Rulemaking History for OTC Daytime Sedative Drug Products
Final Monograph (21 CFR 310.519):
Drug products marketed as over-the-counter (OTC) daytime sedatives
Daytime Sedative Drug Products
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 12/8/1975 | 40FR57292 |
| Correction | 1/8/1976 | 41FR1498 |
| Correction | 1/26/1976 | 41FR3745 |
| Correction | 1/30/1976 | 41FR4600 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph | 6/13/1978 | 43FR25544 |
| Final Rule | Date | FR Citation |
| Final Monograph | 6/22/1979 | 44FR36378 |
| Correction | 7/15/1980 | 45FR47422 |