Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic and foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Additionally, foreign establishments must identify a U.S. agent and importers at the time of registration.
The FDA relies on registration and listing information for administering many key programs, including:
- Post-marketing surveillance;
- Potential user fee assessments;
- Monitoring of drug shortages and availability;
- Determining products that are being marketed without an approved application.
Regulations governing drug establishment registration and listing have long appeared in 21 CFR Part 207 (human drugs, animal drugs, and certain human biologics). In August 2016, FDA published a final rule amending these regulations. This rule updates these regulations with recent statutory amendments and current practice.