Rulemaking History for OTC Expectorant Drug Products

Final Monograph(21 CFR part 341):
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use

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OTC Expectorant Drug Products found on this page:

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	9/9/1976	41FR38312
Reopening of Administrative Record	3/21/1980	45FR18400
Reopening of Administrative Record	9/26/1980	45FR63874
Proposed Rule	Date	FR Citation
Tentative Final Monograph	7/9/1982	47FR30002
Extension of Comment Period	8/27/1982	47FR37934
Final Rule	Date	FR Citation
Final Monograph	2/28/1989	54FR8494
Correction	3/22/1989	54FR11866
Technical Amendment: Replaces "sputum" with "mucus" in indication	6/30/1992	57FR29176
Final Rule: Classifies ipecac as nonmonograph	9/14/1992	57FR41857
Correction	10/6/1992	57FR46067

Proposed Rule	Date	FR Citation
Proposed Rule: Miscellaneous combinations	8/12/1988	53FR30522
Clarification: Includes promethazine HCl combinations	11/14/1988	53FR45774
Notice: Prohibits OTC marketing of promethazine HCl combinations	9/5/1989	54FR36762
Reopening of Administrative Record: Promethazine HCl combinations	11/28/1989	54FR48914
Correction	1/4/1990	55FR310
Extension of Comment Period	1/24/1990	55FR2387
Proposed Rule: Bronchodilator, expectorant, and nasal decongestant combinations nonmonograph	7/13/2005	70FR40232

Proposed Rule	Date	FR Citation
Notice: Advisory Committee Meeting	8/16/2007	72FR46091
Amendment of Notice: Advisory Committee Meeting	10/1/2007	72FR55784
Notice of Public Hearing: Request for comments	8/25/2008	73FR50033
Notice of Public Hearing: Correction	9/2/2008	73FR51309