The U.S. Nuclear Regulatory Commission (NRC) announced a proposed rule May 18 that addresses long-standing inefficiencies in the licensing framework governing radioisotopes in nuclear medicine.
The proposed rule -- Modernizing NRC Regulations for Byproduct Material Use -- is a direct response to an executive order signed in May 2025 by President Donald Trump that directed the NRC to eliminate unnecessary regulatory burdens and expedite licensing timelines, as well as the bipartisan ADVANCE Act of 2024. The rule is projected to generate net savings of roughly $3 million for industry, agreement states, and the NRC, according to the agency.
Specifically, the rule eliminates decommissioning financial assurance (DFA) -- the financial guarantees licensees must maintain to cover potential decommissioning costs -- for all radionuclides with half-lives of 120 days or less, including lutetium-177, yttrium-90, actinium-225, and radium-223. The rule would also provide 100-fold relief in DFA thresholds for germanium-68/gallium-68 generators.
The rule would also permit commercial radiopharmacies to prepare and distribute radioactive microspheres, a pathway currently unavailable because microspheres are regulated as medical devices rather than radioactive drugs, the agency said.
Additionally, the rule would repeal a geographic restriction on consortium arrangements for PET radionuclide production that required production facilities and medical-use licensees to be in the same area. The change would enable centralized production and shipment of longer-lived PET radionuclides such as copper-64 and Ga-68 regardless of distance.
Public comments are due July 2, 2026, the NRC said.
