Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

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 can be found here.

503B Initial drug product reports

Federal Enterprise Architecture: Health - Consumer Health and Safety