Documentation, it requires that records be maintained for “End product radiochemical and other testing, as applicable, results of preparations, preparations with minor deviations, and compounded preparations.” For some radiopharmaceutical kits, the package insert preparation instructions require QC testing, but for other radiopharmaceutical kits they do not. Assigning BUD, there is discussion of factors that must be considered in determining BUD, including maintenance of radiochemical purity (which may require studies of QC testing over time), but this would rarely be applicable for Immediate Use. Section 3 is not fully prescriptive on all factors. Any extremity dosimeter must be worn underneath the gloves and must not interfere with proper fit of gloves.” As another example, Section 5.7 states “ll RAM users must comply with the conditions specified in their approved RAM license application and regulations, and RAM license conditions may supersede the requirements for environmental controls described in this section.” For sterile radiopharmaceuticals, balances aseptic handling practices with radiation protection practices to describe appropriate strategies that provide assurance of maintaining patient safety while also ensuring the safety of individuals performing these activities. For example, in Section 2 it states “as per RAM license requirements, individuals must wear body and as required extremity dosimeters (e.g., a ring worn on a finger) for long term monitoring of personnel radiation exposure. In other words, nothing in supersedes NRC regulations and RAM license requirements.
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