Drug Enforcement Administration 2015 – Federal Register Recent Federal Regulation Documents

Alltech Associates, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Alltech Associates, Inc. registration as an importer of those controlled substances.

The Drug Enforcement Administration (DEA) is correcting a final rule that appeared in the Federal Register of November 12, 2015 (80 FR 69861). The document issued an action placing the substance 5- [[[(2S)-2-amino-3-[4-aminocarbonyl)-2,6-dimethylphenyl]-1- oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]meth yl]-2- methoxybenzoic acid (eluxadoline), including its salts, isomers, and salts of isomers, into schedule IV of the Controlled Substances Act. This document inadvertently included a paragraph in the regulatory text that was not intended for publication, and was unable to be removed before being placed on public inspection. This document corrects the final rule by removing this paragraph.

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.

Navinta, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Navinta, LLC registration as a manufacturer of those controlled substances.

Catalent CTS, LLC applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Catalent CTS, LLC registration as an importer of this controlled substance.

The Administrator of the Drug Enforcement Administration is issuing this final order extending the temporary schedule I status for three synthetic phenethylamines into the Controlled Substances Act pursuant to the temporary scheduling provisions of the Act. The substances are: 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2- methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5), 2-(4- chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82), and 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2- methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) [hereinafter 25I-NBOMe, 2C-NBOMe, and 25-NBOMe, respectively]. The initial temporary scheduling was based on a finding by the Deputy Administrator that the placement of these synthetic phenethylamines and their optical, positional, and geometric isomers, salts, and salts of isomers into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. The current final order temporarily placing 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe in schedule I is due to expire on November 14, 2015. This final order will extend the temporary scheduling of 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe for one year, or until the permanent scheduling action for these three substances is completed, whichever occurs first. As a result of this order, the full effect of the Controlled Substances Act and its implementing regulations, including criminal, civil and administrative penalties, sanctions, and regulatory controls of schedule I substances will be imposed on the manufacture, distribution, possession, importation, and exportation of these synthetic phenethylamines.

With the issuance of this final rule, the Administrator of the Drug Enforcement Administration places the substance 5-[[[(2S)-2-amino- 3-[4-aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-( 4-phenyl- 1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid (eluxadoline), including its salts, isomers, and salts of isomers, into schedule IV of the Controlled Substances Act. This 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. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule IV controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities, or possess) or propose to handle eluxadoline.

The Drug Enforcement Administration is amending the table of Excluded Nonnarcotic Products to update the company name for the drug product Nasal Decongestant Inhaler/Vapor Inhaler (containing 50 milligrams levmetamfetamine) to Aphena Pharma SolutionsNew York, LLC. This over-the-counter, nonnarcotic drug product is excluded from the provisions of the Controlled Substances Act.

Unither Manufacturing, LLC applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Unither Manufacturing, LLC registration as an importer of this controlled substance.