The 340B Drug Pricing Program’s annual recertification period has been set by HRSA and will run from August 10th through September 9th. Authorizing Officials and Primary Contact will begin receiving notice of pending recertifications. The emails will continue until the recertification is fully completed. If you continue to receive emails, it means the process has not yet been fully completed. Failure to recertify by the applicable deadline results in termination from the 340B Program, a consequence that can mean losing access to 340B pricing for several months and having to re-enroll during a future registration period.
Accordingly, covered entities should begin preparing now to ensure a smooth, timely submission.
What Is 340B Recertification?
340B recertification is the Health Resources and Services Administration’s (HRSA) Office of Pharmacy Affairs (OPA) annual process for confirming that covered entities continue to meet all 340B Program eligibility requirements and that their records in the 340B Office of Pharmacy Affairs Information System (340B OPAIS) are accurate and current.
During the recertification window, each covered entity’s Authorizing Official (“AO”) must log into 340B OPAIS and formally attest that: (1) the entity’s OPAIS record is complete, accurate, and correct; (2) the entity continues to meet applicable 340B Program eligibility requirements; (3) the entity will comply with Section 340B of the Public Health Service Act, including the prohibitions against duplicate discounts and drug diversion; and (4) the entity maintains auditable records of its 340B Program compliance.
Recertification is staggered by entity type. Non-hospital grantee entities — including federally qualified health centers, Ryan White clinics, and comprehensive hemophilia treatment centers — completed their 2026 recertification window earlier this year, from February 2 through March 2. Hospital-type covered entities recertify later in the year; HRSA has set the 2026 hospital recertification period for August 10 through September 9.
How to Prepare
We recommend reviewing the following before the recertification period begins:
- Confirm AO and Primary Contact (PC) access. AOs and PCs must each maintain their own individual 340B OPAIS user account. Confirm now that the right individuals can log in, rather than discovering an access issue mid-window.
- Verify contact information is current. HRSA sends recertification notifications, task assignments, and status updates only to the AO and PC on file, so outdated contact information can mean missed deadlines. These will be sent daily.
- Verify that all registered child sites remain eligible and that your 340B OPAIS records for each are accurate and up to date.
- Review your contract pharmacy registrations to confirm they remain accurate and reflect your current arrangements.
- Confirm your Medicaid billing information and Medicaid Exclusion File (MEF) status. Duplicate-discount and MEF inaccuracies are a recurring finding in HRSA audits. Hospitals that bill Medicaid fee-for-service for 340B drugs should confirm their billing numbers are properly reflected for each applicable state.
- Gather your most recently filed Medicare Cost Report, including any amended filing.
- Account for recent organizational changes — mergers, acquisitions, site closures, or leadership changes that may affect your OPAIS record.
- Plan to monitor OPAIS daily once the window opens. HRSA may return tasks to the AO for correction, and returned tasks typically expire after five calendar days if not addressed. AOs should be prepared to check for pending items throughout the period rather than only at the outset.
Why This Matters
Recertification is a condition of continued 340B Program participation, not a routine formality. A missed deadline results in outright termination, and reinstatement requires re-enrollment in a future registration cycle, a gap during which the entity has no access to 340B savings, which can disrupt the patient services and pharmacy operations those savings support.
How Advis Can Help
Our team will continue to provide guidance throughout the 2026 hospital recertification period. If you have questions about your organization’s 340B eligibility, OPAIS record, or recertification preparation — or would like assistance completing the process — please don’t hesitate to contact us.
Published August 5, 2026