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Rulemaking History for OTC Nasal Decongestant Drug Products
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Final Monograph (21 CFR 341):  
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
[PDF] [HTML]

Date Federal Register Citation Description

9/9/1976

41FR38312 Adobe Acrobat Symbol

Advance Notice of Proposed Rulemaking

10/28/1977

42FR56756 Adobe Acrobat Symbol

Proposed Rule: phenylpropanolamine (PPA) dosage clarification

3/21/1980

45FR18400 Adobe Acrobat Symbol

Notice acceptance of data into record

9/26/1980

45FR63874 Adobe Acrobat Symbol

Reopening of administration record

9/30/1980

44FR64709 Adobe Acrobat Symbol

Notice: pseudoephedrine dosage

12/19/1980 44FR83671 Adobe Acrobat Symbol Notice: pseudoephedrine dosage: effective date delay
5/5/1981 46FR25144 Adobe Acrobat Symbol Notice: pseudoephedrine dosage

8/30/1983

48FR39242 Adobe Acrobat Symbol

Reopening of Administrative Record: Metaproterenol sulfate inhaler

9/19/1983 48FR41786 Adobe Acrobat Symbol Correction: 8/30/1983 Reopening of Administrative Record
1/15/1985 50FR2220  Adobe Acrobat Symbol Proposed Rule: nasal decongestant

8/12/1988

53FR30522 Adobe Acrobat Symbol

Proposed Rule: combination

11/14/1988

53FR45774 Adobe Acrobat Symbol

Clarification notice: Proposed Rule: combination

5/16/1990 55FR20434 Adobe Acrobat Symbol Proposed Rule: Classifies category II and III ingredients without data as nonmonograph
6/7/1990 55FR23235 Adobe Acrobat Symbol Correction: 5/16/1990 Proposed Rule

6/20/1990

55FR25234 Adobe Acrobat Symbol

Proposed Rule: Classified diaper rash indication as nonmonograph
11/7/1990 55FR46914 Adobe Acrobat Symbol Final Rule: Classifies category II and III ingredients without data as nonmonograph
12/3/1990 55FR49973 Adobe Acrobat Symbol Correction: 11/7/1990 Final Rule
6/19/1992 57FR27658 Adobe Acrobat Symbol Proposed Rule: nasal decongestant amendment
7/30/1992 57FR33663 Adobe Acrobat Symbol Correction: nasal decongestant
8/6/1992 57FR34734 Adobe Acrobat Symbol Extension of comment period: nasal decongestant
8/23/1994 59FR43386 Adobe Acrobat Symbol Final Rule: nasal decongestant
3/8/1996 61FR9570 Adobe Acrobat Symbol
[HTML]		 Partial stay: Final Rule: nasal decongestant
7/30/1998 63FR40647 Adobe Acrobat Symbol
[HTML]		 Final Rule: nasal decongestant Final Monograph amendment

8/30/2000

65FR52775 Adobe Acrobat Symbol
[HTML]

Notice: Non-prescription Drugs Advisory Committee meeting (PPA)

8/14/2001

66FR42665 Adobe Acrobat Symbol
[HTML]

Opportunity for a hearing: proposal to withdraw approval of NDA and ANDA (PPA)

9/27/2001

66FR49276 Adobe Acrobat Symbol
[HTML]

Final Rule: Nonmonograph combinations

10/19/2001

66FR53088 Adobe Acrobat Symbol
[HTML]

Correction: 9/27/2001 Final Rule

12/23/2002

67FR78158 Adobe Acrobat Symbol
[HTML]

Final Rule: combination drug products

8/2/2004  69FR46119 Adobe Acrobat Symbol
[HTML]		 Final monograph amendment
11/2/2004 69FR63482 Adobe Acrobat Symbol
[HTML]		 Proposed Rule: nasal decongestant drug products
7/13/2005 70FR40232 Adobe Acrobat Symbol
[HTML]		  Proposed Rule: Bronchodilator, expectorant, and nasal decongestant combinations nonmonograph
7/13/2005 70FR40237 Adobe Acrobat Symbol
[HTML]		 Proposed rule: withdrawal of previous proposed rule
10/11/2005 70FR58974 Adobe Acrobat Symbol
[HTML]		 Amendment of Final Monograph for Over-the-Counter Nasal Decongestant Drug Products; Final Rule
12/22/2005 70FR75988 Adobe Acrobat Symbol
 Proposed Rule: Reclassifies phenylpropanolamine from category I to II
8/1/2006 71FR43358 Adobe Acrobat Symbol
[HTML]		 Final Rule: Phenylephrine bitartrate (PEB)
3/19/2007 72FR12730 Adobe Acrobat Symbol
[HTML]		 Technical Amendment: Correction (12/23/2002 Final Rule)
8/16/2007 72FR46091 Adobe Acrobat Symbol
[HTML]		 Notice: Advisory Committee Meeting
10/1/2007 72R55784 Adobe Acrobat Symbol
[HTML]		 Amendment of Notice: Advisory Committee Meeting
10/24/2007 72FR60377 Adobe Acrobat Symbol
[HTML]		 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

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Date updated: September 8, 2008
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