In This Section
Is the preparation of 99mTc-sulfur colloid low risk or medium risk level?
Low risk level.
Low-risk-level procedures typically require no more than two entries into any one sterile container. Because the preparation of 99mTc-sulfur colloid requires the addition of three separate components (namely, 99mTc-sodium pertechnetate, acid, and buffer), it may appear to be medium risk level. However, the “Radiopharmaceuticals as CSPs” section in USP <797> states that “for the purposes of this chapter, radiopharmaceuticals compounded from sterile components in closed sterile containers and with a volume of 100 mL or less for a single-dose injection or not more than 30 mL taken from a multiple dose container…shall be designated as, and conform to, the standards for Low-Risk Level CSPs.”