Drug Enforcement Administration August 2014 – Federal Register Recent Federal Regulation Documents

With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance [(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan- 1-yl][5- methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone (suvorexant), 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 suvorexant.

Patheon Pharmaceuticals, Inc., applied to be registered as a manufacturer of a certain basic class of controlled substance. The DEA grants Patheon Pharmaceuticals, Inc., registration as a manufacturer of the controlled substance.

Almac Clinical Services, Inc. (ACSI) applied to be registered as an importer of certain basic classes of narcotic controlled substances. The Drug Enforcement Administration (DEA) grants Almac Clinical Services, Inc. (ACSI) registration as an importer of those controlled substances.