[Federal Register Volume 71, Number 81 (Thursday, April 27, 2006)]
[Notices]
[Pages 24856-24857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-6312]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0202]


Guidance for Industry on 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 guidance for industry entitled ``Bar Code Label 
Requirements--Questions and Answers.'' FDA regulations require certain 
human drug and biological products to have on their labels a linear bar 
code that identifies the drug's National Drug Code (NDC) number. We 
have received several inquiries about how the requirements apply to 
specific products or circumstances. The purpose of the guidance is to 
respond to the questions.

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

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857; or the Office of Communication, Training, 
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation 
and Research, Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the guidance to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: For products regulated by the Center 
for Drug Evaluation and Research: Valerie L. Whipp, Center for Drug 
Evaluation and Research (HFD-310), Food and Drug Administration, 11919 
Rockville Pike, Rockville, MD 20852, 301-827-8963. For products 
regulated by the Center for Biologics Evaluation and Research: 
Elizabeth Callaghan, Center for Biologics Evaluation and Research (HFM-
370), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852, 301-827-8963.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Bar Code Label Requirements--Questions and Answers.'' In the 
Federal Register of February 26, 2004 (69 FR 9120), FDA issued a final 
rule that requires certain human drug and biological product

[[Page 24857]]

labels to have a bar code containing the drug's NDC number. Bar codes 
will help reduce the number of medication errors in hospitals and other 
health care settings by allowing health care professionals to use bar 
code scanning equipment to verify that the right drug (in the right 
dose and right route of administration) is being given to the right 
patient at the right time. This guidance is intended to explain certain 
bar code labeling requirements and their application to human drug and 
biological products.
    In the Federal Register of June 7, 2005 (70 FR 33182), FDA 
announced the availability of a draft version of this guidance. FDA 
received comments in response to the draft guidance. The agency has 
considered those comments carefully and has revised the answer to 
Question 7 (which has been renumbered to Question 9) regarding the 
application of the 2-year implementation date. In response to recent 
inquiries from a trade association, the agency has also added Questions 
3 and 4 regarding the application of the bar code labeling requirements 
to over-the-counter drug products. In addition, the agency has made 
minor editorial changes to the guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on certain questions and answers on bar code 
labeling requirements. 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. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: April 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-6312 Filed 4-26-06; 8:45 am]
BILLING CODE 4160-01-S