21CFR PART 312 -§ 312.69 受控物质处理(中英文)

文摘   2023-05-25 12:00   湖北  

接上文21CFR PART 312 -§ 312.68 检查研究者的记录和报告(中英文)

§ 312.69 Handling of controlled substances. 受控物质处理

If the investigational drug is subject to the Controlled Substances Act, the investigator shall take adequate precautions, including storage of the investigational drug in a securely locked, substantially constructed cabinet, or other securely locked, substantially constructed enclosure, access to which is limited, to prevent theft or diversion of the substance into illegal channels of distribution.

如果试验药物受《受控物质法》约束,研究者应采取充分的预防措施,包括将试验药物储存在安全上锁的、结构严密的橱柜中,或其他安全上锁的、结构严密的封闭物中,限制进入,以防止被盗或将药物转移到非法分销渠道。

未完待续。。。

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