FDA Registration For Drugs
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. Additionally, foreign establishments must identify a U.S. agent and importers at the time of their registration.
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. Registration information must be renewed annually. The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, now requires drug firms to submit annual establishment registrations in the period from October 1st to December 31st of each calendar year. In addition, we remind you that at the time of annual registration, firms must list any drugs not previously listed. The FDA no longer accepts drug establishment registration and drug listing information in paper format unless a waiver is granted.
Any additional updates to drug listing information must be submitted in June and December of each year. Drug establishment registration information allows FDA to identify all manufacturing facilities involved in producing drugs that are in commercial distribution in the United States, and drug listing information helps the FDA maintain a catalogue of all drugs in commercial distribution in the United States. Drugs that are manufactured in establishments that are not properly registered and drugs that are not properly listed as required are misbranded and may be subject to regulatory action.
The FDA relies on registration and listing information for administering many key programs, including post marketing surveillance; user fee assessments; counterterrorism; monitoring of drug shortages and availability; and determining products that are being marketed without an approved application.