Background

The Drug Enforcement Administration is accepting comments through Oct. 12 on a proposal to add mesocarb (N-phenyl-N'-(3-(1-phenylpropan-2-yl)-1,2,3-oxadiazol-3-ium-5-yl)carbamimidate), including its salts, isomers, and salts of isomers, to schedule I of the Controlled Substances Act. This substance is marketed in Russia as a treatment for attention deficit hyperactivity disorder but has no approved medical use in the U.S.

This rule would impose the administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I substances on the importation, exportation, manufacture, distribution, reverse distribution, possession, research, conduct of instructional activities, and chemical analysis of this substance.

Separately, the DEA has issued a final rule that, effective Sept. 13, places the synthetic stimulant 4,4’-dimethylaminorex (4,4’-DMAR), including its salts, isomers, and salts of isomers, in schedule I. This rule makes permanent the administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I substances on persons who import, export, manufacture, distribute, possess, engage in research on, or conduct instructional activities or chemical analysis of this substance.  

In both cases, the applicable sanctions and regulatory controls include the following.

- any person who engages in the above activities with respect to these substances must be registered with the DEA to conduct such activities

- all importation and exportation of these substances must be in compliance with 21 USC 952, 953, 957, and 958 and in accordance with 21 CFR part 1312

- all labels and labeling for commercial containers of these substances must comply with the requirements of 21 CFR part 1302

- any activity involving these substances that is not authorized under the CSA or the Controlled Substances Import and Export Act is unlawful and potentially subject to criminal penalties

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