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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).
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Action Timeline
2025-04-01
Referred to the House Committee on Energy and Commerce.
2025-04-01
Introduced in House
2025-04-01
Introduced in House
Full Bill Text
119 HR 2541 IH: Nuclear Medicine Clarification Act of 2025 U.S. House of Representatives 2025-04-01 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. I 119th CONGRESS 1st Session H. R. 2541 IN THE HOUSE OF REPRESENTATIVES April 1, 2025 Mr. Davis of North Carolina (for himself, Mr. Griffith , and Mr. Cline ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To require the Nuclear Regulatory Commission to revise its regulations to protect patients from unintended exposure to radiation during nuclear medicine procedures, and for other purposes. 1. Short title This Act may be cited as the Nuclear Medicine Clarification Act of 2025 . 2. Medical event reporting of unintended irradiation (a) Revision of regulations required Not later than 120 days after the date of enactment of this Act, the Nuclear Regulatory Commission shall revise section 35.3045(a)(1) of title 10, Code of Federal Regulations, by adding at the end the following: (iv) A dose that is due to an extravasation and exceeds— (A) 0.5 Sv (50 rem) dose equivalent to the 5 cubic centimeter volume of tissue receiving the highest absorbed dose during residence time; or (B) 0.5 Sv (50 rem) shallow dose equivalent to the contiguous 10 square centimeters of skin receiving the highest absorbed dose during residence time. . (b) Effective date The revision required under subsection (a) shall take effect on the date that is 18 months after the date of enactment of this Act.
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