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Staying Compliant: Understanding the New USP 797 Changes

The latest revisions to USP 797 were published on June 1, 2019. These revisions are the result of evidence and new science based on best practices, updated guidance documents, and enhanced understanding. LicenseTrak compliance software is the key to helping you obtain the compliance you need with the latest changes to USP 797.

The most immediately and significantly impacted entities from these changes are small to medium-sized organizations. Smaller pharmacies that provided compounding services for both hazardous and nonhazardous drugs and have not been using negative pressure environments are compelled now to adjust to the changes as quickly as possible. The revisions to USP 797 impact larger organizations by challenging them with necessary adjustments involving modified storage requirements, handling measures, and operational changes.

Dates for Classification and Beyond-Use

The categories of low, medium, and high microbial risk involving compounded sterile preparation (CSP) have been changed to Category 1 CSPs and Category 2 CSPs. The CSPs for Category 1 now have a shorter beyond-use date – they may be prepared in a segregated, unclassified compounding area. The CSPs for Category 2 now have a longer beyond-use date – they must be prepared in a cleanroom set-up that includes an ante room and buffer room.

The changes to USP 797 include a modification to the system for assigning beyond-use dates to CSPs. These dates are now based on a number of factors related to obtaining and maintaining sterility.

Certifications and Investigations

With the updates to USP 797, there is now a greater focus on performing investigations in instituting corrective steps. The updates cover various scenarios in which investigations and corrective actions are required. These include:

  • Complaints that point to a quality control issue involving CSPs
  • Facility certification failure
  • Media fill failure
  • Adverse events
  • Failures in quality control checks
  • Personnel qualification failure
  • Out of specification results for laboratory tests

The USP 797 update puts more emphasis on certifications, calibrations, and qualifications of classified areas and equipment. All tests conducted related to the certification of a facility must be performed under a dynamic operating environment.

For information about our LicenseTrak software and how it can help you maintain compliance with the USP 797 standard, call us today at (480) 500-6236 or fill out our contact form and schedule a demo.