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Food and Drug Administration (FDA)

A federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.

Prescription Drug

A pharmaceutical drug that legally requires a medical prescription from a doctor or other qualified medical practitioner to be dispensed.

Federal Food, Drug, and Cosmetic Act

The main federal law that grants the FDA authority to oversee the safety of food, drugs, medical devices, and cosmetics.

Subsection (b) of section 503

A specific part of the Federal Food, Drug, and Cosmetic Act that gives the FDA the power to determine which drugs must be sold only with a prescription.

Enactment Date

The date on which a bill officially becomes a law after passing through all necessary legislative steps and being signed by the President.

Secretary of Health and Human Services

The head of the U.S. Department of Health and Human Services, a cabinet-level position responsible for advising the President on health matters and managing numerous federal health agencies, including the FDA.