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Regulatory guidance went into effect December 12, 2011 regarding positron emission tomography (PET) radiopharmaceuticals used in clinical and research procedures. As of that date, production of PET radiopharmaceuticals must comply with Current Good Manufacturing Practices (cGMP) and/or USP chapter 823 guidelines and thus should be reflected in the MRSC/RDRC protocol reviews. For more information about the changes, please see the Regulatory Guidance.