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November 14, 2022

IV Robotics and the Latest USP Revisions

Bethany Donato
Director, Product Marketing 

On November 1, the U.S. Pharmacopeia (USP) published revisions to the general chapters on compounding Nonsterile <795> and Sterile <797> preparations, including robotic technology for the very first time.

USP is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medications. The latest revisions, which take effect November 1, 2023, exempt some robotic devices from surface sampling after every batch of Category 3 compounded sterile products (CSPs) and instead allow users of self-enclosed robotic devices to surface sample once per day.

Sterile compounding is one of the most labor-intensive and risky areas of pharmacy. IV robotics have demonstrated proven benefits for safe, efficient sterile compounding for over 15 years, but market adoption has been slow.

Kevin Hansen, PharmD, MS, BCPS, BCSCP, the systemwide director of pharmacy at Cone Health in Greensboro, NC, noted in a recent Pharmacy Practice News article, "We have sophisticated technology and automation available on the market today that can prevent or catch compounding errors and provide safe patient care. However, the adoption of this technology throughout the nation is extremely low, leaving our patients vulnerable to harm from preventable errors." As a USP's Compounding Expert Committee member, he was on hand Tuesday, November 8, for the USP Virtual Open Forum Series panel session.

When the USP <797> revisions take effect next year, manual compounders will face the additional challenge of surface sampling after every batch of Category 3 compounded sterile products. With the continuing nationwide shortage of pharmacy technicians, this additional requirement will pile on an already overstretched pharmacy staff.

Health systems are continuously challenged to ensure IV preparations are compounded safely and accurately while complying with increasingly complex regulations like these new USP standards. This is why they need to explore the opportunity of robotic compounding technology. The IVX Station robot delivers the safety, accuracy, cost savings, supply chain control, and compliance benefits needed to support a comprehensive, in-house sterile compounding operation. Available through Omnicell's IV Compounding Service – which combines the technology, tools, and experts to operate and optimize the robot – this comprehensive offering is designed to provide a reliable, safe, and cost-effective supply of CSP production to meet patient demand.

Learn more about the innovations in robotic compounding technology and how Cone Health has improved safety and efficiency.

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The views and opinions expressed in this blog are those of the authors. They do not necessarily reflect the official policy or position of any other agency, organization, employer, or company. Assumptions made in the analysis do not reflect the position of any entity other than the author(s). These views are always subject to change, revision, and rethinking at any time and may not be held in perpetuity.