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Imports and Exports of Two Synthetic Opioids Restricted

Thursday, May 12, 2016
Sandler, Travis & Rosenberg Trade Report

The Drug Enforcement Administration has issued a final order that temporarily schedules the following synthetic opioids and their isomers, esters, ethers, salts, and salts of isomers, esters and ethers into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act.

- N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide, also known as N-(1-phenethylpiperidin-4-yl)-N-phenylbutanamide (butyryl fentanyl)

- N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-Nphenylpropionamide, also known as N-[1-[2-hydroxy-2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenylpropanamide (beta-hydroxythiofentanyl)

As a result, butyryl fentanyl and beta-hydroxythiofentanyl are subject to the regulatory controls and administrative, civil and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, research, conduct of instructional activities and chemical analysis, and possession of schedule I controlled substances. This order is effective May 12 and will be in effect for two years, with a possible extension of one year, pending completion of the permanent scheduling process.

According to the DEA, available data and information indicate that butyryl fentanyl and beta-hydroxythiofentanyl have a high potential for abuse, no currently accepted medical use in treatment in the U.S. and a lack of accepted safety for use under medical supervision.

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