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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance is intended to help small businesses better understand and comply with the final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic wash products are not generally recognized as safe and effective (GRASE), and thus, are ineligible for inclusion in the OTC topical antiseptic monograph. On September 6, 2016, FDA published a final rule that finalizes the nonmonograph status of 19 active ingredients, including triclosan and triclocarban, which are intended for use in OTC consumer antiseptic wash products (81 FR 61106) (Consumer Antiseptic Wash Final Rule). Three active ingredients— benzalkonium chloride, benzethonium chloride, and chloroxylenol — were deferred from the final rule to allow more time for sponsors who proposed to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients. These deferrals are for one year, subject to renewal if adequate progress is made in filling the data gaps.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-3906.