Which statement best describes how importation of pharmaceutics is regulated?

• A. The FDA regulates which drugs can be imported, while the CBP, along with the FDA, regulate the actual physical importation of drugs
• B. Only the FDA regulates importation
• C. Only CBP regulates importation
• D. FTC regulates importation

Answer: (A)

Importation of pharmaceutics is regulated by both the FDA and the U.S. Customs and Border Protection (CBP). The FDA decides which drugs may be imported and under what safety, efficacy, labeling, and quality standards they must meet, while CBP handles the physical entry of goods at the border and enforces compliance with those FDA requirements as shipments cross into the U.S. In practice, FDA sets the eligibility and regulatory framework, and CBP works at the point of entry to ensure those rules are followed.

The option that says only the FDA regulates importation overlooks CBP’s border-enforcement role. The one that says only CBP regulates importation ignores FDA’s responsibility for drug safety and regulatory approval. The option invoking the FTC is not correct because the FTC does not regulate drug imports.