340B covered entities are required to annually recertify their eligibility to participate in the 340B Drug Pricing Program and continue purchasing covered outpatient drugs at discounted 340B prices.
Prior to the recertification deadline for each covered entity type, the 340B Program sends advanced email notifications with preliminary information about the recertification process to the following contacts:
It is the covered entity’s responsibility to ensure that the contacts listed in the 340B database are accurate at all times to receive all notifications. The Authorizing Official will be required to log into the 340B database, update information as needed, and attest to the covered entity’s compliance with 340B Program requirements.
Database Guide to Recertification (PDF - 1.6 MB)
340B Drug Pricing Program covered entities must ensure program integrity and maintain accurate records documenting compliance with all 340B Program requirements.
Covered entities are subject to audit by manufacturers or the federal government. Failure to comply may make the 340B covered entity liable to manufacturers for refunds of discounts obtained.
Learn more: Program Integrity