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Import and Export Controls Continued on Synthetic Opioid

Wednesday, May 08, 2019
Sandler, Travis & Rosenberg Trade Report

The Drug Enforcement Administration has issued a final rule that, effective May 8, places the synthetic opioid beta-hydroxythiofentanyl, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, into schedule I of the Controlled Substances Act.

This substance was previously placed into schedule I temporarily; as a result, this rule permanently continues 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, conduct instructional activities or chemical analysis, or possess) or proposed to handle this substance. 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

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

- every DEA registrant that possesses any quantity of this substance must maintain an inventory of all stocks on hand as of May 8

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