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SNMMI Submits Comments to USP on General Chapter <825>

December 6, 2018

On Friday November 30th, 2018, SNMMI submitted comments to USP on its 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 non-sterile 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

You can read SNMMI’s cover letter here. You can read the detailed line by line submission here.