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How do I market an Over-the-Counter (OTC) drug?
Over 100,000 OTC drug products, which contain approximately 700 active ingredients, are currently marketed. OTC drug products are legally marketed in the United States as a result of two types of review by the FDA: OTC drug monograph review or new drug review. The majority of currently marketed OTC drug products have been evaluated under the OTC drug monograph review. Under this review, the FDA evaluates the active ingredients in products after they have met certain marketing requirements to affirm that they are safe, effective, and properly labeled for their intended uses. This is an active ingredient review, rather than a product-by-product (new) drug review. As a result, the FDA publishes OTC drug monographs that list active ingredients, allowed combinations, and required labeling for classes of OTC drug products (e.g., antacids, cough-cold products). In general, to market an OTC product, the product must meet the standards of the OTC monograph.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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