Recertification

You must be the logged-in AO or PC for to recertify a covered entity.

The ClosedOffice of Pharmacy Affairs (OPA) The HRSA office responsible for administering the 340B program. is required to recertify all participating 340B covered entities annually to ensure that they are eligible to remain in the 340B Drug Pricing Program and that the application is accurate. ClosedRecertification 340B covered entities must annually recertify their eligibility to remain in the 340B Program and continue purchasing covered outpatient drugs at discounted 340B prices. As part of this process, the Authorizing Official of each 340B covered entity certifies basic information about the entity and its 340B compliance. Covered entities with inaccurate information in the 340B OPAIS run a high risk of being removed from the program. also gives OPA an opportunity to verify compliance with the program requirements and update the 340B application.

Both the AO and the ClosedPC External user who is designated as a Primary Contact for an entity. This user can enter registrations and update entity information. This user can enter registrations, and update entity information. Any changes to an entity performed by the PC user must be attested to by the AO for that entity. will receive an Advanced Notification email when OPA creates a recertification initiative that includes one or more of your active entities to tell you when the recertification period will begin. Recertification initiatives will not include terminated entities, entities pending termination, or newly registered entities that have not yet reached their participation start date.

For Hospitals, if the “Cost Reporting Period End Date” and/or the “Gov Contract End Date” will expire prior to the end of the recertification end date, there will be a message included in the Advance Notification email notifying the AO and PC of various actions that need to be taken.

For all Ryan White entity types, if the “Time period the Assistance was received” has expired or will expire by the recertification end date, a message to take action will be included in the Advance Notification email sent to the AO and PC.

For all Ryan White entity types, if the “Time period funding or in-kind support was received” has expired or will expire by the recertification end date, a message to take action will be included in the Advance Notification email sent to the AO and PC.

For all CH and FQHCLA entity types, if the entity is no longer “active” in EHBs, which is a requirement for 340B participation, a message to take action will be included in the Advance Notification email sent to the AO and PC.

On the first day of the recertification period, both the AO and the PC will receive an email notification containing the recertification start and end dates.

Recertification Activities