Rulemaking History for OTC Oral Wound Healing Drug Products
Final Monograph (21 CFR 310.5341):
Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents
Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents
Oral Wound Healing Drug Products
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking:2 Includes oral wound cleansers and healing agents | 11/2/1979 | 44FR63270 |
| Correction | 2/1/1980 | 45FR7268 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph: Includes oral wound cleansers and healing agents | 7/26/1983 | 48FR33984 |
| Correction | 8/9/1983 | 48FR36133 |
| Final Rule | Date | FR Citation |
| Final Monograph:6 No GRASE oral wound healing agents; transfers oral wound cleansers to oral healthcare monograph | 7/18/1986 | 51FR26112 |