USP General Chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging

Radiopharmaceuticals represent a unique class of drug products where compounding and other handling activities include the use of radionuclide generators, the preparation of commercially-manufactured radiopharmaceutical kits, the dilution of FDA-approved multi-dose vials, the labeling of human blood products with radionuclides, the preparation of patient-specific radiopharmaceutical doses, and other activities. These activities occur in an environment where individualized patient needs and the safe handling of radioactive materials demand a high level of care and clearly-defined standards that support these activities.

Important Updates

  • July 27, 2018 - The proposed <825> was posted for public comment*
  • September 4, 2018 - <825> was formally published in the Pharmacopeial Forum
  • October 10, 2018 - Open Microphone Session – Recorded Session
  • November 30, 2018 - Public Comment Period for <825> closed
  • June 1, 2019 - Intended Publication Date of <825> in USP–NF
  • December 1, 2019 - Anticipated Official Date for <825>

Updates on Compounding related chapters

Developing USP General Chapter <825>

USP is a not-for-profit, science-driven organization that has an established process for convening independent experts for the development and maintenance of quality standards. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing opportunities for public input from stakeholders throughout the standard setting process.

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

In the 2008 revision of <797> (published for public comment in PF 32(3) May-June 2006) a new section was added on Radiopharmaceuticals as Compounded Sterile Preparations (CSPs). In September 2015 (published for public comment in PF 41(6) Nov-Dec 2015), the Compounding Expert Committee proposed to revise <797> including some expansion of the section on compounding radiopharmaceuticals. 

Based on the nature and significance of the comments received in this area, USP held a Radiopharmaceutical Roundtable in February 2017. The roundtable was attended by stakeholders from the nuclear medicine community, regulatory agencies, and USP staff. During the roundtable, participants discussed potential approaches to address the challenges associated with this class of products. Based on this discussion, the stakeholders from the nuclear medicine community strongly favored the development of a new general chapter for compounding radiopharmaceuticals. After considering these stakeholder inputs, the USP Compounding and Chemical Medicines Monograph 4 Expert Committees proposed the development of a General Chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging tailored to the specific needs of sterile and nonsterile radiopharmaceutical preparations.

In June 2017, USP opened a Call for Candidates to form an Expert Panel focusing on compounding practices in Nuclear Pharmacy. The Expert Panel developed General Chapter <825> to provide clear and effective USP public standards that meet patient and practitioner needs for compounded sterile radiopharmaceuticals today and in the future. The proposed new general chapter will delineate compounding activities for radiopharmaceuticals and provide standards associated with these activities. 

The USP Chemical Medicines Monographs 4 Expert Committee is responsible for the development of General Chapter <825>. Review their work plan and past meeting summaries

Stay Involved: Stakeholder Engagement

Stay involved and return to Radioactive Articles for continued updates on this chapter and other information on USP efforts to update and modernize radioactive article monographs and general chapters.

Public comment is integral to the standard setting process. During standard development, USP seeks to obtain input from stakeholders such as patients, healthcare practitioners, policymakers, academicians, and industry, to ensure that broad perspectives are included in the standard.