Are we exempt from entirely?

For radiopharmaceutical compounding, yes — supersedes . For any non-radiopharmaceutical sterile compounding in the same facility, continues to apply.

Guide

USP <825> radiopharmaceutical compounding readiness

USP General Chapter <825> is the compendial standard for radiopharmaceutical preparation, compounding, dispensing, and repackaging. Effective from 1 November 2024 after multiple delays, <825> sits alongside <795> (non-sterile) and <797> (sterile) but supersedes both for radiopharmaceuticals — it acknowledges that the radiation-safety constraints of hot cells and shielded glove boxes make literal <797> compliance physically impossible. This guide covers what <825> actually requires for nuclear pharmacies, hospital radiopharmacies, and PET centers that compound under state pharmacy practice rather than 21 CFR 212 commercial cGMP.

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Scope: who is in and who is out

<825> applies to all radiopharmaceutical preparation activities — including reconstitution of FDA-approved kits (Tc-99m kits, Ga-68 generators), repackaging of unit doses, and minor compounding. It does not apply to commercial PET drug manufacture under an approved NDA/ANDA — that is 21 CFR 212. It does apply to investigational PET drugs distributed under <823> and to most academic radiopharmacy operations.

BUD framework — the practical centerpiece

<825> sets Beyond-Use Dates by category: minor deviations from manufacturer instructions follow the labeled expiry, more significant alterations get shortened BUDs, and immediate-use compounded radiopharmaceuticals can be administered up to one hour after preparation under defined personnel, environment, and documentation conditions. The decay-corrected expiry must always be the limiting factor — a 1-hour BUD on a 110-minute F-18 product is decay-driven, not microbiological.

Hot cell and cleanroom design — the <797> reconciliation

<825> recognizes the laminar-flow hood-in-cleanroom model from <797> is incompatible with hot-cell shielding. The standard accepts a Class II Type A2 or B2 biological safety cabinet inside a hot cell, a shielded glove box with ISO 5 critical zone, or a totally enclosed automated dispensing system. Background classification (ISO 7 / ISO 8) is required around the critical zone, with environmental monitoring frequency matched to risk.

Personnel competency and gowning

All personnel performing compounded sterile radiopharmaceutical preparation must complete initial competency assessment and recompete annually. Gowning follows <797> principles adapted for radiation safety: dosimetry under the gown, shielded eyewear instead of standard goggles. Media fills are required initially and annually per category of compounding performed.

Documentation and the inspection pattern

State boards of pharmacy (rather than FDA) inspect against <825>. The four recurring deficiencies in early 2025 inspections: incomplete BUD justification documentation, missing or generic environmental monitoring procedures, lack of competency-assessment records, and inadequate dispensing records for patient-specific unit doses. Surface-sampling frequency is the single most common environmental-monitoring finding.

Standards covered in this guide

Each standard, retailer code or assurance scheme referenced above has its own deep-dive page with scope, audit detail and common pitfalls.

ALCOA+

The nine-letter mnemonic regulators use to grade your data integrity — and what every Part 11 audit really tests.

ICH Q10

The international model for a Pharmaceutical Quality System covering the entire product lifecycle from development to discontinuation.

CAPA

Structured investigation + fix loop for recurring problems — required by every quality regime.

Where this lives in V5 Ultimate

The clauses above aren't theoretical — every one maps to a shipped module and an industry profile. Jump to the parts of the product that turn this guide into evidence on a Monday morning.

Industries this hits hardest

Frequently asked

Does <825> apply if we only reconstitute kits?

Yes. Reconstitution of an FDA-approved kit is in scope. The BUD framework typically lets you follow the manufacturer's instructions if no significant deviation occurs, but environment, personnel, and documentation requirements still apply.

Are we exempt from <797> entirely?

For radiopharmaceutical compounding, yes — <825> supersedes <797>. For any non-radiopharmaceutical sterile compounding in the same facility, <797> continues to apply.

Can a hospital radiopharmacy operate under <825> and ship to off-site clinics?

Generally only within the same state and under intrastate pharmacy practice rules. Interstate shipment usually requires 503B outsourcing facility registration or commercial cGMP under 21 CFR 212.

How does <825> interact with NRC / 10 CFR 35?

They run in parallel. <825> is a pharmacy-practice standard enforced by the state board of pharmacy. 10 CFR 35 is the federal medical-use licensing rule enforced by NRC or Agreement State. A facility needs to satisfy both simultaneously — see the 10 CFR 35 guide.

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