HRSA Audit (340B)
Definition
An HRSA audit is the federal government’s primary mechanism for verifying 340B program compliance at covered entities. When selected for audit, a covered entity typically receives an audit notice letter and a data request list (DRL) asking for eligibility and registration documentation, policies and procedures, purchasing and dispensing records, contract pharmacy agreements, and evidence of diversion and duplicate discount prevention controls.
HRSA conducts audits through contracted audit firms. The audit process typically includes a document review phase, data analysis, and may include interviews with program staff. HRSA may issue findings that identify specific compliance deficiencies. Findings can require a Corrective Action Plan (CAP) and may result in repayment obligations if the entity received 340B pricing on drugs that were not dispensed to eligible patients or that were subject to duplicate discounts.
Audit selection is not entirely random—HRSA has indicated that risk-based factors may influence selection. Covered entities with complex contract pharmacy networks, high savings volumes, or prior findings may face elevated audit risk. The best defense against adverse audit outcomes is a proactive, well-documented compliance program built to HRSA’s standards.
Frequently Asked Questions
Why HRSA Audit (340B) Matters
HRSA audits can drive findings, repayment obligations, and reputational risk. The documentation gaps that produce adverse outcomes are often preventable. Covered entities that invest in audit readiness before an audit notice arrives are far better positioned to navigate the process successfully.
How Virtue 340B Uses It
Virtue 340B prepares covered entities for HRSA audits by conducting independent assessments that mirror HRSA's audit methodology, identifying documentation and control gaps before an official audit occurs, and helping entities build the evidence base needed to respond confidently.