USP<797> & <800> Compliance

In an effort to increase patient safety, the U.S. Pharmacopeia has implemented USP<797> to control the compounding and administration of pharmaceutical products in the United States. The regulations comprising USP<797> are intended to protect patients by preventing the contamination of compounded sterile preparations. USP<800> has also been adopted to protect patients and pharmacy personnel from exposure to hazardous drugs as part of compounding.


Recognizing the impact of these standards on compounding pharmacies, TSS has developed a systematic approach to helping facilities achieve regulatory compliance. Following a comprehensive gap analysis, TSS will provide CETA National Board of Testing (CNBT) certified technicians to conduct all necessary testing and certification. Further, TSS offers training programs designed to provide pharmacists and support personnel with a better understanding of USP<797> & <800>, and the best practices for maintaining compliance.

USP compliance testing includes

  • Biosafety cabinet and isolator testing and certification
  • Clean bench or laminar airflow workbench testing and certification
  • Ceiling HEPA filter integrity testing
  • Non-viable airborne particulate counting
  • Room air exchange rate calculation
  • Room differential pressurization measurement
  • Calibration of room pressure gauges and additional critical devices
  • Dynamic airflow visualization studies
  • Sampling of work areas for hazardous drug residue
  • Gap analysis to offer a roadmap to compliance

Viable environmental monitoring

In addition to the semiannual monitoring and certification of ISO classified rooms and devices, viable environmental monitoring must be conducted. A formal sampling plan should be put in place for the implementation and scheduling of environmental monitoring, including a diagram of intended sample locations and a baseline for the minimum acceptable limits of viable organisms. Regular sampling by TSS will allow you to monitor trends in the presence of viable organisms, thus helping you evaluate the effectiveness of your cleaning and standard operating procedures. TSS offers microbiological services scaled to meet the needs of all of our USP<797> & <800> clients, including genus/species identification and the option to include fungal-selective media.


TSS understands that delivering safe, effective medication to patients is more than just a good idea – it is an obligation. For more detailed information about our USP<797> & <800> compliance services or to find out if you qualify for a complimentary USP gap analysis, contact your local TSS representative today.

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