NRC taking feedback on radiopharma user rules

2018 12 11 00 02 7009 Atom Nuclear Lab 400

The U.S. Nuclear Regulatory Commission (NRC) has commenced a 30-day comment period and has scheduled two public meetings on its proposal to revise training and experience requirements for administering radiopharmaceuticals.

The NRC is considering the creation of a "limited user" category for physicians with little or no background in nuclear medicine. While no formal framework is in place, it is anticipated that the criteria to become a limited user would be much less rigorous than the current standards for authorized users and other nuclear medicine practitioners.

Proponents assert that a limited user classification would improve patient access to treatment, especially in rural and underserved areas, and satisfy future demand for qualified physicians and other medical staff to administer radiopharmaceuticals.

However, organizations such as the Society of Nuclear Medicine and Molecular Imaging (SNMMI) and the American College of Nuclear Medicine (ACNM) have submitted a joint statement opposing any changes. Maintaining current standards is "critical to be able to provide high-quality care to patients and to ensure their safety, as well as that of their families and the general public," they wrote.

Along with the comment period that ends on June 3, the NRC will take oral comments during public meetings on May 14 and May 23. The May 14 meeting is open to the public at the NRC's headquarters in Rockville, MD. Both sessions will be accessible for remote participation.

Additional details are available in the May 2 edition of the Federal Register.

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