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Register today! USP to Host Open Mic Session on <825> Radiopharmaceuticals

September 26, 2018

USP is hosting an open microphone session October 10, 2018 to discuss the Proposed General Chapter <825> Radiopharmaceuticals — Preparation, Compounding, Dispensing, and Repackaging. During the session, USP will highlight contents in the proposed standard and answer stakeholder questions about the approach and methodology of the new chapter. All members are encouraged to attend. There is no cost to participate. Click here to register.

USP develops standards for radiopharmaceuticals, including monographs for radioactive drug products and general chapters related to radioactivity, radiopharmaceuticals and certain aspects for the compounding of positron-emitting radiopharmaceuticals. 

Included in Chapter <825> 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.  

SNMMI will be submitting comments on USP <825>. Members are encouraged to submit their own comments, as well. Comments can be submitted directly to USP here.