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  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Drug Products Containing Alcohol
  1. Historical Status of OTC Rulemakings

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 found on this page:

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

 

 

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