How can you prepare your team for a 340B HRSA audit? 

Published: January 2026

If you participate in the 340B program, HRSA audits are not a matter of “if,” they’re a matter of “when.” Whether it’s your first audit or your tenth, it’s normal to have questions:  

• What should you expect?  
• What will auditors look for?  
• How should you prepare?  

Each phase of the audit brings its own challenges and expectations. We break down what to expect in each phase, share timelines, and highlight common risk areas to help covered entities anticipate what’s ahead and prepare effectively. 

Understanding how HRSA evaluates compliance is essential for maintaining program integrity and avoiding surprises. Continuous readiness isn’t just a best practice—it’s a necessity, because audits can occur at any time. 

Fill out the form below to get the 340B HRSA Audit Timeline Breakdown: