |
|   | w.baxter.com/utilities/news/releases/2002/barcode_factsheet.html). |
|   |                                                                    |
|   | ![](media/image1.png){width="0.1875in" height="0.1875in"}**Media   |
|   | Contacts:**                                                        |
|   |                                                                    |
|   | > Cindy Resman, 847-948-2815\                                      |
|   | > Lisa Farrugia, 847-270-2320                                      |
|   |                                                                    |
|   | ![](media/image1.png){width="0.1875in"                             |
|   | height="0.1875in"}**Investor Contacts:**                           |
|   |                                                                    |
|   | > Neville Jeharajah, Baxter, 847-948-2875\                         |
|   | > Mary Kay Ladone, Baxter, 847-948-3371                            |
|   |                                                                    |
|   |                                                                    |
+---+--------------------------------------------------------------------+
|   |                                                                    |
+---+--------------------------------------------------------------------+

## APPENDIX DD PFIZER 

**Pfizer to Implement New Product Bar Coding to Help Reduce Medical
Errors in Hospitals and Pharmacies**\
New York, Jan. 15, 2003 --- Pfizer Inc (NYSE: PFE) said today that it
will begin utilizing an innovative new bar code technology on its
Hospital Unit Dose products in an effort to help reduce dispensing
errors at hospitals and pharmacies nationwide.

The new bar code system, developed in accordance with the new Reduced
Space Symbology standards established by the Uniform Code Council,
allows for each Pfizer unit dose of product to be identified by its
national drug code, expiration date and lot number in both machine and
human readable format. This miniaturized bar code, applied to product
containers at the time of packaging by Pfizer, utilizes a relatively
small amount of label space and can be read with conventionally
available bar code readers.

Medical errors, including dispensing errors, account for nearly 100,000
deaths annually in hospitals within the United States according to a
1999 report by the Institute of Medicine (IOM). In addition, a growing
shortage of health care professionals such as registered nurses and
pharmacists could exacerbate the potential for errors.

Pfizer said it had recently began printing these bar codes on their
Hospital Unit Dose packages, which contain individual drug doses, at one
manufacturing site and plans to introduce production at other sites
shortly. It is anticipated Pfizer will be imprinting on all Hospital
Unit Dose packages produced by the end of 2003. Pfizer is committed to
evaluating and implementing these bar codes on other types of packaging
as technology permits.

\"The application of this new technology to all unit dose packages will
ensure that the medicines administered to a patient are exactly what was
intended by the patient\'s doctor, pharmacist and nurse,\" said Henri R.
Manasse, Jr., Ph.D., Sc.D., Executive Vice President and Chief Executive
Officer of the American Society of Health System Pharmacists, an
organization that represents over 30,000 hospital and health system
pharmacists. \"We commend Pfizer for this important step to improve
patient safety.\"

Although many pharmaceutical manufacturers and healthcare organizations
have supported comprehensive bar code labeling, until today, technical
and financial impediments have prohibited the development of a standard
system. The U.S. Food and Drug Administration is currently working to
develop a rule that will require all drug manufacturers to place bar
codes on every individual product. Currently, most medicines carry the
national drug code (NDC), which identifies the drug by name and dosage,
but this is done voluntarily as the FDA does not require the NDC on
product labeling.

\"We hope our investment in this technology will help establish a bar
code standard for the healthcare industry,\" said Byron Bond,
Director/Team Leader of Trade Operations and Customer Service, Pfizer
Pharmaceuticals Group. \"Through wide-spread availability, we hope to
make it easier for hospitals and pharmacies to invest in the scanner
technology necessary to maximize the benefits of bar coded
pharmaceutical products.\"

Pfizer\'s bar code technology is compatible with current hospital
hardware and will allow nurses and pharmacists to use existing hand-held
scanners to read a product package. These same scanners can be used to
read a patient\'s identification bracelet when medications are
administered in the hospital to ensure the prescribed medicine reaches
the appropriate patient.

\"It is important that patients receive the right dose of the right drug
at the right time throughout the medication use process,\" said John A.
Gans, Executive Vice President of the American Pharmaceutical
Association, the largest professional association of pharmacists in the
United States. \"Pfizer\'s new bar code technology has the potential to
significantly decrease medication dispensing errors and improve
healthcare outcomes.\"

Pfizer Inc discovers, develops, manufactures and markets leading
prescription medicines for humans and animals, and many of the world\'s
best-known consumer products.

SOURCE Pfizer Inc.

