Posted on December 2, 2016 | By Pharmacy OneSource
December 2, 2016 – Numerous incidents resulting in preventable adverse events continue to occur at sterile compounding facilities. Accrediting and governing agencies such as The Joint Commission, Centers for Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA) and State Boards of Pharmacy regularly inspect compounding pharmacies, paying particular attention to quality control, training and documentation, which are guided by USP Chapter 797 and USP Chapter 800. The failure to adhere to these standards increases preventable incidents that result in infections or death, as well as increases the risk to employees from exposure to hazardous drugs.
Simplifi 797®, a quality management system for USP 797, offers everything needed to establish the training, risk management and quality assurance practices necessary for a safe and efficient sterile compounding environment where the potential for errors is minimized. It now also includes content designed to help facilities meet the requirements of compounding hazardous drugs. With added policies and procedures, assessments and other tools to address the specific requirements of USP 800, Simplifi 797 enables compounding facilities to manage the hazardous drug compounding that is essential to patient safety and risk mitigation.
The additional USP 800 content enables staff to:
“Simplifi 797 provides the tools and resources needed to ensure compliance with USP Chapter <797> and <800> standards,” said Eric S. Kastango, MBA, BSPharm, FASHP. “Using Simplifi 797 with the included proper policies and procedures, competencies and staff training program will streamline your cleanroom operation and protect patients from the risks of sterile and hazardous drug compounding.”
For more information on Simplifi 797, visit www.simplifi797.com.
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