McElhiney Linda F
Clarian Health Partners, Inc., Indianapolis, Indiana.
Int J Pharm Compd. 2009 Nov-Dec;13(6):525-30.
Hospital pharmacy departments should be compliant with the standards of United States Pharmacopeia Chapter 795. In order to remain compliant, small hospitals and institutions must properly train their staff to ensure that their compounding procedures and the resultant preparations are in compliance with the standards in Chapter 795. For reasons outlined in this article, it is more challenging for large hospitals and institutions to remain compliant; they require a specialized staff that must keep all compounding personnel updated with the constant changes in compounding practices and standards outlined by the United States Pharmacopeial Convention. This article summarizes Chapter 795 on Pharmaceutical Compounding Nonsterile Preparations, key points in the American Society of Health-System Pharmacists TAB guidelines on compounding nonsterile products in pharmacies, and author recommendations on applying these standards and guidelines in hospital pharmacy departments.
医院药房应符合美国药典第795章的标准。为保持合规，小型医院和机构必须对其员工进行适当培训，以确保其配制程序及最终制剂符合第795章的标准。出于本文所述的原因，大型医院和机构保持合规更具挑战性；它们需要专业人员，这些人员必须使所有配制人员随时了解美国药典委员会概述的配制操作和标准的不断变化。本文总结了关于非无菌制剂配制的第795章、美国卫生系统药师协会药房非无菌产品配制TAB指南的要点，以及作者关于在医院药房部门应用这些标准和指南的建议。
