Training and Experience Requirements for Authorized Users of Therapeutic Radiopharmaceuticals (10CFR35.390): A Critical Update

Abstract

In April 2002, the US Nuclear Regulatory Commission (NRC) published a final rule for medical use of byproduct material that continued to emphasize NRC’s concerns regarding the primacy of public safety. The 2002 final rule, in combination with later clarifying rules over the course of several years, precisely documented the requirements for required hours of training and experience (T & E) including essential components of classroom and laboratory training and work experience. The regulatory schema provided that NRC-recognized medical specialty board-certified individuals, and those “who meet the requirements” specified in the regulation (known as the “alternate pathway”), would be eligible to be authorized users (AUs) of byproduct materials for the corresponding sections [ 1 US Nuclear Regulatory CommissionFederal Register Final Rule 10CFR Parts 20, 32 and 35, April 24, 2002. https://www.govinfo.gov/content/pkg/FR-2002-04-24/pdf/02-9663.pdfDate accessed: August 10, 2022 Google Scholar , 2 Wallner P.E. Lieto R.P. Dillehay G.L. et al. 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; 16: 1572-1576 Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar ]. The commission indicated its intention to periodically request review of the regulations by its Advisory Committee on the Medical Use of Isotopes (ACMUI). Notwithstanding several subsequent rulemakings to refine or clarify aspects of the initial regulatory reforms, the 2002 rules have remained essentially intact.