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General information only, not medical or pharmacy-practice advice. It does not give preparation procedures.
Short answer
USP <825> is the United States Pharmacopeia general chapter titled “Radiopharmaceuticals: Preparation, Compounding, Dispensing, and Repackaging.” It sets minimum standards for handling sterile and nonsterile radiopharmaceuticals in the practice of pharmacy and medicine, in nuclear pharmacies, nuclear cardiology clinics and hospital nuclear medicine departments alike.
Definition and scope
The chapter exists because radiopharmaceutical work sat awkwardly under USP <797> (sterile compounding). According to a continuing-education article in the Journal of Nuclear Medicine Technology (Hinkle, 2020), <797> was first issued in 2004 and revised in 2008 to cover radiopharmaceuticals, but some requirements clashed with radiation-safety practice: absorbent pads, shielding, an L-block and a dose calibrator inside a hood, for example. More than 1,500 comments from the nuclear medicine community on the 2016 <797> revision led to an expert panel and, in turn, to <825>.
The same article describes the scope as follows:
- Settings: all settings where radiopharmaceuticals are prepared, compounded, dispensed or repackaged.
- Equipment: radionuclide generators and direct-infusion devices are included.
- People: all personnel involved, including pharmacists, authorized-user physicians, technologists, technicians, residents and students.
USP itself has no inspection authority. The article notes that state boards of pharmacy, The Joint Commission and CMS use USP standards, which is how a chapter becomes enforceable in practice.
How the chapter divides the work
Preparation, minor deviations and compounding
The chapter separates three activities, and the line between them decides which rules apply (Hinkle, 2020).
| Activity | What the source says it is | Examples given |
|---|---|---|
| Preparation | Radiolabeling according to FDA-approved labeling, such as mixing, diluting or reconstituting. Manufacturer directions must be followed except for minor deviations. | Reconstituting an approved kit as labeled |
| Minor deviation | A change that keeps the same ingredients and adds no extra components. | A different quantity of radioactivity, final volume or kit proportion; a different needle or syringe; a heating block instead of a water bath; alternative quality control |
| Compounding | A major alteration of approved directions or formulation, or work from bulk substances. | The chapter prohibits compounding conventionally marketed FDA-approved radiopharmaceuticals, except clinically relevant changes requested by a licensed physician for a specific patient |
Immediate use versus beyond immediate use
The second major division is the immediate-use provision, the main practical difference from a full sterile-compounding environment.
| Item | Immediate use | Beyond immediate use |
|---|---|---|
| Definition | Single dose, single patient, administered within 1 hour of first vial puncture, from sterile FDA-approved kits; leftover material is discarded | Anything that does not meet the immediate-use conditions |
| Where | A hot lab in an unclassified area is acceptable | A primary engineering control (an ISO Class 5 hood) in a segregated radiopharmaceutical processing area (SRPA) or a cleanroom |
| Sterile compounding environment | No primary engineering control required | ISO 5 hood inside an ISO 7 buffer area with an ISO 8 anteroom |
| Personnel checks | Not described in the source for this tier | Gloved fingertip sampling, media-fill and aseptic competency tests, with requalification every 12 months |
| Dose handling | Splitting a dose among multiple patients is not allowed; pooling doses for one patient and adding a nonradioactive drug to a unit dose are allowed | Beyond-use date set from the control, environment and manipulations involved |
The ISO classes in the chapter’s air-quality table correspond to particle limits of 3,520 particles per cubic metre for ISO 5, 352,000 for ISO 7 and 3,520,000 for ISO 8 (Hinkle, 2020). For background on the top class see ISO Class 5 cleanroom air; for a neighbouring compounding chapter see USP 800 cleanroom requirements.
Radiolabeled red blood cells
For technetium-99m labeled red blood cells, the article states that immediate use carries a 1-hour limit with no cap on needle punctures, unlike the two punctures permitted for immediate use under <797>. Labeling of other blood components does not qualify as immediate use.
What is outside the chapter
- PET radiopharmaceuticals: USP <823> supersedes both <797> and <825> for PET compounding.
- Unit-dose receivers: a department that only administers unit doses from a nuclear pharmacy, with no further manipulation, is not subject to other <825> standards beyond making sure the pharmacy is compliant.
- Nonradioactive drugs: adjuncts such as morphine, sincalide, furosemide and regadenoson are not covered by <825>; <797> applies.
Where it matters for labs, clinics and supply decisions
Because the rules turn on the immediate-use test, the category a site works in depends on how a product is actually used: a sterile FDA-approved kit prepared for one patient within an hour sits in a different category from the same kit used to supply several patients. The chapter’s definitions, not the product name, decide which requirements apply, and the classified-room and hood requirements belong to the beyond-immediate-use tier. Sterility-related concepts are covered in the sterilizing filter guide.
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) submitted comments on proposed revisions to <825> in January 2026. Its news item says it asked USP to harmonize the 1-hour immediate-use beyond-use date in <825> with the 4-hour period in <797>, and raised concerns that a single standard is hard to apply across such different settings and that the scope outside nuclear pharmacy is unclear. These are proposals and comments, not adopted text; the current chapter text is published in USP-NF.
Common misunderstandings
- “It is the same as USP 797.” It was created because <797> conflicted with radiation-safety practice, and it has its own immediate-use rule.
- “USP inspects sites.” It does not; state boards, The Joint Commission and CMS apply its standards.
- “Any change to a kit is compounding.” Minor deviations that keep the same ingredients are still preparation.
- “It covers PET.” <823> governs PET.
FAQ
What does USP 825 cover?
The preparation, compounding, dispensing and repackaging of sterile and nonsterile radiopharmaceuticals, in any setting and for all personnel involved.
What is the immediate-use time limit in USP 825?
One hour from the first vial puncture, for a single dose for a single patient from a sterile FDA-approved kit, according to the 2020 article.
Does USP 825 apply to PET drugs?
No. USP <823> applies to PET radiopharmaceuticals.
Can a hot lab be used?
For immediate use, yes: an unclassified hot lab is acceptable and no primary engineering control is required.
Sources
- Hinkle GH. USP <825>: Impact on Nuclear Medicine Technology Practice. J Nucl Med Technol 2020;48(2):106-113. DOI 10.2967/jnmt.120.243378. Full text. Read 2026-11-08. The article describes the chapter as it was then proposed.
- SNMMI. SNMMI Submits Comments on Proposed Revisions to USP General Chapter <825>. snmmi.org. Read 2026-11-08.
