22 Sep Registering, Recertifying and Keeping Your 340B OPAIS Records Straight
If you came here for the login, it is at the 340B OPAIS site and this post will not help you find it faster. What follows is for the person who has to keep the record behind that login accurate, because that record is read by manufacturers, by HRSA, and eventually by an auditor.
What OPAIS Is and What It Controls
340B OPAIS is HRSA’s Office of Pharmacy Affairs Information System, the public database of participating covered entities, their outpatient facilities and their contract pharmacy arrangements. Manufacturers check it to confirm who is entitled to 340B pricing. Registration and annual recertification both run through it, and HRSA’s audits include verification of the accuracy of the covered entity’s OPAIS record. It is the system of record, not a directory.
Registering a Covered Entity
Registration is not open all year. HRSA’s registration page sets four quarterly windows, each running from the first to the fifteenth of the month.
| Register during | Participation starts |
|---|---|
| January 1 to 15 | April 1 |
| April 1 to 15 | July 1 |
| July 1 to 15 | October 1 |
| October 1 to 15 | January 1 |
If the fifteenth falls on a weekend or federal holiday the deadline moves to the next business day, and registrations cannot be submitted outside these windows unless the Secretary of Health and Human Services declares a public health emergency.
Several procedural rules catch first-time registrants. The registration has to be completed in one session, and an unfinished one closes and has to be started over. Supporting files must be uploaded the same day the registration is submitted, and HRSA may reject a registration whose documentation is missing. The Authorizing Official must be someone who can bind the organization, such as a chief executive, chief operating or chief financial officer, clinic administrator or program manager, and the Primary Contact must be an employee of the organization rather than a consultant or contractor, and cannot be the same person as the Authorizing Official. If HRSA returns a registration for action, the entity has five days to respond before it is automatically returned and rejected.
One more, because it is a common misconception. A covered entity cannot register a contract pharmacy as a covered entity.
Adding and Maintaining Child Sites
What listing a child site actually asserts
An outpatient facility is added through the same quarterly windows, and adding it is an assertion that the site meets the eligibility conditions for your entity type. For hospital types that runs through the cost report; for grantees it runs through scope. The listing is a claim about a real operational and financial relationship, and HRSA verifies outpatient clinic eligibility as part of an audit.
The records HRSA expects behind a listing
The supporting record has to make the same statement as the listing. For hospitals that means the cost report line and the relationship it evidences. For grantees it means the scope documentation. And for everyone it means a change-control habit, because the failure mode is almost never a bad registration. It is a good registration that stopped being true when a service line moved, a clinic closed, or an address changed, and nobody went back to OPAIS.
The federal court decision on HRSA’s child site registration policy is a live area, and our note on that ruling records where it landed. It does not change the practical point that the listing and the underlying records have to agree.
The Annual Recertification Window
Recertification is annual and it is not optional. HRSA’s recertification page states that covered entities must annually recertify their eligibility to stay in the program and to continue purchasing at 340B prices, and that an entity that fails to recertify during the scheduled time frame will be terminated from the 340B Program.
The mechanics are worth knowing before the window opens. HRSA emails the Primary Contact and the Authorizing Official. Once the period begins, the Authorizing Official’s account access is limited to recertification tasks. Both roles must log in to update information for accuracy, and the Authorizing Official must verify the entity’s compliance with all 340B Program requirements and submit.
Two things follow. First, that verification is a compliance attestation by a named officer, not an administrative confirmation, and it deserves the same internal preparation as any other officer certification. Second, HRSA’s notifications go to the contact details in OPAIS, so an entity whose Primary Contact left the organization can miss the window without ever seeing a warning. Termination for a missed recertification is an avoidable, administrative way to lose a program. Entities that want the record and the calendar owned properly rather than remembered use our implementation support for exactly that.
Preparing for the window rather than reacting to it
The preparation that makes recertification straightforward happens before the notification arrives. Confirm the Authorizing Official and Primary Contact details in OPAIS are current, and confirm both are people still in post who know they hold the role. Reconcile the listed outpatient facilities and contract pharmacy arrangements against operational reality, so the accuracy step is a confirmation rather than a discovery. And assemble whatever the Authorizing Official will want to see before attesting to compliance, because an officer asked to certify with no supporting material will either sign without basis or delay.
Roles, and why succession is the real risk
Two role rules are worth restating because they constrain who you can name. The Authorizing Official must be someone able to bind the organization, and the Primary Contact must be an employee rather than a consultant or contractor, cannot be the same person as the Authorizing Official, and is the address HRSA’s notifications reach.
Put those together and the exposure is obvious. The two people who can act on your registration and your recertification are two named individuals, and nothing in the system notices when one of them leaves. Reviewing both names on a fixed date each year, independently of the recertification window, costs nothing and removes the single most avoidable way to lose a 340B program.
Contract Pharmacy Records in OPAIS
Contract pharmacy arrangements are registered in OPAIS, and the registered arrangement is what manufacturers and auditors treat as authoritative. The recurring gap is between the arrangements you have and the arrangements you have registered. HRSA reviews compliance at contract pharmacies, so an unregistered arrangement is not a paperwork omission, and a registered arrangement that has ended is a misstatement in the other direction. Our contract pharmacy overview covers the arrangement itself.
Where OPAIS Records and Audit Findings Meet
This is the connection worth carrying away, and it is the reason we treat OPAIS accuracy as compliance work rather than administration. HRSA lists the accuracy of the covered entity’s 340B OPAIS record inside what an auditor verifies. So the register is not a form you filed once. It is standing evidence, refreshed by you, read by everyone, and checked against reality by someone eventually. Our audit requirements post earlier this month maps that verification to the documents that satisfy it.
Across the 148 HRSA audits we have supported, OPAIS discrepancies are among the most preventable findings we see, because unlike patient definition questions they involve no judgment at all. The record is right or it is not.
Getting the Record Straight Before It Is Read
If nobody owns the OPAIS record by name, that is the finding in advance.
Our implementation support covers registration and record design for entities entering the program or restructuring.
Our HRSA audit support is for entities whose record is about to be examined, which is a narrower and more urgent job.
If the basics above are unfamiliar, start with what the 340B program is.
Procedures in this post were verified against HRSA’s published pages on 2026-08-24. OPAIS procedures change, so confirm current requirements with HRSA before acting.
FAQ
What is Opais 340B?
340B OPAIS is HRSA’s Office of Pharmacy Affairs Information System. It is the database of participating covered entities, their outpatient facilities and their contract pharmacy arrangements, and it is where registration and annual recertification are carried out.
What does opais mean?
OPAIS stands for Office of Pharmacy Affairs Information System. The Office of Pharmacy Affairs is the part of HRSA that administers the 340B Drug Pricing Program.