What is the regulatory approach to the importation of drugs into the United States?

• A. FDA regulates drug imports under the FD&C Act; facilities must comply with import requirements and may be subject to inspections
• B. Import is unrestricted if drugs are approved elsewhere
• C. Only herbal products can be imported without inspections
• D. Import is regulated by the DEA

Answer: (D)

Drug importation is overseen by the FDA under the Federal Food, Drug, and Cosmetic Act. When a drug is brought into the United States, the FDA reviews it to ensure it meets safety, efficacy, labeling, and manufacturing standards. Importers must follow FDA import requirements, register with FDA, and the facilities involved may be inspected to verify good manufacturing practices and quality controls.

The DEA does have authority over controlled substances and their import, requiring specific permits and registrations, but the general pathway for most drugs is through the FDA. This means that approvals in another country do not remove import oversight, and importation is not limited to herbal products.