As of November 1, full compliance to the revised USP 797 is expected. Below is a quick guide to the changes, and LAB 797 is here to help you and your pharmacy navigate.
Media Fill and Personnel Testing: Personnel compounding Category 1 and 2 CSPs must test initially and every 6 months. Personnel compounding Category 3 CSPs must test initially and every 3 months.
Dual Incubation: Dual incubation, or the use of general-use media in both low and high incubation temperatures, is now an acceptable method for recovering both bacterial and fungal contaminants. This is a great, cost-effective option for pharmacies! Dual Incubation is also required for personnel samples.
ISO Class Action Limits: Air Sampling limits remain the same as previously. Surface Sampling limits have changed. See https://www.lab797.com/faqs for details on the current action limits.
Increased Surface Sampling: Monthly surface sampling throughout all ISO-classified areas is now recommended for most pharmacies. This can be done internally
No Pathogenic Species: Pathogenic species, such as molds, yeasts, and Gram-negative rods, are no longer action items.
Certification: Done externally every 6 months.
Reminders
USP 800 is enforceable as of November 1, 2023
USP 797 is enforceable November 1, 2023
Let LAB 797 help you navigate through these changes in USP 797. We can create custom environmental and personnel sampling solutions for your pharmacy to make compliance easy. Custom solutions include recurring shipping of surface/personnel plates, custom media-fill testing kits, and quick identification and results.