0910-AF69 201604 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products

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.

 

]]> Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes Private Sector 21 CFR 201 21 CFR 310 21 CFR 330 to 358 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 Judicial NPRM 09/15/2015 No NPRM (Healthcare) 06/17/1994 59 FR 31402 Comment Period End 12/15/1995 NPRM (Consumer Hand Wash Products) 12/17/2013 78 FR 76443 NPRM (Consumer Hand Wash) Comment Period End 06/16/2014 NPRM (Healthcare Antiseptic) 05/01/2015 80 FR 25166 NPRM Comment Period End (Healthcare Antiseptic) 10/28/2015 NPRM (Consumer Hand Rub) 06/00/2016 Final Rule (Consumer Hand Wash) 09/00/2016 Yes Businesses Local State Yes Yes No Janice Adams-King Regulatory Project Manager 0910 Food and Drug Administration FDA 301 796-3713 janice.adams-king@fda.hhs.gov Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring MD 20993