December 17, 2021
BUD restrictions: We need your real-world examples
How do you think currently proposed revisions to USP Chapters 795 and 797 will affect your patients and pharmacy practice? We need to hear from you, and soon!
While the science underlying the USP Compounding Expert Committee recommendations for using stability studies to establish extended BUDs may be sound, and the documentation provided by the Compounding Expert Committee supporting the processes involved in these studies may be valid, the imposition of arbitrary limits to BUDs (despite these studies, along with other arbitrary changes to batch sizes, microbial risk levels, etc.) only serves to generate noise. What is missing is any evidence to show that USP’s proposed changes represent any improvement in compounding quality and public safety over the chapters that have been in place for the past ten years.
To help you in determining your feedback, here is a summary of the proposed <795> and <797> changes by APhA’s Seth DePasquale that you may find helpful.