Independent 340B compliance audits
Annual external HRSA-aligned audits of your 340B records, transactions, and controls, with findings your team can use.
What it is
External audits help covered entities examine program risks and prepare for oversight. The review period, activities, sample, and reporting are agreed around your organization.
Who it is for
Covered entities seeking an independent assessment, preparing for an audit, or following up on identified concerns.
What we do
Services may include the following, depending on your program and agreed scope.
1Eligibility and registration
- Covered-entity and site documentation
- OPAIS records and pharmacy arrangements
- Patient and prescriber eligibility controls
2Claims and purchasing
- Transaction sampling and traceability
- Diversion and duplicate-discount controls
- Purchasing, inventory, and split-billing reconciliation
3Policies and operations
- Policies and procedures
- Staff responsibilities and oversight
- Contract pharmacy and TPA processes
4Findings and follow-up
- Documented findings and evidence gaps
- Prioritized corrective-action recommendations
- Follow-up review and reporting options
A review built around your program
Site count, pharmacy relationships, transaction volume, available records, and the purpose of the review shape the engagement. Timing, sampling, deliverables, and fees are agreed privately.
Common questions
What does an independent 340B audit review?
The review may address eligibility, OPAIS records, purchasing, patient and prescriber controls, contract pharmacies, duplicate discounts, and program oversight. The agreed scope identifies the activities and records to be assessed.
How long does an audit take and how are fees set?
Timing and fees depend on program complexity, record availability, and the work requested. We confirm these in the engagement proposal.
Is this a HRSA audit?
This is a separate review commissioned by your organization. It does not replace an agency audit or guarantee its outcome.
Discuss the support your program needs
Tell us about your entity, priorities, and timing. We will discuss an appropriate scope.