In what situation can a pharmacist or technician be exempt from passing a media fill test prior to compounding?

A pharmacist or technician can be exempt from passing a media fill test prior to compounding if they have evidence of passing a test in the last 9 months for low/medium risk compounding. This requirement is established to ensure that individuals engaged in compounding are competent and have demonstrated their ability to maintain aseptic conditions to minimize contamination.

The rationale for a 9-month timeframe specifically allows for a reasonable period of time for skills to remain relevant and applicable, especially in low/medium risk compounding, where the expected level of sterility assurance is less stringent compared to higher risk categories. This recognizes the importance of practical experience and maintains a standard that balances safety with practicality in compounding practice.

In contrast, while passing a media fill test within the last 6 months may typically suffice, it does not encompass the broader acceptance of a slightly longer timeframe—up to 9 months—that is allowed for those in lower risk compounding scenarios. The requirement for supervision is unnecessary for the exemption from testing since competency has already been established through past testing. Lastly, the inability to have compounded in the last year does not provide an exemption but rather indicates a gap that would require retesting to re-establish competencies.