Drug Enforcement Administration May 2016 – Federal Register Recent Federal Regulation Documents

Pharmacore, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Pharmacore, Inc. registration as a manufacturer of those controlled substances.

The applications for exempt chemical preparations received by the Drug Enforcement Administration (DEA) between January 1, 2016, and March 31, 2016, as listed below, were accepted for filing and have been approved or denied as indicated.

Johnson Matthey, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Johnson Matthey, Inc. registration as a manufacturer of those controlled substances.

Johnson Matthey Pharmaceutical Materials, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Johnson Matthey Pharmaceutical Materials, Inc. registration as a manufacturer of those controlled substances.

AMRI Rensselaer, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants AMRI Rensselaer, Inc. registration as a manufacturer of those controlled substances.

The Administrator of the Drug Enforcement Administration is issuing this final order to temporarily schedule the synthetic opioids, N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide, also known as N-(1- phenethylpiperidin-4-yl)-N-phenylbutanamide, (butyryl fentanyl) and N- [1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N- phenylpropionamide, also known as N-[1-[2-hydroxy-2-(2-thienyl)ethyl]- 4-piperidinyl]-N-phenylpropanamide, (beta-hydroxythiofentanyl), 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. This action is based on a finding by the Administrator that the placement of butyryl fentanyl and beta- hydroxythiofentanyl into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. 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, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, butyryl fentanyl and beta-hydroxythiofentanyl.

Noramco, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Noramco, Inc. registration as a manufacturer of those controlled substances.

Sharp Clinical Services, Inc. applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Sharp Clinical Services, Inc. registration as an importer of this controlled substance.

Noramco, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Noramco, Inc. registration as an importer of those controlled substances.