The International Pharmacopoeia (Ph. Int.) - Radiopharmaceuticals
WHO and the International Atomic Energy Agency (IAEA), a United Nations specialized agency, have been working jointly on specifications for radiopharmaceuticals since 2001. Both organizations recognize that radiopharmaceuticals are unique medicinal formulations containing radioisotopes which are used in major clinical areas for diagnosis and/or therapy. This collaboration resulted in the elaboration of 3 general texts and 24 monographs for radiopharmaceuticals preparations that are included in the Second Supplement of The International Pharmacopoeia. Further revisions and development of new monographs and texts are in progress.
Current advice and guidance concerning regulations governing radioactive materials including those on safe handling and production of radioisotopes can be found on the IAEA website.
The monographs and associated texts listed here have been adopted by the Expert Committee on Specifications for Pharmaceutical Preparations.