View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AH97 Publication ID: Spring 2018 
Title: ●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.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 310   
Legal Authority: 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   
Legal Deadline:
Action Source Description Date
Final  Judicial  NRDC V FDA, Consent Decree  04/15/2019 

Overall Description of Deadline: 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)

Action Date FR Cite
Final Rule  04/00/2019 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Anita Kumar
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 22, Room 5445,
Silver Spring, MD 20993
Phone:301 796-1032