CONTACT: Francisco Gebauer, +1-212-733-5191, for Pfizer Inc

**APPENDIX EE Aventis Behring**

KING OF PRUSSIA, Pa.\--(BUSINESS WIRE)\--March 27, 2003\--Aventis
Behring L.L.C.\
\
Aventis Behring plans to bar code its entire U.S. product line by
beginning of 2004\
\
Aventis Behring L.L.C., a global leader in the plasma protein industry,
announced today a two-phase plan to introduce bar coding technologies to
all its U.S. products in an effort to increase available packaging
information, to enhance patient safety and to improve operational
efficiencies throughout the healthcare system.\
Aventis Behring will be the first company in the plasma protein industry
to introduce bar coding technologies at the unit of dose level to its
complete U.S. product line including hospital products in critical care
settings, coagulation products used in the treatment of bleeding
disorders, and immunoglobulins used in the treatment of immunological
disorders. The new bar code system should enhance the healthcare
system\'s capability to track individual components of products, or
unit-of-use level, from labeling/packaging to patient dosing. This can
assist in the effort to ensure that the appropriate medication is
dispensed, administered and used by the right patient. The bar code
system should also increase the efficiency of product manufacturing,
distribution and recall processes.\
\"Bar coding at the unit-of-use level is critical for promoting a safe
and healthy environment for patients and healthcare workers. Novation
supports this initiative and commends Aventis Behring for taking a major
step forward in helping all of us reach this goal, and hopes this step
will inspire others in the industry to adopt bar coding technologies,\"
said John H. Riddick, director of quality assurance and regulatory
affairs for Novation, a leading supply chain management company in the
healthcare industry.\
Aventis Behring\'s bar coding initiative is designed to allow each
\'unit-of-use\' dose of medication to be identified by its National Drug
Code (NDC), expiration date and lot number. The NDC for a product is
established by the U.S. Food and Drug Administration, and serves as a
universal product identifier for human drugs. It enables patients and
healthcare providers to locate important information about a
medication\'s manufacturer, distributor, strength, dosage, formulation
and package size. The bar coding system will utilize a new technology
known as Reduced Space Symbology(R) (RSS) established by the Uniform
Code Council, a not-for-profit standards organization that developed and
administered the Universal Product Code (UPC). RSS is a miniaturized bar
code that utilizes a relatively small amount of label space as it is
stored in two-dimensions, vertically and horizontally. This new bar code
can also be read by commercially available bar code scanners.
Previously, \'unit-of-use\' sized vials and containers could not be
effectively bar coded due to space constraints.\
Aventis Behring will implement its bar coding initiative in two
successive phases. The goal of Phase I is to affix the NDC portion of
the bar code on every unit by the third quarter of 2003. The goal of
Phase II is to add the expiration date and lot number to the bar code at
the time of packaging. The target for completion of phase II is the
first quarter of 2004.\
\"As an industry leader, it is our duty to support innovations and new
technologies that can improve the healthcare system. Our bar coding
initiative is just another way for us to demonstrate our commitment to
enhancing patient safety and improving standards in product quality,\"
said Joe Pugliese, Vice President and General Manager, Aventis Behring,
North America.\
\
About Aventis Behring\
\
Aventis Behring, part of the Aventis family of companies, is a global
leader in the plasma protein industry, providing a wide range of
innovative and high-quality medicines to patients worldwide. Aventis
Behring is dedicated to research and development in the area of human
blood plasma as well as in emerging technologies. For more information
about Aventis Behring, please visit:
[www.AventisBehring.com](http://www.AventisBehring.com/)
[\<]{.underline}[http://www.AventisBehring.com](http://www.AventisBehring.com/)[\>]{.underline}.\
Aventis (NYSE: AVE) is dedicated to treating and preventing disease by
discovering and developing innovative prescription drugs and human
vaccines. In 2002, Aventis generated sales of EUR 17.6 billion, invested
EUR 3.1 billion in research and development and employed approximately
71,000 people in its core business. Aventis corporate headquarters are
in Strasbourg, France. For more information, please visit:
[www.aventis.com](http://www.aventis.com/)
[\<]{.underline}[http://www.aventis.com](http://www.aventis.com/)[\>]{.underline}\
\
Statements in this news release other than historical information are
forward-looking statement subject to risks and uncertainties. Actual
results could differ materially depending on factors such as the
availability of resources, the timing and effects of regulatory actions,
the strength of competition, the outcome of litigation and the
effectiveness of patent protection. Additional information regarding
risks and uncertainties is set forth in the current Annual Report on
Form 20-F of Aventis on file with the Securities and Exchange
Commission.