USP General Chapters
USP <797> - Pharmaceutical Compounding - Sterile Preparations
Plain-language explanation, inspection context and common violation patterns.
What it says
General Chapter <797> establishes requirements for compounding sterile preparations in pharmacy and healthcare settings, including facility design, personnel training and garbing, environmental monitoring, beyond-use dating, and categorisation of compounded sterile preparations by risk level.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- This chapter applies specifically to sterile compounding in pharmacy and healthcare settings, a distinct regulatory context from commercial sterile manufacturing under 21 CFR Part 211 and EU GMP Annex 1, though it shares many of the same underlying contamination control principles.
- Risk-level categorisation of compounded preparations, based on factors like the number of sterile components combined and the compounding environment, directly determines the beyond-use dating and environmental control expectations that apply.
- Personnel garbing and hand hygiene competency assessment is a specific, required element, similar in principle to aseptic gowning qualification in commercial sterile manufacturing.
What inspectors look for
- Whether compounded preparations are correctly categorised by risk level, with beyond-use dating and environmental controls matching that categorisation.
- Whether personnel garbing and aseptic technique competency is assessed and documented, not simply assumed based on general pharmacy training.
- Whether environmental monitoring data for compounding areas is trended and reviewed, consistent with broader contamination control principles.
Most common violation
Compounded sterile preparations assigned a beyond-use date inconsistent with their actual risk-level categorisation, often extending shelf life beyond what the compounding environment and process would support.
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