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
- November 1, 2023 – Role and Applicability of USP <825> Related to Radiopharmaceuticals
- June 1, 2020 – Announcement of new implementation date
- March 12, 2020 – Appeals Panel issues decisions on the Appeals to USP <795>, <797>, and <825> (see FAQs on USP Compounding Appeals)
- September 23, 2019 – General Chapter <825> is postponed until further notice. Click here for more information
- June 1, 2019 – Publication Date of <825> in USP–NF
For more information on other compounding chapters click here.
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.
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. General Chapter <825> was published on June 1, 2019.
Stay Involved: Stakeholder Engagement
Your participation is integral to the standard setting process. Stay involved and sign up to receive updates from USP. Return to Radioactive Articles for continued updates and other information on USP efforts to update and modernize radioactive article monographs and general chapters.
Resources
- USP <825> FAQs
- USP <825> Commentary (published 06/01/2019)
- Decisions on Appeals to USP <795>, <797>, and <825> (published 03/12/2020)
- Expert Committee Decisions on Appeal to General Chapter <825> (published 09/13/2019)
- FAQs on USP Compounding Appeals
- Link to Radioactive Articles
- Sign up for USP Healthcare Quality & Safety Updates