By Cindy Tomlinson, Senior Patient Safety and Regulatory Affairs Manager

In 2022, the American Board of Radiology announced that it was terminating the Nuclear Regulatory Commission recognition of all ABR certification processes after December 31, 2023. This change is important for radiation oncologists that want to begin offering radiopharmaceuticals but have not previously offered treatments regulated by the NRC, such as brachytherapy or radiopharmaceutical therapy.

What does this change mean? Starting on January 1, 2024, any radiation oncologist who is interested in becoming an Authorized User (AU) under 10 CFR 35, Medical Use of Byproduct Material, must obtain AU status via the “alternate pathway.”

What is the “alternate pathway”? The “alternate pathway” is how radiation oncologists become AUs without using board certification to prove compliance with training and experience requirements.

Simply put, if you are not already an AU, are within seven years of completion of training, and you want to become an AU, you must have all the proper paperwork, signatures and attestations as required by either the NRC or Agreement State. Note: if you are more than seven years after completion of training, there may be additional training and experience requirements needed to obtain AU status, but the process will be the same. You will need to contact your state radiation control program (for agreement states) or the NRC (for all others).

What can I do? Current trainees should ensure that your training program maintains meticulous records, complete with preceptor attestations, and fills out both NRC form 313A (AUT) and form 313A (AUS) and provides those to you upon graduation. This information must also be accessible to you indefinitely. Also, current trainees should ask their training programs to make them an AU under their training program’s license. This will be dependent on what type of license your facility has and the structure of your training program. The first step is to discuss this with your program director, your radiation safety officer (RSO) and your radiation safety committee.

ABR’s change puts greater onus on radiation oncologists, trainees and training programs to obtain AU status, particularly those that wish to deliver brachytherapy and radiopharmaceuticals.

More information, including links to state-specific radiation control programs and forms (where available), can be found on ASTRO’s How to Obtain AU Status webpage.

If you have any questions, please contact Cindy Tomlinson.

Learn more about radiopharmaceutical therapies in the Winter 2023 ASTROnews.

By John Buatti, MD, FASTRO, Vice-Chair, Science Council and Chair, RPT Work Group

ASTRO’s RPT Work Group has been leading efforts since 2018 to promote radiation oncologists as key leaders in the burgeoning field of radiopharmaceuticals (RPTs). To this end, in March 2023, ASTRO hosted more than 40 individuals, including academic and community practice physicians, physician scientists and industry, to engage in a dialogue between radiation oncologists and industry thought leaders about key strategic issues and opportunities related to RPTs. There was excellent engagement from participants and several priority areas emerged from the conversation:

• Supply Chain Issues. The challenges of creating and distributing RPTs once an agent is approved for therapy is a global concern. Structural and regulatory barriers were reviewed and the need for broad investment in infrastructure and engagement with government agencies was supported.


• Dosimetry. There was agreement that better understanding of dosimetry is important to achieving the optimal therapeutic potential of RPTs. However, much remains to be learned and consensus guidance is needed on key aspects of dose response both for tumor and normal tissues.


• Rational Trials Design. Another important theme that emerged was the importance of trials. This discussion included questions such as whether animal studies are valuable in the context of RPTs and whether removal or liberalization of dose limits for Phase 1 trials should be considered instead of dose extrapolation from EBRT.


• Educational Needs. Another theme that was discussed was the need to educate various stakeholders on issues related to effective practices. Better understanding by regulatory agencies and other health care disciplines about appropriate risks regarding radiation dose limits and level setting on acceptable toxicities with RPT development is needed. Failure to educate relevant stakeholders may limit the application of these highly effective agents and is a concern for industry as they bring more agents to market.

Industry leaders indicated that they would be interested in learning more about how to leverage the existing infrastructure in RO departments both to improve standardization for dosimetry and for clinical trials. To help support research, ASTRO is assembling a list of centers interested in participating in clinical trials with RPTs. If your practice currently participates in RPT and in NIH or NCTN trials and would be interested in opening industry-funded RPT trials, please contact ASTRO staff.

In addition to this inaugural stakeholder discussion, in the first half of 2023, ASTRO offered the RPT Masterclass as an add-on to the Refresher Course, with over 100 members taking advantage of this opportunity. The winter issue of ASTROnews was dedicated to RPTs, providing members with firsthand accounts on how to set up a program and gain authorized user status, patient-centered treatments and emerging advances. ASTRO also submitted comments to the International Accreditation Committee (IAC) on its proposed standards for RPTS specifically asking that the standards be modified to:

• Address patient care and management;


• Allow radiation oncologists to be the medical director of an RPT practice; and


• Allow therapy medical physicists to be the technical director of an RPT practice.

ASTRO is also in the process of updating our APEx standards for accreditation and we have posted those proposed changes, including standards to evaluate practices that offer RPTs for public comment. Please  review the proposed standards and provide your feedback.

In April, ASTRO surveyed the chairs of academic practices and learned that almost half (45%) of academic centers either have or are in the process of developing a multidisciplinary clinic for RPTs. ASTRO strongly supports multidisciplinary care and our Framework for Patient-Centered Care describes an idealized way to manage patients receiving RPT. This framework was developed to incorporate the strengths of both radiation oncologists and nuclear medicine physicians. A multidisciplinary approach requires enhanced coordination and collaboration among appropriately qualified personnel with diverse expertise in image acquisition, image interpretation, quantitative imaging, dosimetry calculation, radiation quality assurance and safety as well as oncology care and RPT-induced sequelae and response assessment. There is ample opportunity for our specialty to work alongside nuclear medicine physicians to realize the potential of these new agents.

The RPT Work Group continues to creatively advance the field of RPTs and radiation oncology’s role. If you have suggestions for other activities ASTRO can support to promote this field, please email me via ASTRO staff.