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

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

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

Radiology

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

2 Scopus citations

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 language	English (US)
Pages (from-to)	312-317
Number of pages	6
Journal	Journal of the American College of Radiology
Volume	18
Issue number	2
DOIs	https://doi.org/10.1016/j.jacr.2020.07.035
State	Published - 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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10.1016/j.jacr.2020.07.035

Cite this

Wallner, P. E., Lieto, R. P., Dillehay, G. L., Ghesani, M. V., Rosenthal, S. A., Rosenzweig, K. E., Steinberg, M. L., Yoo, D. C., & Small, W. (2021). Potential Significant Changes in Nuclear Regulatory Commission Policies Regarding Training and Experience Requirements for the Use of Radiopharmaceuticals. Journal of the American College of Radiology, 18(2), 312-317. https://doi.org/10.1016/j.jacr.2020.07.035

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

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",

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.} and William Small",

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year = "2021",

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doi = "10.1016/j.jacr.2020.07.035",

language = "English (US)",

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Wallner, PE, Lieto, RP, Dillehay, GL, Ghesani, MV, Rosenthal, SA, Rosenzweig, KE, Steinberg, ML, Yoo, DC & Small, W 2021, 'Potential Significant Changes in Nuclear Regulatory Commission Policies Regarding Training and Experience Requirements for the Use of Radiopharmaceuticals', Journal of the American College of Radiology, vol. 18, no. 2, pp. 312-317. https://doi.org/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. / Wallner, Paul E.; Lieto, Ralph P.; Dillehay, Gary L. et al.
In: Journal of the American College of Radiology, Vol. 18, No. 2, 02.2021, p. 312-317.

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.

AU - Small, William

PY - 2021/2

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N2 - 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.

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

Abstract

Keywords

ASJC Scopus subject areas

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