340B Recertification

Active 340B covered entities must recertify their eligibility annually to remain in the 340B Program. Visit the HRSA OPA website for information on registration and recertification. Recertification is performed via the HRSA 340B Office of Pharmacy Affairs Information System (340B OPAIS) during quarterly open registration windows.

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FAQ ID: 4292

Last Modified: 03/25/2020

Q: How should a covered entity prepare for recertification?

A: The Authorizing Official (AO) and Primary Contact (PC) should review the covered entity’s 340B OPAIS record to ensure the record is accurate and correct. Any inaccurate information should be corrected in advance of recertification by submitting an on-line change request.

FAQ ID: 1634

Last Modified: 01/24/2020

Q: Once a covered entity submits a change request form, must the covered entity do anything else to recertify?

A: Yes. A change request form only updates the covered entity's 340B OPAIS information. Recertification requires the covered entity's Authorizing Official to:
(1) update 340B OPAIS information if necessary and;
(2) certify compliance with 340B Program requirements.

HRSA strongly r...
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FAQ ID: 1463

Last Modified: 12/23/2019

Q: How is the HRSA Electronic Handbook system used in the 340B recertification process?

A: Section 330 health center grantee and FQHC look-alike site names and addresses will be updated in the recertification process to match those on file in HRSA’s Electronic Handbooks (EHB) system. Authorizing officials will be able to review any changes before they are effective; any major discrepancie...
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FAQ ID: 1394

Last Modified: 11/01/2019

Q: Must a covered entity complete a change request form for recertification if 340B OPAIS is correct?

A: No change request form will be required if all information in 340B OPAIS is accurate.

FAQ ID: 1468

Last Modified: 11/01/2019

Q: Why are the changes not listed on 340B OPAIS after the Authorizing Official has certified and updated the 340B OPAIS record?

A: The Health Resources and Services Administration (HRSA) reviews all information provided during recertification for completeness and compliance with 340B program requirements. Changes submitted during recertification will be reflected in 340B OPAIS once approved by HRSA. HRSA reserves the right to a...
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FAQ ID: 1693

Last Modified: 11/27/2017

Q: We received recertification materials from HRSA, but no longer plan to participate in the 340B Program. How should a covered entity notify HRSA it does not want its recertification to be processed?

A: If the recertification period has not yet begun, the PC/AO can prepare an online termination request to terminate the entity from the 340B Program. If the recertification period has begun, the PC/AO can request the entity's decertification from the 340B Program during the recertification process.

FAQ ID: 1434

Last Modified: 08/14/2014

Q: Our entity is not prepared to recertify. What can we expect regarding 340B Program eligibility/termination?

A: Failure to recertify will result in termination from the 340B Program effective on the first day of the next quarter.

340B Recertification

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