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OTC Drugs

FAQ: OTC Drugs

An Overview of FDA Requirements for OTC Drugs (Over the Counter Products ) and understanding FDA regulation for OTC drugs

FDA requirements for OTC drugs vary for OTC monograph products and new OTC drugs. Drugs with active ingredients published in the OTC final monograph can be marketed without prior approval from FDA. However, if you plan to market OTC drugs with active ingredients that are not part of the OTC monograph, you should obtain FDA… Read More