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Import and Export Restrictions Modified on Controlled Substances

Friday, January 24, 2020
Sandler, Travis & Rosenberg Trade Report

Synthetic Cannabinoids. The Drug Enforcement Administration has issued a final rule adding the following synthetic cannabinoids to schedule I of the Controlled Substances Act along with their salts, isomers, and salts of isomers.

- methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-ADB; 5FMDMB-PINACA]

- methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [5F-AMB]

- N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]

- N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide [ADB-FUBINACA]

- methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate [MDMBCHMICA, MMB-CHMINACA]

- methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate [MDMB-FUBINACA]

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

Brexanolone. The DEA has adopted without change a July 2019 interim final rule that placed the substance brexanolone (3α-hydroxy-5α-pregnan-20-one), including its salts, isomers, and salts of isomers, in schedule IV of the CSA. This rule thus continues the regulatory controls and administrative, civil, and criminal sanctions applicable to the importation, exportation, manufacture, distribution, reverse distribution, dispensation, research, and conduct of instructional activities and chemical analysis with schedule IV substances. These include the following.

- all importation and exportation 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

Naltrexol. The DEA has issued a final rule removing (5a,6b)-17-(cyclopropylmethyl)-4,5-

epoxymorphinan-3,6,14-triol (6b-naltrexol) and its salts from Schedule II. This rule removes the regulatory controls and administrative, civil, and criminal sanctions applicable to Schedule II controlled substances on persons who import, export, manufacture, distribute, reverse distribute, dispense, or conduct research or chemical analysis with this substance.

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