Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

Manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and biological products, including bulk drug substances and bulk drug substances for prescription compounding, and drug premixes as well as finished dosage forms, whether prescription or over-the-counter, are required to register their establishments. In addition, manufacturers, repackers, and relabelers are required to submit a listing of every drug or biological product in commercial distribution. Foreign drug establishments must also comply with the establishment registration and product listing requirements if they import or offer for import their products into the United States. This information collection supports agency regulations regarding these requirements.

The latest form for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution expires 2021-12-31 and can be found here.

Initial establishment registration

Federal Enterprise Architecture: Health - Consumer Health and Safety