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U.S. Department of Health and Human Services

Drugs

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Rulemaking History for OTC Drug Products Containing Containing Alcohol

Final 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:


OTC Drug Products Containing Alcohol: Original Active Ingredients & Labeling
Advance Notice Of Proposed RulemakingDateFR Citation
 Advance Notice of Proposed Rulemaking (PDF)5/21/198247FR22324

OTC Drug Products Containing Alcohol: Inactive Alcohol Concentrations
Proposed RuleDateFR Citation
 Proposed Rule: Alcohol concentration limit for orally ingested products (PDF)10/21/199358FR54466
Final RuleDateFR Citation
Final Rule (PDF)3/13/199560FR13590

OTC Drug Products Containing Alcohol: Ipecac Syrup Alcohol Concentrations
Proposed RuleDateFR Citation
Proposed Rule: Exclusion of Ipecac Syrup from 3/13/1995 Final Rule (PDF)5/10/199661FR21392
Final RuleDateFR Citation
Final Rule (PDF)11/18/199661FR58629
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