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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 Stimulant Drug ProductHistorical Status of OTC Rulemakings Rulemaking History for OTC Stimulant Drug Product
  
  	
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    Print**Final Monograph**(21 CFR part 340)**:***Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use*

OTC Stimulant Drug Products found on this page:

Original Active Ingredients and Labeling
	Hangover Symptoms**Stimulant Drug Products: Original Active Ingredients and Labeling**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			12/8/1975
			40FR57292Correction
			1/8/1976
			41FR1498Correction
			1/26/1976
			41FR3745Correction
			1/30/1976
			41FR4600Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			6/13/1978
			43FR25544Reopening of Administrative Record: Category II and III active ingredients
			10/26/1979
			44FR61611Correction
			11/16/1979
			44FR65992Reopening of Administrative Record
			3/21/1980
			45FR18399Notice: Prohibits combination of caffeine, PPA, and ephedrine
			8/13/1982
			47FR35344Notice: Prohibits combination of caffeine, PPA, and ephedrine; allows only caffeine
			11/18/1983
			48FR52513Final Rule
			Date
			*FR* CitationFinal Monograph
			2/29/1988
			53FR6100Correction
			4/8/1988
			53FR11731

**Stimulant Drug Products: Hangover Symptoms**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Adds hangover relief indication
			12/24/1991
			56FR66758Correction
			2/24/1992
			57FR6352Correction
			3/17/1992
			57FR9346

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                                                                                  Content current as of:
      03/01/2022Historical Status of OTC Rulemakings
 
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