The Drug Enforcement Administration has issued an interim final rule placing the sedative lemborexant, including its salts, isomers, and salts of isomers whenever their existence is possible, into schedule IV of the Controlled Substances Act. Comments are due no later than May 7.
This rule imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule IV controlled substances on persons who import, export, manufacture, distribute, reverse distribute, dispense, or engage in research, instructional activities, or chemical analysis with respect to this substance. These include the following.
- all importation and exportation of these substances must continue to be in compliance with 21 USC 952, 953, 957, and 958 and in accordance with 21 CFR part 1312
- any activity involving this substance that is not authorized by, or is in violation of, the CSA or its implementing regulations continues to be unlawful and may subject the person to administrative, civil, or criminal sanctions
- any person who handles or desires to handle this substance must be registered with the DEA to conduct such activities
- all labels, labeling, and packaging for commercial containers of this substance must comply with 21 USC 825 and 958(e) and be in accordance with 21 CFR part 1302
Separately, the DEA is accepting through June 8 comments on a proposed rule that would place 4,4’-DMAR (4,4’-dimethylaminorex), along with its salts, isomers, and salts of isomers, into schedule I of the CSA. This rule would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I substances on the importation, exportation, manufacture, distribution, reverse distribution, and conduct of research, instructional activities, and chemical analysis of this substance. Comments are due no later than June 8.
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