USP General Chapter <825> Impact on Nuclear Medicine Technology Practice.

U.S. Pharmacopeia (USP) general chapter <825>, "Radiopharmaceuticals: Preparation, Compounding, Dispensing, and Repackaging," is a new standard proposed to provide minimum requirements for the preparation, compounding, dispensing, and repackaging of sterile and nonsterile radiopharmaceuticals. This new standard represents endeavors on the part of the USP to respond to appeals by nuclear medicine professionals to move beyond a minimal supplement to USP <797> and provide policies specific to radiopharmaceuticals. USP <825> provides nuclear pharmacies and nuclear medicine departments in hospitals and clinics with the benchmarks to assess current practice activities and integrate needed changes to meet regulatory and accreditation audit reviews. This continuing education article focuses on components of USP <825> specific to the nuclear medicine technologist for a better understanding of obligations when preparing sterile radiopharmaceuticals for clinical use.