BUDs: An update on USP <795> and <797>

Published December 4, 2020

The USP Compounding Expert Committee is — thanks to APC’s earlier work — in the process of reconsidering BUDs. It met Wednesday to discuss revisions to USP <795> and <797>.

The gist: The <795> subcommittee has been reviewing appeal letters and stakeholder engagement reports to get a handle on the issues stakeholders had with the proposed chapter. It’s looking at ways to provide explanations for the scientific rationale used in establishing the default BUDs for nonsterile compounds.

The <797> subcommittee has also been going through stakeholder feedback. It’s looking at the overall framework for assigning BUDs to sterile items. Current thinking: Keep the current category 1 and category 2 CSP structure for assigning BUDs, but create a framework for allowing the extension of BUDs beyond the current defaults. (Subcommittee chair Connie Sullivan made it clear that the subcommittee has heard and understands the gap that exists between small 503A pharmacies and 503B outsourcing facilities.)

Both reports were somewhat encouraging in the sense that the subcommittees seem to have taken a deep dive into the comments and rationale provided by us — comments that point out the practical problems with the BUDs in both chapters.