November 30, 2015
The US Pharmacopeia (USP) is forming a Radioactive Drugs Expert Panel. The panel will make recommendations to and work under the direction of the Monographs-Chemical Medicines Expert Committee. The purpose of this Expert Panel is to review and make recommendations to revise the existing official USP monographs for the articles which are radioactive drugs used in nuclear medicine for imaging procedures or for radiopharmaceutical therapy.
The panel will evaluate the parameters necessary for inclusion in public standard for all the radioactive imaging agents which will ensure the identity, strength and quality. The panel will also evaluate the deletion of tests such a bio distribution from the existing monographs. Some of the radioactive imaging agents currently in use are in the form of a kit which in the end deliver the imaging agent in the form an injection suitable for administration to the patient. The panel will evaluate such products in the field and determine the need to introduce a separate article with “For Injection” designation. If the need to have such category arises, the panel will develop the monographs and recommend them to the Expert Committee for publication in PF for public comments. This is likely to result in addition of a few articles to USP as new monographs.