Drug Enforcement Administration 2015 – Federal Register Recent Federal Regulation Documents
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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.
Controlled Substances: Proposed Adjustments to the Aggregate Production Quotas for Difenoxin, Diphenoxylate (for conversion), and Marijuana
The Drug Enforcement Administration is proposing to adjust the established 2015 aggregate production quota for difenoxin, diphenoxylate (for conversion), and marijuana which are schedule I and II controlled substances under the Controlled Substances Act.
Substances Temporarily Controlled Under Schedule I of the Controlled Substances Act
This final rule makes technical and conforming amendments to the Drug Enforcement Administration regulations listing substances temporarily controlled under schedule I of the Controlled Substances Act. This final rule eliminates references to 7 substances that were previously subject to temporary control, but which have since been permanently controlled under schedule I, and redesignates 23 other substances that are currently temporarily controlled under schedule I. This action makes no substantive changes to the affected regulation.
Controlled Substances: 2015 Proposed Aggregate Production Quotas for Three Temporarily Controlled Synthetic Cannabinoids
Three 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-car boxamide (AB-PINACA), and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1- yl)methanone (THJ-2201) were temporarily placed in schedule I of the Controlled Substances Act by a final order published by the Drug Enforcement Administration on January 30, 2015 (80 FR 5042). This means that any person that wishes to manufacture AB-CHMINACA, AB-PINACA, or THJ-2201 after January 30, 2015, must be registered with the Drug Enforcement Administration and have obtained a manufacturing quota pursuant to 21 CFR part 1303. The Drug Enforcement Administration cannot issue individual manufacturing quotas for AB-CHMINACA, AB-PINACA, or THJ-2201 until it establishes aggregate production quotas. Therefore, this notice proposes the 2015 aggregate production quotas for AB-CHMINACA, AB- PINACA, and THJ-2201.
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