Understanding the Potential Impacts of USP <825> for Radiopharmaceutical Compounding
In recent years, there has been a significant amount of regulatory focus on compounding pharmacies. Specifically, regulatory agencies want to establish guidance for quality and sterility of products with the goal of providing the highest standard of finished product for patient administration. While new guidelines were created in various USP chapters, there has not been guidance for every aspect of compounding pharmacy practices. One notable exclusion was radiopharmaceutical compounding and therefore, USP <825> was created to help address this area of practice.
USP <825> provides formal guidance for radiopharmaceutical compounding pharmacies in multiple areas; from the actual pharmaceutical facilities to the specific compounding and dispensing procedures themselves. USP <825> was officially announced on June 1, 2019 and will go into effect on Dec. 1, along with General Chapter <800> and revisions to <795> and <797>.
The minimum standards required to be compliant with the USP <825> guidance could mean a significant financial undertaking, depending on the existing equipment and space design of the pharmacy. However, with new guidance into compounding practice, more standardized quality of products will be dispensed. New requirements around activities like kit-splitting or fractionation will help to drive more consistency in the quality of dispensed radiopharmaceuticals for patient administration.
The biggest question and concern for many nuclear imaging departments, hospitals and imaging centers revolve around their future budget. The radiopharmaceutical distribution space is notorious for being difficult to accurately project a budget. The supply chain of radiopharmaceuticals is affected each step of the way from raw material and manufacturer increases to nuclear pharmacy facility upgrades (due to evolving regulations) and department updates. The culmination of all of these factors will result in increased costs to the purchasing departments.
In addition to the nuclear pharmacies themselves, USP <825> establishes guidance as to the minimum standards which need to be met within the department’s hot lab. Some doses are still being compounded within the department’s hot lab, whether it be reconstitution of a cold kit or drawing or administration of a dose. These additional standards may result in costs to the department for facility upgrades or process changes.
It’s traditionally expected, due to the aforementioned complex radiopharmaceutical supply chain, that price increases will be seen each year in the radiopharmaceutical space. This year end will be exceptionally difficult to predict expected price increases due to the implementation of USP <825>.
So what is the final recommendation when planning a radiopharmaceutical budget? The best practice is the same as it’s always been. Work closely with your local nuclear pharmacy to ask questions around their progress in USP <825> compliance. If the local nuclear pharmacy can offer insight into expected or known annual increases that will additionally help with budgeting concerns. Finally, work with your group purchasing organization to find out if they have negotiated USP <825> - compliant language, as well as line item and aggregate price increase maximums in their national agreements. The utilization of a GPO-contracted supplier for radiopharmaceutical distribution will help your department budget appropriately in an unpredictable nuclear landscape.