**Bar Code Label Requirements for Human Drug Products**

Rick Schuessler, Symbol Technologies Inc.

A majority of the speakers at the FDA's July 26^th^ public meeting
suggested that the quickest and surest path to reducing medication
errors would be for the FDA to mandate bar coding of the NDC number
immediately, but to *phase in* the additional requirement for bar coded
Expiration Date and Lot Number at a later date. Symbol Technologies
Inc., one of the world's leading manufacturers of bar code scanning
equipment, supports that view. Furthermore, we would like to supply the
following information, exploring the implications of an "NDC-only" short
term scenario, to help the FDA reach a decision on bar coding technology
that will provide the most cost-effective approach for the industry.

## Size Comparisons

Many of the speakers on July 26^th^ recommended that the FDA mandate
only **linear** symbologies (Code 128 where space permits, and RSS
otherwise) rather than Data Matrix, because it is well understood that a
much broader choice of reading equipment would then be available
(especially for cost-sensitive bedside applications). Although the cost
advantage (for health care providers) of picking linear bar codes rather
than Data Matrix is clear, the FDA may not be aware that, if only the
NDC or UPN is encoded (i.e., no Expiration Date or Lot Number), then RSS
is *not* more difficult to fit on a small label than Data Matrix. In
fact, encoding this primary identifier in an RSS linear symbol uses
slightly *less* area on the label than would the alternative 2D Data
Matrix symbol. The data for these comparisons is taken from the relevant
documentation provided by the proponents of the two symbology choices
(that is, the Data Matrix option is shown as per HIBCC draft guidelines,
and the RSS options are per published EAN.UCC guidelines).

**Option 1: Using Data Matrix**, encode UPN in HIBCC-compliant format.

-   Data from Section 2 of the current draft of the HIBCC supplier
    guideline entitled "Selecting 2D Bar Code Symbols for Small
    Packages"

-   Size of the resulting Data Matrix symbol, printed at 10 mils per the
    HIBCC spec:

-   **0.19" by 0.19" (including minimum 1X symbology-required quiet
    zones).**

# Area: 0.03610 square inch

**Option 2a: Using RSS Limited**, encode NDC in EAN.UCC-compliant format

-   Encoded per the EAN.UCC ***Global Application Guideline*** for
    Healthcare

-   Size of the resulting RSS Limited symbol printed at 6.67mils[^1]:

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-   **0.4933" wide by 0.0667" tall (including required quiet zones)**

-   **Area: 0.03289 square inch**

**Option 2b: Using Stacked RSS-14**, again encoding NDC in
EAN.UCC-compliant format:

-   Size of the resulting Stacked RSS-14symbol printed at 6.67mils:

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```
-   **0.3335" wide by 0.08671" tall (including required quiet zones)**

-   **Area: 0.02889 square inch**

**Additional Observations:**

-   If the FDA decides not to mandate Expiration Date and Lot Number as
    part of the barcode printed on unit doses of medication, then the
    mandated bar code has no *dynamic* data content, and may be produced
    as part of the label artwork (no need to ink-jet the symbol as an
    in-line secondary printing step). In this scenario, either symbology
    should be easy to print with high quality and readability.

-   There is a far broader choice of scanning technologies offered for
    RSS than for Data Matrix. In addition to 2D Imagers (which can read
    either symbology), RSS can be scanned by lower-cost technologies
    including single-line laser, single-line CCD, and rastering laser
    scanners. At the 7/26 meeting, John Combes, M.D. representing the
    AHA, recommended that the requirements for labeling be compatible
    with existing technology presently deployed in hospitals. Venture
    Development Corporation reports that in 2001, CCD/CMOS imaging
    accounted for only 1.8% of the revenue for Americas shipments of
    hand held scanners.

-   RSS provides a natural upgrade path, should the FDA decide on a
    Phase 1 requirement for NDC marking, coupled with a plan for Phase 2
    requirements that add Expiration Date and Lot Number in the future.
    A drug manufacturer who has been marking with RSS may 'graduate' to
    marking with an RSS-based Composite (in order to add Lot and/or
    Expiration Date), without obsoleting existing RSS-only scanning
    equipment (which can continue to read the NDC portion of a
    Composite, exactly as if only the RSS linear had been printed).

