Regulation of cyclotron radiopharmaceutical production and distribution: An agreement state perspective

While research accelerators producing radioactive material have been regulated for some time, the use of such devices in the preparation and distribution of radiopharmaceuticals has been confined to a few commercial firms and pioneering medical institutions. Such use requires multi-agency approval. The agencies involved, particularly state agencies, may not always be equally informed in the state of the art, may not have adopted positions or developed guidance with regard to their own rules for such activities and may not have staff trained and/or available to respond expeditiously to authorization requests. This presentation will describe the recent experience of the Texas Bureau of Radiation Control with two cyclotron facilities within its jurisdiction