Review of Drug Quality and Security Act of 2013: The Drug Supply Chain Security Act (DSCSA)
Review of Drug Quality and Security Act of 2013: The Drug Supply Chain Security Act (DSCSA)
复制标题
2013 年药品质量与安全法回顾：药品供应链安全法 (DSCSA)
DOI：
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发表时间：
2016
期刊：
影响因子：
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通讯作者：
A. Wertheimer
中科院分区：
文献类型：
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作者：
Elona Gjini;A. Wertheimer
奥巴马总统于2013年11月27日签署的《药品供应链安全法案》(DSCSA)为通过供应链追踪药品创建了统一的国家标准。DQSA的目标是通过检测和移除药品分销供应链中的潜在危险产品，增强FDA帮助保护消费者的能力。一种新的电子、可互操作的系统将只识别和跟踪在美国分销的人类使用的成品处方药。这项审查的目的是阐明一个复杂而复杂的过程，它将需要FDA与药品制造商、药品批发商、重新包装商和分销商之间的合作。DSCSA的实施基于几项法律要求，食品和药物管理局制定了一份时间表，其中每一项都要在10年内执行。从这次审查中，FDA的建议通过FDA关于识别可疑产品的指导文件来提供，以帮助贸易伙伴并提供有关可疑药物进入供应链的风险的信息。此外，FDA于2016年4月5日至6日在马里兰州银泉组织了一次公开研讨会，以收集利益相关者的宝贵反馈，他们分享了他们对新电子系统的实施及其要求的意见。到2023年底，统一的系统将提供更容易的数据交换和更少的错误，并将增加药品分销供应链的安全保障。
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类型：学生项目
The Drug Supply Chain Security Act (DSCSA) signed into law in November 27, 2013 by president Obama creates a uniform national standard for tracing drug products through the supply chain. The goal of DQSA is to enhance FDA’s ability to help protect consumers by detecting and removing potential dangerous products from the pharmaceutics distribution supply chain. A new electronic, interoperable system will identify and trace only prescription drugs in the finished form for human use while distributed in the United States. The purpose of this review was to shed light on a complex and complicated process that it will require cooperation between FDA and drug manufactures, wholesale drug distributors, repackagers and dispensers. The implementation of the DSCSA is based on several law requirements and FDA has developed a schedule with time frames for each of them to be executed over a 10-year period. From this review, FDA recommendations are provided through the FDA Guidance on Identifying Suspect Product document to help trading partners and provide information about the risk of suspect drugs entering the supply chain. Moreover, FDA organized on April 5-6, 2016 in Silver Spring, MD a public workshop to gather valuable feedback from stakeholders who shared their input about the implementation of the new electronic system and its requirements. By the end of 2023, a unified system will provide easier data exchange and less errors, and will increase the safety and security of the pharmaceutical distribution supply chain.
Type: Student Project