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  GlaxoSmithKline   

  Diamond View      

  512 South Mangum  
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  Durham            

  North Carolina    
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  Tel:              919 483 2100

  www.gsk.com       
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June 11, 2003

Dockets Management Branch \[HFA-305\]

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Re: Docket No. 02N-0204

Bar Code Label Requirements for Human Drug Products and Blood; Proposed
Rule; 68 Federal Register 12500 (March 14, 2003)

Dear Sir/Madam:

GlaxoSmithKline (GSK) is pleased to provide the following comments to
the above noted proposed rule. GSK supports the initiative of the
Secretary of Health and Human Services to reduce medication errors and
the proposed rule that would require certain human drugs and biological
product labels to have bar codes. GSK believes that the National Drug
Code (NDC) number will provide a unique product identifier through the
use of standard approved bar code technology. This will assist in the
reduction of medical errors in hospital type settings and will provide
an increase in patient safety throughout our country's healthcare
system.

GSK is committed to the highest standards of patient safety. Our mission
is to improve the quality of human life by enabling people to do more,
feel better and live longer. We appreciate FDA's work to reduce hospital
medication errors and hope that the proposed rule on bar coding will
accelerate the adoption of safety related information technologies
throughout our healthcare system.

GlaxoSmithKline values the work FDA has put into the proposed rule. The
industry participants and I appreciate the spirit of collaboration and
openness, which has guided this effort. GSK would like to propose some
modifications to the proposed rule prior to finalization. Our
suggestions for modifications and our comments on the proposed rule are
detailed in the following sections.

GSK Comment to Docket No. 02N-0204

June 11, 2003

Page 2

1.  Bar Code Standard and Data Elements

> GSK supports a standard bar code containing the National Drug Code
> (NDC) number on prescription drug packaging destined for hospital
> administration. Standards developed by the Uniform Code Council
> (UCC/EAN) are generally recognized, and equipment is readily available
> to read such bar codes. We wish the wording of the Final Rule to be
> flexible enough to accommodate new technologies as they become
> available and are added to the UCC/EAN standards, thus ensuring that
> future improvements may be readily adapted without the need for
> revised regulations. The Final Rule should allow flexibility to select
> from any approved standard UCC/EAN bar code symbology or data carrier.
> This flexibility will allow sponsors to consider alternatives when
> label space is severely limited (e.g. single-dose vaccines and
> injectables).
>
> The UCC/EAN standard format is moving towards a Global Trade
> Identification Number (GTIN), whose data carrier or bar code
> accommodates a 14-digit data structure. The current standard bar code
> symbology for UPC and UCC/EAN-128 are acceptable to convey the NDC
> number. The addition of the RSS symbology will allow the use of the
> GTIN format in a small bar code. The 10 digit NDC number can easily be
> incorporated into the GTIN data structure, thus meeting the intent of
> the FDA proposed rule.

2.  The Need for a Small Container Waiver

> GlaxoSmithKline fully supports the PhRMA position regarding the need
> for a small container label exemption as noted here. " FDA notes in
> this proposed rule that they have declined to create an exemption
> provision but request comment on whether any specific product or class
> of products should be exempt from the bar code requirements. A survey
> of PhRMA member companies indicates that while all are committed to
> implementing bar codes on medicines designed for use in the hospital
> setting, there are a number of products currently manufactured whose
> immediate packaging simply precludes the inclusion of a bar code under
> this Proposed Rule. Such products include solid oral dosage forms in
> blister packs, pre-filled syringes, suppositories, and small vials
> that are either packaged alone or in multi-vial packs. There are also
> kits that contain both the active drug product and a diluent.
> Immediate packaging that comes in contact with active drug product is
> carefully evaluated and the manufacturing process controlled to assure
> proper quality, purity, and potency of the pharmaceutical/biological.
> Redesign of such packaging to accommodate the placement of a bar code
> is not trivial and in certain cases, may not be possible.
> Additionally, changing the immediate container packaging may, in some
> cases, affect drug product quality, purity and potency, necessitating
> the filing of a supplemental New Drug Application. If two dimensional
> codes are not allowed, it will be impossible for some products
> packaged in small containers to comply with the regulation as even the
> smallest linear barcode in the EAN/UCC standard; RSS will not have
> sufficient space to be read. In such cases, a significant period of
> time may pass before the company can come into compliance with this
> proposed rule.

