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Import and Export Controls Imposed on Three Chemical Substances

Wednesday, May 11, 2016
Sandler, Travis & Rosenberg Trade Report

The Drug Enforcement Administration has issued a final rule that, effective May 11, will permanently place the following substances, including their salts, isomers and salts of isomers whenever their existence is possible, into schedule I of the Controlled Substances Act.

- (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144)

- [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-

UR-144, XLR11)

- N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48)

The DEA states that these substances have a high potential for abuse comparable to other schedule I substances and have no currently accepted medical use in treatment in the U.S.

These substances were previously temporarily placed in schedule I; as a result, this rule will continue on a permanent basis the regulatory controls and administrative, civil and criminal sanctions applicable to schedule I controlled substances on persons who handle (import, export, manufacture, distribute, engage in research or conduct instructional activities with) any of these substances. These include the following.

- any person who handles or desires to handle one of these substances must be registered with the DEA to conduct such activities

- all labels, labeling and packaging for commercial containers of these substances must comply with 21 USC 825 and 958(e) and be in accordance with 21 CFR part 1302

- only registered manufacturers are permitted to manufacture these substances in accordance with an assigned quota

- every DEA registrant required to keep records and who possesses any quantity of these substances is required to maintain an inventory of all stocks on hand

- 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

- any activity involving these substances 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

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