Upcoming Changes to USP 797

September 18, 2019

USP 797 revisions were published on June 1, 2019. The clarity and readability of documentation is a concern for all facilities and significantly impacts those who compound both hazardous and non-hazardous drugs or those who administer CSPs. The revisions to USP 797 reflect new science and evidence based on updated guidance documents, best practices, and new learnings. 

For some facilities, these updates will not require immediate improvements to current practices. Most urgently impacted are small and medium sized organizations. Smaller pharmacies that compound both hazardous and non-hazardous drugs that previously did not require negative pressure environments are pressed to make updates as soon as possible. Larger organizations are challenged with acute adjustments like operational changes, new storage requirements, and new handling measures.

Classification and Beyond-Use Dates

Compounded sterile preparation (CSP) microbial risk levels have been simplified from 3 down to 2. Instead of low, medium, and high risk, there are now Category 1 CSPs and Category 2 CSPs. Category 1 CSPs have a shorter beyond-use date and can be prepared in an unclassified segregated compounding area. Category 2 CSPs have a longer beyond-use date and must be prepared in a cleanroom suite consisting of a buffer room and an ante room.

The section in radiopharmaceuticals as CSPs has been removed and now resides in Radiopharmaceuticals - Preparation, Compounding, Dispensing, and Repackaging 825.

The system for assigning beyond-use dates (BUDs) to CSPs has also changed. Now, BUDs will be based on several factors related to achieving and maintaining sterility. Category 1 CSPs are only allowed a BUD of 12 hours at controlled room temperature or 24 hour if refrigerated. Category 2 CSPs are allowed a longer BUD, especially those terminally sterilized, prepared with only sterile components, tested for sterility, or refrigerated or frozen when stored.

Investigations and Certifications

Now there is a greater emphasis on conducting investigations and implementing corrective actions, expanding beyond investigations only in the event of a sterility test failure or the recovery of colony-forming units during environmental monitoring. The updated chapter outlines a number of scenarios that require investigations and corrective actions, such as:

  • Media fill failure
  • Personnel qualification failure
  • Facility certification failure
  • Out-of-specification results on laboratory tests
  • Quality control check failures
  • Complaints that indicate a quality control issue with CSPs
  • Adverse events

The update places a greater emphasis on routine calibrations, certifications, and qualifications of equipment and classified areas. Any testing performed as part of facility certification must be conducted under dynamic operating conditions.

Implementing Changes to USP 797

Carrying out the updates to USP 797 in a facility requires a plan specific to the application. Although ensuring compliance depends heavily on the facility itself, there are a few general guidelines to take into consideration. Each facility must have at least one designated person responsible and accountable for operations and the preparation of CSPs. If there is more than one designated person, responsibilities must be allocated between them.

Particle counting is equally important for maintaining compliance. Both viable and non-viable particle counters need to be running in a space. Setra's particle counters are non-viable samplers and can provide instant results on particle counts.

Click here for more information on complying with USP 797.

Continuous airborn particle counting - email header - AQM7000

Topics: Compound, Critical Environments, Particle Counting