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U.S. Department of Health and Human Services


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Rulemaking History for OTC Leg Muscle Cramp Drug Products

Final 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

Leg Muscle Cramp Drug Products
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 10/1/1982 47FR43562
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 11/8/1985 50FR46588
    Correction [PDF] 12/2/1985 50FR49409
Final Rule Date FR Citation
Final Monograph [PDF] 8/22/1994 59FR43234
    Correction [PDF] 9/28/1994 59FR49350
    Notice: Enforcement Action [PDF] 12/15/2006 71FR75557