It also proposed placing a temporary exemption to the 400-elution limit of generators almost immediately, and for the use of cyclotron-generated gallium with an acqueous target to increase production at mostly academic sites for the next three to six months to relieve the need for a GMP-grade generator in particular locations.

Another aspect is raising awareness and educating radiopharmacies about these generators and how they can apply for the appropriate licensure status with the Nuclear Regulatory Commission and applicable state regulatory bodies to obtain and use them.


“The market is demanding quick access, but the licensing process, focused primarily on public safety, can take time to address with new technology, and timing may vary between different jurisdictions,” he said. “When regulators seek feedback from their licensed stakeholders, Cardinal Health offers its experience and expertise to encourage discussions on comprehensive and efficient regulatory procedures, with standardization and consistency across the different regulatory bodies, when possible.”

The NETSPOT scan is required for the administration of Lutathera, the only therapeutic for treating neuroendocrine tumors. The U.S. Advanced Accelerator Applications (AAA) has rapidly adopted NETSPOT, expanding the network of pharmacies distributing it and raising demand for it among imaging providers to 500 as of June 2018.

Distribution of the generators is expected to begin prior to the end of 2018.

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