The revisions took effect in November 2023
To help ensure you’ve got everything covered, we’ve created this guide to be your go-to resource for all USP Chapter <797> changes related to environmental monitoring. We cover a wide range of topics including:
- USP <797> BUD: Categories of Compounded Sterile Preparations (CSPs)
- Cleanroom Classifications
- Garbing & Gloved Fingertip Sampling
- Viable Air Sampling & Viable Surface Sampling Requirements
- Choosing a Lab Partner
- Media-Fill Testing
- Documentation & Training
- Checklist for Creating an Environmental Monitoring Plan
- Ordering Supplies & Proper Shipping and Handling of Samples
- Do’s and Don’ts – and more!



