BCPS Regulatory Practice Test

The FDA’s authority to regulate the import of drugs comes from the Federal Food, Drug, and Cosmetic Act. This act grants the agency power to ensure that drugs entering the United States are safe, effective, properly labeled, and not adulterated or misbranded, and it provides authority to inspect, detain, and refuse admission of imported drugs that don’t meet those standards. The Public Health Service Act covers other public health areas but not the core authority for drug import regulation. Labeling rules are part of overall FD&C Act requirements, but the key source for regulating imports is the FD&C Act. Therefore, the Federal Food, Drug, and Cosmetic Act is the correct basis for regulating drug imports.