Guidelines for Sterile Compounding and the Safe Use of Sterile Compounding Technology

The ISMP Guidelines for Sterile Compounding and the Safe Use of Sterile Compounding Technology were developed to help healthcare facilities identify best practices to support safe use of technology and automation in sterile compounding and to recommend best practices associated with sterile compounding when technology cannot be used.  

In response to several serious and fatal compounding errors reported to the ISMP National Medication Errors Reporting Program (ISMP MERP), the first national ISMP Sterile Product Compounding Safety Summit was held to address best practices for preparing and verifying sterile preparations. The inaugural summit resulted in the far-reaching, and frequently referenced, ISMP Guidelines for Safe Preparation of Compounded Sterile Preparations (released 2013, revised 2016). In the 10 years since that summit, the sterile compounding technology market has widened with more products available and more organizations adopting the use of technology solutions in the sterile compounding process.1,2 Despite these advancements, an ISMP survey on compounding practices revealed that opportunities remain to improve the safety of sterile compounding practices as well as increase and enhance the safe use of technology in the process.3

ISMP convened an invitational, multi-stakeholder, virtual sterile compounding safety summit to address safe practices related to the use of sterile compounding workflow management systems, automated compounding devices, and robotic compounding automation. The recommendations within the safe practice guideline focus on essential technology attributes, safe pharmacy processes, best practices for mitigating harm due to system safety gaps, and best practices for sterile compounding when technology cannot be used.   

The summit and development of the guidance document was funded through the generous support of ARxIUM, Baxter, B. Braun Medical, BD, ConsortiEX, Grifols, ICU Medical, and Omnicell.

How to cite: Institute for Safe Medication Practices (ISMP). ISMP Guidelines for Sterile Compounding and the Safe Use of Sterile Compounding Technology. ISMP; 2022.

  1. Paytes A, Hansen KN, Boiallis CJ. The state of sterile compounding technology. Pharmacy Purchasing & Products. 2022;19(3):s2-4.
  2. Pedersen CA, Schneider PJ, Ganio MC, Scheckelhoff DJ. ASHP National survey of pharmacy practice in hospital settings: Dispensing and administration- 2020. Am J Health Syst Pharm. 2021;78(12):1074–93.
  3. Institute for Safe Medication Practices. Survey provides insights into pharmacy sterile compounding systems and practices. ISMP Medication Safety Alert! Acute Care. 2020;25(21):1-5.

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