United States Nuclear Regulatory Commission - Protecting People and the Environment

Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses (NUREG-1556, Volume 13, Revision 1)

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Publication Information

Manuscript Completed: November 2007
Date Published: November 2007

Prepared by:
D.E. White, J.F. Katanic, D.B. Howe

Office of Federal and State Materials and
Environmental Management Programs
U.S. Nuclear Regulatory Commission
Washington, DC 20555-0001

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Abstract

On August 8, 2005, the Energy Policy Act of 2005 (EPAct) gave NRC new regulatory authority over additional byproduct material. This new byproduct material now also includes naturally occurring materials, such as discrete sources of Radium-226, and accelerator-produced radioactive materials (NARM). This revision of NUREG-1556, Vol. 13, adds guidance needed to license commercial radiopharmacies as a result of the regulatory changes made by the EPAct and the NARM rule, “Requirements for Expanded Definition of Byproduct Material.”

This guidance document contains information that is intended to assist applicants for commercial radiopharmacy licenses in preparing their license applications. In particular, it describes the type of information needed to complete NRC Form 313, “Application for Materials License.” This document both describes the methods acceptable to NRC license reviewers in implementing the regulations and the techniques used by the reviewers in evaluating the application to determine if the proposed activities are acceptable for licensing purposes.

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