NCPA's qAM

qAM

NCPA working to address concerns on new <797> standards

by NCPA | Jun 11, 2019

Earlier this month, USP finalized <797> standards, but did not include resources to extend beyond use dates of sterile preparations. Therefore, the maximum BUDs you can have under the new <797> are the ones in the chart in the chapter, despite any valid scientific data or studies you may have obtained to substantiate a longer BUD.

These new restrictive BUDs will force pharmacies to make smaller batches of compounded sterile preparations much more frequently. When pharmacies make a batch, the testing requirements, and thus the costs, are approximately the same regardless 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. NCPA is engaged with IACP and other pharmacy groups to address our concerns with USP, aiming to push USP to reconsider its position and possibly issue a revision bulletin on <797>. For more information, please review IACP’s White Paper on these changes.