Which federal act established the framework for regulating prescription medications in the United States?

The Food, Drug, and Cosmetic Act plays a foundational role in the regulation of prescription medications in the United States. Enacted in 1938, this act established rigorous procedures for the approval, safety, and efficacy of drugs before they can be marketed. It also granted the FDA the authority to oversee the safety of food, drugs, and cosmetics, marking a significant shift in public health policy by ensuring that medications are safe for consumption.

By mandating that pharmaceutical manufacturers provide evidence of safety and effectiveness through clinical trials, this act set the groundwork for modern drug approval processes. The establishment of these standards helped to protect the public from harmful substances and deceptive practices, serving as a crucial regulatory framework that continues to influence drug regulation today.

The other acts mentioned serve specific purposes related to drug regulation but do not establish the broad framework for medication approval and oversight that the Food, Drug, and Cosmetic Act provides. Each of those acts addresses more specialized aspects of pharmaceutical regulation, such as controlled substances, user fees for drug applications, or competition and patent issues.