In This Section
Does USP <797> affect drawing multiple doses from a Tc-99m MAA vial prepared by and obtained from an outside nuclear pharmacy?
Yes.
If at least Low-Risk Level conditions are not met where the Tc-99m MAA vial is prepared or where doses are drawn, not more than two entries into the vial may be made. Therefore, if the kit is prepared outside appropriate USP risk level conditions the two entries are (1) injecting Tc-99m pertechnetate into the cold MAA kit, and (2) withdrawing one dose. If the Tc-99m MAA vial is prepared in the nuclear pharmacy under appropriate USP risk level conditions but delivered for use outside the pharmacy, the maximum two entries are made withdrawing a maximum of two doses. Both scenarios are subject to the one-hour restriction as per USP Immediate-Use provision (i.e., “Administration begins not later 1 hour following the start of the preparation of the CSP”.)