General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions

The information collection supports agency regulations at 21 CFR 201.66. Respondents to the collection of information are producers or manufacturers of drug products requiring over-the-counter (OTC) labeling subject to these regulatory requirements.

The latest form for General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions expires 2022-12-31 and can be found here.

Format and Content Requirements for Over--the-Counter Drug Product Labeling; new OTC drug products (including sunscreen products)

Federal Enterprise Architecture: Health - Consumer Health and Safety