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

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