Ensuring Safety in Compounding: USP 797 Competency Assessments and Implications for Anesthesiology

TO THE EDITOR

Compounding medications is critical to healthcare delivery, especially in specialized fields such as anesthesiology, where custom formulations are often required to meet patient-specific needs. However, compounding errors can result in contamination, infection, or incorrect dosing, potentially leading to severe harm or even death. The United States Pharmacopeia Chapter 797 (USP 797) sets rigorous standards to minimize these risks and emphasizes the importance of competency assessments for individuals involved in sterile compounding.¹

USP 797 establishes standards for preparing compounded sterile preparations (CSPs) to ensure patient safety and product quality. These standards apply to all healthcare personnel who prepare, store, or handle CSPs, including pharmacists, technicians, and anesthesia staff. The guidelines cover various topics, including environmental controls for sterile compounding areas, aseptic technique and hand hygiene practices, facilities, equipment, environmental monitoring requirements, personnel training, competency assessments, and qualification processes. The updated USP 797 guidelines, effective November 1, 2023, strongly emphasize training, competency assessments, and documentation to prevent errors and contamination. These updates reflect an evolving understanding of the best practices in sterile compounding and address gaps identified in previous standard versions.¹

Competency assessments are formal evaluations designed to ensure that individuals involved in sterile compounding possess the knowledge and skills to perform their duties safely. According to USP 797, competency assessments must be conducted initially before personnel begin compounding, including the following: 1) a written or electronic evaluation to test theoretical knowledge; 2) practical demonstrations of aseptic techniques such as hand hygiene, garbing, and the proper use of equipment; and 3) annual evaluations for anesthesiology staff performing compounding. These assessments must also evaluate adherence to standard operating procedures (SOPs) and observe aseptic practices in actual or simulated settings.¹

Individuals administering anesthesia frequently compound medications in fast-paced, high-pressure environments such as operating rooms (ORs) and intensive care units (ICUs). Examples include the reconstitution of antibiotics for perioperative prophylaxis, preparation of vasopressors or inotropes for hemodynamic support, and compounding local anesthetics for regional anesthesia or pain management. Under the 2023 revision, any CSP prepared in an OR without an ISO 5 primary engineering control defaults to the immediate-use exemption and must be administered within four hours of the start of preparation—batching for later cases is no longer compliant. While these practices are essential for patient care, they carry inherent risks if performed improperly. Common challenges include time constraints, as anesthesia staff often prepare CSPs in real-time while balancing aseptic technique with the need for rapid action; environmental limitations, as operating rooms are not designed for sterile compounding, increasing the risk of contamination; and the immediate-use exemption, which allows certain CSPs to be prepared and administered without meeting full USP 797 requirements, provided they are used within one hour. However, this exemption does not absolve anesthesiology staff from adhering to fundamental aseptic practices or maintaining competency.^2,3

Medical accrediting organizations now routinely trace USP <797> compliance—especially documented competency—during surveys. Compliance is now a focal point of facility inspections and can significantly influence accreditation outcomes. This shift highlights the need for healthcare organizations to institutionalize these standards as part of broader quality and safety initiatives.

To comply with USP 797 and enhance patient safety, healthcare organizations should integrate anesthesia staff into their sterile compounding training and assessment programs. Standardized training programs should address general aseptic principles and scenarios specific to anesthesia practice. These include proper hand hygiene and garbing procedures, sterile vial access techniques, correct labeling and documentation of CSPs, and management of spills and contamination. Organizations can leverage online modules, in-person workshops, and simulation-based training to deliver these programs. Practical evaluations can include simulation scenarios that mimic real-world conditions, such as preparing a vasopressor infusion during a code situation or compounding local anesthetics for a peripheral nerve block. These scenarios can help identify gaps in the aseptic technique and provide targeted feedback and improvement opportunities.^4,5

Concurrently, healthcare facilities should consider incorporating competency assessments into the credentialing and re-credentialing processes for anesthesia staff and other personnel involved in compounding. By embedding these evaluations into initial credentialing and focused proctoring for new staff, organizations can ensure that staff demonstrate proficiency in sterile compounding practices before assuming full clinical responsibilities. Periodic reassessment during re-credentialing cycles provides an additional safeguard, reinforcing adherence to USP 797 guidelines and promoting continuous improvement. Regular audits of compounding practices in the OR can reinforce adherence to USP 797 standards. Observational checklists can be used to evaluate compliance with aseptic techniques and identify areas for improvement. Collaboration between pharmacy and anesthesia teams is also essential to develop tailored training programs and SOPs, with pharmacy teams providing oversight and guidance for high-risk compounding tasks.⁶

While implementing USP 797 training and competency assessments may present logistical and financial challenges, the potential benefits far outweigh the costs. Key benefits include enhanced patient safety by reducing the risk of contamination, medication errors, and adverse events; regulatory compliance to help organizations avoid citations and penalties from accreditation bodies; and professional development opportunities for anesthesia staff to refine their skills and stay current with best practices.

USP 797’s emphasis on competency assessments highlights the importance of ensuring that all personnel involved in sterile compounding, including anesthesiology staff, possess the knowledge and skills to perform their roles safely. By integrating these assessments into routine practice and fostering a safety culture, healthcare organizations can protect patients, enhance outcomes, and maintain compliance with regulatory standards. Adhering to USP 797 is not just a regulatory requirement but a professional obligation to ensure the highest standards of care in the perioperative setting.

Sunny Jha, MD, MS, FASA is President of SJMD Solutions.

REFERENCES

1. United States Pharmacopeia. USP Chapter <797>: Pharmaceutical Compounding – Sterile Preparations. Rockville, MD: The United States Pharmacopeial Convention; 2023. Available at: https://www.usp.org/standards/compounding/797. Accessed February 14, 2025.
2. The Joint Commission. Safe Use of Compounded Medications. Available at: https://www.jointcommission.org. Published 2021. Accessed February 14, 2025.
3. Institute for Safe Medication Practices. Guidelines for Sterile Compounding Practices. Available at: https://www.ismp.org/guidelines/sterile-compounding. Published 2022. Accessed February 14, 2025.
4. American Society of Anesthesiologists. Guidelines for Medication Safety in Anesthesia Practice. Available at: https://www.asahq.org. Published 2021. Accessed February 14, 2025.
5. Centers for Disease Control and Prevention (CDC). Injection Safety and Aseptic Technique. Available at: https://www.cdc.gov/injectionsafety/aseptic-technique.html. Published 2020. Accessed February 14, 2025.
6. ASHP Guidelines on Compounding Sterile Preparations. Am J Health-Syst Pharm. 2021;78(24):2097-2114. Available at: https://academic.oup.com/ajhp/article/78/24/2097/5875317. Accessed February 14, 2025.