Which federal agency is responsible for the regulation of labeling on prescription and OTC medications?

The Food and Drug Administration (FDA) is the federal agency responsible for regulating the labeling of both prescription and over-the-counter (OTC) medications. This regulation includes ensuring that labels provide adequate directions for use, appropriate warnings, and other necessary information to help consumers and healthcare providers make informed decisions regarding the safe and effective use of medications. The FDA's role is crucial in maintaining public health by overseeing that all information on medication labels is accurate, truthful, and not misleading.

Regulation of medication labeling is part of the FDA's broader mandate to ensure the safety and efficacy of drugs available to the public. This includes reviewing labels during the drug approval process and enforcing regulations once the drugs are on the market. Through these measures, the FDA helps ensure that patients receive vital information regarding their medications, which can help avoid misuse and enhance treatment outcomes.