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

Bulk Manufacturer of Controlled Substances Application: Rhodes Technologies
Document Number: 2016-12752
Type: Notice
Date: 2016-05-31
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Wildlife Laboratories, Inc.
Document Number: 2016-12751
Type: Notice
Date: 2016-05-31
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Mallinckrodt, LLC
Document Number: 2016-11940
Type: Notice
Date: 2016-05-20
Agency: Drug Enforcement Administration, Department of Justice
Manufacturer of Controlled Substances Registration: Pharmacore, Inc.
Document Number: 2016-11939
Type: Notice
Date: 2016-05-20
Agency: Drug Enforcement Administration, Department of Justice
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.
Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chemicals
Document Number: 2016-11938
Type: Notice
Date: 2016-05-20
Agency: Drug Enforcement Administration, Department of Justice
Exempt Chemical Preparations Under the Controlled Substances Act
Document Number: 2016-11937
Type: Notice
Date: 2016-05-20
Agency: Drug Enforcement Administration, Department of Justice
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.
Superior Pharmacy I and Superior Pharmacy II Decision and Order
Document Number: 2016-11550
Type: Notice
Date: 2016-05-18
Agency: Drug Enforcement Administration, Department of Justice
Manufacturer of Controlled Substances Registration: Johnson Matthey, Inc.
Document Number: 2016-11415
Type: Notice
Date: 2016-05-16
Agency: Drug Enforcement Administration, Department of Justice
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.
Importer of Controlled Substances Registration: Siegfried USA, LLC
Document Number: 2016-11414
Type: Notice
Date: 2016-05-16
Agency: Drug Enforcement Administration, Department of Justice
Siegfried USA, LLC applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Siegfried USA, LLC registration as an importer of those controlled substances.
Manufacturer of Controlled Substances Registration: Johnson Matthey Pharmaceutical Materials, Inc.
Document Number: 2016-11394
Type: Notice
Date: 2016-05-16
Agency: Drug Enforcement Administration, Department of Justice
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.
Manufacturer of Controlled Substances Registration: Organix, Inc.
Document Number: 2016-11393
Type: Notice
Date: 2016-05-16
Agency: Drug Enforcement Administration, Department of Justice
Organix, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Organix, Inc. registration as a manufacturer of those controlled substances.
Manufacturer of Controlled Substances Registration: AMRI Rensselaer, Inc.
Document Number: 2016-11392
Type: Notice
Date: 2016-05-16
Agency: Drug Enforcement Administration, Department of Justice
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.
Schedules of Controlled Substances: Placement of Brivaracetam Into Schedule V
Document Number: 2016-11245
Type: Rule
Date: 2016-05-12
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is placing the substance brivaracetam ((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide) (also referred to as BRV; UCB-34714; Briviact) (including its salts) into schedule V of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act, as revised by the Improving Regulatory Transparency for New Medical Therapies Act which was signed into law on November 25, 2015.
Schedules of Controlled Substances: Temporary Placement of Butyryl Fentanyl and Beta-Hydroxythiofentanyl Into Schedule I
Document Number: 2016-11219
Type: Rule
Date: 2016-05-12
Agency: Drug Enforcement Administration, Department of Justice
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.
Schedules of Controlled Substances: Placement of UR-144, XLR11, and AKB48 into Schedule I
Document Number: 2016-11204
Type: Rule
Date: 2016-05-11
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Drug Enforcement Administration places (1-pentyl-1H-indol-3-yl)(2,2,3,3- tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H- indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11), and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances 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 UR-144, XLR11, or AKB48.
Manufacturer of Controlled Substances Registration: Noramco, Inc.
Document Number: 2016-10731
Type: Notice
Date: 2016-05-06
Agency: Drug Enforcement Administration, Department of Justice
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.
Importer of Controlled Substances Registration: Almac Clinical Services Incorp (ACSI)
Document Number: 2016-10730
Type: Notice
Date: 2016-05-06
Agency: Drug Enforcement Administration, Department of Justice
Almac Clinical Services Incorp (ACSI) applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Almac Clinical Services Incorp (ACSI) registration as an importer of this controlled substance.
Importer of Controlled Substances Registration: Sharp Clinical Services, Inc.
Document Number: 2016-10728
Type: Notice
Date: 2016-05-06
Agency: Drug Enforcement Administration, Department of Justice
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.
Importer of Controlled Substances Registration: Myoderm
Document Number: 2016-10727
Type: Notice
Date: 2016-05-06
Agency: Drug Enforcement Administration, Department of Justice
Myoderm applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Myoderm registration as an importer of those controlled substances.
Importer of Controlled Substances Registration: Noramco, Inc.
Document Number: 2016-10726
Type: Notice
Date: 2016-05-06
Agency: Drug Enforcement Administration, Department of Justice
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.