How often must pharmacists and technicians pass a media fill test if compounding high-risk CSPs?

Pharmacists and technicians involved in the compounding of high-risk sterile compounding preparations (CSPs) are required to demonstrate their competency in aseptic technique through media fill tests. These evaluations must be passed at least twice a year to ensure that compounding personnel maintain high standards of sterility and quality in their practices.

The rationale for this frequency is based on the inherent risks associated with high-risk CSPs, which are exempt from the normal supply chain and introduce more variables that can lead to contamination. Regular testing not only confirms the competence of staff in maintaining sterility but also reinforces practices that prevent microbial contamination from entering the preparation process.

This requirement underscores the importance of ongoing proficiency in sterile compounding, ensuring that compounding staff remain vigilant about cleanliness and aseptic techniques over time, rather than just at the point of hire or infrequently thereafter. It aligns with regulatory guidelines and pharmaceutical best practices to maintain patient safety and medication integrity.