FAQs

USP<797>/<800> Guidelines
Frequently Asked Questions

Find answers to some of the most common questions about the upcoming changes to the USP<797>/<800> compliance guidelines.
  • Why are the USP<797> and USP<800> guidelines important to sterile compounding pharmacies?
    After years of discussion, USP<797> and USP<800> represent a set of national standards for sterile compounding pharmacies under one quality assurance umbrella with the primary purpose of protecting patients and staff using the following mechanisms:

    • • Appropriate Cleanroom Design Standards
    • • Cleanroom Certification
    • • Pharmacy Environmental Testing
    • • Personnel Training and Competency Assessments
    • • Continuous Monitoring of pressures, temperatures, humidity in storage and compounding areas
    • • Implementation of Standard Operating Procedures for all aseptic processes including workflows, handling, storage, compounding, staff behaviors, maintenance, testing, cleaning
    • • Quality System that maintains a documented state of control over sterile and hazardous compounding
  • Who will enforce USP<797> and USP<800>?
    State Boards of Pharmacy and the Joint Commission will enforce the USP compliance guidelines.
  • When is the revised USP<797> and USP<800> go-live date, and how soon after will the guidelines be enforceable?
    The estimated go-live date is November 1st, 2023.
  • Does the new USP<797> require monthly environmental testing?
    Yes, current guidelines require routine/periodic testing. The new revision will require monthly environmental testing as stipulated in the Pharmacy SOPs for environmental sampling plan. That is why we strongly recommend that Pharmacies begin to plan for an ongoing environmental testing solution, whether that’s through USP<797>environmental testing kits or on-site environmental testing.
  • How many times per year is chemo wipe testing required in USP<800>?
    USP<800> HD wipe testing guidelines stipulate that chemo wipe sampling should take place 2 times per year.
  • How many times per year are media fill and gloved fingertip assessments required in the new USP<797>?
    A minimum of 2X for Category 1 and 2 compounding and every 3 months for Category 3 as part of a complete training and competency assessment program.
  • Will all CFUs found during environmental testing need to be identified under the new USP<797>?
    No, at minimum, microbial identification must be performed on samples that exceed the specification.
  • What is required to perform USP<797> environmental testing?
    In addition to Standard Operating Procedures for microbiological air and surface monitoring, sampling and analysis, consumables/plates, 2 incubators for each required incubation temperature, temperature monitoring system, air impaction sampler. Note: all equipment requires routine preventative maintenance and calibration. Working with a trusted USP compliance service provider like Quality Solutions can help ensure that you remain compliant while navigating the complexities of the upcoming changes to USP guidelines.
  • How can Quality Solutions help me maintain compliance when the new USP<797>/<800> guidelines go into effect?
    As a trusted provider of USP<797> Services with more than 20 years of experience, Quality Solutions can assist your pharmacy with USP<797>/<800> compliance in a comprehensive and cost-effective manner. We offer a wide range of USP<797>/<800> services, including:
    • • USP<797> Certification
    • • USP<797>Microbiological Air and Surface Monitoring
    • • USP<797> Testing Kits
    • • USP<800> HD wipe testing

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