Potential Significant Changes in Nuclear Regulatory Commission Policies Regarding Training and Experience Requirements for the Use of Radiopharmaceuticals

Paul E Wallner; Ralph P Lieto; Gary L Dillehay; Munhir V Ghesani; Seth A Rosenthal; Kenneth E Rosenzweig; Michael L Steinberg; Don C Yoo; William Small Jr

doi:10.1016/j.jacr.2020.07.035

Potential Significant Changes in Nuclear Regulatory Commission Policies Regarding Training and Experience Requirements for the Use of Radiopharmaceuticals

J Am Coll Radiol. 2021 Feb;18(2):312-317. doi: 10.1016/j.jacr.2020.07.035. Epub 2020 Aug 27.

Authors

Paul E Wallner¹, Ralph P Lieto², Gary L Dillehay³, Munhir V Ghesani⁴, Seth A Rosenthal⁵, Kenneth E Rosenzweig⁶, Michael L Steinberg⁷, Don C Yoo⁸, William Small Jr⁹

Affiliations

¹ 21st Century Oncology, Moorestown, New Jersey; Chair, Work Group of the ACR Commission on Government Relations, Federal Regulatory Committee; Chair, Physicians Consortium for Performance Improvement, Oncology Technical Expert Panel. Electronic address: [email protected].
² Monroe, Michigan.
³ Feinberg School of Medicine, Chicago, Illinois.
⁴ Chief of Nuclear Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.
⁵ Sutter Medical Group, Sacramento, California.
⁶ Icahn School of Medicine at Mount Sinai, New York, New York; Chair, Department of Radiation Oncology, Mount Sinai Health System, New York, New York; Vice Chair, ACGME Radiation Oncology Review Committee.
⁷ David Geffen School of Medicine at UCLA, Los Angeles, California; Chair, Radiation Oncology, University of California, San Francisco, San Francisco, California.
⁸ The Warren Alpert Medical School of Brown University, Providence, Rhode Island; Chair, ACR Commission on Nuclear Medicine and Molecular Imaging.
⁹ Chair, Department of Radiation Oncology, and Director, Cardinal Bernardin Cancer Center, Loyola University Chicago, Maywood, Illinois; Co-Chair, NRG Oncology Gynecologic Cancer Committee; Chair, ACR Commission on Radiation Oncology.

PMID: 32860755
DOI: 10.1016/j.jacr.2020.07.035

Abstract

The Code of Federal Regulations is a single-source repository of all rules and regulations promulgated by federal departments and agencies. In Title 10, Chapter 1, Part 35, Subpart D, §§35.100 to 35.290 detail regulations for the use of unsealed by product material not requiring a written directive (ie, diagnostic radiopharmaceuticals), and in Subpart E, §§35.300 to 35.396 detail regulations for the use of unsealed by product material requiring a written directive (ie, therapeutic radionuclides). Currently proposed changes for both Subparts D and E could have profound effects on patient care, public safety, and the practice of nuclear medicine, diagnostic radiology, and radiation oncology. This article details those proposed changes and actions under way to prevent promulgation of proposals that could negatively affect patient care and public safety.

Keywords: Nuclear regulatory commission; diagnostic and therapeutic radiopharmaceutical regulations; radiopharmaceutical authorized users.

MeSH terms

Humans
Nuclear Medicine*
Policy
Radionuclide Imaging
Radiopharmaceuticals*

Substances

Radiopharmaceuticals