FDA to Require Drug Applications for 19 Ingredients of Antibacterial Soaps, Including Triclosan

The Food and Drug Administration on Sept. 6 issued a final rule (here) listing 19 ingredients used in consumer antibacterial soaps, including triclosan and triclocarban, as not generally recognized as safe and effective. Effective Sept. 6, 2017, these 19 consumer antiseptic wash drug products are considered by FDA to be misbranded, and are new drugs for which applications are required for marketing, FDA said. The final rule covers these ingredients only when used in consumer antiseptic washes, it said. Other rulemakings are currently ongoing for ingredients of healthcare antiseptics, consumer antiseptic rubs, first aid antiseptics and antiseptics used by the food industry.