Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use

Résumé

The Nuclear Regulatory Commission (NRC) is amending its regulations for the medical use of byproduct material. This action is being taken in response to a petition for rulemaking. This final rule is intended to provide greater flexibility by allowing properly qualified nuclear pharmacists and authorized users who are physicians greater discretion to prepare radioactive drugs containing byproduct material for medical use. This final rule, while allowing research involving human subjects using byproduct material, requires NRC licensees who conduct such research to obtain the informed consent of the human subjects and the prior review and approval of an ``institutional review board'' within the meaning of the Federal Policy for the Protection of Human Subjects. This final rule also allows medical use of radiolabeled biologics. In addition, this final rule contains other miscellaneous and conforming amendments necessary to clarify or update the current regulations.