In This Section
If I receive a bulk vial of Tc-99m pertechnetate from my USP 797 compliant pharmacy, can I withdraw from that vial multiple times throughout the day as long as what I am compounding is used within one
No. In a non-controlled air quality environment, a kit using Tc-99m withdrawn from the Tc-99m sodium pertechnetate vial could be prepared under the immediate use exemption and used for immediate patient injection within one hour of preparation, but the remaining contents in both the kit vial and the sodium pertechnetate vial must be discarded after that hour. Multiple uses (more than two needle punctures or a second needle puncture beyond one hour of the first) of the Tc-99m sodium pertechnetate vial constitutes low-risk level compounding and therefore must be performed in an ISO Class 5 environment (e.g., laminar flow hood) located in an ISO Class 7 buffer area or segregated compounding area.
Statements such as "immediate-use CSPs are not intended for storage for anticipated needs or batch compounding" and "needle-punctured single-dose containers, such as…vials of sterile products and CSPs shall be used within 1 hour if opened in worse than ISO Class 5…air quality…and any remaining contents must be discarded" point to a one kit and one-patient dosage being the "best case" scenario intent.