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:
- Original Active Ingredients & Labeling
- Inactive Alcohol Concentrations
- Ipecac Syrup Alcohol Concentrations
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