drug establishment Registration

January 9, 2014

FDA DRUG ESTABLISHMENT REGISTRATION AND LISTING

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States. Drug Registration and Listing System Fees – Click here