USP publishes new and revised sterile compounding standards

Standards help ensure quality compounded preparations to safeguard the well-being of patients and those handling the compounds

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USP has released new and revised standards to help ensure the quality of compounded medicines. The updates pertain to the USP General Chapters on:

  • Compounding nonsterile medicines (USP <795> Pharmaceutical Compounding—Nonsterile Preparations)
  • Compounding sterile medicines (USP <797> Pharmaceutical Compounding— Sterile Preparations)
  • New standards for compounding radiopharmaceutical drugs (USP <825> Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging)

Collectively, these USP General Chapters are a set of standards that assist healthcare practitioners with consistently producing quality compounded medicines to help ensure patients receive medicines that are the right strength, quality and free of contaminants.

USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings is another relevant chapter for compounding to help promote the safe handling of hazardous drugs by healthcare workers.

Janet Woodcock, Director of the Center for Drug Evaluation and Research at the US FDA, said: “The revised USP standards recognise risks associated with nonsterile and sterile compounding and tighten controls in areas that directly affect the quality and safety of compounded medicines. The changes to these USP chapters should improve the quality of compounded products and help protect public health.”

Revisions to chapters <795> and <797> and the implementation of the new chapter <825> reflect new science and evidence based on updated guidance documents, best practices and new learnings. The revisions also incorporate stakeholder input and clarify topics that are frequently misunderstood.

“We appreciate the thoughtful feedback from stakeholders within the public health community,” said Jaap Venema, CSO of USP. “Participation in our public comment process is critical to ensuring the standards we develop have the intended effects of advancing quality and patient safety.”

Venema continued: “Furthermore, we realise in this ever-changing industry it can at times be challenging for healthcare organisations to implement new standards, which is why we are committed to providing innovative solutions to help healthcare teams successfully translate the new standards into their practice settings.”

USP offers educational programmes and practical tools to support healthcare practitioners and organisations with adopting the updated standards and ensuring the safety of patients and healthcare workers.

Key resources include:

  • Complimentary access to Chapters: From June 1, 2019 – January 1, 2020, access the updated and new standards for free digitally to prepare for compliance.
  • USP Education Courses: Participate in live and recorded courses and webinars to better understand the standards and tips for implementation.
  • HazRx Mobile App and HazRx Data Set (Institution Solution)

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