Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

This information collection supports implementation of Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and includes reporting, recordkeeping, and disclosures. Section 503B pertains to outsourcing facilities and sets forth criteria under which sections 502(f)(1), 505, and 582 do not apply for a drug compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility. Section 503A pertains to human drug compounding and sets forth criteria under which sections 501(a)(2)(b), 502(f)(1), and 505 of the FD&C Act do not apply for a drug product compounded for an identified individual patient based on the receipt of a valid prescription order approved by a practitioner. Respondents to the collection are those who compound drugs, outsourcing facilities, and State Boards of Pharmacy or other State Agencies entering into a MOU with FDA to address certain distributions of compounded human drug products.

The latest form for Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act expires 2023-10-31 and can be found here.

503B Reporting: AERs

Federal Enterprise Architecture: Health - Consumer Health and Safety