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 In this section:

                Historical Status of OTC Rulemakings

Historical Status of OTC Rulemakings Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Over-the-Counter OTC | Nonprescription Drugs
          Historical Status of OTC Rulemakings
          Rulemaking History for OTC Nasal Decongestant Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Nasal Decongestant Drug Products
  
  	
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    Print**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 InhalerNasal Decongestant Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			9/9/1976
			41FR38312Reopening of Administrative Record
			3/21/1980
			45FR18400Reopening of Administrative Record
			9/26/1980
			45FR63874Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			1/15/1985
			50FR2220Notice: Advisory Committee Meeting
			10/24/2007
			72FR60377Final Rule
			Date
			*FR* CitationFinal Monograph
			8/23/1994
			59FR43386Partial Stay of Effective Date: l-desoxyephedrine
			3/8/1996
			61FR9570Final Rule: Adds and renames l-desoxyephedrine to levmetamphetamine
			7/30/1998
			63FR40647

Nasal Decongestant Drug Products: Nonmonograph Ingredients

Proposed Rule
			Date
			*FR* CitationProposed Rule: Classifies category II and III ingredients without data as nonmonograph
			5/16/1990
			55FR20434Correction
			6/7/1990
			55FR23235Final Rule
			Date
			*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph
			11/7/1990
			55FR46914Correction
			12/3/1990
			55FR49973Technical Amendment: Corrects an ingredient name
			1/30/1992
			57FR3526

Nasal Decongestant Drug Products: Combination Products

Proposed Rule
			Date
			*FR* CitationProposed Rule
			8/12/1988
			53FR30522Clarification: Promethazine HCL combinations
			11/14/1988
			53FR45774Proposed Rule: Bronchodilator, expectorant, and nasal decongestant combinations nonmonograph
			7/13/2005
			70FR40232Final Rule
			Date
			*FR* CitationFinal Rule: nonmonograph combinations
			9/27/2001
			66FR49276Correction
			10/19/2001
			66FR53088Final Rule: GRASE combinations
			12/23/2002
			67FR78158Technical Amendment: Correction
			3/19/2007
			72FR12730

Nasal Decongestant Drug Products: Phenylephrine Bitartrate

Proposed Rule
			Date
			*FR* CitationProposed Rule: Adds effervescent tablet as GRASE dosage form
			11/2/2004
			69FR63482Notice: Advisory Committee Meeting
			10/24/2007
			72FR60377Final Rule
			Date
			*FR* CitationFinal Rule: Adds effervescent tablet as GRASE dosage form
			8/1/2006
			71FR83358

Nasal Decongestant Drug Products: Pseudoephedrine

Final Rule
			Date
			*FR* CitationFinal Rule: Reduces maximum daily dose
			9/30/1980
			45FR64709Extension of Effective Date
			12/19/1980
			44FR83671Stay
			5/5/1981
			46FR25144

Nasal Decongestant Drug Products: Drug Interaction Warning

Proposed Rule
			Date
			*FR* CitationProposed Rule: Revises drug interaction warning
			6/19/1992
			57FR27658Correction
			7/30/1992
			57FR33663Extension of Comment Period
			8/6/1992
			57FR34734

Nasal Decongestant Drug Products: Sinusitis

Proposed Rule
			Date
			*FR* CitationProposed Rule: Prohibits sinusitis claim
			8/2/2004
			69FR46119Final Rule
			Date
			*FR* CitationFinal Rule
			10/11/2005
			70FR58974

Nasal Decongestant Drug Products: Pediatric Use

Proposed Rule
			Date
			*FR* CitationNotice: Advisory Committee Meeting
			8/16/2007
			72FR46091Amendment of Notice: Advisory Committee Meeting
			10/1/2007
			72FR55784Notice of Public Hearing: Request for comments
			8/25/2008
			73FR50033Notice of Public Hearing: Correction
			9/2/2008
			73FR51309

Nasal Decongestant Drug Products: Phenylpropanolamine (PPA)

Proposed Rule
			Date
			*FR* CitationProposed Rule: Clarifies dosage
			10/28/1977
			42FR56756Proposed Rule: Required labeling
			2/14/1996
			61FR5912Notice: Advisory Committee meeting
			8/30/2000
			65FR52775Notice: Hearing on NDA withdrawal
			8/14/2001
			66FR42665Proposed 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* CitationReopening of Administrative Record
			8/30/1983
			48FR39242Correction
			9/19/1983
			48FR41786

                                                                                  Content current as of:
      02/28/2022Historical Status of OTC Rulemakings
 
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