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Sterile Compounding: Clinical, Legal, and Regulatory Implications for Patient Safety

机译:无菌复合:对患者安全的临床,法律和法规影响

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BACKGROUND: Poor compounding practices by the New England Compounding Center resulted in the 2012-2013 fungal Infections outbreak. Contaminated Injectable methylprednisolone led to the diagnosis of fungal Infections In 751 patients and 64 deaths. In the United States, pharmacy compounding has traditionally been regulated by state boards of pharmacy rather than the FDA. To minimize safety risks related to pharmacy compounding, the Drug Quality and Security Act (DQSA) was signed Into law November 27, 2013, to improve regulation of compounding pharmacies.
机译:背景:新英格兰混合中心的不良混合做法导致2012-2013年真菌感染暴发。注射用甲基强的松龙的污染导致751名患者的真菌感染被诊断为64例死亡。在美国,传统上是由国家药房委员会而非FDA监管药房配制。为了最大程度地降低与药房配制相关的安全风险,2013年11月27日,《药品质量和安全法》(DQSA)签署成为法律,以改善对药房配制的监管。

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