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  7. Rulemaking History for OTC Nasal Decongestant Drug Products
  1. Status of OTC Rulemakings

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 Rulemaking9/9/197641FR38312
   Reopening of Administrative Record3/21/198045FR18400
   Reopening of Administrative Record9/26/198045FR63874
Proposed RuleDateFR Citation
Tentative Final Monograph1/15/198550FR2220
Notice: Advisory Committee Meeting10/24/200772FR60377
Final RuleDateFR Citation
Final Monograph8/23/199459FR43386
   Partial Stay of Effective Date: l-desoxyephedrine3/8/199661FR9570
Final Rule: Adds and renames l-desoxyephedrine to levmetamphetamine7/30/199863FR40647

Nasal Decongestant Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
   Correction6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
   Correction12/3/199055FR49973
   Technical Amendment: Corrects an ingredient name1/30/199257FR3526

Nasal Decongestant Drug Products: Combination Products

Proposed RuleDateFR Citation
 Proposed Rule8/12/198853FR30522
   Clarification: Promethazine HCL combinations11/14/198853FR45774
Proposed Rule: Bronchodilator, expectorant, and nasal decongestant combinations nonmonograph7/13/200570FR40232
Final RuleDateFR Citation
Final Rule: nonmonograph combinations9/27/200166FR49276
   Correction10/19/200166FR53088
Final Rule: GRASE combinations12/23/200267FR78158
   Technical Amendment: Correction3/19/200772FR12730

Nasal Decongestant Drug Products: Phenylephrine Bitartrate

Proposed RuleDateFR Citation
Proposed Rule: Adds effervescent tablet as GRASE dosage form11/2/200469FR63482
Notice: Advisory Committee Meeting10/24/200772FR60377
Final RuleDateFR Citation
Final Rule: Adds effervescent tablet as GRASE dosage form8/1/200671FR83358

Nasal Decongestant Drug Products: Pseudoephedrine

Final RuleDateFR Citation
Final Rule: Reduces maximum daily dose9/30/198045FR64709
   Extension of Effective Date12/19/198044FR83671
   Stay5/5/198146FR25144

Nasal Decongestant Drug Products: Drug Interaction Warning

Proposed RuleDateFR Citation
Proposed Rule: Revises drug interaction warning6/19/199257FR27658
   Correction7/30/199257FR33663
   Extension of Comment Period8/6/199257FR34734

Nasal Decongestant Drug Products: Sinusitis

Proposed RuleDateFR Citation
Proposed Rule: Prohibits sinusitis claim8/2/200469FR46119
Final RuleDateFR Citation
Final Rule10/11/200570FR58974

Nasal Decongestant Drug Products: Pediatric Use

Proposed RuleDateFR Citation
Notice: Advisory Committee Meeting8/16/200772FR46091
Amendment of Notice: Advisory Committee Meeting10/1/200772FR55784
Notice of Public Hearing: Request for comments8/25/200873FR50033
Notice of Public Hearing: Correction9/2/200873FR51309

Nasal Decongestant Drug Products: Phenylpropanolamine (PPA)

Proposed RuleDateFR Citation
Proposed Rule: Clarifies dosage10/28/197742FR56756
Proposed Rule: Required labeling2/14/199661FR5912
Notice: Advisory Committee meeting8/30/200065FR52775
Notice: Hearing on NDA withdrawal8/14/200166FR42665
Proposed Rule: Reclassifies phenylpropanolamine from category I to II12/22/200570FR75988

Nasal Decongestant Drug Products: Metaproterenol Sulfate Inhaler

Advance Notice Of Proposed RulemakingDateFR Citation
Reopening of Administrative Record8/30/198348FR39242
   Correction9/19/198348FR41786