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:

• Original Active Ingredients and Labeling
• Nonmonograph Ingredients
• Combination Products
• Phenylephrine Bitartrate
• Pseudoephedrine
• Drug Interaction Warning
• Sinusitis
• Pediatric Use
• Phenylpropanolamine (PPA)
• Metaproterenol Sulfate Inhaler

Nasal Decongestant Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	9/9/1976	41FR38312
Reopening of Administrative Record	3/21/1980	45FR18400
Reopening of Administrative Record	9/26/1980	45FR63874
Proposed Rule	Date	FR Citation
Tentative Final Monograph	1/15/1985	50FR2220
Notice: Advisory Committee Meeting	10/24/2007	72FR60377
Final Rule	Date	FR Citation
Final Monograph	8/23/1994	59FR43386
Partial Stay of Effective Date: l-desoxyephedrine	3/8/1996	61FR9570
Final Rule: Adds and renames l-desoxyephedrine to levmetamphetamine	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	5/16/1990	55FR20434
Correction	6/7/1990	55FR23235
Final Rule	Date	FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph	11/7/1990	55FR46914
Correction	12/3/1990	55FR49973
Technical Amendment: Corrects an ingredient name	1/30/1992	57FR3526

Nasal Decongestant Drug Products: Combination Products

Proposed Rule	Date	FR Citation
Proposed Rule	8/12/1988	53FR30522
Clarification: Promethazine HCL combinations	11/14/1988	53FR45774
Proposed Rule: Bronchodilator, expectorant, and nasal decongestant combinations nonmonograph	7/13/2005	70FR40232
Final Rule	Date	FR Citation
Final Rule: nonmonograph combinations	9/27/2001	66FR49276
Correction	10/19/2001	66FR53088
Final Rule: GRASE combinations	12/23/2002	67FR78158
Technical Amendment: Correction	3/19/2007	72FR12730

Nasal Decongestant Drug Products: Phenylephrine Bitartrate

Proposed Rule	Date	FR Citation
Proposed Rule: Adds effervescent tablet as GRASE dosage form	11/2/2004	69FR63482
Notice: Advisory Committee Meeting	10/24/2007	72FR60377
Final Rule	Date	FR Citation
Final Rule: Adds effervescent tablet as GRASE dosage form	8/1/2006	71FR83358

Nasal Decongestant Drug Products: Pseudoephedrine

Final Rule	Date	FR Citation
Final Rule: Reduces maximum daily dose	9/30/1980	45FR64709
Extension of Effective Date	12/19/1980	44FR83671
Stay	5/5/1981	46FR25144

Nasal Decongestant Drug Products: Drug Interaction Warning

Proposed Rule	Date	FR Citation
Proposed Rule: Revises drug interaction warning	6/19/1992	57FR27658
Correction	7/30/1992	57FR33663
Extension of Comment Period	8/6/1992	57FR34734

Nasal Decongestant Drug Products: Sinusitis

Proposed Rule	Date	FR Citation
Proposed Rule: Prohibits sinusitis claim	8/2/2004	69FR46119
Final Rule	Date	FR Citation
Final Rule	10/11/2005	70FR58974

Nasal Decongestant Drug Products: Pediatric Use

Proposed Rule	Date	FR Citation
Notice: Advisory Committee Meeting	8/16/2007	72FR46091
Amendment of Notice: Advisory Committee Meeting	10/1/2007	72FR55784
Notice of Public Hearing: Request for comments	8/25/2008	73FR50033
Notice of Public Hearing: Correction	9/2/2008	73FR51309

Nasal Decongestant Drug Products: Phenylpropanolamine (PPA)

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

Nasal Decongestant Drug Products: Metaproterenol Sulfate Inhaler

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Reopening of Administrative Record	8/30/1983	48FR39242
Correction	9/19/1983	48FR41786