Which act governs drug safety and efficacy generally?

• A. Narcotics
• B. Kefauver Harris Amendment
• C. Harrison Narcotic Act
• D. Federal Food, Drug, and Cosmetic Act

Answer: (D)

The Federal Food, Drug, and Cosmetic Act provides the framework for drug safety and efficacy by giving the FDA authority to ensure that drugs are safe for their intended use and properly labeled before they can be marketed. It established the baseline requirement that products entering the market meet safety standards and that manufacturers follow proper labeling and manufacturing practices. Later, the Kefauver Harris Amendment added the explicit requirement that drugs also prove efficacy through controlled testing, but the overarching statute governing safety and efficacy is the FD&C Act. The other options relate to specific aspects or historical controls (such as narcotics regulation) rather than the general framework for drug safety and efficacy.