Guidance for Industry Labeling OTC Human Drug Products

• Date: February 16, 2010
• Source: www.fda.gov

The Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act. 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. Additional information is available in the guidance for industry Labeling OTC Human Drug Products Questions and Answers.

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