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If I make a kit of Tc-99m MAA or Tc-99m MDP and inject multiple patients from that vial all within one hour of preparation does this fall within the immediate use category?
USP does not clearly articulate that the immediate use exemption is limited to single doses. Our interpretation of the USP Immediate-Use provision is that it applies to single-dose containers (i.e., products without antimicrobial preservatives, including these radiopharmaceuticals). A kit of Tc-99m MAA or a kit of Tc-99m MDP could be prepared under the immediate use exemption and used for immediate patient injection within 1-hour of preparation, but the remaining contents in the vial must be discarded after that hour.
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. Moreover, the Immediate Use restriction that there be no more than two entries into a container appears to preclude the possibility of withdrawing multiple doses from one vial.