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HHS/FDA | RIN: 0910-AF33 | Publication ID: Spring 2014 |
Title: Combinations of Bronchodilators With Nasal Decongestants or 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 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 |
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Timetable:
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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: 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 |