GSK Comment to Docket No. 02N-0204

June 11, 2003

Page 3

> PhRMA strongly believes that there must be a waiver or exemption
> process established for such products.

To this end, PhRMA proposes the following two changes in the proposed
regulation

(proposed new language is underlined):

§ 201.25 Bar code label requirements

(a) Who is subject to these bar code requirements? [Except where waived
    by the Commissioner as in subsection (d),]{.underline}
    manufacturers, repackers, relabelers, and private label
    distributors.......

> and,

[(d) What products are subject to waivers under this section? The
Commissioner may waive the requirements for a marketed drug product
described in subsection (b), if there is insufficient room on the
immediate container to affix a bar code using any standard available as
of the implementation date of the final rule. A request for a waiver
shall be accompanied by a sample of the packaging, reason for the
request, and alternative packaging (if available) that meets the intent
of this rule. Such alternative packaging could be an outer package
containing the applicable bar code. The Commissioner shall issue a
decision on all waiver requests within sixty days of
application.]{.underline}

> Many solid oral dosage form blister packs can accommodate a bar code
> provided FDA grants an exemption from certain labeling regulations in
> 21 CFR Part 201.10(i). This section of the pharmaceutical labeling
> regulations requires the proprietary name of the drug, the established
> name, an identifying lot or control number, the name of the
> manufacturer, packer, or distributor on the packaging of containers
> too small to otherwise accommodate all the information required to
> comply with the FD&C Act Section 502(e)(1)(A)(ii) and (B). For
> example, eliminating this requirement for unit dose blister packaging
> will, in many, cases free up space for the bar code and allow greater
> legibility for the product name and dosage strength. This past summer
> PhRMA submitted to the FDA an example of printing both with and
> without the manufacturer's name. PhRMA strongly believes that FDA
> should alter the wording of the final regulation to make this
> possible. Proposed language to accomplish this

is as follows:

> § 201.25(c)(2) The bar code must appear on the drug's label as defined
> by section 201(k) of the act. Any drug complying with the provisions
> of this section are exempt from the provisions of Sec.
> 201.10(i)(1)(iii and iv) if the packaging size is such that the other
> required information is not easily readable.

GSK Comment to Docket No. 02N-0204

June 11, 2003

Page 4

> The above comments in this section also apply to the biological
> labeling requirements that are found at 21 CFR 610.60."

3.  Over the Counter (OTC) Drug Products

> OTC drug products pose a special issue relative to this proposed rule.
> At present the vast majority of OTC products are labeled with an all
> numeric Universal Product Code (UPC) in bar code format that is used
> by retail stores to facilitate point-of-sale transactions with
> automated check-out counters. The encoded UPC number may or may not be
> a manufacturer's NDC number. Thus, there is a significant commercial
> issue that will not permit replacing the UPC number with an NDC bar
> code. Retail facilities will not stock products that do not have a bar
> code that meets their needs. Thus, manufacturers of OTC drug products
> would have to potentially maintain a duplicate inventory of packaged
> drugs: those with a UPC bar coded and those with an NDC bar code.
> Shipping logistics will also have to be carefully managed so that the
> NDC bar coded package does not get inadvertently shipped to the
> non-hospital retail setting and vice versa.
>
> A second consideration is that many OTC solid oral dosage forms come
> in blister packs, such packs may not be perforated, limiting their use
> in "unit dose" dispensing in a hospital setting (these blister packs
> may also have size limitations, preventing routine bar coding as noted
> in 2 above). GSK believes that the regulation needs to be modified to
> accommodate those OTC products whose bar code does not already
> incorporate the NDC number.

