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Compounded Sterile Preparations and USP 797 Compliance

Image of biological safety cabinet with particulate counter inside.

The latest version of the United States Pharmacopeia (USP) General Chapter 797 Pharmaceutical Compounding – Sterile Preparations, requires several environmental controls and monitoring including particulate counting in buffer and preparation areas where compounded sterile preparations (CSP) are processed and monthly microbial monitoring.

If you are interested in submitting your biological sampling results, click below. Facilities that submit data will receive reports that outline the sampling results from other facilities in the state. All facilities will be kept confidential.

Submit your sampling data here.