Which legislation governs the approval and regulation of medications in the United States?

The Food, Drug, and Cosmetic Act (FDCA) establishes the foundation for the regulation of medications in the United States. This legislation grants the Food and Drug Administration (FDA) the authority to oversee the safety, efficacy, and labeling of drugs and medical devices. It requires that all new medications undergo rigorous testing and approval processes before they can be marketed to the public, ensuring that only safe and effective products enter the consumer marketplace.

The FDCA was enacted in 1938, significantly expanding the FDA's responsibilities to include not only the regulation of food and drugs but also cosmetics and medical devices. The act has undergone several amendments, which have further strengthened regulatory processes, including provisions for expedited approvals for certain drugs, especially during public health emergencies.

In contrast, other options like the Health Insurance Portability and Accountability Act primarily concern patient privacy and health information security rather than drug approval processes. The Controlled Substances Act focuses specifically on the regulation of controlled substances and their distribution, while the Drug Enforcement Administration Policy relates to the enforcement of laws surrounding controlled substances rather than the general approval and regulation of all medications.