Radiopharmacies

Radiopharmacies are licensed facilities that manufacture, quality-control, and dispense radiopharmaceuticals used in nuclear medicine. They may be stand-alone units, part of a hospital radiology department, or centralized centers serving multiple clinics. They operate under strict regulatory oversight and radiation safety programs to protect staff and patients.

Products and processes: Radiopharmacies produce diagnostic tracers such as technetium-99m labeled compounds, fluorine-18 labeled PET tracers, and iodine-123 thyroid agents, as well as therapeutic radiopharmaceuticals like lutetium-177 and actinium-225 compounds. Production may occur via on-site generators (for example Mo-99/Tc-99m), kit labeling, or cyclotron-based synthesis. Doses are prepared in sterile, shielded environments using hot cells or cleanrooms, with automated dispensing systems to minimize radiation exposure. Quality control checks confirm radiochemical purity, sterility, pyrogenicity, and correct dose labeling before release.

Regulatory framework and safety: Radiopharmacies operate under licensing and GMP-like guidelines, with comprehensive radiation safety programs, dose tracking, and waste management in compliance with national laws. They maintain rigorous quality documentation and traceability. Staff typically includes radiopharmacists, radiochemists, and radiopharmacy technicians trained in handling radioactive materials and aseptic technique. Distribution is coordinated with nuclear medicine departments to ensure timely delivery, accurate dosing, and adherence to the short half-lives of many radiopharmaceuticals.