Rulemaking History for OTC Stimulant Drug Product
Final Monograph (21 CFR part 340):
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
OTC Stimulant Drug Products found on this page:
Stimulant Drug Products: Original Active Ingredients and Labeling
| 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 |
| Reopening of Administrative Record: Category II and III active ingredients | 10/26/1979 | 44FR61611 |
| Correction | 11/16/1979 | 44FR65992 |
| Reopening of Administrative Record | 3/21/1980 | 45FR18399 |
| Notice: Prohibits combination of caffeine, PPA, and ephedrine | 8/13/1982 | 47FR35344 |
| Notice: Prohibits combination of caffeine, PPA, and ephedrine; allows only caffeine | 11/18/1983 | 48FR52513 |
| Final Rule | Date | FR Citation |
| Final Monograph | 2/29/1988 | 53FR6100 |
| Correction | 4/8/1988 | 53FR11731 |
Stimulant Drug Products: Hangover Symptoms
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Adds hangover relief indication | 12/24/1991 | 56FR66758 |
| Correction | 2/24/1992 | 57FR6352 |
| Correction | 3/17/1992 | 57FR9346 |