Auditable Records (340B)
Definition
Auditable records are the foundation of 340B compliance. The 340B statute requires covered entities to maintain records that allow HRSA to audit compliance with program requirements. These records must be organized, accessible, and retained for a minimum of three years.
Auditable records include drug purchasing records (showing 340B purchases by NDC, quantity, and date), dispensing records (showing which patients received which drugs), patient eligibility documentation, contract pharmacy transaction data, Medicaid billing records, split-billing software reports, and OPAIS registration history.
The concept of auditability goes beyond simply having records—it means the records are organized in a way that allows an auditor to trace a transaction from purchase through dispensing to patient eligibility verification. Records that exist but cannot be quickly located, correlated, or explained are not effectively auditable.
Frequently Asked Questions
Why Auditable Records (340B) Matters
HRSA auditors expect to be able to trace 340B transactions from purchase to dispensing to patient eligibility. Covered entities that cannot produce organized, traceable records face findings based on documentation failures alone, even if their underlying operations are compliant.
How Virtue 340B Uses It
Virtue 340B evaluates the auditability of covered entity records as part of every audit engagement, assessing whether records are organized, complete, and traceable in the way HRSA expects. We help entities build record-keeping systems that can withstand scrutiny.