|View EO 12866 Meetings||Printer-Friendly Version Download RIN Data in XML|
|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:|
|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|
|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|
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue,
Silver Spring, MD 20993