Drugs

Rulemaking History for OTC Nasal Decongestant Drug Products

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

OTC Nasal Decongestant Drug Products found on this page:


Nasal Decongestant Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 9/9/1976 41FR38312
    Reopening of Administrative Record [PDF] 3/21/1980 45FR18400
    Reopening of Administrative Record [PDF] 9/26/1980 45FR63874
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 1/15/1985 50FR2220
Notice: Advisory Committee Meeting [PDF] 10/24/2007 72FR60377
Final Rule Date FR Citation
Final Monograph [PDF] 8/23/1994 59FR43386
    Partial Stay of Effective Date: l-desoxyephedrine [PDF] 3/8/1996 61FR9570
Final Rule: Adds and renames l-desoxyephedrine to levmetamphetamine [PDF] 7/30/1998 63FR40647
 
Nasal Decongestant Drug Products: Nonmonograph Ingredients
Proposed Rule Date FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 5/16/1990 55FR20434
    Correction [PDF] 6/7/1990 55FR23235
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 11/7/1990 55FR46914
    Correction [PDF] 12/3/1990 55FR49973
    Technical Amendment: Corrects an ingredient name [PDF] 1/30/1992 57FR3526
 
Nasal Decongestant Drug Products: Combination Products
Proposed Rule Date FR Citation
 Proposed Rule [PDF] 8/12/1988 53FR30522
    Clarification: Promethazine HCL combinations [PDF] 11/14/1988 53FR45774
Proposed Rule: Bronchodilator, expectorant, and nasal decongestant combinations nonmonograph [PDF] 7/13/2005 70FR40232
Final Rule Date FR Citation
Final Rule: nonmonograph combinations [PDF] 9/27/2001 66FR49276
    Correction [PDF] 10/19/2001 66FR53088
Final Rule: GRASE combinations [PDF] 12/23/2002 67FR78158
    Technical Amendment: Correction [PDF] 3/19/2007 72FR12730

Nasal Decongestant Drug Products: Phenylephrine Bitartrate
Proposed Rule Date FR Citation
Proposed Rule: Adds effervescent tablet as GRASE dosage form [PDF] 11/2/2004 69FR63482
Notice: Advisory Committee Meeting [PDF] 10/24/2007 72FR60377
Final Rule Date FR Citation
Final Rule: Adds effervescent tablet as GRASE dosage form [PDF] 8/1/2006 71FR83358

Nasal Decongestant Drug Products: Pseudoephedrine
Final Rule Date FR Citation
Final Rule: Reduces maximum daily dose [PDF] 9/30/1980 45FR64709
    Extension of Effective Date [PDF] 12/19/1980 44FR83671
    Stay [PDF] 5/5/1981 46FR25144

Nasal Decongestant Drug Products: Drug Interaction Warning
Proposed Rule Date FR Citation
Proposed Rule: Revises drug interaction warning [PDF] 6/19/1992 57FR27658
    Correction [PDF] 7/30/1992 57FR33663
    Extension of Comment Period [PDF] 8/6/1992 57FR34734

Nasal Decongestant Drug Products: Sinusitis
Proposed Rule Date FR Citation
Proposed Rule: Prohibits sinusitis claim [PDF] 8/2/2004 69FR46119
Final Rule Date FR Citation
Final Rule [PDF] 10/11/2005 70FR58974

Nasal Decongestant Drug Products: Pediatric Use
Proposed Rule Date FR Citation
Notice: Advisory Committee Meeting [PDF] 8/16/2007 72FR46091
Amendment of Notice: Advisory Committee Meeting [PDF] 10/1/2007 72FR55784
Notice of Public Hearing: Request for comments [PDF] 8/25/2008 73FR50033
Notice of Public Hearing: Correction [PDF] 9/2/2008 73FR51309

Nasal Decongestant Drug Products: Phenylpropanolamine (PPA)
Proposed Rule Date FR Citation
Proposed Rule: Clarifies dosage [PDF] 10/28/1977 42FR56756
Proposed Rule: Required labeling [PDF] 2/14/1996 61FR5912
Notice: Advisory Committee meeting [PDF] 8/30/2000 65FR52775
Notice: Hearing on NDA withdrawal [PDF] 8/14/2001 66FR42665
Proposed Rule: Reclassifies phenylpropanolamine from category I to II [PDF] 12/22/2005 70FR75988

Nasal Decongestant Drug Products: Metaproterenol Sulfate Inhaler
Advance Notice Of Proposed Rulemaking Date FR Citation
Reopening of Administrative Record [PDF] 8/30/1983 48FR39242
    Correction [PDF] 9/19/1983 48FR41786

 

 

Page Last Updated: 10/29/2014
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