[Federal Register Volume 74, Number 2 (Monday, January 5, 2009)]
[Notices]
[Pages 303-304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-31321]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-D-0437] (formerly Docket No. 2004D-0549)


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 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 in complying with the agency's regulation on 
standardized content and format requirements for the labeling of OTC 
drug products. This guidance primarily discusses labeling questions 
that have been frequently asked by manufacturers, packers, and 
distributors relating to these requirements. The labeling examples in 
this guidance show various format and content features and suggest how 
OTC drug monograph labeling information finalized before the new 
requirements can be converted to the new format. This guidance 
finalizes the draft guidance of the same name published January 13, 
2005 (70 FR 2415).

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, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002. 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.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5496, Silver Spring, MD 20993-0002, 301-
796-2090.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Labeling OTC Human Drug Products-- Questions and Answers.'' 
This is one of several guidances the agency has developed to help 
manufacturers, packers, and distributors implement the final rule 
establishing standardized content and format requirements for the 
labeling of all OTC drug products. Once finalized, these guidances 
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 (Sec.  201.66 (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 requires manufacturers to present OTC drug labeling 
information in a prescribed order and format. The standardized format 
requires revision of all prior labeling and covers all OTC drug and 
drug-cosmetic products, whether marketed under a new drug application, 
abbreviated new drug application, or OTC drug monograph (or drug 
product not yet the subject of a final OTC drug monograph).
    Following issuance of the final rule, the agency received a number 
of inquiries from manufacturers seeking guidance on how to present the 
labeling information for their OTC drug products using the standardized 
content and format requirements. To address these inquiries, FDA 
published a notice in the Federal Register of January 13, 2005 (70 FR 
2415), announcing the availability of a draft guidance for industry 
entitled ``Labeling OTC Human Drug Products--Questions and Answers.'' 
That draft guidance summarized the new Drug Facts labeling requirements 
as set forth in Sec.  201.66. The draft guidance discussed those 
industry inquiries and

[[Page 304]]

provided labeling examples to show various format and content features 
of the labeling requirements, and suggested how OTC drug monograph 
labeling finalized before the new regulation was issued can be 
converted to the new format. The draft guidance also described how to 
list inactive ingredients that may or may not be contained in the OTC 
drug product.
    The notice invited interested persons to submit comments on the 
draft guidance by March 14, 2005. FDA did not receive any comments in 
response to the notice. Therefore, we are announcing the availability 
of this final guidance with only editorial changes.
    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 how OTC drug monograph labeling finalized 
before or after the new requirements can be converted to the new OTC 
Drug Facts labeling format. 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

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.regulations.gov.

    Dated: December 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-31321 Filed 1-2-09; 8:45 am]
BILLING CODE 4160-01-S