Radiopharmaceuticals — Preparation, Compounding, Dispensing, and Repackaging
The USP general chapter for handling radiopharmaceuticals outside industrial manufacture — preparation, compounding, dispensing, and repackaging in nuclear pharmacies, nuclear medicine departments, and PET facilities. Official since 1 December 2020, it is the fourth chapter of the US compounding cluster alongside <795>, <797>, and <800>, written because radiopharmaceuticals' short half-lives, small batches, and radiation-protection constraints make the general sterile-compounding chapter a poor fit.
What this does not cover
stated in the document's own scope- Covers preparation, compounding, dispensing, and repackaging in licensed nuclear pharmacy and nuclear medicine settings; industrial manufacture, including PET drug production under 21 CFR Part 212, is a separate CGMP regime.
- An adopted standard: it binds where state boards, licensing, or accreditation reference it — not by USP's own authority.
- Radiation-safety licensing (NRC/agreement-state) runs alongside but is not part of the chapter's quality framework.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
USP General Chapter <825> governs the handling of radiopharmaceuticals outside industrial manufacture: preparation, compounding, dispensing, and repackaging in nuclear pharmacies, hospital nuclear medicine departments, and PET facilities. Official since 1 December 2020, it exists because radiopharmaceuticals fit the general sterile-compounding chapter poorly — half-lives measured in hours or minutes, single-batch patient doses, and radiation-protection constraints that shape every manipulation. The chapter therefore scales its requirements by activity: immediate-use preparation, preparation with prepared kits and generators, preparation with minor deviations, and compounding each carry proportionate environmental, personnel, and documentation controls, with beyond-use dating that reflects both sterility risk and radiochemical stability.
Scope & applicability
Sterile and nonsterile radiopharmaceutical handling by licensed facilities — from immediate-use preparation with prepared kits and generators through compounding and repackaging. Industrial radiopharmaceutical manufacture under CGMP, and PET drug production under 21 CFR Part 212, remain separate regimes. Like other USP chapters, <825> binds through adoption and reference.
Legal basis & how it acquires force
A USP–NF general chapter, made official on 1 December 2020 after the originally announced December 2019 date was postponed on appeal and the postponement lifted with the new date. Like the other compounding chapters, <825> acquires legal force through adoption — state boards of pharmacy and other authorities incorporating USP compounding standards by reference — and through accreditation and licensing frameworks; USP itself enforces nothing.
Document structure
| Part | Covers |
|---|---|
| Scope and activity classification | The immediate use / preparation / preparation with minor deviations / compounding tiers that drive every other requirement |
| Personnel training and qualification | Competency, garbing, and aseptic technique requirements for radiopharmaceutical handling |
| Facilities and environmental controls | Engineering controls and classified environments proportionate to the activity tier and radiation safety |
| Beyond-use dating | BUD assignment reflecting sterility risk and radiochemical stability |
| Documentation and quality assurance | Records, labelling, and the QA program supporting each activity tier |
Key requirements
- Activity-based requirements scaled from immediate use through preparation with minor deviations to compounding
- Environmental and personnel controls appropriate to the activity level and radiation-safety constraints
- Assignment of beyond-use dates reflecting radiochemical stability and sterility risk
- Documentation, training, and competency requirements for personnel handling radiopharmaceuticals
Implementation tips
- Classify each activity first (immediate use / preparation / preparation with minor deviations / compounding) — the chapter's controls scale by that classification, and misclassification cascades into the wrong environmental and BUD requirements
Revision notes
First published for December 2019, postponed on appeal, and official since 1 December 2020. Radiopharmaceutical handling was carved out of the general sterile-compounding chapter's scope in its favour.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Chapter <825> is the fourth member of the US compounding cluster — <795> nonsterile, <797> sterile, <800> hazardous drugs — carved out because radiopharmaceutical practice needed its own scaled framework; radiopharmaceutical handling was removed from the general sterile-compounding chapter's scope in its favour. Internationally, PIC/S PE 010's Annex 3 covers radiopharmaceutical preparation in healthcare establishments, and industrial radiopharmaceutical manufacture (including PET drugs under 21 CFR Part 212) remains a CGMP matter outside the chapter.
USP <825>: frequently asked questions
Quick answers to common questions about USP <825>.
When did USP <825> become official?
On 1 December 2020. The chapter was first published with a December 2019 official date, postponed following an appeal, and the expert committee then lifted the postponement with the new official date.
How does <825> relate to USP <797>?
Radiopharmaceutical handling was carved out of the general sterile-compounding chapter into <825>, whose activity-tier model fits the realities of short half-lives and kit-based preparation. Facilities handling both conventional steriles and radiopharmaceuticals apply <797> and <825> to their respective activities.
What are the activity tiers in <825>?
Immediate use; preparation (with prepared kits and generator elutions); preparation with minor deviations; and compounding. Each successive tier carries stricter environmental, personnel, and documentation requirements, and beyond-use dating scales accordingly.
Is USP <825> mandatory?
It binds through adoption: state boards of pharmacy and licensing or accreditation frameworks that incorporate USP compounding chapters give it enforceable effect. USP itself does not enforce; the chapter is the recognised practice standard for the activities it covers.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.