Rulemaking History for OTC Antiflatulent Drug Products
Final Monograph (21 CFR part 332):
Antiflatulent Products for Over-the-Counter Human Use
OTC Antiflatulent Drug Products found on this page:
Antiflatulent Drug Products: Original Active Ingredients and Labeling
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking [PDF] | 4/5/1973 | 38FR8714 |
| Correction [PDF] | 5/29/1973 | 38FR14111 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph [PDF] | 11/12/1973 | 38FR31260 |
| Correction [PDF] | 12/7/1973 | 38FR33774 |
| Final Rule | Date | FR Citation |
| Final Monograph [PDF] | 6/4/1974 | 39FR19862 |
| Technical Amendment: Revises indications [PDF] | 3/13/1975 | 40FR11718 |
| Technical Amendment: Extends effective date [PDF] | 5/23/1975 | 40FR22542 |
Antiflatulent Drug Products: Statement of Identity and Indications
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule [PDF] | 1/29/1988 | 53FR2716 |
| Correction [PDF] | 3/3/1988 | 53FR6916 |
| Extension of Comment Period [PDF] | 4/19/1988 | 53FR12778 |
| Final Rule | Date | FR Citation |
| Final Rule [PDF] | 3/5/1996 | 61FR8836 |
Antiflatulent Drug Products: Warnings
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Exempts from "accidental overdose" warning [PDF] | 4/13/1984 | 49FR14908 |
| Correction [PDF] | 5/21/1984 | 49FR21350 |
| Final Rule | Date | FR Citation |
| Final Rule [PDF] | 8/1/1986 | 51FR27762 |
| Correction [PDF] | 9/10/1986 | 51FR32212 |