An updated draft of USP Chapter 797 was released today. Updated Chapter 797 Posted for Public Comment: Separate Requirements for In-office Compounding of Allergen Extract Restored In September 2015, the United States Pharmacopeia (USP) released a proposed updated Chapter 797 on procedures for sterile compounding. The existing chapter had provided procedures for allergen immunotherapy extracts…
A letter from the USP Healthcare Quality & Safety from March 12th, 2020
We are writing to provide an update on the USP compounding standards.
After thoughtful deliberation and evaluation, the USP Appeals Panel has issued final decisions on the appeals to revisions to General Chapters <795> Pharmaceutical Compounding – Nonsterile Preparation, <797> Pharmaceutical Compounding – Sterile Preparations, and new chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging, which were published on June 1, 2019.
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.
USP remains committed to supporting the quality of and access to compounded preparations. Any questions about these Chapters or the USP appeals process should be directed to the USP Healthcare Quality and Safety staff at CompoundingSL@usp.org.
Healthcare Quality & Safety Team