Rulemaking History for OTC Smoking Deterrent Drug Products
Final Monographs (21 CFR 310.544):
Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent
Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent
OTC Smoking Deterrent Drug Products found on this page:
Smoking Deterrent Drug Products: Active Ingredients and Labeling
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 1/5/1982 | 47FR490 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph | 7/3/1985 | 50FR27552 |
| Extension of Comment Period | 7/17/1986 | 51FR25899 |
| Final Rule | Date | FR Citation |
| Final Rule: No GRASE active ingredients | 6/1/1993 | 58FR31236 |
Smoking Deterrent Drug Products: Nonmonograph Ingredients
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Classifies category II and III ingredients without data as nonmonograph | 5/16/1990 | 55FR20434 |
| Correction | 6/7/1990 | 55FR23235 |
| Final Rule | Date | FR Citation |
| Final Rule: Classifies category II and III ingredients without data as nonmonograph | 11/7/1990 | 55FR46914 |
| Correction | 12/3/1990 | 55FR49973 |
| Technical Amendment: Corrects an ingredient name | 1/30/1992 | 57FR3526 |