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FDA Guidance for Industry: Labeling OTC Human Drug Products

Origin/Publisher:

Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

Document Type:
Guidance
Content:
It is intended to help small businesses better understand the new over-the-counter (OTC) labeling requirements set forth in 21 CFR 201.66 and prepare new labeling within the prescribed implementation compliance dates.

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