OMB control number

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

OMB 0910-0800 · HHS/FDA.

OMB 0910-0800

This information collection supports implementation of Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) - which governs pharmacy compounding and outsourcing facilities. The requirements include reporting, recordkeeping, and disclosures.

The latest form for Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act expires 2026-04-30 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Outsourcing Facilities: Registration and reporting of drugs under 503B(b) Other-Statutory Authority
503A; Disclosure Other-Memorandum of Understanding
503A; Recordkeeping Other-Memorandum of Understanding
503A; Reporting Other-Memorandum of Understanding
503B Recordkeeping; AERs Other-Guidance
503B Reporting: AERs Other-Guidance

All Historical Document Collections

202603-0910-014	Extension without change of a currently approved collection	2026-03-27
202512-0910-009	Extension without change of a currently approved collection	2026-01-30
202210-0910-015 Approved without change	Revision of a currently approved collection	2022-10-25
202005-0910-004 Approved without change	Revision of a currently approved collection	2020-05-14
201808-0910-004 Approved without change	Extension without change of a currently approved collection	2018-09-27
201507-0910-008 Approved without change	New collection (Request for a new OMB Control Number)	2015-08-04

OMB Details

503B Reporting: AERs

Federal Enterprise Architecture: Health - Consumer Health and Safety