Abstract
Use of byproduct materials requires authorization by appropriate authorities. The NRC and the Agreement States are the essential authorities to control the use of byproduct materials. Conditions of different licenses for use of different radioactive materials are presented in this chapter. General domestic license, specific license of limited scope, and specific license of broad scope are discussed, and procedure to apply for each type of license is described. The chapter includes a section on accreditation requirements of nuclear facilities by the American College of Radiology (ACR) and the Intersocietal Commission for Accreditation of Nuclear Medicine Laboratories (ICANL).
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References and Suggested Reading
FDA 21CFR 314. New Drug Application. 2018.
FDA 21CFR312. Investigational New Drug Application. 2018.
FDA 21CFR361.1(c). Radioactive Drug Research Committee. 2018.
NRC 10CFR 30. Rules and General Applicability to Domestic Licensing of Byproduct Material. 2018.
NRC 10CFR 31. General Domestic Licenses For Byproduct Material. 2018.
NRC 10CFR33.11. Types of specific licenses of broad scope. 2014.
NRC NUREG 1556 Consolidated Guidance About Materials Licenses: Program – Specific Guidance About Medical Use Licenses. vol 9, rev 2. 2008.
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Saha, G.B. (2019). Regulatory Framework for Radiation Protection. In: Radiation Safety in Nuclear Medicine. Springer, Cham. https://doi.org/10.1007/978-3-030-16406-5_5
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DOI: https://doi.org/10.1007/978-3-030-16406-5_5
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Online ISBN: 978-3-030-16406-5
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