Schedules of Controlled Substances: Placement of Eluxadoline Into Schedule IV

The Drug Enforcement Administration proposes to place the substance eluxadoline (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), including its salts, isomers, and salts of isomers, into schedule IV of the Controlled Substances Act (CSA). This proposed 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. If finalized, this action would impose 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.