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HHS/FDA RIN: 0910-AA01 Publication ID: Spring 2002 
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: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 310; 21 CFR 340 to 345; 21 CFR 330; 21 CFR 333 to 339 
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
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

 
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