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.
What this does not cover
stated in the document's own scope- Covers sterile compounding; nonsterile compounding is governed by USP <795>.
- Applies to traditional §503A pharmacy compounding, not the industrial cGMP that governs §503B outsourcing facilities.
- Adds the sterile-preparation controls; hazardous-drug containment and handling requirements come from USP <800>.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
USP General Chapter <797>, Pharmaceutical Compounding — Sterile Preparations, sets the minimum standards for compounding sterile preparations to reduce the risk of microbial, particulate, and endotoxin contamination that could harm patients. It covers facility design and air quality, personnel garbing and competency (including gloved-fingertip sampling and media-fill testing), environmental monitoring, sterilisation and depyrogenation, master formulation and compounding records, and the assignment of beyond-use dates by preparation category. The revised chapter became official on 1 November 2023 and reorganised sterile compounding around defined preparation categories with corresponding controls.
Scope & applicability
Any setting preparing compounded sterile preparations, including hospital pharmacies, infusion providers and 503B outsourcing facilities.
Legal basis & how it acquires force
Chapter <797> is a USP–NF general chapter numbered below 1000, making it potentially mandatory when invoked. For sterile compounding, that force comes primarily from State Boards of Pharmacy that adopt the chapter by reference into state law, and from the FD&C Act §503A, which conditions traditional compounding on compliance with applicable USP chapters. Accreditation and facility-licensing bodies also require it. So §503A and state pharmacy law, not the chapter number alone, give <797> its legal weight.
Document structure
| Part | Covers |
|---|---|
| Personnel training and garbing | Garbing, hand hygiene, gloved-fingertip sampling, and aseptic-technique competency |
| Facilities and engineering controls | Primary and secondary engineering controls, air quality, and cleanroom classification |
| Environmental monitoring | Viable and non-viable air and surface monitoring of the compounding area |
| Sterilisation and depyrogenation | Sterilisation methods, filtration, and endotoxin (depyrogenation) control |
| Beyond-use dating by category | Assigning beyond-use dates according to preparation category and storage |
| Documentation and quality assurance | Master formulation and compounding records and the QA/QC program |
Key requirements
- 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
- BUDs assigned per CSP category, with the required testing in place
- Master formulation and compounding records for each preparation
Implementation tips
- Decide the CSP category from the sterility-assurance system you can actually sustain, then let the BUD follow — never the reverse
- Media fills are the qualification most often deferred and the one an inspector asks for first
- Where the site is a 503B facility, run <797> and 21 CFR 211 as one programme rather than two parallel ones
Revision notes
Revised chapter official 1 November 2023: CSP Categories 1–3, revised BUD framework, strengthened personnel qualification.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Chapter <797> is the sterile member of the USP compounding family with <795> (nonsterile) and <800> (hazardous drugs); a hazardous sterile preparation is subject to both <797> and <800>. Its engineering-control and environmental-monitoring approach is conceptually aligned with the cleanroom and aseptic-processing expectations of EU GMP Annex 1 and USP <1116>, though <797> is written for the pharmacy compounding setting rather than for industrial manufacture under §503B cGMP.
USP <797>: frequently asked questions
Quick answers to common questions about USP <797>.
When did the revised USP <797> become official?
It became official on 1 November 2023. The revision reorganised sterile compounding around defined preparation categories, each with corresponding facility, monitoring, and beyond-use-dating controls.
What competency testing does <797> require of personnel?
It requires garbing and aseptic-technique competency evaluation, including gloved-fingertip sampling and media-fill testing, to demonstrate that personnel can compound sterile preparations without introducing contamination.
Does <797> apply to §503B outsourcing facilities?
No. Chapter <797> is written for traditional §503A pharmacy compounding. Outsourcing facilities registered under §503B must comply with cGMP, a separate and more extensive manufacturing framework.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.