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U.S. Department of Health and Human Services

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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 RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]9/9/197641FR38312
    Reopening of Administrative Record [PDF]3/21/198045FR18400
    Reopening of Administrative Record [PDF]9/26/198045FR63874
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]1/15/198550FR2220
Notice: Advisory Committee Meeting [PDF]10/24/200772FR60377
Final RuleDateFR Citation
Final Monograph [PDF]8/23/199459FR43386
    Partial Stay of Effective Date: l-desoxyephedrine [PDF]3/8/199661FR9570
Final Rule: Adds and renames l-desoxyephedrine to levmetamphetamine [PDF]7/30/199863FR40647
 
Nasal Decongestant Drug Products: Nonmonograph Ingredients
Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]5/16/199055FR20434
    Correction [PDF]6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]11/7/199055FR46914
    Correction [PDF]12/3/199055FR49973
    Technical Amendment: Corrects an ingredient name [PDF]1/30/199257FR3526
 
Nasal Decongestant Drug Products: Combination Products
Proposed RuleDateFR Citation
 Proposed Rule [PDF]8/12/198853FR30522
    Clarification: Promethazine HCL combinations [PDF]11/14/198853FR45774
Proposed Rule: Bronchodilator, expectorant, and nasal decongestant combinations nonmonograph [PDF]7/13/200570FR40232
Final RuleDateFR Citation
Final Rule: nonmonograph combinations [PDF]9/27/200166FR49276
    Correction [PDF]10/19/200166FR53088
Final Rule: GRASE combinations [PDF]12/23/200267FR78158
    Technical Amendment: Correction [PDF]3/19/200772FR12730

Nasal Decongestant Drug Products: Phenylephrine Bitartrate
Proposed RuleDateFR Citation
Proposed Rule: Adds effervescent tablet as GRASE dosage form [PDF]11/2/200469FR63482
Notice: Advisory Committee Meeting [PDF]10/24/200772FR60377
Final RuleDateFR Citation
Final Rule: Adds effervescent tablet as GRASE dosage form [PDF]8/1/200671FR83358

Nasal Decongestant Drug Products: Pseudoephedrine
Final RuleDateFR Citation
Final Rule: Reduces maximum daily dose [PDF]9/30/198045FR64709
    Extension of Effective Date [PDF]12/19/198044FR83671
    Stay [PDF]5/5/198146FR25144

Nasal Decongestant Drug Products: Drug Interaction Warning
Final RuleDateFR Citation
Proposed Rule: Revises drug interaction warning [PDF]6/19/199257FR27658
    Correction [PDF]7/30/199257FR33663
    Extension of Comment Period [PDF]8/6/199257FR34734

Nasal Decongestant Drug Products: Sinusitis
Proposed RuleDateFR Citation
Proposed Rule: Prohibits sinusitis claim [PDF]8/2/200469FR46119
Final RuleDateFR Citation
Final Rule [PDF]10/11/200570FR58974

Nasal Decongestant Drug Products: Pediatric Use
Proposed RuleDateFR Citation
Notice: Advisory Committee Meeting [PDF]8/16/200772FR46091
Amendment of Notice: Advisory Committee Meeting [PDF]10/1/200772FR55784
Notice of Public Hearing: Request for comments [PDF]8/25/200873FR50033
Notice of Public Hearing: Correction [PDF]9/2/200873FR51309

Nasal Decongestant Drug Products: Phenylpropanolamine (PPA)
Proposed RuleDateFR Citation
Proposed Rule: Clarifies dosage [PDF]10/28/197742FR56756
Proposed Rule: Required labeling [PDF]2/14/199661FR5912
Notice: Advisory Committee meeting [PDF]8/30/200065FR52775
Notice: Hearing on NDA withdrawal [PDF]8/14/200166FR42665
Proposed Rule: Reclassifies phenylpropanolamine from category I to II [PDF]12/22/200570FR75988

Nasal Decongestant Drug Products: Metaproterenol Sulfate Inhaler
Advance Notice Of Proposed RulemakingDateFR Citation
Reopening of Administrative Record [PDF]8/30/198348FR39242
    Correction [PDF]9/19/198348FR41786