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HHS/FDA RIN: 0910-AA01 Publication ID: Spring 2004 
Title: Over-the-Counter (OTC) Drug Review 
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. SMALL ENTITIES AFFECTED: The effects, if any, vary depending on the individual rulemaking. However, the Agency anticipates that the rules would not have a significant economic impact on a substantial number of small entities as defined by the Regulatory Flexibility Act. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed 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 351 to 353    21 USC 355    21 USC 360a    21 USC 371a    21 USC 331    21 USC 360    21 USC 360b    21 USC 361    21 USC 371   

Legal Deadline:  None
Timetable:
Action Date FR Cite
Actions Will Continue Under Separate Rulemakings  06/08/2004    
Child RIN List:
RIN Title
0910-AC65 Anorectal Products
0910-AC71 Antiemetic Products
0910-AC89 Antiperspirant Products
0910-AD31 Cough/Cold (Antihistamine) Products
0910-AD24 Cough/Cold (Antitussive) Products
0910-AD25 Cough/Cold (Combination) Products
0910-AD43 Cough/Cold (Nasal Decongestant) Products
0910-AD06 External Analgesic Products
0910-AD21 Ingrown Toenail Relief Products
0910-AD07 Internal Analgesic Products
0910-AD47 Labeling of Drug Products for OTC Human Use
0910-AD11 Nighttime Sleep Aid Products
0910-AC72 Ophthalmic Products
0910-AC98 Oral Health Care Products
0910-AC79 Pediculicide Products
0910-AD13 Salicylate (Reye's Syndrome)
0910-AC68 Sunscreen Products
0910-AD19 Vaginal Contraceptive Products
0910-AC93 Weight Control Products
0910-AC85 Laxative Drug Products
0910-AC82 Antidiarrheal Products
0910-AD33 Cough/Cold (Bronchodilator) Products
0910-AC96 Skin Protectant Products
0910-AF17 Skin Bleaching Products
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
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