A 340B audit is a review of a covered entity’s 340B program to verify compliance with HRSA requirements, including patient eligibility, duplicate discount prevention, diversion controls, and contract pharmacy oversight. HRSA conducts roughly 200 audits a year, and manufacturers may also audit entities with HRSA approval. Most finalized audits surface at least one adverse finding, most commonly duplicate discounts, diversion, or reporting errors.

340B health systems have been under increasing scrutiny and regulatory oversight in recent years. The Health Resources and Services Administration (HRSA) has indicated that it plans to increase the number and complexity of 340B program audits it conducts. Here’s how your health system can prepare every aspect of your 340B program for compliance reviews.

Continue reading on VytlOne: The definitive 340B compliance checklist for 2026