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Import and Export Controls on Substance Used in Epilepsy Drug

Tuesday, March 10, 2020
Sandler, Travis & Rosenberg Trade Report

The Drug Enforcement Administration has issued an interim final rule placing cenobamate, including its salts, into schedule V of the Controlled Substances Act. As a result, this substance will be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, dispensing, importing, exporting, research, and conduct of instructional activities and chemical analysis of schedule V substances. These include the following.

- all importation and exportation of this substance must 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 Controlled Substances Act or its implementing regulations is 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

- every DEA registrant who possesses any quantity of this substance must take an initial inventory and update it every two years

Comments on this action may be submitted by April 9.

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