Guidelines

Guidelines for Safe Preparation of Compounded Sterile Preparations

sterile preparation

The ISMP Guidelines for Safe Preparation of Compounded Sterile Preparations were developed to help healthcare facilities identify safe guards to prevent errors during pharmacy preparation of parenteral admixtures.  

In 2016, ISMP revised the initial set of consensus guidelines that were published in 2013 based on the proceedings from a summit held by ISMP of key stakeholders in 2011.  Following the summit and initial publication of the guidelines, ISMP continued to gain further understanding of reported events involving IV admixture preparation practices, including the causative factors, and identified the need for additional action to help prevent such errors. The revisions were based on feedback received by an advisory panel and through public comment to address and emphasize ISMP’s support for the use of IV admixture technologies to enhance safety.   

The recommendations contained within the safe practice guidelines focus on the following processes:

  • Policies and procedures for compounding sterile preparations
  • Order entry and verification
  • Drug inventory storage
  • Assembling products and supplies for preparation
  • Compounding
  • Drug conservation
  • Compounding performed outside the pharmacy IV admixture service
  • Preparation of source/bulk containers
  • Technology/automation used for compounding sterile products
  • Automated compounding (pumping) systems
  • Quality control/final verification
  • Product labeling
  • Staff management

The summit and the original guidance document were funded through the generous support of Ameridose, Baxa, Baxter, B. Braun, and Hospira.

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