Sterile compounding carries significant patient safety implications. State boards and USP have responded with increasingly rigorous training and competency requirements.
USP 797 competency requirements
The revised USP 797 (effective November 2023) establishes specific competency requirements: initial and annual aseptic technique assessments, gloved fingertip sampling (GFS), media fill testing (MFT), and documented training records.
Gloved fingertip sampling
GFS is required before personnel begin compounding and at least annually thereafter. Personnel must demonstrate they can don sterile gloves without contaminating them. Three consecutive passing results required initially.
Media fill testing
MFT evaluates aseptic technique using sterile growth medium instead of active drug. Frequency depends on the category of sterile preparation. Failures must be investigated and remediated before resuming sterile compounding.
State-specific requirements
Illinois publishes specific sterile compounding self-inspection forms. Pennsylvania’s 2025 compounding regulations added documentation requirements. California and Texas conduct frequent pharmacy inspections with sterile compounding-specific checklists.
Outsourced USP 797 training
Several accredited programs offer USP 797 competency training and documentation. Verify that any training program meets your state’s specific requirements, not just USP minimums.