Tag: FDA drug 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…
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US FDA Drug Establishment Registration: Regulatory Requirements for Drug Facilities
Any facility involved in the manufacturing, processing, packing, or labeling of drugs for the United States market must comply with US FDA Drug Establishment Registration requirements. This obligation is enforced by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA drug establishment registration is mandatory for…