We received word today that the USP panel has granted our appeal and will remand the BUD date issues in Chapters <795> and <797> to the Compounding Expert Committee for review and engagement with stakeholders. It’s a big win for our APC members – and for all pharmacy compounders (USP Grants Appeals Response *PDF)
March 12, 2020 – Appeals Panel issues decisions on the Appeals to USP <795>, <797>, and <825> (see FAQs on USP Compounding Appeals)
The final decisions are as follows:
- The Appeals Panel has granted the appeals to General Chapters <795> and <797> and is remanding the chapters to the Compounding Expert Committee (CMP EC) with the recommendation for further engagement on the issues raised in the appeals.
- The Appeals Panel has denied the appeal to General Chapter <825> and is encouraging the appellant to submit the narrower request presented at the hearing before the Panel to the Chemical Medicines Monographs 4 Expert Committee (CHM4 EC) as a request for revision.
The impact of these decisions on the appealed chapters is as follows:
- The currently official versions of <795> (last revised in 2014) and <797> (last revised in 2008) remain official as a result of the remand. Recognizing the public health impact of these standards, USP is committed to further stakeholder engagement through forums, roundtables, and other avenues to gather more input on the issues raised in the appeals. USP and the CMP EC are committed to moving forward in an open, transparent, and balanced manner as soon as practicable to enable the chapters to be finalized and implemented in a timely manner.
- Due to the denial of the appeal to <825>, the CHM4 EC may reinstate the official date of this new chapter. Based on USP’s Bylaws, the Expert Committee must provide at least another six-month implementation period for this chapter. The CHM4 EC will announce an official date once it is determined. General Chapter <825> will be informational unless otherwise required by a regulatory body.
You can read the complete findings on the Updates on appeals to USP Compounding Standards on the website: https://www.usp.org/compounding/compounding-appeals