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

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

doi:10.1016/j.jacr.2019.04.010

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

Paul E. Wallner^*, Ralph P. Lieto, Gary L. Dillehay, Munhir V. Ghesani, Seth A. Rosenthal, Kenneth E. Rosenzweig, Michael L. Steinberg, Don C. Yoo

^*Corresponding author for this work

Radiology

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

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.

Original language	English (US)
Pages (from-to)	1572-1576
Number of pages	5
Journal	Journal of the American College of Radiology
Volume	16
Issue number	11
DOIs	https://doi.org/10.1016/j.jacr.2019.04.010
State	Published - Nov 2019

Keywords

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

ASJC Scopus subject areas

Radiology Nuclear Medicine and imaging

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10.1016/j.jacr.2019.04.010

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Wallner, P. E., Lieto, R. P., Dillehay, G. L., Ghesani, M. V., Rosenthal, S. A., Rosenzweig, K. E., Steinberg, M. L., & Yoo, D. C. (2019). Training and Education Requirements for Authorized Users of Therapeutic Radiopharmaceuticals: Changes Under Consideration for 10CFR35.390 and Their Potential Impact. Journal of the American College of Radiology, 16(11), 1572-1576. https://doi.org/10.1016/j.jacr.2019.04.010

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

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",

author = "Wallner, {Paul E.} and Lieto, {Ralph P.} and Dillehay, {Gary L.} and Ghesani, {Munhir V.} and Rosenthal, {Seth A.} and Rosenzweig, {Kenneth E.} and Steinberg, {Michael L.} and Yoo, {Don C.}",

note = "Funding Information: The authors acknowledge the support and assistance of ACR Government Relations staff members, Michael Peters, BS, Gloria Romanelli, JD, and Tina Getachew, BS, without whom this effort would not have been possible. Publisher Copyright: {\textcopyright} 2019 American College of Radiology",

year = "2019",

month = nov,

doi = "10.1016/j.jacr.2019.04.010",

language = "English (US)",

volume = "16",

pages = "1572--1576",

journal = "Journal of the American College of Radiology",

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Wallner, PE, Lieto, RP, Dillehay, GL, Ghesani, MV, Rosenthal, SA, Rosenzweig, KE, Steinberg, ML & Yoo, DC 2019, 'Training and Education Requirements for Authorized Users of Therapeutic Radiopharmaceuticals: Changes Under Consideration for 10CFR35.390 and Their Potential Impact', Journal of the American College of Radiology, vol. 16, no. 11, pp. 1572-1576. https://doi.org/10.1016/j.jacr.2019.04.010

Training and Education Requirements for Authorized Users of Therapeutic Radiopharmaceuticals: Changes Under Consideration for 10CFR35.390 and Their Potential Impact. / Wallner, Paul E.; Lieto, Ralph P.; Dillehay, Gary L. et al.
In: Journal of the American College of Radiology, Vol. 16, No. 11, 11.2019, p. 1572-1576.

Research output: Contribution to journal › Article › peer-review

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AU - Wallner, Paul E.

AU - Lieto, Ralph P.

AU - Dillehay, Gary L.

AU - Ghesani, Munhir V.

AU - Rosenthal, Seth A.

AU - Rosenzweig, Kenneth E.

AU - Steinberg, Michael L.

AU - Yoo, Don C.

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

Abstract

Keywords

ASJC Scopus subject areas

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