[Federal Register Volume 70, Number 9 (Thursday, January 13, 2005)]
[Notices]
[Pages 2415-2416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-696]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0549]


Draft Guidance for Industry on Labeling Over-the-Counter Human 
Drug Products; 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availability of a draft guidance for industry entitled ``Labeling OTC 
Human Drug Products--Questions and Answers.'' This guidance is intended 
to assist manufacturers, packers, and distributors of over-the-counter 
(OTC) drug products to implement the agency's regulation on 
standardized content and format requirements for the labeling of OTC 
drug products. This draft guidance discusses labeling questions that 
have been frequently asked by manufacturers, packers, and distributors 
in implementing the new requirements. The labeling examples in this 
draft guidance show various format and content features and suggest how 
OTC drug monograph labeling information finalized before the new

[[Page 2416]]

requirements can be converted to the new format.

DATES: Submit written or electronic comments on the draft guidance for 
industry by March 14, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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. 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on the draft guidance to the Division of Dockets Management (HFA-305), 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://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Cazemiro R. Martin or Gerald M. 
Rachanow, Center for Drug Evaluation and Research (HFD-560), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
2222.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Labeling OTC Human Drug Products--Questions and Answers.'' 
This is one of several draft guidances the agency is developing to help 
manufacturers, packers, and distributors implement the regulation 
establishing standardized content and format requirements for the 
labeling of all OTC drug products. Once finalized, these draft 
guidances will supersede all other statements, feedback, and 
correspondence provided by the agency on these matters since the 
issuance of the final rule.
    In the Federal Register of March 17, 1999 (64 FR 13254), FDA 
published a final rule establishing standardized content and format 
requirements for the labeling of OTC drug products (21 CFR 201.66). 
This regulation is intended to standardize labeling for all OTC drug 
products so consumers can easily read and understand OTC drug product 
labeling and use these products safely and effectively.
    The regulation for this standardized labeling requires 
manufacturers to present OTC drug labeling information in a prescribed 
order and format. The standardized format will require revision of all 
labeling in use before the compliance date of the final rule. The final 
rule covers all OTC drug and drug-cosmetic products, whether marketed 
under a new drug marketing application, abbreviated new drug 
application, or OTC drug monograph (or product not yet the subject of a 
final OTC drug monograph).
    Following issuance of the final rule, the agency received a number 
of inquires from manufacturers seeking guidance on how to present the 
labeling information for their OTC drug products using the standardized 
content and format requirements. This draft guidance discusses those 
inquiries and provides labeling examples to show various format and 
content features of the labeling requirements and suggest how OTC drug 
monograph labeling finalized before the new regulation was issued can 
be converted to the new format. This draft guidance also discusses how 
to list inactive ingredients that may or may not be contained in the 
OTC drug product.
    This level I draft guidance is being issued consistent with FDA's 
good guidance practices (21 CFR 10.115). The draft guidance includes 
labeling examples that are consistent with the new OTC drug products 
standardized labeling content and format. The draft guidance represents 
the agency's current thinking on how OTC drug monograph labeling can be 
converted to the new OTC ``Drug Facts'' format labeling. 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 
an 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 on the draft guidance. 
Submit a single copy of electronic comments or two 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. The draft guidance and received comments are 
available for public examination 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://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: December 28, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 05-696 Filed 1-12-05; 8:45 am]
BILLING CODE 4160-01-S