Which regulation serves as the foundation for drug regulation in the United States?

The Federal Food, Drug, and Cosmetic Act (FDCA) serves as the foundational regulation for drug regulation in the United States. Enacted in 1938, this act established the legal framework for the regulation of food, drugs, and cosmetics by the FDA. It set forth the required standards for premarket approval of new drugs, ensuring that they are safe and effective before they can be sold to the public.

The FDCA introduced several important provisions, including the necessity for evidence of safety prior to marketing and the requirement for drugs to be properly labeled with accurate information. This act has been amended numerous times to improve the regulatory process and address new challenges in drug development and consumer safety.

Other regulations, while important in their own right, do not serve as the foundational framework like the FDCA does. The Controlled Substances Act is primarily focused on the regulation of controlled substances and their classification, while the Drug Enforcement Administration Guidelines outline enforcement and operational procedures related to drug control but are not the primary legal basis for drug regulation. The Biologics Control Act deals specifically with biological products and is not as comprehensive as the FDCA when it comes to all drug regulation.