Summary of HDMA Presentation for July 26 Public Meeting Regarding Bar
Code Labeling Requirements

The HDMA speaker would be Robert Schwartz, current HDMA Chairman of the
Board and President of the Barnes Division of H.D. Smith Wholesale Drug
Company.

Mr. Schwartz will present an overview of HDMA and its membership,
discuss the current state of the industry's acceptance of bar codes, and
describe the technology available to support this initiative. Mr.
Schwartz will also highlight the benefits of bar coding, provide
industry statistics related to bar code usage in the manufacturer,
distributor and customer settings and explain the impact changes to
identification systems would have on the healthcare supply chain.

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**[HDMA's Support of Efforts to Reduce Medical Errors and History with
Bar Codes:]{.underline}**

HDMA has been an active participant in the National Coordinating Council
for Medication Error Rates and Prevention since 2000. We have been
pioneers in promoting the usage of bar code standards in the healthcare
industry since the early 90's. We have worked collaboratively with the
Health Industry Business Communications Council (HIBCC) and the Uniform
Code Council (UCC) to develop voluntary guidelines for the industry, and
have developed an industry position on the usage of bar codes

### Current State of the Industry and Technology Capabilities

Mr. Schwartz will review a flow map showing the entire pharmaceutical
distribution chain, noting the places where a bar code labeling
requirement would have the most impact. He will discuss current levels
of bar code usage, providing statistics related to manufacturer,
distributor and pharmacy settings.

#### Benefits of Bar Coding

Mr. Schwartz will discuss the benefits of bar coding in ensuring the
accuracy of medication identification and administration and improving
efficiencies within the medication-use process, monitoring of drug-use
trends, and overall efficiencies in the supply system and public health
and patient safety.

### HDMA's Position on Bar Codes

-   Identify all levels of packaging, (SKUs, inner packs and shipping
    cases) with a barcode symbol or symbols that comply with the HDMA
    Numerical and Automatic Identification of Drug Products Guideline,
    as revised.

-   Use the National Drug Code (NDC) as defined by the Food and Drug
    Administration (FDA) as the preferred numbering system for drug
    products.

HDMA Summary -- page 2

-   Follow bar code standards published by the Uniform Code Council
    (UCC) for OTC drug products and Health Industry Business
    Communications Council (HIBCC) for medical-surgical devices for all
    packaging levels.

-   Apply bar code labeling as early in the supply system as possible,
    e.g. manufacturing or packaging.

-   Conduct appropriate symbology evaluations to determine optimal
    technology in applying and scanning bar codes.

-   Implement bar coding of unit of use and small packages (goal: to
    have all drug and device products used at the patient bedside
    carrying a barcode).

-   Use bar codes internally wherever possible. Use of bar codes to
    identify healthcare products has been shown to reduce labor costs in
    distribution and dispensing while, at the same time, reducing
    errors.

#### Impact of Bar Code Changes

Mr. Schwartz will discuss the potential impacts of a bar code
requirement on the health care distribution chain. He will discuss the
large costs that would be incurred if lot number and expiration date
were required as part of the bar code label, as is being discussed. He
will discuss the HDMA view that FDA be flexible as to symbology chosen.
He will describe the overall huge economic impact on manufacturers and
distributors in the areas of packaging technology, equipment components,
integration of computer systems, and other implementation costs.

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