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

Manufacturer of Controlled Substances Registration: Halo Pharmaceutical, Inc.
Document Number: C1-2016-06532
Type: Notice
Date: 2016-03-31
Agency: Drug Enforcement Administration, Department of Justice
Avi Weisfogel, D.D.S.; Decision and Order
Document Number: 2016-07111
Type: Notice
Date: 2016-03-30
Agency: Drug Enforcement Administration, Department of Justice
Exempt Chemical Preparations Under the Controlled Substances Act
Document Number: 2016-06624
Type: Notice
Date: 2016-03-25
Agency: Drug Enforcement Administration, Department of Justice
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
Document Number: 2016-06548
Type: Notice
Date: 2016-03-23
Agency: Drug Enforcement Administration, Department of Justice
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.
Document Number: 2016-06547
Type: Notice
Date: 2016-03-23
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 substance.
Importer of Controlled Substances Application: Meda Pharmaceuticals, Inc.
Document Number: 2016-06544
Type: Notice
Date: 2016-03-23
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mallinckrodt LLC
Document Number: 2016-06543
Type: Notice
Date: 2016-03-23
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: R & D Systems, Inc.
Document Number: 2016-06542
Type: Notice
Date: 2016-03-23
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Pharmacore
Document Number: 2016-06541
Type: Notice
Date: 2016-03-23
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics, Inc.
Document Number: 2016-06540
Type: Notice
Date: 2016-03-23
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc.
Document Number: 2016-06539
Type: Notice
Date: 2016-03-23
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC
Document Number: 2016-06537
Type: Notice
Date: 2016-03-23
Agency: Drug Enforcement Administration, Department of Justice
Manufacturer of Controlled Substances Registration: Cambrex Charles City
Document Number: 2016-06536
Type: Notice
Date: 2016-03-23
Agency: Drug Enforcement Administration, Department of Justice
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
Document Number: 2016-06535
Type: Notice
Date: 2016-03-23
Agency: Drug Enforcement Administration, Department of Justice
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.
Document Number: 2016-06534
Type: Notice
Date: 2016-03-23
Agency: Drug Enforcement Administration, Department of Justice
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.
Document Number: 2016-06533
Type: Notice
Date: 2016-03-23
Agency: Drug Enforcement Administration, Department of Justice
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.
Manufacturer of Controlled Substances Registration: Halo Pharmaceutical, Inc.
Document Number: 2016-06532
Type: Notice
Date: 2016-03-23
Agency: Drug Enforcement Administration, Department of Justice
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.
Manufacturer of Controlled Substances Registration: Chattem Chemicals, Inc.
Document Number: 2016-06531
Type: Notice
Date: 2016-03-23
Agency: Drug Enforcement Administration, Department of Justice
Chattem Chemicals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Chattem Chemicals, Inc. registration as a manufacturer of those controlled substances.
Schedules of Controlled Substances: Temporary Placement of Butyryl Fentanyl and Beta-Hydroxythiofentanyl Into Schedule I
Document Number: 2016-06468
Type: Proposed Rule
Date: 2016-03-23
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 opioids, N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide (butyryl fentanyl) and N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N- phenylpropionamide (beta-hydroxythiofentanyl), 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 these synthetic opioids 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, and exportation of, and research and conduct with, instructional activities of these synthetic opioids.
Schedules of Controlled Substances: Placement of UR-144, XLR11, and AKB48 Into Schedule I; Correction
Document Number: 2016-06474
Type: Proposed Rule
Date: 2016-03-22
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration published a document in the Federal Register of May 14, 2015, concerning the proposal to place (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)metha none (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 (CSA), specifically under cannabimimetic agents. This corrected notice of proposed rulemaking proposes to place such substances into schedule I of the CSA under hallucinogenic substances.
Kristen Lee Raines, A.P.R.N.; Decision and Order
Document Number: 2016-06103
Type: Notice
Date: 2016-03-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cambrex Charles City
Document Number: 2016-06102
Type: Notice
Date: 2016-03-18
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Extension of Temporary Placement of 10 Synthetic Cathinones in Schedule I of the Controlled Substances Act
Document Number: 2016-05004
Type: Rule
Date: 2016-03-04
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this final order to extend the temporary schedule I status of 10 synthetic cathinones pursuant to the temporary scheduling provisions of the Controlled Substances Act. The 10 substances are: 4-methyl-N- ethylcathinone (4-MEC); 4-methyl-alpha-pyrrolidinopropiophenone (4- MePPP); alpha-pyrrolidinopentiophenone ([alpha]-PVP); 1-(1,3- benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone); 2- (methylamino)-1-phenylpentan-1-one (pentedrone); 1-(1,3-benzodioxol-5- yl)-2-(methylamino)pentan-1-one (pentylone); 4-fluoro-N-methylcathinone (4-FMC); 3-fluoro-N-methylcathinone (3-FMC); 1-(naphthalen-2-yl)-2- (pyrrolidin-1-yl)pentan-1-one (naphyrone); and alpha- pyrrolidinobutiophenone ([alpha]-PBP) [hereinafter 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP, respectively], including their optical, positional, and geometric isomers, salts, and salts of isomers. The current final order temporarily placing 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP into schedule I is in effect through March 6, 2016. This final order will extend the temporary scheduling of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]- PBP for one year, or until the permanent scheduling action for these 10 substances is completed, whichever occurs first.
Schedules of Controlled Substances: Placement of 10 Synthetic Cathinones Into Schedule I
Document Number: 2016-05002
Type: Proposed Rule
Date: 2016-03-04
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing 10 synthetic cathinones: 4-methyl-N-ethylcathinone (4-MEC); 4-methyl- alpha-pyrrolidinopropiophenone (4-MePPP); alpha- pyrrolidinopentiophenone ([alpha]-PVP); 1-(1,3-benzodioxol-5-yl)-2- (methylamino)butan-1-one (butylone); 2-(methylamino)-1-phenylpentan-1- one (pentedrone); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone); 4-fluoro-N-methylcathinone (4-FMC); 3-fluoro-N- methylcathinone (3-FMC); 1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan- 1-one (naphyrone); alpha-pyrrolidinobutiophenone ([alpha]-PBP) and their optical, positional, and geometric isomers, salts and salts of isomers into schedule I of the Controlled Substances Act. This proposed 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. If finalized, this action would impose 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, conduct instructional activities or chemical analysis, or possess), or propose to handle 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP.