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Production (Including Import) Limits for Three List I Chemicals Proposed for 2016

Friday, July 17, 2015
Sandler, Travis & Rosenberg Trade Report

The Justice Department’s Drug Enforcement Administration has issued a notice proposing the 2016 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act as well as an assessment of annual needs for the List I chemicals ephedrine, pseudoephedrine and phenylpropanolamine. These amounts represent those quantities of the covered substances to be manufactured in the U.S. to provide for the estimated medical, scientific, research and industrial needs of the U.S., lawful export requirements, and the establishment and maintenance of reserve stocks. These quotas include imports of ephedrine, pseudoephedrine and phenylpropanolamine but do not include imports of controlled substances necessary to provide for the medical, scientific or other legitimate needs of the U.S. Comments on this proposal are due no later than Aug. 17.

Separately, the DEA has issued a final order temporarily scheduling the synthetic opioid N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl) and its optical, positional and geometric isomers, salts and salts of isomers into schedule I, pursuant to the temporary scheduling provisions of the Controlled Substances Act. As a result of this order, the regulatory controls and administrative, civil and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, import, export, engage in research or possess) or propose to handle acetyl fentanyl.

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