USP 797 is the United States Pharmacopeia chapter that governs sterile compounding, and the version in force took effect on 1 November 2023. It sets out how a compounded sterile preparation is classified, what environment it must be made in, how the people making it must be garbed and trained, and how long the finished preparation may be kept. For a Canadian compounding pharmacy the chapter is not a federal licence, but it is the standard that most contracts, accreditation schemes and provincial expectations point to, so the practical answer is to follow it and document that you did.
What are the USP 797 compounding categories?
The 2023 chapter replaced the older low, medium and high risk language with three categories. Category 1 preparations are the least exposed to contamination risk and carry the longest beyond-use dates; Category 3 are the most exposed and carry the shortest.
The category is not a comment on how complicated a recipe looks. It reflects how the preparation is made and stored, and it has to be assigned in writing before a beyond-use date can be set at all.
Which ISO air classes apply to each category?
The direct compounding area is an ISO Class 5 environment in every category; that is the air right where the needle and the vial meet. What changes is the controlled space around it, which is why the supporting-room expectation is written per category rather than as one rule for every pharmacy.
| Requirement | Category 1 | Category 2 | Category 3 |
|---|---|---|---|
| Direct compounding environment | ISO Class 5 PEC | ISO Class 5 PEC | ISO Class 5 PEC |
| Supporting room expectation | Risk-based, per chapter | ISO Class 7 buffer with ISO 8 ante-area | ISO Class 7 with stricter control |
| Beyond-use date | Longest of the three | Shorter than Category 1 | Shortest of the three |
| Personnel monitoring | Gloved fingertip and thumb sampling, media fill | Same, at defined intervals | Same, at defined intervals |
The table is a starting point, not a substitute for the chapter. Layout, workflow and risk assessment decide how the supporting rooms are configured and how they are monitored.
How long can a compounded sterile preparation be stored?
The beyond-use date is set by the category and the storage condition together, so there is no single number to quote here. The chapter carries the permitted values in its own tables, and the current chapter is the only reliable source, so treat the chapter as the authority on the hours.
What a pharmacy can control is the paperwork. Record the category, the storage condition and the resulting date for every batch, so the number is traceable to a written decision rather than copied from memory or from an old worksheet.
What garbing and cleaning supplies does USP 797 require?
Garbing is a sequence rather than a checklist. Low-lint coveralls or gowns, head and hair covers, face masks, eye protection where specified, and shoe covers go on first; sterile gloves go on last, so they are not contaminated while the rest of the garb is adjusted.
The compounding area and the supporting rooms need a written cleaning and disinfection routine with the agents used and the contact times recorded. Personnel monitoring, including gloved fingertip and thumb sampling and periodic media fills, is what proves the garbing actually works.
How is USP 797 different from USP 800?
USP 797 governs sterile compounding for all preparations and sets the environment, garbing and beyond-use rules. USP 800 adds containment requirements for hazardous drugs such as chemotherapy agents. A pharmacy preparing hazardous drugs has to meet both chapters, and the containment measures are stricter. The two run in parallel; the second does not replace the first.
Which consumables does a Canadian compounding pharmacy keep on the shelf?
The list is short and ordinary: a supply of low-lint head covers, sterile gloves in the sizes actually used, individually wrapped swabs and alcohol pads for surface and port care, and containers for the preparations themselves. Individually wrapped cotton swabs, 15 mL sterile centrifuge tubes and non-woven bouffant caps are the kind of lines that sit behind the chapter's requirements without appearing in it by name.
Related Reading
- Compounding and sterile practice learning hub
- USP 71 sterility testing for pharmacies and compounding labs
- Compounding pharmacy supplies: gloves and alcohol pads
- free Ontario sterilization compliance log
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Related Reading
- USP 71 sterility testing for pharmacies and compounding labs
- Compounding pharmacy supplies: gloves and alcohol pads
- Compounding and sterile practice learning hub
- Wholesale and multi-site ordering
Frequently Asked Questions
What is the difference between Category 1 and Category 3 in USP 797?
The category reflects how the preparation is made and stored rather than how complicated it looks. Category 1 preparations are the least exposed to contamination risk and carry the longest beyond-use dates; Category 3 are the most exposed and carry the shortest. The category has to be assigned in writing before a BUD can be set.
Does USP 797 require a separate cleanroom room?
It requires a direct compounding area that meets ISO Class 5 and a controlled environment around it appropriate to the category. That can be a cleanroom suite or another configuration that meets the chapter, which is why the design decision is documented and monitored rather than assumed.
What garb does USP 797 require in the compounding area?
Low-lint coveralls or gowns, head and hair covers, face masks, eye protection when specified, shoe covers, and sterile gloves put on last. The sequence matters: gloves go on after the rest of the garb so they are not contaminated while dressing.
How is USP 797 different from USP 800?
USP 797 governs sterile compounding for all preparations and sets the environment, garbing and BUD rules. USP 800 adds containment requirements for hazardous drugs, such as chemotherapy agents. A pharmacy preparing hazardous drugs has to meet both, and the containment measures are stricter.
CliniEco Medical is a licensed medical device establishment (MDEL #35334).
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