NRC Assessing Feasibility of Limited AU Status for Radiopharmaceutical Administration

The Nuclear Regulatory Commission (NRC) is studying the feasibility of creating a limited authorized user (AU) status for radiopharmaceutical administration. In its "Staff Evaluation of Training and Experience Requirements for Administering Different Categories of Radiopharmaceuticals," dated August 28, 2018, NRC staff stated it may be feasible to establish tailored training and experience requirements for categories of radiopharmaceuticals under 10 CFR Part 35 subpart E. The NRC Advisory Committee on the Medical Uses of Isotopes meeting September 20–21 provided a forum for discussion of this issue.

The ACMUI's Training and Experience for all Modalities Subcommittee presented an update on its activities and the planned path forward to explore a limited AU pathway for administering radiopharmaceuticals. The subcommittee stressed the necessity of determining appropriate training and experience requirements. ACMUI members expressed concern that any alternate pathway protects patient safety and ensures the quality of administrations. Members acknowledged the availability of patient-ready doses that simplify administrations, yet they cautioned that administrations of new radiopharmaceutical therapies are getting more complicated and questioned whether new agents would fit into any newly crafted requirements.

Stakeholders in attendance at the ACMUI meeting expressed a range of opinions on advancing a limited AU status. A representative of the Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR) advocated for an alternative to the current 700 hours of training and experience, citing physicians' limited role in handling patient ready doses and existing safety profiles. In contrast, the American Society for Radiation Oncology (ASTRO) recommended staying with current requirements.

A nuclear medicine physician from the Society of Nuclear Medicine and Molecular Imaging (SNMMI) talked about the evolving nuclear medicine field. He explained the United states is falling behind European and other countries, where there is a greater variety of therapeutics being offered to patients. He believed that loosening training requirements would not help patient access. He argued that the United States needed a strong, clear pathway to nuclear medicine sub-specialization for the new age of targeted therapies and recommended mastery of the current curriculum, including complex medical and safety risks, to ensure that a physician administering radiopharmaceuticals has broad expertise in nuclear medicine—not just in one procedure.

The NRC staff plans to conduct extensive outreach over the next 12–14 months with the medical community, including international groups, on how to tailor training and experience requirements to establish a limited AU status. We will keep you updated on developments and opportunities for engagement.

If you have any questions or concerns about this issue, please contact Richard Martin, JD, AAPM Government Relations Program Manager.