View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML
HHS/FDA RIN: 0910-AH16 Publication ID: Spring 2018 
Title: Combinations of Bronchodilators With Expectorants; 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 expectorant.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: State, local, or tribal governments 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 201    21 CFR 310    21 CFR 330 to 358   
Legal Authority: 21 U.S.C. 321p    21 U.S.C. 331    21 U.S.C. 351 to 353    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 371   
Legal Deadline:
Action Source Description Date
Final  Statutory    12/01/2014 
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: 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-AF33 
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