USP <825> Readiness for Nuclear Pharmacies and Radiopharmaceutical Preparation
Combine radiation safety with aseptic practice, qualify every person, and check what your state board enforces.
In Short
- Applicable since 1 Nov 2023.
- Qualify staff before sterile work.
- Pharmacists decide dispensing.
The Radiopharmaceutical Operations Guide
Release timing by framework, supplier to dispatch, late failures and four worksheets.
- Release timing, framework by framework
- Supplier to dispatch, step by step
- When things go wrong
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The Radiopharmaceutical Operations Guide
Release timing by framework, supplier to dispatch, late failures and four worksheets.
USP General Chapter <825> sets standards for preparing, compounding, dispensing and repackaging radiopharmaceuticals, from kit preparation to patient doses. It became official on 1 December 2020 and compendially applicable once the revised <795> and <797>, which reference it, became official on 1 November 2023. Enforcement depends on your state board of pharmacy and other regulators. This guide is orientation, not regulatory advice. Sources checked 4 Oct 2026.
Who is in scope
USP describes the chapter as covering state-licensed activities in nuclear pharmacies, nuclear medicine areas of hospitals and clinics, and other healthcare settings. USP's FAQ quotes the chapter as not applying to manufacturing of approved radiopharmaceuticals in FDA-registered establishments or to manufacturing of investigational agents.
More on who is in scope
Check which rules apply to each activity and how your state board and radiation control programme apply <825>.
Radiation safety and aseptic practice together
USP says the chapter balances aseptic handling with radiation protection for sterile radiopharmaceuticals. Its public FAQ groups questions under topics such as immediate use, aseptic qualification, garbing, facilities, cleaning and disinfecting, and beyond-use dates.
What the chapter covers
| Area | Examples |
|---|---|
| Radiation safety | Time, distance, shielding, contamination |
| Personnel | Aseptic qualification, garbing, hygiene |
| Facilities | Classified areas, hot cells |
| Monitoring and cleaning | Air and surface sampling, disinfection |
| BUD and documentation | Master formulation and preparation records |
- Radiation safety
- Examples
- Time, distance, shielding, contamination
- Personnel
- Examples
- Aseptic qualification, garbing, hygiene
- Facilities
- Examples
- Classified areas, hot cells
- Monitoring and cleaning
- Examples
- Air and surface sampling, disinfection
- BUD and documentation
- Examples
- Master formulation and preparation records
More on radiation safety and aseptic practice together
Read the current official text for the requirements in each area.
Personnel Qualification
USP's public FAQ refers to gloved fingertip and media-fill testing as aseptic qualification for sterile preparation beyond immediate use. Take intervals and the steps after a failed test from the current official chapter and your regulator, write them into your procedures, and keep qualification records with dates, results and the trainer.
Worked Example: a Failed Fingertip Test
Beyond-Use Dates and Records
The chapter addresses beyond-use dates and documentation. Confirm the specific dating and record rules in the current official text rather than in summaries.
More on beyond-Use Dates and Records
Whatever records your procedures require, link each one to the dose or lot it supports so questions can be answered quickly.
Who decides, and what is changing
The pharmacist decides whether a preparation can be dispensed, and the authorised physician decides on patient administration. USP published proposed revisions to <825> in Pharmacopeial Forum 51(6) in November 2025, with comments closing on 31 January 2026, so confirm the current official text before updating procedures.
Questions
Is <825> enforceable?
It has been compendially applicable since 1 November 2023, but enforcement depends on your state board of pharmacy and other regulators. Check their current rules.
Does <825> apply to manufacturing?
USP's FAQ quotes the chapter as not applying to manufacturing of approved radiopharmaceuticals in FDA-registered establishments or to manufacturing of investigational agents. Check which rules apply to each activity at your site.
Is a revision coming?
USP published proposed revisions in Pharmacopeial Forum 51(6) in November 2025. Until a revision becomes official, the current text applies.
Where does V5 fit?
V5 keeps controlled procedures, training and qualification records, equipment and calibration, deviations and CAPA. It does not calculate activity, decay or beyond-use dates; your pharmacist decides.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
Radiopharmaceutical Manufacturing Readiness: Runs and Dispatch
10 CFR Part 35 Medical Use: Written Directives, Dosage Records and Medical Events
21 CFR 212 PET Drug cGMP Readiness: Production Evidence Guide
Radiopharmaceutical Release Before All Tests Finish: PET Evidence
Ga-68 Generator Elution Readiness for PET Imaging Sites
Lu-177 Radioligand Production in the US: Parts 210/211, Not Part 212, and NRC Licensing