Training and Education Requirements for Authorized Users of Therapeutic Radiopharmaceuticals: Changes Under Consideration for 10CFR35.390 and Their Potential Impact

J Am Coll Radiol. 2019 Nov;16(11):1572-1576. doi: 10.1016/j.jacr.2019.04.010. Epub 2019 May 16.

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: NRC training and experience requirements for radiopharmaceuticals; Radiopharmaceutical administration regulations; Radiopharmaceutical approved users.

MeSH terms

  • Clinical Competence
  • Female
  • Government Agencies / legislation & jurisprudence
  • Humans
  • Male
  • Nuclear Medicine / legislation & jurisprudence*
  • Nuclear Medicine / methods
  • Occupational Health*
  • Radiation Exposure / prevention & control*
  • Radioisotopes / administration & dosage
  • Radiologists / education*
  • Radiopharmaceuticals / administration & dosage*
  • United States

Substances

  • Radioisotopes
  • Radiopharmaceuticals