Reducing Barriers to Medical Use Licensing
Published Date: 7/27/2026
Proposed Rule
Summary
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations to reduce barriers to medical use licensing. This proposed rule responds to Executive Order 14300, "Ordering the Reform of the Nuclear Regulatory Commission," which requires the NRC to conduct a review and wholesale revision of its regulations. This proposed rule, if adopted, would reduce overly prescriptive regulations, increase flexibility, and modernize radiation safety practices for the medical use of byproduct material. It also would enable more efficient and predictable licensing for emerging medical technologies and reduce unnecessary burden in training and experience requirements for medical authorized users. The NRC is revising guidance for this proposed rule. This proposed rule also would incorporate minor editorial corrections.
Analyzed Economic Effects
15 provisions identified: 15 benefits, 0 costs, 0 mixed.
Replace 7-Year Rule With Continuing Education
The rule would remove the 7-year ‘‘recentness of training’’ requirement and instead require performance-based continuing education and training documentation (new Sec. 35.2059). Licensees would keep records of continuing education and experience instead of submitting proof with applications.
Residency-Based Training Pathway
The rule would remove prescriptive classroom, laboratory, and work-hour requirements for physicians who completed accredited residencies that include radiation safety training, allowing a residency plus written attestation from a preceptor to qualify instead of fixed hour counts.
Codify Some Emerging Medical Technologies
The rule would codify licensing pathways, training, and performance-based safety criteria for certain well-established emerging medical technologies (EMTs), including modern gamma stereotactic radiosurgery (GSR) devices, ophthalmic applicators, generators, and microsources, moving them out of subpart K into the main body of 10 CFR part 35.
Longer Decay-In-Storage Eligibility
The rule would expand decay-in-storage eligibility by increasing the allowable half-life from 120 days to 275 days, permitting onsite disposal of longer-lived materials such as lutetium-177 metastable (Lu-177m) and cobalt-57 (Co-57), which can reduce waste disposal costs.
Estimated Net Savings and Costs
The NRC estimates net savings of $39.1 million (undiscounted) over 2027–2031 from this proposed deregulatory action; NPV is $35.6 million discounted at 3% and $31.7 million at 7%. Licensees would save about $30.5 million (undiscounted) over 5 years. Additional recordkeeping costs are estimated at $2.4 million (undiscounted) and implementation costs about $2.9 million (undiscounted) over that period.
Foreign-Trained Physicians Eligible
The rule would broaden the definition of “physician” so foreign-trained individuals who are licensed by a U.S. State or Territory, the District of Columbia, or Puerto Rico to prescribe drugs can qualify as authorized users (AUs). This changes the current MD/DO-only wording to include other primary medical qualifications if the person holds a U.S. license to practice medicine.
Add Diagnostic Authorized Users Internally
For diagnostic (non-therapeutic) uses, licensees would no longer need to file license amendments to add authorized users; licensees could approve and document those users internally because the rule treats these uses as lower risk.
Flexible Work-Experience Categories
Work experience categories for oral and parenteral administration of radioactive drugs that require a written directive would be updated to allow flexibility for future radiopharmaceuticals and remove some prescriptive device-/case-count requirements.
Rubidium-82 Generator Requirements Clarified
The rule would establish codified requirements for rubidium-82 (Rb-82) generators, including definitions for breakthrough, flexibility for calibration of dynamic systems, and updated licensing and training provisions to reflect enforcement guidance (EGM 13-003).
Remove Written Directive for Diagnostic I-131
The rule would remove the written directive requirement for diagnostic sodium iodide I-131 administrations above 1.11 MBq (30 microcuries) and move authorization for these diagnostic uses from subpart E to subpart D, aligning them with other diagnostic procedures.
Narrower Medical Event Reporting Rules
Medical event reporting would be refined to exclude events caused by emergent patient conditions (e.g., vascular spasms, seizures) or real-time clinical decisions, while continuing to require reporting for events with safety significance such as equipment defects or unintended harm.
Refine Embryo/Fetus Dose Reporting
The rule would refine embryo/fetus dose reporting to exclude cases where pregnancy could not reasonably be determined prior to administration, aligning reporting obligations with clinical realities and reducing unnecessary reports.
Streamline IRB-Approved Human Research
The rule would eliminate the license amendment requirement for human subject research that is already approved by an Institutional Review Board (IRB) and covered under existing medical use authorizations, allowing such research to proceed without a separate license amendment.
Flexibility for Mobile Medical Services
The rule would remove duplicative and prescriptive requirements for mobile medical services and align mobile service rules with general radiation safety regulations, giving licensees greater flexibility in how they provide mobile services without compromising safety.
Extend Temporary RSO Duration
The rule would extend the allowable duration for a temporary Radiation Safety Officer (RSO) and refine Radiation Safety Committee (RSC) requirements to reflect current clinical practice and focus oversight on higher-risk therapeutic uses.
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