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Imports of Two Chemicals Restricted as Controls on Another Substance May Be Removed

The Drug Enforcement Administration has issued a final rule designating the chemical alpha-phenylacetoacetonitrile and its salts, optical isomers and salts of optical isomers as a list I chemical under the Controlled Substances Act. Effective 14 August, this rule will subject importers, exporters, manufacturers and distributors of any amount of APAAN to all of the regulatory controls (registration, records and reporting, inspection, etc.) and administrative, civil and criminal actions applicable to the importing, exporting, manufacturing and distribution of a list I chemical.

This rule does not establish a threshold for domestic and import transactions of APAAN; as a result, all such transactions regardless of size will be regulated. Chemical mixtures containing any amount of APAAN will also be regulated unless the DEA approves an application for exemption. According to the DEA, APAAN meets the criteria for designation as a list I chemical because it is used in clandestine laboratories to illicitly manufacture the schedule II controlled substances phenylacetone (also known as phenyl-2-propanone or P2P), methamphetamine and amphetamine.

In a separate action, the DEA has issued an order temporarily including the synthetic opioid N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide (acryl fentanyl or acryloylfentanyl), as well as its isomers, esters, ethers, salts and salts of isomers, esters and ethers, into schedule I of the CSA. Available data and information indicate that this substance has a high potential for abuse, no currently accepted medical use in treatment in the United States and a lack of accepted safety for use under medical supervision.

This order imposes the administrative, civil and criminal sanctions and regulatory controls applicable to schedule I substances under the CSA on the importation, exportation, manufacture, distribution, reverse distribution, possession, research and conduct of instructional activities and chemical analysis of this substance. It is effective as of 14 July and will remain in effect until 15 July 2019 unless it is extended for an additional year or a permanent scheduling proceeding is completed.

Finally, the DEA is accepting comments through 11 August on a proposed rule that would remove naldemedine and its salts from the schedules of the CSA. This would remove the regulatory controls and administrative, civil and criminal sanctions applicable to controlled substances on persons who import, export, manufacture, distribute, reverse distribute, dispense or conduct research or chemical analysis on this substance. Naldemedine is currently a schedule II controlled substance as a derivative of opium alkaloids and opiates but was recently approved by the Food and Drug Administration for treating opioid-induced constipation in adults with chronic non-cancer pain.

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