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Import and Export Controls Continued on Thiafentanil

Thursday, June 20, 2019
Sandler, Travis & Rosenberg Trade Report

The Drug Enforcement Administration has issued a final rule that, effective June 18, places the substance thiafentanil, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers in schedule II of the Controlled Substances Act.

This substance was previously placed into schedule II temporarily; as a result, this rule permanently continues 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 with, and possession involving schedule II 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 CSA 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 and labeling for commercial containers of this substance must comply with 21 USC 825 and 958(e) and conform with 21 CFR part 1302, as well as with certain additional labeling requirements provided by the Food and Drug Administration

- only registered manufacturers are permitted to manufacture this substance in accordance with an assigned quota

- every DEA registrant who desires to possess any quantity of this substance must take an inventory of the substance on hand

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