Nuclear medicine admixing and USP 797 implications

During client work at one organization, I heard that nuclear medicine folks were doing some admixing of nuke med preparations. A question was raised as to whether there would be a need for USP 797 compliance.

Some of you may remember the rage several years back behind USP 797, formally titled Pharmaceutical Compounding–Sterile Preparations. Part of USP 797 deals with the physical environment in which compounding occurs.

I indicated to the client that yes, USP 797 compliance was necessary in regards to nuke med admixing, so the next step would be to conduct a gap analysis similar (though likely lesser in scope) to that done for the main pharmacy preparation area.

Be it low-, medium-, or high-risk preparations, the determination of appropriate environmental support must be made and then acted upon (with due consideration for mitigation or other interim measures) to ensure appropriate levels of safety are maintained for medications.

Any drug preparation activities nominally occur under the auspices of the pharmacy director’s license. If there is potential for issues of contamination with the preparations emanating from nuke med because of environmental shortcomings, there is some exposure for the license as well as the organization in general.

That said, this is more about doing the right thing than it is a question of discoverability relative to The Joint Commission (though you can still be taken to task during survey for not appropriately managing the risks). Every once in a while I will hear some chatter that The Joint Commission might reinstate scrutiny of USP 797 compliance, but I suspect that, unless you happen to run into a surveyor for whom USP 797 is a cause celebre, this would be a minor consideration for survey.