Drug Enforcement Administration 2016 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 196
Manufacturer of Controlled Substances Registration: Pharmacore, Inc.
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.
Exempt Chemical Preparations Under the Controlled Substances Act
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.
Manufacturer of Controlled Substances Registration: Johnson Matthey, Inc.
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
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.
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.
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.
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
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
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
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.
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)
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.
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
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.
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.
Importer of Controlled Substances Registration: Johnson Matthey, Inc.
Johnson Matthey, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Johnson Matthey, Inc. registration as an importer of those controlled substances.
Importer of Controlled Substances Registration: Meridian Medical Technologies
Meridian Medical Technologies applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Meridian Medical Technologies registration as an importer of this controlled substance.
Manufacturer of Controlled Substances Registration: Cody Laboratories, Inc.
Cody Laboratories, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cody Laboratories, Inc. registration as a manufacturer of those controlled substances.
Importer of Controlled Substances Registration: Research Triangle Institute
Research Triangle Institute applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Research Triangle Institute registration as an importer of those controlled substances.
Importer of Controlled Substances Registration: Mylan Technologies, Inc.
Mylan Technologies, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Mylan Technologies, Inc. registration as an importer of those controlled substances.
Manufacturer of Controlled Substances Registration: Stepan Company
Stepan Company applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Stepan Company registration as a manufacturer of those controlled substances.
Schedules of Controlled Substances: Placement of AH-7921 Into Schedule I
With the issuance of this final order, the Administrator of the Drug Enforcement Administration places the substance AH-7921 (Systematic IUPAC Name: 3,4-dichloro-N- [(1dimethylamino)cyclohexylmethyl]benzamide), including its isomers, esters, ethers, salts, and salts of isomers, esters and ethers, into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act and is required in order for the United States to discharge its obligations under the Single Convention on Narcotic Drugs, 1961. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research or conduct instructional activities with, or possess), or propose to handle, AH-7921.
Importer of Controlled Substances Registration: VHG Labs DBA LGC Standards Warehouse
VHG Labs DBA LGC Standards Warehouse applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants VHG Labs DBA LGC Standards Warehouse registration as an importer of those controlled substances.
Importer of Controlled Substances Registration: Mylan Pharmaceuticals, Inc.
Mylan Pharmaceuticals, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Mylan Pharmaceuticals, Inc. registration as an importer of those controlled substances.
Importer of Controlled Substances Registration: Fisher Clinical Services, Inc.
Fisher Clinical Services, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Fisher Clinical Services, Inc. registration as an importer of those controlled substances.
Exempt Chemical Preparations Under the Controlled Substances Act
The applications for exempt chemical preparations received by the Drug Enforcement Administration (DEA) between April 1, 2013, and December 31, 2015, as listed below, were accepted for filing and have been approved or denied as indicated.
Importer of Controlled Substances Registration: Cerilliant Corporation
Cerilliant Corporation applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cerilliant Corporation registration as an importer of those controlled substances.
Importer of Controlled Substances Registration: Noramco, Inc.
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 substance.
Manufacturer of Controlled Substances Registration: Cambrex Charles City
Cambrex Charles City applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cambrex Charles City registration as a manufacturer of those controlled substances.
Manufacturer of Controlled Substances Registration: Cerilliant Corporation
Cerilliant Corporation applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cerilliant Corporation registration as a manufacturer of those controlled substances.
Manufacturer of Controlled Substances Registration: Cody Laboratories, Inc.
Cody Laboratories, Inc. applied to be registered as a manufacturer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Cody Laboratories, Inc. registration as a manufacturer of this controlled substance.
Manufacturer of Controlled Substances Registration: Halo Pharmaceutical, Inc.
Halo Pharmaceutical, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Halo Pharmaceutical, Inc. registration as a manufacturer of those controlled substances.
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