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HHS/FDA RIN: 0910-AF33 Publication ID: 2012 
Title: Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) 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. This action addresses cough/cold drug products containing an oral bronchodilator (ephedrine and its salts) in combination with any expectorant or any oral nasal decongestant. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
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 331    21 USC 351 to 353    21 USC 355    21 USC 360    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM (Amendment)  07/13/2005  70 FR 40232   
NPRM Comment Period End  11/10/2005    
Final Action (Technical Amendment)  03/19/2007  72 FR 12730   
Final Action  03/00/2013 
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 
Related RINs: Split from 0910-AA01 
Agency Contact:
Mary Chung
Regulatory Health Project Manager
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:301 796-0260
Fax:301 796-9899
Email: mary.chung@fda.hhs.gov