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<825> Radiopharmaceuticals— Preparation, Compounding, Dispensing, and Repackaging

Type of Posting: Notice of Intent to Revise
Posting Date: 27-Jul-2018
Targeted Official Date: 01-Dec-2019, Second Supplement to USP 42-NF 37
Expert Committee: Chemical Medicines 4 Expert Committee

In accordance with section 7.04 (c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that the Chemical Medicines 4 Expert Committee intends to introduce a new 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.

This proposed new General Chapter will be published in Pharmacopeial Forum 44(5) [Sep-Oct 2018] pursuant to section 7.02 of the Rules and Procedures. The comment period for this revision ends on November 30, 2018. In the absence of any adverse comments the proposed chapter will become official on December 1, 2019.  To allow additional time for public review and comment, the new General Chapter is linked here in advance of its publication in PF 44(5).  

Please use the electronic form to submit your comments. Comments should include corresponding section and line number of the new General Chapter. 

Should you have any questions, please contact Ravi Ravichandran, Principal Scientific Liaison to the Chemical Medicines 4 Expert Committee (301–816–8330 or