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SMALL ENTITY COMPLIANCE GUIDE

Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective Guidance for Industry June 2011

Final
Docket Number:
FDA-2011-D-0404
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to help small businesses understand and comply with FDA’s regulation regarding over-the-counter (OTC) topical acne drug products published in the Federal Register on March 4, 2010 (75 FR 9767). The final rule makes the following changes to the OTC regulations at 21 CFR 333, subpart D:

• Adds benzoyl peroxide as a generally recognized as safe and effective (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 21 CFR 201.66

FDA has prepared this guidance in accordance with section 212 of the Small Business Regulatory Fairness Act (Public Law 104-121).


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-D-0404.