USP General Chapter <825> Impact on Nuclear Medicine Technology Practice. 2020

George H Hinkle
Radiation Safety Office, Environmental Health and Safety, Ohio State University, Columbus, Ohio hinkle.5@osu.edu.

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.

UI MeSH Term Description Entries
D009683 Nuclear Medicine A specialty field of radiology concerned with diagnostic, therapeutic, and investigative use of radioactive compounds. Atomic Medicine,Nuclear Radiology,Medicine, Atomic,Medicine, Nuclear,Radiology, Nuclear
D009939 Organizations, Nonprofit Organizations which are not operated for a profit and may be supported by endowments or private contributions. Nonprofit Organizations,Non-Profit Organizations,Organizations, Non-Profit,Non Profit Organizations,Non-Profit Organization,Nonprofit Organization,Organization, Non-Profit,Organization, Nonprofit,Organizations, Non Profit
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014481 United States A country in NORTH AMERICA between CANADA and MEXICO.
D019985 Benchmarking Method of measuring performance against established standards of best practice. Benchmarking, Health Care,Benchmarks,Best Practice Analysis,Metrics,Benchmark,Benchmarking, Healthcare,Analysis, Best Practice,Health Care Benchmarking,Healthcare Benchmarking

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