[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Rules and Regulations]
[Pages 36307-36308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-15560]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 333

[Docket No. FDA-2011-D-0404]


Guidance for Industry on Topical Acne Drug Products for Over-the-
Counter Human Use--Revision of Labeling and Classification of Benzoyl 
Peroxide as Safe and Effective; Small Entity Compliance Guide; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; guidance.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for small business entities entitled 
``Topical Acne Drug Products for Over-the-Counter Human Use--Revision 
of Labeling and Classification of Benzoyl Peroxide as Safe and 
Effective.'' This guidance is intended to help small businesses 
understand and comply with the requirements of the final rule that adds 
benzoyl peroxide as a generally recognized as safe and effective 
(GRASE) active ingredient in over-the-counter (OTC) topical acne drug 
products and provides new labeling requirements applicable to all OTC 
topical acne products marketed under the monograph (75 FR 9767, March 
4, 2010) (final rule). The guidance describes the requirements of the 
final rule in plain language and provides answers to common questions 
on how to comply with the rule. This guidance was prepared in 
accordance with the Small Business Regulatory Fairness Act.

DATES: Submit either electronic or written 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. 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: Arlene H. Solbeck, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5426, Silver Spring, MD 20993-0002, 301-
796-2090.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for small business 
entities entitled ``Topical Acne Drug Products for Over-the-Counter 
Human Use--Revision of Labeling and Classification of Benzoyl Peroxide 
as Safe and Effective; Small Entity Compliance Guide.'' This guidance 
summarizes the March 4, 2010, final rule regarding topical acne drug 
products for OTC use that makes the following changes to the OTC 
regulations:
     Adds benzoyl peroxide as a GRASE active ingredient in OTC 
topical acne drug products.
     Sets forth new warnings and a direction that must be 
included in labeling of OTC topical acne drug products that contain 
benzoyl peroxide.
     Revises labeling requirements for all OTC topical acne 
drug products to ensure consistency with the standardized drug facts 
formatting and requirements set forth in Sec.  201.66 (21 CFR 201.66).
    The guidance summarizes in table form the requirements for specific 
warnings and directions in the labeling that apply to all OTC acne drug 
products marketed under the monograph (i.e., products that contain any 
of the active ingredients permitted under the OTC topical acne drug 
monograph, including benzoyl peroxide, resorcinol, resorcinol 
monoacetate, salicylic acid, and/or sulfur) (21 CFR part 333, subpart 
D)). The summaries include new warnings and a new ``direction for use'' 
required specifically for OTC topical acne products that contain 
benzoyl peroxide. The revised labeling requirements ensure that the 
labeling of OTC topical acne drug products is consistent with the 
standardized drug facts labeling content and format requirements in 
Sec.  201.66.
    FDA is issuing this small entity compliance guide as level 2 
guidance consistent with FDA's good guidance practices regulation (21 
CFR 10.115). The guidance represents the Agency's current thinking on 
the classification of benzoyl peroxide as GRASE in the OTC topical acne 
drug monograph, and revised labeling requirements for OTC topical acne 
products, as set forth in the final rule. 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) 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.

[[Page 36308]]

III. Electronic Access

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

    Dated: June 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15560 Filed 6-21-11; 8:45 am]
BILLING CODE 4160-01-P