Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents
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Manufacturer of Controlled Substances Registration: Insys Therapeutics, Inc.
Insys Therapeutics, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Insys Therapeutics, Inc. registration as a manufacturer of those controlled substances.
Manufacturer of Controlled Substances Registration: Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Siemens Healthcare Diagnostics, Inc. registration as a manufacturer 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.
Adjusted Aggregate Production Quotas for Difenoxin, Diphenoxylate (for Conversion), and Marijuana
This final order establishes the adjusted 2015 aggregate production quotas for difenoxin, diphenoxylate (for conversion), and marijuana.
Controlled Substances: 2015 Established Aggregate Production Quotas for Three Temporarily Controlled Synthetic Cannabinoids
This final order establishes the initial 2015 aggregate production quotas for three temporarily controlled synthetic cannabinoids: N-(1-amino-3-methyl-1-oxobutan-2-yl)-1- (cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA), N-(1-amino- 3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB- PINACA), and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1- yl)methanone (THJ-2201).
Manufacturer of Controlled Substances Application: MALLINCKRODT, LLC; Correction
The Drug Enforcement Administration (DEA) published a document in the Federal Register of January 28, 2015, concerning a notice of application for registration as a bulk manufacturer of four basic classes of controlled substances. The document inadvertently omitted two basic classes of controlled substances.
Manufacturer of Controlled Substances Registration: S & B PHARMA, INC.; Correction
The Drug Enforcement Administration (DEA) published a document in the Federal Register of January 26, 2015, concerning a notice of registration that inadvertently stated no comments or objections were submitted in the notice.
Schedules of Controlled Substances: Removal of [123
The Drug Enforcement Administration proposes to remove [\123\I]ioflupane from the schedules of the Controlled Substances Act. This action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after an opportunity for a hearing through formal rulemaking. [\123\I]Ioflupane is, by definition, a schedule II controlled substance because it is derived from cocaine via ecgonine, both of which are schedule II controlled substances. This action would remove 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 [\123\I]ioflupane.
Schedules of Controlled Substances: Temporary Placement of Acetyl Fentanyl into Schedule I
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-phenylacetamide (acetyl 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 opioid substance 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 substances under the Controlled Substances Act on the manufacture, distribution, possession, importation, exportation, research, and conduct of instructional activities of this opioid 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: 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.
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: Mallinckrodt, LLC
Mallinckrodt, LLC applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Mallinckrodt, LLC 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: Cambrex Charles City
Cambrex Charles City applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cambrex Charles City registration as an importer of those controlled substances.
Schedules of Controlled Substances: Extension of Temporary Placement of UR-144, XLR11, and AKB48 in Schedule I of the Controlled Substances Act
The Administrator of the Drug Enforcement Administration (DEA) is issuing this final order to extend the temporary placement of (1- pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanon e (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, in schedule I of the Controlled Substances Act. The current final order temporarily placing UR-144, XLR11, and AKB48 in schedule I is due to expire on May 15, 2015. This final order will extend the temporary scheduling of UR-144, XLR11, and AKB48 to May 15, 2016, or until the permanent scheduling action for these three substances is completed, whichever occurs first.
Schedules of Controlled Substances: Placement of UR-144, XLR11, and AKB48 Into Schedule I
The Drug Enforcement Administration (DEA) proposes placing (1- pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanon e (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 proposed scheduling action is pursuant to the Controlled Substance 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 possess), or propose to handle UR- 144, XLR11, or AKB48.
Manufacturer of Controlled Substances Registration: Cedarburg Pharmaceuticals, Inc.
Cedarburg Pharmaceuticals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Cedarburg Pharmaceuticals, Inc. registration as a manufacturer of the controlled substances.
Importer of Controlled Substances Registration: Actavis Pharma, Inc.
Actavis Pharma, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Actavis Pharma, Inc., registration as an importer of those controlled substances.
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