In This Section
What is the SNMMI's official stance on UltraTag® in relation to USP <797>?
SNMMI does not take an official stand on the preparation of UltraTag in relation to USP <797>. To reiterate the disclaimer, "These FAQs reflect the authors' views only. They have not been provided or endorsed by the USP Convention or the USP Expert Committee on Sterile Compounding, nor do they necessarily reflect the views of the authors' institutions, SNMMI, or any other entities. This document is provided for informational purposes only and is not intended as legal advice. It should not be used to replace the advice of your own legal counsel."
As stated in the FAQs, Tc-99m in vitro RBCs (UltraTag) can be prepared as immediate use exemption if a special standard operating procedure (SOP) is developed and followed whereby the number of needle puncture entries into the reaction vial is limited to two. Using a special SOP does not necessarily go against package insert instructions, because the package insert uses the words 'transfer' and 'add' without specifying separate needle punctures.
In August, 2008, the SNMMI sent a letter to the US Pharmacopeia Sterile Compounding Committee discussing issues regarding the use of in vitro Tc-99m-labeled red blood cells prepared with the UltraTag RBC Kit as it relates to compliance with USP General Chapter <797>. To read the full letter, please click here. As of this writing, the SNM has not received a response from the USP Sterile Compounding Committee.