Pharmaceutical Compounding — Nonsterile Preparations
The compendial standard for compounding nonsterile preparations: personnel training and evaluation, facilities and equipment, component selection, master formulation and compounding records, beyond-use dating, and quality assurance. The revised chapter became official 1 November 2023.
What this does not cover
stated in the document's own scope- Covers nonsterile compounding; sterile compounding is governed by USP <797>.
- Sets standards for traditional compounding, not the cGMP that applies to §503B outsourcing facilities producing in bulk.
- Addresses compounding quality generally; the additional containment and handling controls for hazardous drugs come from USP <800>.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
USP General Chapter <795>, Pharmaceutical Compounding — Nonsterile Preparations, sets the minimum standards for compounding nonsterile preparations such as capsules, ointments, creams, oral liquids, and suppositories. It covers the elements that make a compounded nonsterile preparation acceptable: personnel training and competency evaluation, facilities and equipment, selection and handling of components, master formulation and compounding records, establishing beyond-use dates, labelling, and a quality-assurance and quality-control program. The revised chapter became official on 1 November 2023, replacing the earlier version and updating the documentation and beyond-use-dating framework.
Scope & applicability
Any setting compounding nonsterile preparations — community and health-system pharmacies, physician offices, and 503B facilities for their nonsterile work.
Legal basis & how it acquires force
Chapter <795> is a USP–NF general chapter numbered below 1000, so it is potentially mandatory when invoked. For compounding, the invoking mechanism is chiefly state adoption: pharmacy practice is regulated by State Boards of Pharmacy, many of which adopt USP compounding chapters by reference into state law, and the FD&C Act §503A also ties traditional compounding to compliance with applicable USP chapters. So <795>’s legal force comes from state pharmacy law and §503A rather than from the chapter number alone.
Document structure
| Part | Covers |
|---|---|
| Personnel training and evaluation | Training, competency assessment, and hygiene of compounding personnel |
| Facilities and equipment | The compounding environment, equipment, and cleaning and sanitation |
| Components and preparation | Selecting components, handling, and the compounding process for nonsterile preparations |
| Documentation | Master formulation records and compounding records for each preparation |
| Beyond-use dating and labelling | Assigning beyond-use dates and labelling the finished preparation |
| Quality assurance and control | Release checks, complaint handling, and the QA/QC program |
Key requirements
- Designated person responsible for the compounding programme
- Documented training and periodic competency assessment for compounding personnel
- Master formulation records and per-batch compounding records
- BUDs assigned per the chapter defaults or a documented stability justification
- Defined facility and equipment controls appropriate to nonsterile compounding
Implementation tips
- Confirm what your state has actually adopted and in which version — adoption lags and varies, and the state text governs
- Treat BUD justification as a records exercise: the default table is defensible, a longer date needs data
- Keep the master formulation record separate from the compounding record; conflating them is a routine finding
Revision notes
Revised chapter official 1 November 2023, alongside the revised <797>.
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 <795> is the nonsterile member of the USP compounding family, paired with <797> for sterile preparations and <800> for hazardous drugs; where a hazardous drug is compounded nonsterile, <795> and <800> apply together. It operates within the §503A framework for traditional pharmacy compounding and is distinct from the cGMP that applies to §503B outsourcing facilities. Its practical force depends on adoption by each State Board of Pharmacy.
USP <795>: frequently asked questions
Quick answers to common questions about USP <795>.
When did the revised USP <795> become official?
The revised chapter became official on 1 November 2023, replacing the prior version and updating the requirements for documentation, personnel evaluation, and beyond-use dating for nonsterile compounding.
Is USP <795> legally enforceable?
It can be. As a chapter numbered below 1000 it is potentially mandatory, and it acquires legal force chiefly through adoption by State Boards of Pharmacy into state law and through the FD&C Act §503A framework for traditional compounding.
How does <795> relate to <797> and <800>?
They are the USP compounding family: <795> covers nonsterile preparations, <797> covers sterile preparations, and <800> covers handling of hazardous drugs. A hazardous nonsterile preparation is subject to both <795> and <800>.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.