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USP Releases Chapter 825 on Radiopharmaceuticals

July 27, 2018

Today, July 27, 2018, the U.S. Pharmacopeia Convention released their prepublication of General Chapter <825> Radiopharmaceuticals ‒ Preparation, Compounding, Dispensing, and Repackaging. This General Chapter provides uniform minimum standards for the preparation, compounding, dispensing, and repackaging of sterile and nonsterile radiopharmaceuticals for humans and animals that occur as part of state-licensed activities.

Included are the definition, delineation and description of the following:

  • The various activities related to the provision of radiopharmaceuticals, including preparation, preparation with minor deviations, compounding, dispensing, and repackaging
  • Requirements for the environment appropriate for each of these activities 
  • Qualifications for personnel involved in these activities
  • Practices that are necessary and balanced to ensure personal safety, environmental safety, and patient safety related to radiation risks and radiopharmaceutical quality

General Chapter <825> is available for public comment between July 27 and November 30, 2018. 

USP also has  proposed revisions to USP General Chapter <797> Pharmaceutical Compounding –Sterile Preparations . This Chapter is open for a second round of public comment. USP General Chapter <797> provides standards for compounding quality sterile preparations. In the revision proposal, the section "Radiopharmaceuticals as Compounded Sterile Preparations (CSPs)" has been eliminated and replaced with a reference to General Chapter <825>. 

To learn more about general chapter <825>, USP will provide an open-microphone session scheduled for October 10, 2018. During the open-microphone session, USP will highlight contents in the proposed standard and answer stakeholder questions about the approach and methodology of the new chapter. The registration link will be made available on September 5, 2018.

As previously reported, SNMMI submitted comments to USP recommending that a new chapter be established to address the ambiguity in the field of nuclear pharmacy, which threatens the availability and the safe usage of radiopharmaceuticals in the U.S. SNMMI commends USP on the timely release of the new general chapter and looks forward to reviewing it and providing comments. Though SNMMI will be submitting comments, we encourage members to submit comments as well.