Frequently asked questions about usp 797

What is USP 797 Compliance? 

USP 797 was developed to establish best practices for the production of compounded sterile preparations (CSPs). As part of these regulations pharmacies producing CSPs must periodically perform environmental testing to ensure compliance with USP 797.

When must environmental and personnel sampling be performed?

Environmental and personnel sampling must be performed:

  • As part of the commissioning and certification of new facilities and equipment

  • Following any servicing of facilities and equipment

  • Air and Surface sampling every 6 months as part of re-certification 

  • Surface/ Personnel sampling done at “regular intervals” internally (such as every month)

  • In response to identified problems with end products or staff techniques 

  • In response to issues with CSPs, observed compounding personnel work practices, or patient-related infections 

How DO I SUBMIT MY SAMPLES?

This document provides an overview of how to submit your samples to our laboratory for analysis. Please contact us with any questions.

Surface Sampling instructions

This document provides an overview of how to perform surface sampling.

How can I get Pricing?

Please contact us here for a quote.

How DO I obtain my results?

Results are obtained through Sharefile, a secure document sharing service. Please contact us if you need help creating an account or accessing your account.

What are action levels?

Action levels are limits set in place by USP as guidelines for the maximum number of viable organisms allowable in a single sample. 

The number of viable organisms recovered from environmental testing must be compared to action levels to determine what corrective actions must be completed. If the number of organisms recovered exceeds the action level for the corresponding sample type, corrective action must be taken.

What are the Current Action Levels - From USP 797 STANDARDS?

As of November 2023, the following standards apply.

  • No pathogenic species (a previous USP 797 regulation considered pathogenic species an actionable item; this is no longer the case)

  • Air Sampling

    • ISO 8: >100 CFU

    • ISO 7: >10 CFU

    • ISO 5: >1 CFU

  • Surface Sampling

    • ISO 8: >50 CFU

    • ISO 7: >5 CFU

    • ISO 5: >3 CFU

  • Personnel Sampling

    • No growth in pre-manipulation samples

    • >3 CFU in post-manipulation samples