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
 


OTC Drug Products Containing Alcohol: Inactive Alcohol Concentrations
Date FR Citation
 Proposed Rule: Alcohol concentration limit for orally ingested products (PDF) 10/21/1993 58FR54466
Final Rule Date FR Citation
Final Rule (PDF) 3/13/1995 60FR13590

OTC Drug Products Containing Alcohol: Ipecac Syrup Alcohol Concentrations
Proposed Rule Date FR Citation
Proposed Rule: Exclusion of Ipecac Syrup from 3/13/1995 Final Rule (PDF) 5/10/1996 61FR21392
Final Rule Date FR Citation
Final Rule (PDF) 11/18/1996 61FR58629

 

 

Page Last Updated: 10/29/2014
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