Drug Enforcement Administration 2016 – Federal Register Recent Federal Regulation Documents

Results 151 - 196 of 196
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.
Removal of Exemption From Registration for Persons Authorized Under U.S. Nuclear Regulatory Commission or Agreement State Medical Use Licenses or Permits and Administering the Drug Product DaTscan
Document Number: 2016-04224
Type: Rule
Date: 2016-02-26
Agency: Drug Enforcement Administration, Department of Justice
On November 25, 2014, the Drug Enforcement Administration published the interim final rule titled ``Exemption from Registration for Persons Authorized Under U.S. Nuclear Regulatory Commission or Agreement State Medical Use Licenses or Permits and Administering the Drug Product DaTscan.'' The Drug Enforcement Administration is hereby removing this interim final rule as it is no longer needed, as a result of the removal of [\123\I]ioflupane from the schedules of controlled substances effective September 11, 2015.
Manufacturer of Controlled Substances Registration: Chemtos, LLC
Document Number: 2016-03856
Type: Notice
Date: 2016-02-24
Agency: Drug Enforcement Administration, Department of Justice
Chemtos, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Chemtos, LLC registration as a manufacturer of those controlled substances.
Bulk Manufacturer of Controlled Substances Application: Insys Therapeutics, Inc.
Document Number: 2016-03855
Type: Notice
Date: 2016-02-24
Agency: Drug Enforcement Administration, Department of Justice
The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA).
Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company
Document Number: 2016-03854
Type: Notice
Date: 2016-02-24
Agency: Drug Enforcement Administration, Department of Justice
Manufacturer of Controlled Substances Registration: Cedarburg Pharmaceuticals, Inc.
Document Number: 2016-03853
Type: Notice
Date: 2016-02-24
Agency: Drug Enforcement Administration, Department of Justice
Cedarburg Pharmaceuticals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cedarburg Pharmaceuticals, Inc. registration as a manufacturer of those controlled substances.
Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceutical, Inc.
Document Number: 2016-03852
Type: Notice
Date: 2016-02-24
Agency: Drug Enforcement Administration, Department of Justice
Arvinder Singh, M.D.; Decision and Order
Document Number: 2016-03361
Type: Notice
Date: 2016-02-18
Agency: Drug Enforcement Administration, Department of Justice
Hatem M. Ataya, M.D.; Decision and Order; Introduction and Procedural History
Document Number: 2016-03359
Type: Notice
Date: 2016-02-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration: Catalent Pharma Solutions, LLC
Document Number: 2016-03358
Type: Notice
Date: 2016-02-18
Agency: Drug Enforcement Administration, Department of Justice
Catalent Pharma Solutions, LLC applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Catalent Pharma Solutions, LLC registration as an importer of this controlled substance.
Manufacturer of Controlled Substances Registration: Mallinckrodt, LLC
Document Number: 2016-03357
Type: Notice
Date: 2016-02-18
Agency: Drug Enforcement Administration, Department of Justice
Mallinckrodt, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Mallinckrodt, LLC registration as a manufacturer of those controlled substances.
Manufacturer of Controlled Substances Registration: Euticals, Inc.
Document Number: 2016-03355
Type: Notice
Date: 2016-02-18
Agency: Drug Enforcement Administration, Department of Justice
Euticals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Euticals, Inc. registration as a manufacturer of those controlled substances.
Importer of Controlled Substances Registration: Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC
Document Number: 2016-03353
Type: Notice
Date: 2016-02-18
Agency: Drug Enforcement Administration, Department of Justice
Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC applied to be registered as an importer of a basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC registration as an importer of this controlled substance.
Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals, Inc.
Document Number: 2016-03350
Type: Notice
Date: 2016-02-18
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.
Document Number: 2016-02863
Type: Notice
Date: 2016-02-12
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Extension of Temporary Placement of PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA in Schedule I of the Controlled Substances Act
Document Number: 2016-02308
Type: Rule
Date: 2016-02-05
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 four synthetic cannabinoids pursuant to the temporary scheduling provisions of the Controlled Substances Act. The substances are: 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 optical, positional and geometric isomers, salts, and salts of isomers. The current final order temporarily placing PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA into schedule I is in effect through February 9, 2016. This final order will extend the temporary scheduling of PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA for one year, or until the permanent scheduling action for these four substances is completed, whichever occurs first.
Schedules of Controlled Substances: Placement of PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA into Schedule I
Document Number: 2016-02305
Type: Proposed Rule
Date: 2016-02-05
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing 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-inda zole-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 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 PB- 22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA.
Schedules of Controlled Substances: Temporary Placement of the Synthetic Cannabinoid MAB-CHMINACA Into Schedule I
Document Number: 2016-02302
Type: Rule
Date: 2016-02-05
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this final order to temporarily schedule the synthetic cannabinoid N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1- (cyclohexylmethyl)-1H-indazole-3-carboxamide (common names, MAB- CHMINACA and ADB-CHMINACA), and its optical, positional, and geometric isomers, salts, and salts of isomers 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 cannabinoid 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, MAB-CHMINACA.
