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:
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.