In This Section
Is the preparation process of SIR-Spheres® (Sirtex Medical Limited, Lane Cove, Australia) or TheraSphere® (MDS Nordion, Ottawa, Canada) 90Y microspheres subject to USP <797> require
Strictly no, but ethically yes.
Both SIR-Spheres® and TheraSphere® are classified as delivery devices by the FDA since they are not metabolized in the human body. Since USP <797> is not applicable to devices, it can be argued that the preparation of SIR-Spheres® and TheraSphere® should not need to meet USP <797> requirements. However, similarly to sterile suspensions of drugs that are injected, these devices share microbial contamination risks. Therefore, similar risk-level practices should ethically be followed. Because administration is generally completed not later than 1 hour after preparation, it could be exempt from USP <797> under the immediate-use provision. If administration is beyond 1 hour after preparation, however, the preparation would need to be performed in an appropriate risk-level facility (e.g., laminar flow hood in a segregated area) with appropriate hand hygiene, garb, personnel practices, etc.