Fed Regist. 2015 Nov 12;80(218):69861-4.
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.
随着本最终规则的发布，美国药品监督管理局局长将物质5-[[[(2S)-2-氨基-3-[4-氨基甲酰基)-2,6-二甲基苯基]-1-氧代丙基][(1S)-1-(4-苯基-1H-咪唑-2-基)乙基]氨基]甲基]-2-甲氧基苯甲酸（eluxadoline），包括其盐、异构体以及异构体的盐，列入《受控物质法》附表四。此 scheduling 行动依据《受控物质法》进行，该法要求此类行动需在通过正式规则制定进行听证的机会之后记录在案。此行动对处理（制造、分销、配药、进口、出口、从事研究、开展教学活动或持有）或拟处理eluxadoline的人员施加适用于附表四受控物质的监管控制以及行政、民事和刑事制裁。
