Radiopharmaceuticals play a critical role in modern diagnostics and targeted therapies, yet they introduce a level of complexity that extends far beyond traditional sterile compounding. Their radioactive nature, extremely short half-lives, and time-sensitive preparation requirements demand a regulatory framework that prioritizes safety for both the patient and clinician, as well as operational precision. USP <825> was created to address these unique challenges and provide consistent standards for radiopharmaceutical preparation, compounding, dispensing, and repackaging across healthcare settings.
As the industry moves toward decentralized, point-of-care production models, USP <825> has become increasingly relevant, especially for facilities that must prepare radiopharmaceuticals as close as possible to the time and location of administration. Read More >
