Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Final Monograph for OTC Nasal Decongestant Drug Products

Streszczenie

The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) nasal decongestant drug products (drug products used to relieve nasal congestion caused by acute or chronic rhinitis) are generally recognized as safe and effective and not misbranded. FDA is issuing this final rule after considering public comments on the agency's proposed regulation, which was issued in the form of a tentative final monograph, and all new data and information on nasal decongestant drug products that have come to the agency's attention. Also, this final rule amends the regulation that lists nonmonograph active ingredients by adding those OTC nasal decongestant ingredients that have been found to be not generally recognized as safe and effective and that were not previously listed in the regulation. This final monograph is part of the ongoing review of OTC drug products conducted by FDA.