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

Schedules of Controlled Substances: Placement of Three Synthetic Phenethylamines Into Schedule I
Document Number: 2016-23185
Type: Rule
Date: 2016-09-27
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Administrator of the Drug Enforcement Administration places three synthetic phenethylamines: 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I- NBOMe; 2C-I-NBOMe; 25I; Cimbi-5), 2-(4-chloro-2,5-dimethoxyphenyl)-N- (2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82), and 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B- NBOMe; 2C-B-NBOMe; 25B; Cimbi-36), including their optical, positional, and geometric isomers, salts 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 continues the application of 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 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe.
Schedules of Controlled Substances: Temporary Placement of Furanyl Fentanyl Into Schedule I
Document Number: 2016-23183
Type: Proposed Rule
Date: 2016-09-27
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to temporarily schedule the synthetic opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide (furanyl fentanyl), 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 this synthetic opioid into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. Any final order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, possession, importation, exportation, research, and conduct of, instructional activities of this synthetic opioid.
Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2016-23019
Type: Notice
Date: 2016-09-26
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Catalent CTS, LLC
Document Number: 2016-23017
Type: Notice
Date: 2016-09-26
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Nanosyn, Inc.
Document Number: 2016-22737
Type: Notice
Date: 2016-09-21
Agency: Drug Enforcement Administration, Department of Justice
Richard J. Settles, D.O.; Decision and Order
Document Number: 2016-22680
Type: Notice
Date: 2016-09-21
Agency: Drug Enforcement Administration, Department of Justice
Charles Szyman, D.O.; Decision and Order
Document Number: 2016-22677
Type: Notice
Date: 2016-09-21
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Euticals Inc.
Document Number: 2016-22527
Type: Notice
Date: 2016-09-20
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.
Document Number: 2016-22526
Type: Notice
Date: 2016-09-20
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: R & D Systems, Inc.
Document Number: 2016-22525
Type: Notice
Date: 2016-09-20
Agency: Drug Enforcement Administration, Department of Justice
Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System; Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments
Document Number: 2016-21589
Type: Proposed Rule
Date: 2016-09-15
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is proposing to update its regulations for the import and export of tableting and encapsulating machines, controlled substances, and listed chemicals, and its regulations relating to reports required for domestic transactions in listed chemicals, gamma-hydroxybutyric acid, and tableting and encapsulating machines. In accordance with Executive Order 13563, the Drug Enforcement Administration has reviewed its import and export regulations and reporting requirements for domestic transactions in listed chemicals (and gamma-hydroxybutyric acid) and tableting and encapsulating machines, and evaluated them for clarity, consistency, continued accuracy, and effectiveness. The proposed amendments clarify certain policies and reflect current procedures and technological advancements. The amendments also allow for the implementation, as applicable to tableting and encapsulating machines, controlled substances, and listed chemicals, of the President's Executive Order 13659 on streamlining the export/import process and requiring the government-wide utilization of the International Trade Data System. This proposal additionally contains amendments that would implement recent changes to the Controlled Substances Import and Export Act (CSIEA) for reexportation of controlled substances among members of the European Economic Area made by the Improving Regulatory Transparency for New Medical Therapies Act. The proposal includes additional substantive and technical amendments.
Bulk Manufacturer of Controlled Substances Application: Alcami Wisconsin Corporation
Document Number: 2016-22100
Type: Notice
Date: 2016-09-14
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2016-22083
Type: Notice
Date: 2016-09-14
Agency: Drug Enforcement Administration, Department of Justice
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of various classes of schedule I or II controlled substances.
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2016-22082
Type: Notice
Date: 2016-09-14
Agency: Drug Enforcement Administration, Department of Justice
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of controlled substances.
Importer of Controlled Substances Application: United States Pharmacopeial Convention
Document Number: 2016-22079
Type: Notice
Date: 2016-09-14
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals LLC
Document Number: 2016-22078
Type: Notice
Date: 2016-09-14
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cambrex Charles City
Document Number: 2016-22077
Type: Notice
Date: 2016-09-14
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Sigma-Aldrich International GMBH-Sigma Aldrich Company LLC
Document Number: 2016-22076
Type: Notice
Date: 2016-09-14
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing LLC
Document Number: 2016-22075
Type: Notice
Date: 2016-09-14
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, Inc.
Document Number: 2016-22074
Type: Notice
Date: 2016-09-14
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Chattem Chemicals, Inc.
Document Number: 2016-21536
Type: Notice
Date: 2016-09-08
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of U-47700 Into Schedule I
Document Number: 2016-21477
Type: Proposed Rule
Date: 2016-09-07
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to temporarily schedule the synthetic opioid, 3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamid e (also known as U-47700), 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 this synthetic opioid into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. Any final order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, possession, importation, exportation, research, and conduct of, instructional activities of this synthetic opioid.
Schedules of Controlled Substances: Placement of PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA into Schedule I
Document Number: 2016-21345
Type: Rule
Date: 2016-09-06
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Drug Enforcement Administration places quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC), quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3- carboxylate (5-fluoro-PB-22; 5F-PB-22), N-(1-amino-3-methyl-1-oxobutan- 2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) and N- (1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3 - carboxamide (ADB-PINACA), 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 PB-22, 5F-PB-22, AB- FUBINACA, or ADB-PINACA.
Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc.
Document Number: 2016-21242
Type: Notice
Date: 2016-09-06
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Isosciences
Document Number: 2016-21241
Type: Notice
Date: 2016-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2016-21240
Type: Notice
Date: 2016-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Unither Manufacturing, LLC
Document Number: 2016-21239
Type: Notice
Date: 2016-09-06
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cody Laboratories, Inc.
Document Number: 2016-21238
Type: Notice
Date: 2016-09-06
Agency: Drug Enforcement Administration, Department of Justice