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


Date Federal Register Citation Description

9/9/1976

41FR38312 PDF document

Advance Notice of Proposed Rulemaking

3/21/1980

45FR18400 PDF document

Reopening of Administrative Record

9/26/1980

45FR63874 PDF document

Reopening of Administrative Record: Camphor-containing products

7/9/1982

 47FR30002 PDF document

Tentative Final Monograph

8/27/1982

 47FR37934 PDF document

Extension of Comment Period: Tentative Final Monograph

8/12/1988

 53FR30522 PDF document

Proposed Rule: Miscellaneous combinations

11/14/1988

 53FR45774 PDF document

Clarification: Includes promethazine HCl combinations (8/12/1988 Proposed Rule)

2/28/1989

 54FR8494 PDF document

Final Monograph

3/22/1989

 54FR11866 PDF document

Correction: Final Monograph

9/5/1989

 54FR36762 PDF document

Notice: Prohibits OTC marketing of promethazine HCl

11/28/1989

 54FR48914 PDF document

Reopening of Administrative Record: Promethazine HCL

1/4/1990

55FR310 PDF document

Correction: 11/28/1989 Reopening of Administrative Record

1/24/1990

 55FR2387 PDF document

Extension of Comment Period: 11/28/1989 Reopening of Administrative Record

6/30/1992

 57FR29176 PDF document

Technical Amendment: Replaces "sputum" with "mucus" in indications (Final Monograph)

9/14/1992

 57FR41857 PDF document

Final Rule: Classifies ipecac as nonmonograph

10/6/1992

 57FR46067 PDF document

Correction: 9/14/1992 Final Rule

7/13/2005 70FR40232 PDF document
[HTML]
Proposed Rule: Bronchodilator, expectorant, and nasal decongestant combinations nonmonograph
8/16/2007 72FR46091 Adobe Acrobat Symbol
[HTML]
Notice: Advisory Committee Meeting

10/1/2007

72R55784 PDF document
[HTML]
Amendment of Notice: Advisory Committee Meeting
8/25/2008 73FR50033 Adobe Acrobat Symbol
Notice of Public Hearing; Request for comments

9/1/2008

73FR51309 PDF document
Notice of Public Hearing: Correction

PDF document PDF requires the free Adobe Acrobat Reader

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Date updated: September 8, 2008

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