United States Pharmacopeia chapter for nonsterile compounding. Covers quality standards, master formulation records, compounding procedures, and beyond-use dating for non-sterile preparations.
USP <795> addresses compounded nonsterile preparations for humans and animals. It is distinct from USP <797>, which addresses sterile preparations; hazardous-drug handling also requires consideration of USP <800>.
For a nonsterile operation, organize the evidence around the formulation, the actual compounding event, personnel preparation, the work area and the quality review. A generic sterile-cleanroom checklist is not a substitute for that record set.
The master formulation describes how a preparation is made. The compounding record documents the particular preparation made using that formulation, including the applicable ingredient and execution evidence. Keep the approved formulation identifiable so a reviewer can connect instructions with the actual work.
Do not assign a beyond-use date from a short list of maximum days alone. Review the current chapter, formulation, water activity, preservation, storage conditions and relevant stability information. Document the rationale used for the actual preparation rather than treating a software default as a determination of stability.
Primary references: USP <795>: Introduction and scope · USP: Chapter <795> resources · USP <1163>: Quality assurance and records
No. USP <795> concerns nonsterile preparations; USP <797> addresses sterile compounding. Start with the preparation and activity to determine which standards to evaluate.
Use USP’s official chapter resources and the applicable requirements of your regulator. The public overview helps identify scope; the complete chapter is available through USP’s compendial resources.
See how CompliRx handles this in practice:
Controlled formulation and SOP recordsCompliRx helps compounding pharmacies keep environmental monitoring, qualifications, cleaning, documents, and CAPA evidence inspection-ready.
