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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)312-317
Number of pages6
JournalJournal of the American College of Radiology
Volume18
Issue number2
DOIs
StatePublished - Feb 2021

Keywords

  • Nuclear regulatory commission
  • diagnostic and therapeutic radiopharmaceutical regulations
  • radiopharmaceutical authorized users

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

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