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Rulemaking History for OTC Drug Products Containing Alcohol
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Final Monograph (21 CFR part 328):  
Over-the-Counter Drug Products Intended for Oral Ingestion that Contain Alcohol 

Date Federal Register Citation Description
5/21/1982 47FR22324 PDF document Advance Notice of Proposed Rulemaking
10/21/1993 58FR54466 PDF document Proposed Rule: Alcohol concentration limit for orally ingested products
3/13/1995 60FR13590 PDF document
[HTML] 		Final Rule: Alcohol concentration limit for orally ingested products
5/10/1996 61FR21392 PDF document
[HTML] 		Proposed Rule: Exclusion of Ipecac Syrup from 3/13/1995 Final Rule
11/18/1996 61FR58629 PDF document
[HTML]    		Final Rule: Exclusion of Ipecac Syrup from 3/13/1995 Final Rule

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Date updated: May 9, 2007

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