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Rulemaking History for OTC Leg Muscle Cramp Drug Products
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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

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Date Federal Register Citation Description
10/1/1982 47FR43562 PDF document Advance Notice of Proposed Rulemaking
11/8/1985 50FR46588 PDF document Proposed Rule
12/2/1985 50FR49409 PDF document Correction: Proposed Rule
8/22/1994 59FR43234 PDF document Final Rule
9/28/1994 59FR49350 PDF document Correction: Final Rule
12/15/2006 71FR75557 PDF document
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Notice: Enforcement Action

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Date updated: December 28, 2006

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