USP releases new <797> without providing resources for extending BUDs of sterile preparations
Does your pharmacy compound sterile preparations? Recent Changes to USP <797> will limit Beyond Use Dates (BUDs) and does not provide a way for pharmacies to use valid scientific data to support longer BUDs.
The vast majority of compounding pharmacies will be preparing Category 2 CSPs under the new system. The Beyond Use Dates (BUDs) allowed for Category 2 CSPs are provided in Table 11 of the new Chapter <797>:
In plain language, the maximum BUDs you can have for any Category 2 CSP under the new <797> are the ones in the chart, despite any valid scientific data you may have obtained to substantiate a longer BUD. The result for formulations stored under refrigeration and sterility tested is approximately 30 useable days for aseptically processed CSPs and 45 useable days for terminally sterilized CSPs when considering the time required to obtain a USP <71> compliant sterility test.
These new restrictive BUDs will force pharmacies to make smaller batches of compounded sterile preparations much more frequently. Pharmacies will have to devote more time to compounding more small batches and will have a higher utilization of consumable items in the process. When pharmacies make a batch, the testing requirements - and thus costs - are approximately the same independent of the size of the batch. All of this will lead to much higher costs for patients, which will create a patient access issue as these medications are pushed out of affordable price ranges for more and more Americans.
Can you think of other ways this will impact your patients and your practice? Let us know today.
IACP is already working with a coalition of sister pharmacy associations and groups to bring our concerns to USP's attention. Our aim is to push USP to reconsider its position and possibly issue a revision bulletin.
In the days ahead, we may be asking for your assistance via email and social media to get USP's attention on this matter. Stay tuned and be prepared to respond quickly when we ask.
 United States Pharmacopeia. General Chapter <797> Pharmaceutical Compounding - Sterile Preparations. USP-NF 42-NF37. 2019.