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U.S. Department of Health and Human Services

Drugs

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Regulatory Guidance Drug Registration and Listing

Section 510 of the Federal Food, Drug, and Cosmetic Act requires manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and human biological products to register their establishment(s) and submit a listing of every product in commercial distribution with the FDA. This information helps FDA maintain a catalog of all human and veterinary drugs and biologics in commercial distribution in the United States.