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Rx-to-nonprescription switch

The process of changing a medicine from requiring a doctor's prescription to being available for purchase directly by consumers without a prescription.

Nonprescription drug

A medicine that can be bought without a doctor's prescription, often called an "over-the-counter" (OTC) drug.

Guidance

Official advice or recommendations issued by a government agency, like the FDA, to explain how it interprets and intends to enforce regulations.

Stakeholders

Individuals, groups, or organizations that have an interest or concern in a particular issue or industry, such as patient advocacy groups, healthcare providers, or drug companies.

Federal Food, Drug, and Cosmetic Act

The main law that gives the FDA authority to oversee the safety of food, drugs, medical devices, and cosmetics in the United States.

Comptroller General of the United States

The head of the Government Accountability Office (GAO), an independent agency that provides auditing, evaluation, and investigative services for the U.S. Congress.

Drug Facts Label

The standardized label required on all nonprescription (over-the-counter) drug products, providing key information about ingredients, uses, warnings, and directions.