OMB control number
Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
OMB 0910-0827 · HHS/FDA.
OMB 0910-0827
After an entity has elected to register as an outsourcing facility, it must report information identifying the drugs compounded at the facility as prescribed by the Drug Quality and Security Act. FDA has issued agency guidance to assist respondents in this regard. This information collection supports implementation of these reporting requirements.
The latest form for Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act expires 2022-11-30 and is listed under ICR 201911-0910-001.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 503B continued product reports |
Information collection |
| 503B Initial drug product reports |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 201911-0910-001 | Extension without change of a currently approved collection | 2019-11-04 | Approved without change | |
| 201610-0910-005 | New collection (Request for a new OMB Control Number) | 2016-10-21 | Approved without change |
OMB Details
503B Initial drug product reports
Federal Enterprise Architecture: Health - Consumer Health and Safety