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HHS/FDA RIN: 0910-AF69 Publication ID: Fall 2009 
Title: Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products 
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. The first action addresses health care products. The second action addresses food handler products. The third action addresses testing requirements. The fourth action addresses consumer products. The final actions listed will address the healthcare, consumer, and first aid antiseptic drug products respectively. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 201    21 CFR 310    21 CFR 330 to 358   
Legal Authority: 21 USC 321p    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 360    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM (Healthcare)  06/17/1994  59 FR 31402   
NPRM (Food Handlers)  To Be Determined    
NPRM (Testing)  To Be Determined    
NPRM (Consumer)  12/00/2010    
Final Action (Healthcare)  To Be Determined    
Final Action (Consumer)  To Be Determined    
Final Action (First Aid Antiseptic)  To Be Determined    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Local, State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Walter J. Ellenberg
Regulatory Project Management Officer
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-2090
Fax:301 796-9899
Email: walter.ellenberg@fda.hhs.gov