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Training and Education Requirements for Authorized Users of Therapeutic Radiopharmaceuticals: Changes Under Consideration for 10CFR35.390 and Their Potential Impact |
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| Authors: | Paul E. Wallner Ralph P. Lieto Gary L. Dillehay Munhir V. Ghesani Seth A. Rosenthal Kenneth E. Rosenzweig Michael L. Steinberg Don C. Yoo |
| Affiliation: | 1. 21st Century Oncology, Inc, Moorestown, New Jersey;2. St Joseph Mercy Health System, Monroe, Michigan;3. Feinberg School of Medicine, Chicago, Illinois;4. NYU Langone Health, New York, New York;5. Sutter Medical Group, Sacramento, California;6. Mt Sinai School of Medicine, New York, New York;7. David Geffen School of Medicine at UCLA, Los Angeles, California;8. Rhode Island Medical Imaging, Providence, Rhode Island |
| Abstract: | The US Nuclear Regulatory Commission (NRC) and 38 Agreement States have the regulatory authority to promulgate and enforce regulations related to the use of radioisotopes for medical purposes. Elements of these regulations include training and experience (T&E) requirements for individuals authorized to use the agents. These regulations are specified in 10CFR35.390. At this time, the NRC is considering significant revisions to the T&E requirements. This article describes current regulations and concerns related to the proposed changes and details the ACR organizational response. |
| Keywords: | Corresponding author and reprints: Paul E. Wallner, DO, 146 Sarazen Drive, Moorestown, NJ 08057. NRC training and experience requirements for radiopharmaceuticals Radiopharmaceutical administration regulations Radiopharmaceutical approved users |
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