[Federal Register: June 7, 2005 (Volume 70, Number 108)]
[Notices]               
[Page 33182-33183]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn05-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0202]

 
Draft Guidance for Industry on Bar Code Label Requirements--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availability of a draft guidance for industry entitled ``Bar Code Label 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 The purpose of the draft guidance 
is to respond to the questions.

DATES: Submit written or electronic comments on the draft guidance by 
August 8, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 See the SUPPLEMENTARY INFORMATION section for electronic 

access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: 
For products regulated by the Center for Drug Evaluation and Research: 
Michael D. Jones, Center for Drug Evaluation and Research (HFD-5), Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
594-2041.

[[Page 33183]]

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 20852-1448, 301-827-3424.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Bar Code Label Requirements--Questions and Answers.'' Under 
FDA regulations, certain human drug and biological product labels must 
have a bar code containing the drug's NDC number (69 FR 9120, February 
26, 2004). 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 draft guidance 
is intended to explain certain bar code labeling requirements and their 
application to human drug and biological products.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.


    Dated: May 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11266 Filed 6-6-05; 8:45 am]

BILLING CODE 4160-01-S