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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 Bronchodilator Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Bronchodilator 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 Bronchodilator Drug Products found on this page:

Original Active Ingredients and Labeling
	Combination Products
	Ephedrine and Epinephrine
	Monoamine Oxidase Inhibitor (MAOI) Warning
	Revised Labeling After 1986 Final Monograph**">Bronchodilator Drug Products: Original Active Ingredients and Labeling**
	Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			9/9/1976
			41FR38312Notice: Prohibits single-ingredient theophylline marketing
			12/10/1976
			41FR54032Reopening of Administrative Record
			3/21/1980
			45FR18400Reopening of Administrative Record: Camphor-containing products
			9/26/1980
			45FR63874Notice: Advisory Committee meeting
			4/29/1983
			48FR19470Notice: Republication of 4/29/1983 notice
			5/6/1983
			48FR20502disclaimer iconProposed Rule
			Date
			*FR* CitationTentative Final Monograph
			10/26/1982
			47FR47520disclaimer iconCorrection
			1/25/1983
			48FR3382disclaimer iconFinal Rule
			Date
			*FR* CitationFinal Monograph
			10/2/1986
			51FR35326disclaimer iconCorrection
			3/13/1987
			52FR7830disclaimer iconCorrection
			4/17/1987
			52FR12521disclaimer iconNotice: OMB approval of final monograph
			3/9/1987
			52FR7126disclaimer iconTechnical Amendment: Clarifies age range for children's dosage
			11/14/1988
			53FR45774disclaimer icon

**">Bronchodilator Drug Products: Combination Products**
	Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationNotice: Classifies caffeine, PPA, ephedrine combinations as nonmonograph
			8/13/1982
			47FR35344disclaimer iconNotice: Classifies caffeine, PPA, ephedrine, pseudoephedrine combinations as nonmonograph
			11/18/1983
			48FR52513disclaimer iconProposed Rule
			Date
			*FR* CitationProposed Rule
			8/12/1988
			53FR30522disclaimer iconClarification: Promethazine HCl combinations
			11/14/1988
			53FR45774disclaimer iconNotice: Bans interim marketing of promethazine HCl combinations
			9/5/1989
			54FR36762disclaimer iconReopening of Administrative Record: Promethazine HCl combinations
			11/28/1989
			54FR48914disclaimer iconCorrection
			1/4/1990
			55FR310disclaimer iconExtension of Comment Period
			1/24/1990
			55FR2387disclaimer iconProposed Rule: Classifies diphenhydramine HCl and citrate combinations as GRASE
			2/23/1995
			60FR10286disclaimer iconProposed Rule: Classifies bronchodilator, expectorant, nasal decongestant combinations as nonmonograph
			7/13/2005
			70FR40232disclaimer iconFinal Rule
			Date
			*FR* CitationFinal Rule: Nonmonograph combinations
			9/27/2001
			66FR49276disclaimer iconCorrection
			10/19/2001
			66FR53088disclaimer iconFinal Rule: GRASE combinations
			12/23/2002
			67FR78158disclaimer iconTechnical Amendment: Correction
			3/19/2007
			72FR12730disclaimer icon

**">Bronchodilator Drug Products: Ephedrine**
	Proposed Rule
			Date
			*FR* CitationProposed Rule: Classifies pressurized metered dose aerosol as nonmonograph
			3/9/1995
			60FR13014disclaimer iconProposed Rule: Classifies ephedrine as nonmonograph
			7/27/1995
			60FR38643disclaimer iconCorrection
			8/18/1995
			60FR43091disclaimer iconProposed Rule: Withdraws 1995 proposed rule and provides additional labeling for products containing ephedrine
			7/13/2005
			70FR40237disclaimer iconFinal Rule
			Date
			*FR* CitationFinal Rule: Classifies pressurized metered dose aerosol as nonmonograph
			5/20/1996
			61FR25142disclaimer iconCorrection
			3/4/1997
			62FR9684disclaimer iconNotice: Public meeting to educate the public about removal of epinephrine metered dose inhalers from the market
			8/20/2009
			74FR42080disclaimer icon

**">Bronchodilator Drug Products: Monoamine Oxidase Inhibitor (MAOI) Warning**
	Proposed Rule
			Date
			*FR* CitationProposed Rule: Requires warning
			6/19/1992
			57FR27662disclaimer iconExtension of Comment Period
			8/6/1992
			57FR34733disclaimer iconFinal Rule
			Date
			*FR* CitationFinal Rule
			10/20/1993
			58FR54238disclaimer icon

                                                                                  Content current as of:
      01/10/2020Historical Status of OTC Rulemakings
 
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