Drugs

Rulemaking History for OTC Drug Products Containing Alcohol

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

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OTC Drug Products Containing Alcohol found on this page:

OTC Drug Products Containing Alcohol: Original Active Ingredients & Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
 Advance Notice of Proposed Rulemaking5/21/198247FR22324

OTC Drug Products Containing Alcohol: Inactive Alcohol Concentrations

Proposed RuleDateFR Citation
 Proposed Rule: Alcohol concentration limit for orally ingested products10/21/199358FR54466
Final RuleDateFR Citation
Final Rule3/13/199560FR13590

OTC Drug Products Containing Alcohol: Ipecac Syrup Alcohol Concentrations

Proposed RuleDateFR Citation
Proposed Rule: Exclusion of Ipecac Syrup from 3/13/1995 Final Rule5/10/199661FR21392
Final RuleDateFR Citation
Final Rule11/18/199661FR58629

 

 

 

 

Page Last Updated: 11/29/2016
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