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U.S. Department of Health and Human Services

About FDA

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February 10, 1959

Pictures of nasal inhalers

Michael A. Bozarth, Ph.D., State University of New York at Buffalo
FDA announces that nasal inhalers containing basic amphetamine may now be sold only by prescription. Previously this product (used for relieving nasal congestion) had been sold directly to the public.


FDA in 2006


Basic amphetamine has been replaced by safer, more effective prescription and over-the-counter (OTC) products for relieving nasal congestion. The FDA monitors more than 100,000 OTC drug products, containing about 800 significant active ingredients. Most OTC drug products have been sold for many years, prior to the laws that require proof of safety and effectiveness before marketing. Through its OTC Drug Review Program, the FDA evaluates the ingredients and labeling of these products and establishes monographs for each class of product. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, labeling, and testing



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