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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

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; guidance.

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.

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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.

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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 § 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 § 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.Start Printed 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.

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Dated: June 16, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2011-15560 Filed 6-21-11; 8:45 am]

BILLING CODE 4160-01-P