USP 797 Compliance

The mission of USP Chapter 797 is to prevent harm from microbial contamination, excessive bacterial endotoxins, variability in intended strength that exceed monograph limits, use of ingredients of inappropriate quality, and unintended physical and chemical contaminants.

USP Chapter 797 is recognized by the FDA and 34 State Boards of Pharmacy. Based on current scientific information and best sterile compounding practices, it is recognized as the national standard of practice. A revision to General Chapter 797 was proposed for public comment in recent years. Based on the nature and significance of the public comments received, the chapter will be revised and is anticipated to be published in the Pharmacopeial Forum 44(5) Fall of 2018 for a second round of public comment.

It is expected to be published in USP 42-NF 37 Second Supplement on June 1, 2019 and become official on December 1, 2019. Proposed revisions to the requirement are outlined below.

Summary of Proposed Changes
  • 3 risk levels changed to 2 categories distinguished by conditions under which they are made and time within which used.
  • Removal of HD handling section and cross-referenced to USP 800.
  • Quarterly requirement for Personnel Monitoring (visual observation of hand hygiene and garbing, Media Fill Testing and ongoing Gloved Fingertip Sampling).
  • Quarterly requirement for Viable Air Sampling and Surface Sampling
  • Beyond Use Data (BUD) and Storage times changed with a maximum BUD of 45 days regardless of sterility test.
  • Introduction of “In-Use time” (time before which conventionally manufactured product or compounded dilution bag must be used after it is punctured).
  • Master formulation and compounding records will be required for all batch and non-sterile compounding.
  • New guidance for sterility testing of compound sterile preparation (CSP) prepared in batch sizes of less than 40 (10% rule).
  • New placement requirements on use of isolators.
  • Requirement for sterile wipers and cleaning tools that need to be re-sterilized but no sterile disinfectants.
Personnel Monitoring and Viable Air and Surface Sampling

AirQuest personnel are experienced in performing air and surface sampling as well as personnel monitoring. AirQuest can help develop a customized environmental sampling plan to help determine if the pharmaceutical compounding laboratory is within the actions levels of USP 797.

Viable Air Sampling is conducted to monitor for airborne bacteria and fungi that pose a threat of contamination of sterile preparations. Non-Viable Particle Sampling is conducted using a particle counter in order to give real time feedback during compounding activities. Viable Surface Sampling is conducted to determine if the laboratory’s cleaning program is keeping surfaces free of microbial contamination.