NRC proposes rule to ease radiopharmaceutical licensing

The U.S. Nuclear Regulatory Commission has proposed a rule to modernize licensing requirements for byproduct material use. The proposal was published May 18 in the Federal Register under docket NRC-2025-1205.

NRC said the rule would revise regulations across 10 CFR parts 30, 31, 32, 34, 39, 40, 70, and 150. Major provisions include changes to decommissioning financial assurance, standard general licenses, microsource distribution pathways, and PET radionuclide consortium definitions.

Decommissioning financial assurance requirements would be revised for sealed and unsealed radioactive materials. NRC said the proposed changes would generally reduce DFA requirements for most licensees and remove radionuclides with half-lives of 120 days or less from the appendix used for DFA calculations.

Short-lived radionuclides are being excluded because NRC said they naturally decay to negligible levels within a few years and do not require major decommissioning efforts.

Germanium-68 and gallium-68 generators are addressed in the proposal. NRC said the current default values created overly conservative DFA requirements, and that changing the values would provide a more stable regulatory framework for applicants, licensees, and regulators.

Commercial radiopharmacies could also gain a new pathway to prepare and distribute radioactive microspheres. NRC said the proposal would revise 10 CFR 32.72 to include microsources, including radioactive microspheres, within its scope.

PET radionuclide production consortiums would no longer need production facilities and medical-use licensees to be in the same geographical area. NRC said the geographic limitation created a barrier to cost-effective PET radionuclide production arrangements.

Agency analysis estimates that the proposed rule and associated guidance would generate net savings of $2.987M for industry, Agreement States, and NRC, using a 7% discount rate.

NRC said comments on the proposed rule must be submitted electronically by July 2, 2026.