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HHS/FDA RIN: 0910-AH40 Publication ID: Fall 2016 
Title: ●Topical Antimicrobial Drug Products for Over-the-Counter Human Use: Final Monograph for Consumer Antiseptic Wash 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 with water (referred to as consumer antiseptic washes) 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: Long-Term Actions 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: 21 CFR 310    21 CFR 333   
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 to 361    21 U.S.C. 371    21 U.S.C. 374 to 375    21 U.S.C. 379    42 U.S.C. 216    42 U.S.C. 241    42 U.S.C. 262   
Legal Deadline:
Action Source Description Date
Final  Statutory    09/15/2016 
Action Date FR Cite
NPRM  12/17/2013  78 FR 764444   
NPRM Comment Period End  06/16/2014 
Final Action  To Be Determined 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Pranvera Ikonomi
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:240 402-0272