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HHS/FDA

RIN: 0910-AF33

Publication ID: Fall 2014

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: 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 (Oral Bronchodilator & Oral Nasal Decongestant)	07/00/2015

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: 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