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On June 1, 2019, USP published revisions to General Chapter <795> for nonsterile compounding and General Chapter <797> for sterile compounding, as well as a new General Chapter <825> for radiopharmaceuticals. After publication of the revised and new compounding standards, USP received appeals on certain provisions in <795>, <797>, and <825>. In accordance with USP’s Bylaws, the responsible Expert Committees considered the information raised in the appeals and issued decisions on the appeals (see Decisions on Appeals to USP <795>, <797>, and <825>). As part of the formal USP appeals process, four (4) stakeholders who submitted appeals to the compounding chapters requested further review by an appointed Appeals Panel.

After thoughtful deliberation and evaluation of the record and hearings from the appellants on January 21 and 22, 2020, the Appeals Panel made the following decisions on the appeals (see Decisions on Appeals to USP <795>, <797>, and <825>).

  • The Appeals Panel granted the appeals to General Chapters <795> and <797> and remanded the Chapters to the Compounding Expert Committee (CMP EC) with the recommendation for further engagement on the issues raised concerning the beyond-use date provisions.
    • The currently official versions of General Chapter <795> (last revised in 2014) and General Chapter <797> (last revised in 2008) remain official until further notice.
  • The Appeals Panel denied the appeal to General Chapter <825> and encouraged the appellant to submit the narrower request presented at the hearing before the Panel to the Chemical Medicines Monograph 4 Expert Committee (CHM4 EC) as a request for revision.
    • General Chapter <825> will become official on a new date to be determined by the Chemical Medicines 4 Expert Committee. The official date will allow at least another six-month implementation period.

With decisions on these appeals having been made and communicated, the Appeals Panel has concluded its service. The members of the Appeals Panel will maintain strict confidentiality in connection with their involvement in the adjudication of the appeals. Any questions about these Chapters or the USP appeals process should be directed to USP Healthcare & Quality staff at CompoundingSL@usp.org.