What is the role of the importer in the FDA’s regulation of drug imports?

• A. Importers decide labeling
• B. Importers perform clinical trials
• C. Importers set pricing
• D. Importers ensure compliance with U.S. regulations, verify product authenticity, and are subject to inspection

Answer: (D)

Importers act as the importer of record and must ensure that drugs entering the United States meet applicable FDA requirements. Their role includes verifying the authenticity of the product and its sources, keeping necessary documentation to demonstrate compliance, and being prepared for FDA inspections of shipments and related records. This structure helps prevent counterfeit or misbranded drugs from reaching patients and supports supply-chain security and regulatory oversight. They are not responsible for deciding labeling, conducting clinical trials, or setting pricing—those tasks lie with the product labelers/manufacturers, sponsors/investigators, and market strategies, respectively.