USP Call for Candidates: Radioactive Drugs Expert Panel

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.  

About 100 monographs exist in USP most of which are used as radioactive imaging agents and a few monographs which are used as radiopharmaceutical therapy agents. These monographs are at least 15 years old and may not reflect the current industry practice and regulatory requirements. Some of the articles are no longer in use in the US.
During the current cycle of 2015-2020, the Expert Panel will:
  • Review all the existing monographs and determine their relevance for continued inclusion in USP
  • Revise the relevant monographs to be consistent with the updated general chapter <821> Radioactivity
  • Review and revise monographs to be consistent with current industry requirements and regulatory expectations.

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.

The application process for this Expert Panel is now open! Visit the USP website to learn more or apply. The deadline to apply is December 20th.