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.
Any setting compounding nonsterile preparations — community and health-system pharmacies, physician offices, and 503B facilities for their nonsterile work.
- 01Designated person responsible for the compounding programme
- 02Documented training and periodic competency assessment for compounding personnel
- 03Master formulation records and per-batch compounding records
- 04BUDs assigned per the chapter defaults or a documented stability justification
- 05Defined facility and equipment controls appropriate to nonsterile compounding
Revised chapter official 1 November 2023, alongside the revised <797>.
USP <795>: frequently asked questions
Quick answers to common questions about USP <795>.
What is USP <795>?
USP <795> — Pharmaceutical Compounding — Nonsterile Preparations — is a standard issued by the United States Pharmacopeia (United States / International). 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.
Who does USP <795> apply to?
Any setting compounding nonsterile preparations — community and health-system pharmacies, physician offices, and 503B facilities for their nonsterile work.
What are the key requirements of USP <795>?
USP <795> requires, among other things: 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.
When was USP <795> last updated?
The current version of USP <795> dates from November 2023. Revised chapter official 1 November 2023, alongside the revised <797>.
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.
Track the standards that move
When USP <795> — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.