Decisions from USP Appeals re. Compounding

 Friday, March 13, 2020

This week, the USP Appeals Panel issued final decisions on appeals to revisions to General Chapters Pharmaceutical Compounding – Nonsterile Preparation, Pharmaceutical Compounding – Sterile Preparations, and new Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging, which were published on Jun. 1, 2019.

On Jun. 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 radiopharmaceutical compounding. After publication of the revised and new compounding standards, USP received appeals on all three provisions, and this week’s announcement was the result of the Appeals Panel discussions. Listed below are the decisions:

  • General Chapters <795> and <797>

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 concerning the beyond-use date provisions.

  • General Chapter <825>

The Appeals Panel has 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.

Click to read the USP’s announcement.

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