Compliance Review Basics

HRSA requires that entities enrolled in the 340B program have documented records and that entities with  contract pharmacies receive an annual audit by an independent agency. The purpose of the annual audit is to ensure that the entity is compliant with all points of 340B eligibility including:

  • Eligibility requirements;
  • All registration information for entity sites and pharmacies is current;
  • Document that no diversion or duplicate discounts have occurred;
  • Create and maintain Policies & Procedures which match the entity information and operations, and;
  • The entity will self report any instance of non-compliance.

The purpose of an external audit is to accurately identify any possible discrepancies or inconsistencies and offer solutions to ensure the highest 340B program standards.

Ensuring compliance protects the integrity of the 340B program in general and its benefit to the safety net community.