Independent 340B Audit
Definition
An independent 340B audit is a proactive compliance assessment performed by a qualified third-party expert—not HRSA—to evaluate how well a covered entity’s 340B program is operating. Unlike an HRSA audit, an independent audit is initiated by the covered entity and is designed to identify problems and opportunities before they become official findings.
A well-structured independent audit examines the same areas HRSA would review: patient eligibility policies and data controls, diversion and duplicate discount prevention, contract pharmacy compliance, OPAIS accuracy, split-billing software configurations, vendor management, and documentation quality. The output is typically a findings report with prioritized recommendations.
Independent audits serve multiple purposes: they identify compliance gaps that can be remediated before an HRSA audit, they provide leadership with an objective view of program health, they support internal accountability, and they demonstrate a good-faith commitment to program integrity. For covered entities with complex programs or prior HRSA findings, independent audits are an essential risk management tool.
Frequently Asked Questions
Why Independent 340B Audit Matters
An independent audit gives covered entities the opportunity to find and fix problems on their own terms—before HRSA does. The cost of remediation is almost always lower than the cost of repayment and reputational damage from an adverse HRSA finding.
How Virtue 340B Uses It
Independent 340B Audit is Virtue 340B's core service. We conduct structured, HRSA-methodology-aligned assessments of covered entity programs, produce clear findings reports, and support remediation so clients can address gaps with confidence.