Drug Enforcement Administration January 2015 – Federal Register Recent Federal Regulation Documents

The Administrator of the Drug Enforcement Administration is issuing this final order to temporarily schedule three synthetic cannabinoids (SCs) into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act (CSA). The substances are: (1) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H- indazole-3-carboxamide (``AB-CHMINACA''); (2) N-(1-amino-3-methyl-1- oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (``AB-PINACA''); and (3) [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanon e (``THJ-2201''). This action is based on a finding by the Administrator that the placement of these synthetic cannabinoids and their optical, positional, and geometric isomers, salts, and salts of isomers into schedule I of the CSA 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, import, export, engage in research, or possess), or propose to handle these SCs.

Research Triangle Institute applied to be registered as an importer of a certain basic class of narcotic controlled substance. The DEA grants Research Triangle Institute registration as an importer of this controlled substance.

Cody Laboratories, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The DEA grants Cody Laboratories, Inc. registration as an importer of those controlled substances.

Euticals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Euticals, Inc. registration as a manufacturer of those controlled substances.

Lin Zhi International, Inc., applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Lin Zhi International, Inc. registration as a manufacturer of those controlled substances.

Noramco, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Noramco, Inc. registration as a manufacturer of those controlled substances.

Cerilliant Corporation applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Cerilliant Corporation registration as a manufacturer of those controlled substances.

AMPAC Fine Chemicals, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants AMPAC Fine Chemicals, LLC registration as a manufacturer of the controlled substances.

Chemtos, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Chemtos, LLC registration as a manufacturer of those controlled substances.

Boehringer Ingelheim Chemical, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Boehringer Ingelheim Chemical, Inc. registration as a manufacturer of the controlled substances.

With the issuance of this final rule, the Administrator of the Drug Enforcement Administration removes naloxegol ((5[alpha],6[alpha])- 17-allyl-6-((20-hydroxy-3,6,9,12,15,18-hexaoxaicos-1-yl)oxy)- 4,5- epoxymorphinon-3,14-diol) and its salts from the schedules of the Controlled Substances Act (CSA). This scheduling action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. Prior to the effective date of this rule, naloxegol 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 naloxegol.