Drug Enforcement Administration April 7, 2020 – Federal Register Recent Federal Regulation Documents
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Schedules of Controlled Substances: Placement of 4,4′-DMAR in Schedule I
The Drug Enforcement Administration proposes placing the substance 4,4'-DMAR (Chemical name: 4,4'-dimethylaminorex), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle 4,4'-DMAR.
Schedules of Controlled Substances: Placement of Lemborexant in Schedule IV
On December 20, 2019, the U.S. Food and Drug Administration approved a new drug application for Dayvigo (lemborexant) tablets for oral use. Lemborexant is chemically known as (1R,2S)-2-[(2,4- dimethylpyrimidin-5-yl)oxymethyl]-2-(3-fluorophenyl)-N-(5- fluoropyridin-2-yl)cyclopropane-1-carboxamide. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place lemborexant in schedule IV of the Controlled Substances Act (CSA). In accordance with the CSA, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing lemborexant, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the CSA.
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