1b Recertattestation Revised

The undersigned represents and confirms that he/she is fully authorized to legally bind the covered entity and
certifies that the contents of any statement made or reflected in this document are truthful and accurate. Failure
to recertify may be grounds for removal from the 340B Program.
The undersigned further acknowledges the 340B covered entity’s responsibility to abide by the following:

As an Authorized Official, I certify on behalf of the covered entity that:
(1) all information listed on the 340B Program database for the covered entity is complete, accurate, and
correct;
(2) the covered entity meets all 340B Program eligibility requirements, including section 340B(a)(4)(L)(iii) if
applicable – the Group Purchasing Organization prohibition - which ensures that the covered entity hospital
does not obtain covered outpatient drugs through a group purchasing organization or other group purchasing
arrangement;
(3) the covered entity is complying with all requirements and restrictions of Section 340B of the Public Health
Service Act and any accompanying regulations or guidelines including, but not limited to, the prohibition against
duplicate discounts/rebates under Medicaid, and the prohibition against transferring drugs purchased under
340B to anyone other than a patient of the entity;
(4) the covered entity maintains auditable records demonstrating compliance with the requirements described in
paragraph (3) above;
(5) the covered entity has systems/mechanisms in place to ensure ongoing compliance with the requirements
described in (3) above;
(6) if the covered entity uses contract pharmacy services, that the contract pharmacy arrangement is being
performed in accordance with OPA requirements and guidelines including, but not limited to, that the covered
entity obtains sufficient information from the contractor to ensure compliance with applicable policy and legal
requirements, and the hospital has utilized an appropriate methodology to ensure compliance (e.g., through an
independent audit or other mechanism);
(7) the covered entity acknowledges its responsibility to contact OPA as soon as reasonably possible if there is
any material change in 340B eligibility and/or material breach by the covered entity of any of the foregoing; and
(8) the covered entity acknowledges that if there is a breach of the requirements described in paragraph (3) that
the covered entity may be liable to the manufacturer of the covered outpatient drug that is the subject of the
violation, and, depending upon the circumstances, may be subject to the payment of interest and/or removal
from the list of eligible 340B entities.

Signature of Authorizing Official:

Date:

__________________________________________________________________________________