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What does the new USP Standards mean for my lab?

What does the new USP Standards mean for my lab?

The most recent revisions to USP 797 came into effect in November 2023, and they focus on strengthening several key areas to ensure the safety and quality of compounded sterile preparations (CSPs). Here's a breakdown of what your facility needs to consider under the new 797 standard:

  1. Enhanced Training and Competency Evaluations: The emphasis is now on stricter training and more frequent competency evaluations for personnel involved in sterile compounding. This includes those overseeing the compounding process.  The guidelines outline the required frequency for evaluations based on personnel categories.
  2. Increased Environmental Monitoring:  The new standard requires viable air sampling in more locations within your cleanroom. Additionally, incubating fungal samples now necessitates an incubator capable of cooler temperatures,  as the revised incubation range falls below typical lab ambient temperatures.

Remember, USP 797 applies to all facilities that prepare, store, or transport CSPs. For a comprehensive understanding of the requirements and how they impact your specific operation, it's recommended to consult the full text of USP Chapter . You can find it in the United States Pharmacopeia (USP) National Formulary.

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