ASTRO submits comments on NRC proposed changes to medical use licensing rule and draft patient release guidance

On September 10, 2026, ASTRO submitted comments on the Nuclear Regulatory Commission’s (NRC) proposed changes to medical use licensing rule and draft patient release guidance. 

ASTRO’s letter on the Reducing Barriers to Medical Use Licensing proposed rule supports the NRC’s proposals, while recommending refinements to avoid unintended safety risks and regulatory confusion. ASTRO’s primary concern with the proposed rule is the proposed definition of “physician,” which we believe could unintentionally allow non-physician prescribers to become Authorized Users; ASTRO urges NRC to retain the current definition or adopt language clearly limited to MDs, DOs, and equivalent foreign-trained physicians. ASTRO also supports recognizing accredited radiation oncology and nuclear medicine residency training, modernizing radioactive drug work experience categories, and codifying pathways for emerging technologies such as gamma stereotactic radiosurgery, microsources, and ophthalmic devices. 

ASTRO’s letter on the Draft Release of Patients Administered Radioactive Material regulatory guide emphasizes that patient safety and practical implementation should remain central. ASTRO supports the NRC’s Advisory Committee on the Medical Use of Isotopes’ (ACMUI’s) concern that evaluating caregiver and bystander exposure across an entire “per-administration regimen” is complex because treatment plans, facilities, caregivers, and patient circumstances can change over time. The letter recommends that NRC use “expected per administrative regimen” instead and provide clearer examples, tables, and flexibility for different caregiver and bystander scenarios. Additionally, ASTRO supports the American Association of Physicists in Medicine’s (AAPM’s) concerns, including that the draft replaces the current patient-release framework with a more complicated methodology based on overly conservative assumptions and numerous technical and clinical errors. ASTRO warns that the proposed guidance may increase administrative burden, delay patient release, require prolonged holding or hospitalization, and reduce access to radiopharmaceutical therapies.