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HHS/FDA | RIN: 0910-AF69 | Publication ID: Fall 2016 |
Title: Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | |
Abstract:
The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses antimicrobial agents in consumer antiseptic hand wash.
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Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Completed Actions |
Major: Yes | Unfunded Mandates: No |
CFR Citation: 21 CFR 310 21 CFR 333 | |
Legal Authority: 21 U.S.C. 321p 21 U.S.C. 331 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 371 21 U.S.C. 361 21 U.S.C. 374 21 U.S.C 375 21 U.S.C 379 42 U.S.C. 216 42 U.S.C. 241 42 U.S.C. 242 42 U.S.C. 262 ... |
Legal Deadline:
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Timetable:
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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: Janice Adams-King Regulatory Project Manager Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-3713 Email: janice.adams-king@fda.hhs.gov |