What agency regulates over-the-counter drugs?

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The agency responsible for regulating over-the-counter drugs is the Food and Drug Administration (FDA). The FDA oversees the safety, efficacy, and proper labeling of both prescription and over-the-counter medications, ensuring that they meet specific standards before they can be marketed to consumers. This regulatory oversight includes evaluating the active ingredients, dosages, and intended uses of these products, as well as ensuring that they are manufactured in accordance with established quality standards.

While other agencies like the Drug Enforcement Administration (DEA) focus on controlled substances and state pharmacy boards deal with state-level pharmacy practices and regulations, they do not have jurisdiction over the regulation of over-the-counter medications. The Environmental Protection Agency (EPA) primarily deals with regulations concerning environmental protection, which does not encompass the regulation of drug products intended for human use. Therefore, the FDA is the definitive authority tasked with regulating over-the-counter drugs.

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