Pharmaceutical Compounding — Sterile Preparations
The compendial standard for compounding sterile preparations: facility design and air quality, personnel garbing and competency including gloved-fingertip and media-fill testing, environmental monitoring, sterilisation and depyrogenation, and beyond-use dating by preparation category. The revised chapter became official 1 November 2023.
Any setting preparing compounded sterile preparations, including hospital pharmacies, infusion providers and 503B outsourcing facilities.
- 01Designated person accountable for the sterile compounding programme
- 02Personnel qualification: garbing competency, gloved-fingertip testing and media fills at defined intervals
- 03Certified engineering controls with ISO-classified air appropriate to the operation
- 04Viable and non-viable environmental monitoring with defined action levels and investigation
- 05BUDs assigned per CSP category, with the required testing in place
- 06Master formulation and compounding records for each preparation
Revised chapter official 1 November 2023: CSP Categories 1–3, revised BUD framework, strengthened personnel qualification.
USP <797>: frequently asked questions
Quick answers to common questions about USP <797>.
What is USP <797>?
USP <797> — Pharmaceutical Compounding — Sterile Preparations — is a standard issued by the United States Pharmacopeia (United States / International). The compendial standard for compounding sterile preparations: facility design and air quality, personnel garbing and competency including gloved-fingertip and media-fill testing, environmental monitoring, sterilisation and depyrogenation, and beyond-use dating by preparation category. The revised chapter became official 1 November 2023.
Who does USP <797> apply to?
Any setting preparing compounded sterile preparations, including hospital pharmacies, infusion providers and 503B outsourcing facilities.
What are the key requirements of USP <797>?
USP <797> requires, among other things: Designated person accountable for the sterile compounding programme; Personnel qualification: garbing competency, gloved-fingertip testing and media fills at defined intervals; Certified engineering controls with ISO-classified air appropriate to the operation; Viable and non-viable environmental monitoring with defined action levels and investigation.
When was USP <797> last updated?
The current version of USP <797> dates from November 2023. Revised chapter official 1 November 2023: CSP Categories 1–3, revised BUD framework, strengthened personnel qualification.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
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When USP <797> — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.