What must domestic and foreign facilities that manufacture, repack, or relabel human or veterinary drug products do?

What must domestic and foreign facilities that manufacture, repack, or relabel human or veterinary drug products do?

• A. Submit quality reports to state agencies
• B. Renew licenses yearly
• C. Implement REMS
• D. Register with the FDA

Answer: (D)

Registration with the FDA is required. All domestic and foreign facilities that manufacture, repack, or relabel human or veterinary drug products must establish FDA registration so the agency knows where these activities occur and can plan inspections and oversight. This registration, which is renewed annually, is the federal requirement to legally distribute these products in the United States. Rems programs are only for specific drugs, state-required quality reporting isn’t universal, and the term licensing isn’t the standard federal requirement for these facilities.

Registration with the FDA is required. All domestic and foreign facilities that manufacture, repack, or relabel human or veterinary drug products must establish FDA registration so the agency knows where these activities occur and can plan inspections and oversight. This registration, which is renewed annually, is the federal requirement to legally distribute these products in the United States. Rems programs are only for specific drugs, state-required quality reporting isn’t universal, and the term licensing isn’t the standard federal requirement for these facilities.