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Summary of Radiopharmaceuticals

Radiopharmaceuticals are unique medicinal formulations containing radioisotopes which are used in major clinical areas for diagnosis and/or therapy. The facilities and procedures for the assembly, use, and storage of radiopharmaceuticals are subject to licensing by national and/or regional authorities. This licensing includes compliance both with regulations governing pharmaceutical preparations and with those governing radioactive materials. Additional regulations may apply for issues such as transportation or dispensing of radiopharmaceuticals. Each producer or user must be thoroughly cognizant of the national requirements regarding the articles concerned. Regulations concerning pharmaceutical preparations include the applying of current Good Manufacturing Practices (GMP).