-   A few speakers suggested that the FDA should mandate the required
    *data* to be encoded, but should not specify or even restrict the
    choice of *symbology*. It was stated more than once that the FDA
    "should not mandate any one technology" so that the industry would
    not be "locked in" to a single approach. Although these comments may
    sound benign, they need to be interpreted carefully. If the FDA
    decides to *not* specify a limited set of symbologies, such a
    decision actually *does* in fact mandate a single technology-- 2D
    Imagers - at the scanning end of the supply chain. This would
    deprive hospitals and other cost-conscious institutions of any
    ability to choose different price/performance tradeoffs for bedside
    systems (in fact, some of the speakers may have actually meant "*do*
    specify a symbology, so you're not mandating a single reading
    technology," but if so, the point was never clearly articulated
    during the 7/26 meeting). Moreover, failure to specify a symbology
    would tend to paralyze purchasing decisions, and delay
    implementations indefinitely while waiting for the 'ideal'
    technology to appear. In order to maximize the end result of
    "reducing medication errors," the barriers to deployment should be
    minimal at the point of care. The FDA cannot mandate that providers
    *use* the technology, but it can *encourage* the most widespread use
    at the point of care, by mandating bar codes that can be read by
    multiple scanning technologies, thus giving the healthcare providers
    the broadest range of cost/performance options.

## Recommendations

-   We recommend that the FDA mandate the bar coding of NDC
    identification on all unit-dose or unit-of-use packaging, as soon as
    possible, as a key technology for reducing medication errors.

-   We recommend that the scope of this regulation apply not only to
    prescription drugs, but to any Over-the-Counter drug packages that
    are sold into institutional settings

-   We recommend that the FDA select the National Drug Code (NDC number)
    as the required form of pharmaceutical identification, and support
    the prevailing view that only one data format (i.e., NDC) should be
    used.

-   We recommend that the FDA specify the following linear symbologies
    for encoding the NDC: UCC/EAN-128 where space permits, and
    RSS-Limited or Stacked RSS-14 on those smaller package sizes where
    UCC/EAN-128 cannot fit. Since reading equipment will transparently
    handle a mix of RSS-Limited and Stacked RSS-14 symbols, there is no
    need for the FDA to specify only one of those two choices
    (manufacturers should be allowed to choose between them, based on
    the width and height of the available label space).

-   We recommend that the FDA's initial regulation include the following
    statements:

    -   A statement that, while the initial regulation requires only the
        primary (NDC) identification be bar coded, the FDA will in the
        future mandate an additional requirement for bar coded
        Expiration Date and Lot Number,

    -   That data items fulfilling this future requirement shall be
        encoded in an EAN.UCC 2D Composite Component associated with the
        NDC's linear symbol (which may be either EAN/UCC-128 or RSS
        Limited or Stacked RSS-14).

    -   That manufacturers are free to begin labeling products with the
        additional data in EAN.UCC Composite symbols (which still encode
        the NDC in a linear Code 128 or RSS component) in advance of the
        future requirement.

> These statements from the FDA would yield two benefits:

-   they would give health care providers the information they need to
    make informed purchasing decisions, allowing each institution to
    minimizing the risks of product obsolescence, balanced against the
    appropriate price/performance characteristics for their operating
    environment;

-   they would allow pharmaceuticals manufacturers to mark items with
    Expiration Date and Lot Number as soon as they wish, in order to
    improve the efficiency of their own operations, without creating any
    cost impact on their customers.

[^1]: As shown in the HIBCC guideline cited above, and according to
    accepted barcode industry practice, the comparisons between a Matrix
    code and other bar codes should be done at different nominal element
    sizes (a/k/a X dimensions), so that an equivalent optical area is
    devoted to each black or white data element (up to a limit where
    additional area offers no significant further improvement in
    scanning performance). Thus, a 10mil Data Matrix symbol should be
    compared to an RSS-based Composite symbol of 6.67 mils (wherein the
    black/white elements of the two-dimensional components have
    equivalent areas). Although the comparison for an RSS symbol
    (without a 2D Composite Component) should by this measure use an RSS
    even smaller than 6.67 mils, we will use 6.67 mils, for two
    reasons: 1) it adheres to the EAN.UCC Guidelines, and allows
    migration to Composites without changing the X dimension, and 2)
    because that is the typical lower bound for standard-density linear
    scanners.