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 2029-05-31 and is listed under ICR 202603-0910-014.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0800 503A 503B SSA 2026 EXT.docx | Supporting Statement A |
 0800 Comment from PhRMA 1-23-2026.pdf | Public Comments |
| 0800 Comment from OFA 1-23-2026.pdf | Public Comments |
| 0800 Comment from MPhA 1-23-2026.pdf | Public Comments |
| 0800 Comment from APhA 1-22-2026.pdf | Public Comments |
| 0800 Comment from APC and NCPA 01-21-2026.pdf | Public Comments |
 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All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 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 | Improperly submitted and continue | |
| 202210-0910-015 | Revision of a currently approved collection | 2022-10-25 | Approved without change | |
| 202005-0910-004 | Revision of a currently approved collection | 2020-05-14 | Approved without change | |
| 201808-0910-004 | Extension without change of a currently approved collection | 2018-09-27 | Approved without change | |
| 201507-0910-008 | New collection (Request for a new OMB Control Number) | 2015-08-04 | Approved without change |
OMB Details
503B Reporting: AERs
Federal Enterprise Architecture: Health - Consumer Health and Safety