federal_register: 94-20449

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
94-20449 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 Uncategorized Document 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. 1994-08-22 1994 8 https://www.federalregister.gov/documents/1994/08/22/94-20449/drug-products-for-the-treatment-andor-prevention-of-nocturnal-leg-muscle-cramps-for-over-the-counter       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...

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