Rulemaking History for OTC Nailbiting and Thumbsucking Drug Products
Final Monograph (21 CFR 310.536):
Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent
Nailbiting and Thumbsucking Drug Products: Original Active Ingredients and Labeling
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 10/17/1980 | 45FR69122 |
| Correction | 12/23/1980 | 45FR84836 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph | 9/3/1982 | 47FR39096 |
| Correction | 11/19/1982 | 47FR52200 |
| Final Rule | Date | FR Citation |
| Final Monograph: No GRASE active ingredients | 9/2/1993 | 58FR46749 |
Nailbiting and Thumbsucking 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 |