0910-AH97 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Topical Antimicrobial Drug Products for Over-the-Counter Human Use: Final Monograph for Consumer Antiseptic Rub Products

This final rule amends the 1994 tentative final monograph (TFM) for over-the-counter (OTC) antiseptic drug products that published in the Federal Register of June 17, 1994,(the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA. In this final rule, we address whether certain active ingredients used in OTC consumer antiseptic products intended for use without water (referred to as consumer antiseptic rubs) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded.

]]> Other Significant First Time Published in The Unified Agenda Final Rule Stage No No Regulatory 21 CFR 310 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 360 and 361 21 U.S.C. 371 21 U.S.C. 374 and 375 21 U.S.C. 379 42 U.S.C. 216 42 U.S.C. 241 and 242 42 U.S.C. 262 Judicial Final 04/15/2019 NRDC V FDA, Consent Decree NRDC and FDA, under a judicial Consent Decree, agreed that FDA would publish the final monograph for Consumer Antiseptic Rub Products in the Federal Register by April 15, 2019 (10 Civ. 5690) No Final Rule 04/00/2019 Undetermined Undetermined Undetermined No No Anita Kumar Biologist 0910 Food and Drug Administration FDA 301 796-1032 anita.kumar@fda.hhs.gov Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 22, Room 5445, Silver Spring MD 20993