Rulemaking History for OTC Leg Muscle Cramp Drug Products
Monograph (21 CFR 310.546):
Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps
FDA Archive-It webpage:
Search for Federal Register documents:
- GPO Federal Register Database (1994 to present)
- HeinOnline
provides online access to Federal Registers from 1936-forward
Leg Muscle Cramp Drug Products
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 10/1/1982 | 47FR43562 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph | 11/8/1985 | 50FR46588 |
| Correction | 12/2/1985 | 50FR49409 |
| Final Rule | Date | FR Citation |
| Final Monograph | 8/22/1994 | 59FR43234 |
| Correction | 9/28/1994 | 59FR49350 |
| Notice: Enforcement Action | 12/15/2006 | 71FR75557 |