Louis Watson, M.D.; Decision and Order
Document Number: 2016-02130
Type: Notice
Date: 2016-02-04
Agency: Drug Enforcement Administration, Department of Justice
Kenneth H. Bull, M.D.; Decision and Order
Document Number: 2016-02129
Type: Notice
Date: 2016-02-04
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Pharmacore, Inc.
Document Number: 2016-02128
Type: Notice
Date: 2016-02-04
Agency: Drug Enforcement Administration, Department of Justice
David W. Bailey, M.D.; Decision and Order
Document Number: 2016-02127
Type: Notice
Date: 2016-02-04
Agency: Drug Enforcement Administration, Department of Justice
Self-Certification and Employee Training of Mail-Order Distributors of Scheduled Listed Chemical Products
Document Number: 2016-01377
Type: Rule
Date: 2016-01-25
Agency: Drug Enforcement Administration, Department of Justice
This document finalizes the Drug Enforcement Administration's rule implementing the requirements of the Combat Methamphetamine Enhancement Act of 2010 establishing self-certification and training requirements for mail-order distributors of scheduled listed chemical products. This action finalizes without change the interim final rule with request for comment published on April 13, 2011.
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey, Inc.
Document Number: 2016-01202
Type: Notice
Date: 2016-01-21
Agency: Drug Enforcement Administration, Department of Justice
Irwin August, D.O.; Decision and Order
Document Number: 2016-00895
Type: Notice
Date: 2016-01-20
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration: Lipomed, Inc.
Document Number: 2016-00789
Type: Notice
Date: 2016-01-19
Agency: Drug Enforcement Administration, Department of Justice
Lipomed, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Lipomed, Inc. registration as an importer of those controlled substances.
Importer of Controlled Substances Application: Siegfried USA, LLC
Document Number: 2016-00783
Type: Notice
Date: 2016-01-19
Agency: Drug Enforcement Administration, Department of Justice
Manufacturer of Controlled Substances Registration: Rhodes Technologies
Document Number: 2016-00781
Type: Notice
Date: 2016-01-19
Agency: Drug Enforcement Administration, Department of Justice
Rhodes Technologies applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Rhodes Technologies registration as a manufacturer of those controlled substances.
Manufacturer of Controlled Substances Registration: American Radiolabeled Chemicals, Inc.
Document Number: 2016-00779
Type: Notice
Date: 2016-01-19
Agency: Drug Enforcement Administration, Department of Justice
American Radiolabeled Chemicals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants American Radiolabeled Chemicals, Inc. registration as a manufacturer of those controlled substances.
Manufacturer of Controlled Substances Registration: Apertus Pharmaceuticals
Document Number: 2016-00778
Type: Notice
Date: 2016-01-19
Agency: Drug Enforcement Administration, Department of Justice
Apertus Pharmaceuticals applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Apertus Pharmaceuticals registration as a manufacturer of those controlled substances.
Manufacturer of Controlled Substances Registration: Cambridge Isotope Lab
Document Number: 2016-00782
Type: Notice
Date: 2016-01-15
Agency: Drug Enforcement Administration, Department of Justice
Cambridge Isotope Lab applied to be registered as a manufacturer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Cambridge Isotope Lab registration as a manufacturer of this controlled substance.
Importer of Controlled Substances Registration: Chattem Chemicals Inc.
Document Number: 2016-218
Type: Notice
Date: 2016-01-11
Agency: Drug Enforcement Administration, Department of Justice
Chattem Chemicals Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Chattem Chemicals Inc. registration as an importer of those controlled substances.
Manufacturer of Controlled Substances Registration: AMPAC Fine Chemicals LLC
Document Number: 2016-217
Type: Notice
Date: 2016-01-11
Agency: Drug Enforcement Administration, Department of Justice
AMPAC Fine Chemicals LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants AMPAC Fine Chemicals LLC registration as a manufacturer of those controlled substances.
Manufacturer of Controlled Substances Registration: Alltech Associates, Inc.
Document Number: 2016-216
Type: Notice
Date: 2016-01-11
Agency: Drug Enforcement Administration, Department of Justice
Alltech Associates, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Alltech Associates, Inc. registration as a manufacturer of those controlled substances.
Manufacturer of Controlled Substances Registration: IRIX Manufacturing, Inc.
Document Number: 2016-215
Type: Notice
Date: 2016-01-11
Agency: Drug Enforcement Administration, Department of Justice
IRIX Manufacturing, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants IRIX Manufacturing, Inc. registration as a manufacturer of those controlled substances.
Importer of Controlled Substances Application: Sharp Clinical Services, Inc.
Document Number: 2016-214
Type: Notice
Date: 2016-01-11
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Myoderm
Document Number: 2016-213
Type: Notice
Date: 2016-01-11
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Hospira
Document Number: 2016-212
Type: Notice
Date: 2016-01-11
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Noramco, Inc.
Document Number: 2016-209
Type: Notice
Date: 2016-01-11
Agency: Drug Enforcement Administration, Department of Justice
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