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Once a covered entity submits an online change request, must the covered entity do anything else to recertify?

Once a covered entity submits an online change request, must the covered entity do anything else to recertify?

Yes. Covered entities should not confuse change requests and recertification. Covered entity’s required to notify the 340B Program as soon as possible after the entity’s information changes to keep the record up-to-date. Recertification is required annually to meet the statutory requirement of keeping the entity’s record up to date and certifying compliance with the 340B Program requirements.

HRSA strongly recommends that the covered entity review and update its 340B OPAIS records using the change request process prior to recertification. 

The Authorizing Official is responsible for ensuring 340B Program compliance for the covered entity. Recertification covers the parent-covered entity and all registered child sites in the 340B Program database.

Annual Recertification
Date Last Reviewed: