In the June 30, 2016, Federal Register, FDA proposed an amendment to its 1994 tentative final monograph for OTC antiseptic drug products (originally published in the June 17, 1994, Federal Register). The proposed rule applies to active ingredients used in consumer antiseptic rub products, also known as rubs, leave-on products, or hand sanitizers, as well as to consumer antiseptic wipes. In light of recent scientific developments and changes in product use patterns, FDA proposes that additional safety and effectiveness data are necessary to support a generally recognized as safe and generally recognized as effective ("GRAS"/"GRAE") determination for OTC antiseptic rub active ingredients intended for use by consumers. FDA also proposes that all consumer antiseptic rub active ingredients have in vitro data characterizing the ingredient's antimicrobial properties and in vivo clinical simulation studies showing that use of the ingredient achieves specified log reductions in the amount of certain bacteria. Comments are due December 27, 2016.
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