
[Federal Register Volume 76, Number 155 (Thursday, August 11, 2011)]
[Notices]
[Pages 49772-49773]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20385]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0426]


Guidance for Industry: Bar Code Label Requirements--Questions and 
Answers; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Guidance for Industry: Bar Code 
Label Requirements--Questions and Answers'' dated August 2011. The 
guidance announced in this notice amends the October 2006 guidance 
document of the same title by incorporating a revised response to 
question 12 (Q12). The revised response concerns the ability of vaccine 
manufacturers to use alternative coding technologies to the linear bar 
code requirement. The guidance announced in this notice finalizes the 
draft guidance entitled ``Guidance for Industry: Bar Code Label 
Requirements--Questions and Answers (Question 12 Update)'' dated August 
2010, and is superseding the guidance entitled ``Guidance for Industry: 
Bar Code Label Requirements--Questions and Answers'' dated October 
2006.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in 
processing your requests. The guidance may also be obtained by mail by 
calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Benjamin A. Chacko, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: Bar Code Label Requirements--Questions and 
Answers'' dated August 2011. In the Federal Register of February 26, 
2004 (69 FR 9120), FDA published a final rule (the February 2004 final 
rule) requiring certain human drug and biological products to have on 
their labels a linear bar code that contains, at a minimum, the drug's 
national drug code number (Sec.  201.25 (21 CFR 201.25)). To explain 
how the bar code label requirements apply to specific products or 
circumstances, in the Federal Register of April 27, 2006 (71 FR 24856), 
FDA announced the availability of a guidance entitled ``Guidance for 
Industry: Bar Code Label Requirement--Questions and Answers'' that was 
revised several months later, as discussed in the Federal Register of 
October 5, 2006 (71 FR 58739). Since then, FDA has received additional 
information concerning vaccines and the linear bar code requirement. In 
light of this information, we are incorporating a new response to 
question 12 in the guidance document entitled ''Guidance for Industry: 
Bar Code Label Requirements--Questions and Answers''. We are providing 
a revised response to manufacturers of licensed vaccines in connection 
with the use of alternative coding technologies because it has become 
increasingly clear that vaccines present unique concerns in the bar 
coding context, particularly with respect to compliance with 
recordkeeping and mandatory adverse event reporting requirements that 
are specific to the administration of childhood vaccines. These 
concerns are particularly important because vaccines are typically 
administered in an office or clinic which may have limited 
administrative support. For example, health care providers who 
administer a vaccine that is subject to the requirements in the 
National Childhood Vaccine Injury Act of 1986 (Pub. L. 99-660) (42 
U.S.C. 300aa-25(a))) (NCVIA) are required to ensure that there is 
recorded in the vaccine recipient's permanent medical record (or in a 
permanent office log or file) the date the vaccine was administered, 
the manufacturer, lot number of the vaccine, and the name, address, and 
title of the person administering the vaccine (42 U.S.C. 300aa-25(a)). 
Manual data entry of this information requires rigorous procedures to 
ensure accurate records as not all of this information is encoded and 
clerical recording errors can diminish the value of information 
available for mandatory adverse event reporting. Furthermore, 
inaccurate recording of a lot number may delay or misdirect FDA's 
investigation of an adverse event. At this time, FDA believes that two 
dimensional symbology technology has advanced such that health care 
providers may wish to invest in the technology to capture information 
from a two dimensional code because, through use of this technology, 
they may more effectively be able to address the reporting requirements 
reflected in NCVIA.
    FDA also believes that enhanced compliance with NCVIA will in turn 
enable compliance with the mandatory reporting of adverse events by 
health care providers under the Vaccine Adverse Event Reporting System 
(VAERS), administered jointly by the Centers for Disease Control and 
Prevention and FDA. For example, complete automatic entry of vaccine 
information would facilitate accurate reporting to VAERS, decrease 
incorrect VAERS entries, and would facilitate rapid, accurate entry 
into immunization registries. Finally, the ready availability of 
information in machine readable format will enable more efficient 
electronic recordation of information, including lot number and vaccine 
expiration dates.
    For these reasons, FDA now will consider requests from vaccine 
manufacturers who request to use alternate coding technologies, such as 
two dimensional symbology, that encode lot number and expiration date 
information, for an exemption under Sec.  201.25(d)(1)(ii) to the 
linear bar code requirement. In particular, the Agency will consider 
granting such an exemption request under Sec.  201.25(d)(1)(ii) on the 
grounds that an alternative regulatory program, comprised of 
alternative technology such as two dimensional symbology used to 
facilitate compliance with requirements of public health programs 
applicable to childhood vaccines, could render the use of linear bar 
codes unnecessary for patient safety, and we would consider granting a 
request for an exemption to the bar code requirement under Sec.  
201.25(d)(1)(ii) in connection with such use. FDA recognizes that it 
may be infeasible for a vaccine manufacturer to implement alternate 
coding technology only for childhood vaccines that are subject to 
NCVIA, while retaining linear bar coding for its

[[Page 49773]]

other vaccines due to practical considerations related to manufacturing 
and cost. Moreover, the schedule of vaccines subject to NCVIA is not 
static and is updated regularly. The Agency therefore will consider a 
vaccine manufacturer's request for an exemption to the linear bar code 
requirement for any of its other licensed vaccines in addition to 
childhood vaccines.
    Note that, as FDA stated in the preamble to the final rule, the 
Agency continues to emphasize that the general exemption provision in 
Sec.  201.25(d)(1)(ii) is intended to be used in rare cases (69 FR 9120 
at 9131). FDA believes that its revised response to Q12 is consistent 
with that view because it is narrowly tailored. Further, as alternative 
technologies continue to advance, the Agency intends to assess these 
technologies in relation to current bar coding practices and other FDA 
initiatives, such as efforts to further enhance the security of the 
drug supply chain through use of a standardized numerical identifier 
for uniquely identifying prescription drug packages, and the 
establishment of a unique device identification system for medical 
devices.
    In the Federal Register of September 7, 2010 (75 FR 54347), FDA 
announced the availability of a draft guidance entitled ``Guidance for 
Industry: Bar Code Label Requirements--Questions and Answers (Question 
12 Update)'' dated August 2010. FDA received several comments on the 
draft guidance and those comments were considered as the guidance was 
finalized. The guidance announced in this notice finalizes the draft 
guidance dated August 2010 and incorporates a revised response to 
question 12 into the guidance entitled ``Guidance for Industry: Bar 
Code Label Requirements--Questions and Answers''. In addition, 
editorial changes were made to the guidance to improve clarity.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA's 
current thinking on this topic. It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    The guidance refers to previously approved collections of 
information found in FDA regulations. The collection of information in 
part 201 has been approved under OMB control number 0910-0537.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20385 Filed 8-10-11; 8:45 am]
BILLING CODE 4160-01-P


