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HHS/FDA RIN: 0910-AF42 Publication ID: Spring 2005 
Title: Over-the-Counter (OTC) Drug Review--Skin Protectant 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. One action addresses labeling for products formulated and marketed as lip protectants. The second action addresses skin protectant products to protect and treat fever blisters and cold sores. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
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 351 to 353    21 USC 355    21 USC 360a    21 USC 371a    21 USC 331    21 USC 360    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Final Action (Technical Amendments)  08/00/2005    
Final Action (Fever Blisters/Cold Sores)  01/00/2006    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Related RINs: Split from 0910-AA01 
Agency Contact:
Gerald M. Rachanow
Regulatory Counsel, Division of Over-the-Counter Drug Products
Department of Health and Human Services
Food and Drug Administration
HFD-560, Center for Drug Evaluation and Research (HFD-560), 5600 Fishers Lane,
Rockville, MD 20857
Phone:301 827-2241
Fax:301 827-2315
Email: gerald.rachanow@fda.hhs.gov