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                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 Drug Products Containing AlcoholHistorical Status of OTC Rulemakings Rulemaking History for OTC Drug Products Containing Alcohol
  
  	
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    PrintFinal Monograph (21 CFR part 328):*Over-the-Counter Drug Products Intended for Oral Ingestion that Contain Alcohol*

OTC Drug Products Containing Alcohol found on this page:

Original Active Ingredients & Labeling
	Inactive Alcohol Concentrations
	Ipecac Syrup Alcohol Concentrations**OTC Drug Products Containing Alcohol: Original Active Ingredients & Labeling**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			5/21/1982
			47FR22324

**OTC Drug Products Containing Alcohol: Inactive Alcohol Concentrations**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Alcohol concentration limit for orally ingested products
			10/21/1993
			58FR54466Final Rule
			Date
			*FR* CitationFinal Rule
			3/13/1995
			60FR13590

**OTC Drug Products Containing Alcohol: Ipecac Syrup Alcohol Concentrations**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Exclusion of Ipecac Syrup from 3/13/1995 Final Rule
			5/10/1996
			61FR21392Final Rule
			Date
			*FR* CitationFinal Rule
			11/18/1996
			61FR58629

                                                                                  Content current as of:
      02/04/2020Historical Status of OTC Rulemakings
 
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