340B Internal Audits

Streamline your 340B program with our expert internal audit services to ensure HRSA compliance and program performance.

What are internal audits?

Internal audits are self-conducted reviews performed by a covered entity at regular intervals to ensure the ongoing compliance and integrity of its 340B Drug Pricing Program. These audits are an essential component of maintaining program oversight and demonstrating a proactive commitment to meeting Health Resources and Services Administration (HRSA) requirements.

Audit Process

Step-by-step audits to identify compliance gaps and enhance program effectiveness.

Audit Program Design

Ongoing support to develop and maintain a robust internal 340B program aligned with HRSA standards.

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340B Internal Audits FAQ

How often should audits occur?

What is the benefit of internal audits?

Who conducts the audits?

What is the purpose of internal audits?

Regular internal audits provide multiple advantages:

Compliance Assurance – Identify and fix errors before they become regulatory violations.
Risk Mitigation – Reduce exposure during external audits by maintaining up-to-date documentation.
Program Optimization – Uncover opportunities to improve purchasing strategies and maximize savings.
Evidence of Oversight – Demonstrate to HRSA that the entity actively monitors its 340B program.

The primary goal of an internal audits is to confirm the covered entity's 340B program operations are compliant with federal regulations, HRSA guidance, and the covered entity’s own policies and procedures.

Internal audits should be performed at the frequency stated in the covered entity’s policies.

Audits can be conducted by internal staff or external consultants with 340B expertise.