A laboratory scientist in a white coat works inside a sterile biosafety cabinet with stacks of petri dishes in the foreground during an environmental testing audit.

USP 797 Testing

What is USP 797?

How Does USP Affect Healthcare and Pharmacy Facilities?

USP 797 refers to chapter 797 "Pharmaceutical Compounding – Sterile Preparations," in the USP National Formulary. It is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP). The USP 797 standard describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded in healthcare and pharmacy settings.

Site Walk - (Optional)
Review of Facility Compliance Program and Standard Operating Procedures
Design, Development and Implementation to improve Environmental Health and Safety
Environmental Sampling and Monitoring Protocols
3D Virtual Facility Capture and Sampling locations
Laboratory Data Interpretation
Corrective Actions for Mitigation, Remediation and Regulatory Compliance Requirements
Customer Support and Education

Who does the USP 797 Standards apply too?

An environmental consultant wearing white gloves examines an agar petri dish during a commercial microbiology testing audit.

The standards in this chapter are intended to apply to all persons who prepare compounded sterile preparations (CSPs) and all places where CSPs are prepared in:

Hospitals and other healthcare institutions, patient treatment clinics, pharmacies, physicians' practice facilities, and other locations and facilities in which CSPs are prepared, stored, and transported.

USP 797 requirements affect all disciplines involved in sterile compounding, including physicians, nurses, pharmacists, and pharmacy technicians

USP 797 Compliance

These facilities are required to comply with USP 797 standards which are designed to reduce and prevent the risk. These standards include primary engineering controls, viable and nonviable environmental sampling cleanliness standards, procedures, practices and protocols.