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2017-01-09
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Drug Products for the Treatment and/or Prevention of Nocturnal Leg Muscle Cramps for Over-the-Counter Human Use; Final Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES
Part IV
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The Food and Drug Administration (FDA) is issuing a final rule establishing that any over-the-counter (OTC) drug product for the treatment and/or prevention of nocturnal leg muscle cramps is not generally recognized as safe and effective and is misbranded. FDA is issuing this final rule after considering public comments on the agency's proposed regulation, which was issued in the form of a tentative final monograph, and all new data and information on drug products for the treatment and/or prevention of nocturnal leg muscle cramps that have come to the agency's attention. This final rule is part of the ongoing review of OTC drug products conducted by FDA.
59 FR 0
https://www.govinfo.gov/app/details/FR-1994-08-22/94-20449
94-20449
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Federal Register: August 22, 1994
https://www.govinfo.gov/app/details/FR-1994-08-22/94-20449
https://www.govinfo.gov/content/pkg/FR-1994-08-22/html/94-20449.htm
1 p.
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Code of Federal Regulations
Title 21 Part 310
21 CFR Part 310
Drug Products for the Treatment and/or Prevention of Nocturnal Leg Muscle Cramps for Over-the-Counter Human Use; Final Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES; Federal Register Vol. 59, Issue
UNKNOWN
94-20449
IV
Federal Register: August 22, 1994
4160-01-F
94-20449
Final rule.
The Food and Drug Administration (FDA) is issuing a final rule establishing that any over-the-counter (OTC) drug product for the treatment and/or prevention of nocturnal leg muscle cramps is not generally recognized as safe and effective and is misbranded. FDA is issuing this final rule after considering public comments on the agency's proposed regulation, which was issued in the form of a tentative final monograph, and all new data and information on drug products for the treatment and/or prevention of nocturnal leg muscle cramps that have come to the agency's attention. This final rule is part of the ongoing review of OTC drug products conducted by FDA.
February 22, 1995.
William E. Gilbertson, Center for Drug Evaluation and Research (HFD-810), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5000.
Federal Register
Vol. 59, no. 161
Office of the Federal Register, National Archives and Records Administration
1994-08-22
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