Topical Drug Products for Over-the-Counter Human Use; Products for the Prevention of Swimmer's Ear and for the Drying of Water-Clogged Ears; Final Rule

摘要

The Food and Drug Administration (FDA) is issuing a final rule establishing that any over-the-counter (OTC) topical otic drug product for the prevention of swimmer's ear or for the drying of water-clogged ears is not generally recognized as safe and effective and is 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 OTC topical otic drug products for these uses that have come to the agency's attention. This final rule is part of the ongoing review of OTC drug products conducted by FDA.