4.  Economic Impact Analysis

> To comply with the regulation, GSK expects to upgrade existing and
> purchase new packaging equipment - initiatives that will require
> substantial investments and likely will exceed FDA's initial cost
> estimates for each manufacturer. GSK believes the expected reduction
> in medication errors is well worth the investment. In the interest of
> patient safety, we are absolutely committed to implementing the rule.

GSK Comment to Docket No. 02N-0204

June 11, 2003

Page 5

**GlaxoSmithKline's Responses to the Specific Questions Posed by the
FDA**

On page 12529 of the proposed rule, the FDA requests responses to a
series of questions. For clarity, the text of each question is
reproduced below followed by GSK's response.

1.  *Whether we should require bar codes on prescription drug samples,
    and the costs and benefits associated with such bar codes.*

> GSK does not believe that there should be a requirement to bar code
> physician samples. The perceived benefit is likely to be minor, as the
> use of these packs is not targeted towards hospital pharmacies.
> However, GSK should be permitted to voluntarily bar code physician
> samples with the NDC number if proven beneficial for tracking samples.
> Additionally, in more technologically advanced offices, bar codes
> could be utilized to link samples to a given patient.

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

> GSK believes that vaccines should be included under the scope of this
> proposed rule. Please note the response from [VISI .]{.underline}

3.  *What terms we should use to describe OTC drugs that should be
    subject to this bar code requirement.*

See the response to OTC products in the previous section.

4.  *Information on the costs and benefits associated with putting lot
    number and expiration date in the bar code.*

GSK agrees with the Agency's statement that there is no evidence that
supports the

> benefit to bar coding lot number and expiration date with respect to
> reducing medication errors.

5.  *Whether the rule should refer instead to linear bar codes without
    mentioning any particular standard or refer to UCC/EAN and HIBCC
    standards.*

As GSK stated in its comments in the previous section, the regulation
should refer to

> UCC/EAN standards but not specify a linear bar code. As currently
> written, the proposed rule limits manufacturers to existing linear
> standards, making it difficult to meet future information needs. In
> addition, GSK , as a vaccine supplier, is moving towards a different
> standard because of increased information requirements from the
> Centers for Disease Control (CDC).

GSK Comment to Docket No. 02N-0204

June 11, 2003

Page 6

6.  *Additional information regarding bar code scanning technology and
    the ability of bar*

*code scanners to read different symbologies.*

Bar code readers exist that can read all of the potential standards.

7\. *Whether the rule should adopt a different format (whether that
format is a symbology,*

*standard, or other technology).*

> As in our response to number 5, above, GSK does not believe the
> standard should be restricted to a linear code.

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 to be
> necessary. In addition, how could we create a waiver provision that
> would minimize the potential for misusing the waiver?*

GSK is committed to the use of bar code technology for the prevention of
medication

> errors. However, there is a subclass of products that is not amenable
> to bar coding The need for an exemption or waiver for these products
> and proposed regulatory language is discussed in the previous section.

9\. *Whether the implementation period for a final rule can and should
be shortened from*

*3 years to some other specific time period.*

> GSK supports an implementation period of 3 years following publication
> of the Final Rule. This will allow manufacturers sufficient time to
> incorporate bar codes on all hospital products as well as time for our
> healthcare partners to fully embrace the technology.

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
§201.25, or*

*machine-readable symbols" as approved by the Director of CBER.*

GSK has no comments on this issue.

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.*

GSK has no comments on this issue.

GSK Comment to Docket No. 02N-0204

June 11, 2003

Page 7

12\. *Whether any of the alternatives discussed in the economic analysis
have merit.*

> With the suggested changes in these comments GSK supports moving
> forward with bar coding of pharmaceuticals as an effective way to
> minimize medication errors.
>
> GlaxoSmithKline trusts that these comments are useful to the FDA as
> the Agency moves forward to
>
> finalize this important regulation. Our industry is committed to
> moving forward on this matter as it represents an important step in
> reducing medication errors in hospital settings.

Sincerely,

GlaxoSmithKline