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HHS/FDA RIN: 0910-AF33 Publication ID: Spring 2018 
Title: Combinations of Bronchodilators With Nasal Decongestant; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use 
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. These actions address cough/cold drug products containing an oral bronchodilator (ephedrine and its salts) in combination with 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: Long-Term Actions 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: 21 CFR 201    21 CFR 310    21 CFR 330 to 358   
Legal Authority: 21 U.S.C. 321p    21 U.S.C. 351 to 353    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 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 Rule  To Be Determined 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Local, State 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Related to 0910-AH16 
Agency Contact:
Janice Adams-King
Regulatory Health Project Manager
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-3713
Fax:301 796-9899
Email: janice.adams-king@fda.hhs.gov