Tag: US FDA registration
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FDA OTC Drug Registration: Regulatory Pathway for Non-Prescription Medicines
Over-the-counter (OTC) drugs are medicines that consumers can purchase without a prescription, but they remain fully regulated by the U.S. Food and Drug Administration (FDA). Any company that manufactures, processes, packs, or labels OTC drug products for the United States market must complete FDA OTC drug establishment registration and product listing before commercial distribution. OTC…