USP General Chapter 795 establishes standards for compounding non-sterile preparations to ensure patient safety. These standards cover personnel training, facility design, quality assurance, and beyond-use dating for compounded preparations.
Compliance with USP 795 requires investment in facilities, equipment, training, and ongoing monitoring. At Nuvexa Pharmaceuticals, our compounding facility features dedicated compounding areas with proper environmental controls and equipment calibration protocols.
Key USP 795 requirements include: designated compounding areas with proper ventilation, personnel training and competency assessment, quality assurance programs, proper beyond-use dating based on stability data, and documentation of all compounding activities.
Our facility undergoes regular third-party audits to verify ongoing compliance with current USP 795 standards, ensuring every preparation meets the highest safety benchmarks.
Nuvexa Clinical Team
PharmD
Clinical pharmacist at Nuvexa Pharmaceuticals specializing in compounded pharmaceutical preparations and quality assurance.