This book was developed to provide guidance to diagnostic nuclear medicine applicants and/or licens- ees in the implementation of the . Nuclear Regula- tory Commission’s (NRC’s) newly revised 10 CFR Part 35, Medical Use of Byproduct Material. This guidance is aimed at all diagnostic nuclear medicine licensees using unsealed byproduct material for uptake, dilution, excretion, and imaging and localization studies for which a written directive (., a written order for the administration of byproduct material to a specific patient or human research subject) is not required. The regulations require that applicants and/or licensees develop, document, and implement operating policies and procedures as part of an overall radiation protec- tion program that will ensure compliance.
