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《受管制物质、列名化学品及压片和胶囊填充机器进出口要求修订案,包括为实施国际贸易数据系统(ITDS)而做出的更改;列名化学品及压片和胶囊填充机器国内交易报告要求修订案;以及技术修订案。最终规则》

Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System (ITDS); Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments. Final rule.

出版信息

Fed Regist. 2016 Dec 30;81(251):96992-7044.

PMID:28068052
Abstract

The Drug Enforcement Administration is updating its regulations for the import and export of tableting and encapsulating machines, controlled substances, and listed chemicals, and its regulations relating to reports required for domestic transactions in listed chemicals, gamma-hydroxybutyric acid, and tableting and encapsulating machines. In accordance with Executive Order 13563, the Drug Enforcement Administration has reviewed its import and export regulations and reporting requirements for domestic transactions in listed chemicals (and gamma-hydroxybutyric acid) and tableting and encapsulating machines, and evaluated them for clarity, consistency, continued accuracy, and effectiveness. The amendments clarify certain policies and reflect current procedures and technological advancements. The amendments also allow for the implementation, as applicable to tableting and encapsulating machines, controlled substances, and listed chemicals, of the President's Executive Order 13659 on streamlining the export/import process and requiring the government-wide utilization of the International Trade Data System (ITDS). This rule additionally contains amendments that implement recent changes to the Controlled Substances Import and Export Act (CSIEA) for reexportation of controlled substances among members of the European Economic Area made by the Improving Regulatory Transparency for New Medical Therapies Act. The rule also includes additional substantive and technical and stylistic amendments.

摘要

美国缉毒局正在更新其关于压片机和胶囊填充机、管制物质及列管化学品进出口的规定,以及与列管化学品、γ-羟基丁酸和压片机及胶囊填充机国内交易所需报告相关的规定。根据行政命令13563,美国缉毒局审查了其关于列管化学品(及γ-羟基丁酸)和压片机及胶囊填充机国内交易的进出口规定和报告要求,并对其清晰度、一致性、持续准确性和有效性进行了评估。这些修订澄清了某些政策,并反映了当前的程序和技术进步。这些修订还允许在适用于压片机和胶囊填充机、管制物质及列管化学品的情况下,实施总统关于简化进出口流程并要求全政府使用国际贸易数据系统(ITDS)的行政命令13659。本规则还包含实施《改善新医疗疗法监管透明度法案》对《管制物质进出口法案》(CSIEA)所做的近期修订的内容,这些修订涉及欧洲经济区成员国之间管制物质的再出口。该规则还包括其他实质性、技术性和文体性修订。

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Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System (ITDS); Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments. Final rule.《受管制物质、列名化学品及压片和胶囊填充机器进出口要求修订案,包括为实施国际贸易数据系统(ITDS)而做出的更改;列名化学品及压片和胶囊填充机器国内交易报告要求修订案;以及技术修订案。最终规则》
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