Drug Enforcement Administration September 2017 – Federal Register Recent Federal Regulation Documents

Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute
Document Number: 2017-20947
Type: Notice
Date: 2017-09-29
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2017-20943
Type: Notice
Date: 2017-09-29
Agency: Drug Enforcement Administration, Department of Justice
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration as importers of various classes of schedule I or II controlled substances.
Importer of Controlled Substances Application: Cody Laboratories, Inc.
Document Number: 2017-20942
Type: Notice
Date: 2017-09-29
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Bellwyck Clinical Services
Document Number: 2017-20941
Type: Notice
Date: 2017-09-29
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Removal of Naldemedine From Control
Document Number: 2017-20919
Type: Rule
Date: 2017-09-29
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Drug Enforcement Administration removes the substance naldemedine (4R,4aS,7aR,12bS)-3- (cyclopropylmethyl)-4a,7,9-trihydroxy-N-(2-(3-phenyl-1,2,4-ox adiazol-5- yl)propan-2-yl)-2,3,4,4a,5,7a-hexahydro-1H-4,12-methanobenzof uro[3,2- e]isoquinoline-6-carboxamide) including its salts from the schedules of the Controlled Substances Act. Prior to the effective date of this rule, naldemedine was a schedule II controlled substance because it can be derived from opium alkaloids. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle naldemedine.
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2017-20479
Type: Notice
Date: 2017-09-26
Agency: Drug Enforcement Administration, Department of Justice
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration as bulk manufacturers of various classes of controlled substances.
Importer of Controlled Substances Application: Sharp Clinical Services, Inc.
Document Number: 2017-19836
Type: Notice
Date: 2017-09-18
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, Inc.
Document Number: 2017-19834
Type: Notice
Date: 2017-09-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Catalent Centers, LLC
Document Number: 2017-19833
Type: Notice
Date: 2017-09-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc.
Document Number: 2017-19832
Type: Notice
Date: 2017-09-18
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals LLC
Document Number: 2017-19831
Type: Notice
Date: 2017-09-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Unither Manufacturing LLC
Document Number: 2017-19830
Type: Notice
Date: 2017-09-18
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Specgx LLC
Document Number: 2017-19786
Type: Notice
Date: 2017-09-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Specgx LLC
Document Number: 2017-19784
Type: Notice
Date: 2017-09-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2017-19067
Type: Notice
Date: 2017-09-15
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of Ortho-Fluorofentanyl, Tetrahydrofuranyl Fentanyl, and Methoxyacetyl Fentanyl Into Schedule I
Document Number: 2017-19283
Type: Proposed Rule
Date: 2017-09-12
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule the synthetic opioids, N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4- yl)propionamide (ortho-fluorofentanyl or 2-fluorofentanyl), N-(1- phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamid e (tetrahydrofuranyl fentanyl), and 2-methoxy-N-(1-phenethylpiperidin-4- yl)-N-phenylacetamide (methoxyacetyl fentanyl), into Schedule I. This action is based on a finding by the Administrator that the placement of these synthetic opioids into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling 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, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of these synthetic opioids.
Schedules of Controlled Substances: Temporary Placement of FUB-AMB Into Schedule I
Document Number: 2017-17639
Type: Proposed Rule
Date: 2017-09-11
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule the synthetic cannabinoid, Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3- carboxamido)-3-methylbutanoate [FUB-AMB, MMB-FUBINACA, AMB-FUBINACA], into Schedule I. This action is based on a finding by the Administrator that the placement of this synthetic cannabinoid into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling 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 of, and research and conduct with, instructional activities of this synthetic cannabinoid.
Importer of Controlled Substances Application: Akorn, Inc.
Document Number: 2017-18803
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Siegfried USA, LLC
Document Number: 2017-18802
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc.
Document Number: 2017-18801
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Stepan Company
Document Number: 2017-18789
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Spex Certiprep Group, LLC
Document Number: 2017-18788
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: KVK-Tech, Inc.
Document Number: 2017-18787
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2017-18785
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Marcus W. Anderson, M.D.; Decision and Order
Document Number: 2017-18784
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice