The DSCSA, Title II of the Drug Quality and Security Act (DQSA) enacted by the United States Congress on Nov. 27, 2013, sets forth requirements for trading partners (i.e., manufacturers, wholesale distributors, repackagers, dispensers, and third-party logistics providers) regarding the tracing of prescription pharmaceutical products during distribution throughout the United States.1这些可互操作的电子追踪系统将允许食品药品监督管理局(FDA)通过轻松识别出受损的处方药产品(包括可能被伪造,被盗,污染,危险或有害或有害的,并将其脱离药物供应链)来保护美国消费者。此外,DSCSA将要求批发分销商和第三方物流提供商每年获得国家许可并报告FDA的国家许可状态。2
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