The Food and Drug Administration (FDA) oversees the regulation of over-the-counter (OTC) drugs in the United States, ensuring they are safe and effective for consumer use. OTC drugs are medications that can be purchased without a prescription and are widely used to treat minor ailments. Registering an OTC drug with the FDA is a crucial step for manufacturers to legally market their products in the US.
Understanding OTC Drug Categories and Requirements
The FDA categorizes OTC drugs into different monographs based on their active ingredients and intended uses. Each monograph outlines the acceptable ingredients, doses, formulations, and labeling requirements for a particular category of OTC drug. To register an OTC drug, manufacturers must ensure their product complies with the relevant monograph or submit a new drug application (NDA) if seeking approval for a novel ingredient or indication. Compliance with FDA regulations is essential to avoid enforcement actions and ensure consumer safety.FDA Drug Establishment Registration
