Rulemaking History for OTC Alcohol Drug Products

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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

OTC Drug Products Containing Alcohol found on this page:

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**OTC Drug Products Containing Alcohol: Original Active Ingredients & Labeling**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	5/21/1982	47FR22324

**OTC Drug Products Containing Alcohol: Inactive Alcohol Concentrations**
Proposed Rule	Date	FR Citation
Proposed Rule: Alcohol concentration limit for orally ingested products	10/21/1993	58FR54466
Final Rule	Date	FR Citation
Final Rule	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	5/10/1996	61FR21392
Final Rule	Date	FR Citation
Final Rule	11/18/1996	61FR58629

Date created: December 28, 2006; Last updated: May 4, 2007