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FDA Takes Action Against Unapproved Prescription Cough, Cold, and Allergy Products
FDA took action against companies that manufacture, distribute, or market certain unapproved and misbranded prescription oral cough, cold, and allergy products, as announced in a Federal Register notice (PDF) on March 3, 2011. The products are marketed without approved applications, and many are inappropriately labeled for use by infants and young children. Further, FDA indicates that “many health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval.” Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, states in a news release that “Removing these unapproved products from the market will reduce potential risks to consumers.” FDA notes that there are many FDA-approved prescription cough, cold, and allergy drug products, as well as appropriately marketed over-the-counter products, and that taking an unapproved prescription product is an unnecessary risk.
Companies that have products subject to this FDA action that are commercially used or sold in the US, have a National Drug Code number listed with FDA, and are in full compliance with section 510 of the Federal Food, Drug, and Cosmetic Act before March 2, 2011 (‘‘currently marketed and listed’’), are expected to stop manufacturing them within 90 days and stop shipping the products within 180 days. A list of unapproved prescription cough, cold, and allergy products is available on the FDA Web site. Companies that have not previously listed products subject to this FDA action, or that have listed products, but the product is not being commercially used or sold, are expected to stop manufacturing and shipping their products immediately. The Federal Register notice provides a detailed explanation of the enforcement dates associated with this action. This action is part of the FDA Unapproved Drugs Initiative, which began in June 2006.
