Nuclear Medicine Clarification Act of 2025

Nuclear Medicine Clarification Act of 2025

This bill requires the Nuclear Regulatory Commission (NRC) to revise its regulations so that health care providers must report to the NRC when a dose of a radioactive drug caused by an extravasation exceeds specified quantities. An extravasation generally means the unintentional presence of a radioactive drug in the tissue surrounding the blood vessel following an injection.

Under the NRC’s current regulations, health care providers licensed by the NRC to use radioactive materials must submit a report to the NRC for any instance, known as a medical event, where the administered dose of a radioactive drug exceeds specified quantities or criteria. 

In 2024, the NRC published a draft proposed rule that would add an extravasation as a medical event that must be reported. The draft proposed rule’s reporting threshold is based on a physician’s determination that the administration results or may potentially result in a radiation injury from an extravasation. The reporting threshold proposed by the NRC does not contain a quantified dose.

The bill requires the NRC to revise its regulations to add an extravasation as a medical event that must be reported, and it additionally requires the reporting threshold to be based on quantified doses (as specified in the bill).