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HHS/FDA RIN: 0910-AG01 Publication ID: Spring 2007 
Title: ●Over-the-Counter (OTC) Drug Review--Multiple Drug Products 
Abstract: Amendments to the Federal Food, Drug, and Cosmetic Act (the act) necessitate several changes to the citations used in Food and Drug Administration (FDA) regulations regarding the prescription-exemption procedure and the list of new drugs that are exempted from the prescription-dispensing requirements. These changes are editorial, pertaining only to citations, and do not constitute a change in FDA regulation. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: First time 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 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a 
Legal Deadline:  None
Timetable:
Action Date FR Cite
Final Action-Technical Amendment  03/30/2007  72 FR 15043 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Local, State 
Small Entities Affected: No  Federalism: Yes 
Included in the Regulatory Plan: No 
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

 
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