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Imports and Exports of Two Synthetic Opioids to be Restricted

Wednesday, March 23, 2016
Sandler, Travis & Rosenberg Trade Report

The Drug Enforcement Administration has announced its intent to temporarily schedule the synthetic opioids butyryl fentanyl and beta-hydroxythiofentanyl into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. The DEA intends to issue a final order effecting this change as soon as possible after April 22, which will mark the end of the 30-day notice period. Upon the issuance of that order, butyryl fentanyl and betahydroxythiofentanyl will be 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 will be effective 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 for butyryl fentanyl and beta-hydroxythiofentanyl indicate that these substances 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. As a result, the DEA has concluded that the continued uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession and abuse of butyryl fentanyl and beta-hydroxythiofentanyl pose an imminent hazard to the public safety.

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