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NRC leaves stringent "authorized user" of radiopharmaceuticals requirements in place

The United States Nuclear Regulatory Commission (NRC) has voted to maintain stringent training and education (T&E) requirements for physicians to be "authorized users" of radiopharmaceutical byproduct materials for medical purposes. 

NRC’s Part 35 regulations require a physician to be an authorized user in order to administer radiopharmaceuticals. Designation as an authorized requires either (1) certification by one of the medical specialty boards recognized in the regulation, such as the American Board of Nuclear Medicine, American Board of Radiology, or American Osteopathic Board of Radiology; or (2) completion of 700 hours of training and supervised work experience. 

Health care facilities that administer radiopharmaceuticals are regulated by NRC directly or are regulated by "agreement states," which are individual states that have established programs to license and regulate byproduct materials. While agreement states can have regulations stricter than the NRC, they cannot be less strict.

At the urging of various stakeholders, including the manufacturers and distributors of isotope materials, the NRC had been assessing its training and experience requirements, which those stakeholders argued were too stringent and served as barriers to patient access to radiopharmaceuticals. These stakeholders had offered a range of suggestions, including establishing a limited-scope authorized user pathway tailored to particular types of radiopharmaceuticals.

Following their multi-year review, NRC Commissioners concluded that the current framework is appropriate, and they voted to maintain the current training and experience requirements for authorized users.

In making this decision, one Commissioner, Jeffrey M. Barun, favorably cited the arguments of the American College of Radiology that the current training and experience requirements are valuable because “safe and effective use of radiopharmaceuticals requires a thorough knowledge and understanding of the modality and experience with the various facets and potential toxicities and dangers to patients, staff, and the public." 

VR-SECY-20-0005: Rulemaking Plan for Training and Experience Requirements for Unsealed Byproduct Material (10 CFR Part 35)

Tags

health care & life sciences, nrc, authorized users, radiopharmaceuticals, medical uses

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