INITIAL DRUG ESTABLISHMENT REGISTRATION, LISTING & U.S.-AGENT

Manufacturers of drugs to be imported in the U.S. need to register with the FDA and list the drugs. TABS can assist you to comply.

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.