340B Compliance Audits

Covered entities are subject to audit by the manufacturer or the federal government. Failure to comply may make the 340B covered entity liable to manufacturers for refunds of discounts or in some cases cause the covered entity to be removed from the 340B Program. Visit the HRSA OPA website for additional information.

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FAQ ID: 1440

Last Modified: 09/19/2022

Q: Can you tell me about the HRSA 340B Program audits?

A: For information on the HRSA 340B Program audits, see the following policy release: https://www.hrsa.gov/sites/default/files/hrsa/opa/audit-clarification-02-08-13.pdf. Information about th...
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FAQ ID: 1474

Last Modified: 08/02/2022

Q: Can a manufacturer audit a covered entity?

A: Yes, section 340B (a)(5)(C) of the PHS Act allows manufacturers to audit a covered entity to ensure compliance with 340B drug diversion and duplicate discount prohibitions and requires entities to permit manufacturers to audit records related to compliance with these prohibitions. A manufacturer m...
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FAQ ID: 1418

Last Modified: 09/14/2020

Q: How can a 340B entity review internal compliance and prepare for a HRSA 340B program audit?

A: Tools and resources to help entities self-assess 340B compliance are available here: https://www.340bpvp.com/resource-center/340b-tools

FAQ ID: 1433

Last Modified: 09/14/2020

Q: I'm new to 340B and need to know some basic resources for how to learn about program compliance. Where should I start?

A: We recommend individuals attend a 340B University session. Registration information is available here: https://www.340bpvp.com/340b-education
The sessions are free to attend; the stakeholder would just need to get to the meet...
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FAQ ID: 1453

Last Modified: 09/14/2020

Q: What must a covered entity do if it finds 340B non-compliance (during an internal audit or through any other means)?

A: The covered entity must notify impacted manufacturers and attempt in good faith to resolve issues directly with manufacturers and wholesalers. Further, the covered entity must notify the HRSA Office of Pharmacy Affairs in writing of the compliance issue and include the following information: 340B ID...
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FAQ ID: 1429

Last Modified: 01/24/2020

Q: What is an acceptable way to calculate the amount owed to a drug manufacturer?

A: HRSA recommends the parties work together to resolve this matter in good faith.

FAQ ID: 1282

Last Modified: 11/01/2019

Q: How would a 340B covered entity lose its 340B eligibility?

A: A covered entity that loses eligibility to participate must notify the HRSA Office of Pharmacy Affairs and immediately stop purchasing 340B drugs in the following situations:

1) The entity lost the grant funding/designation under which it qualified for 340B Program participation;
2...
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FAQ ID: 1386

Last Modified: 11/01/2019

Q: I am currently undergoing a 340B Program audit and am concerned the questions asked by the auditor are outside the scope of the 340B Program. Where do I direct my concerns?

A: Please write to HRSA Office of Pharmacy Affairs with specific information regarding the audit concerns. This information should be mailed to: Health Resources and Services Administration, Office of Pharmacy Affairs, 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857 - or send email to HRSA OP...
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FAQ ID: 1504

Last Modified: 11/01/2019

Q: To what extent is a registered 340B covered entity (parent) is responsible for outpatient facilities (child) it has registered?

A: The covered entity is fully responsible for its registered outpatient facilities’ compliance with all 340B Program requirements. The covered entity is also responsible for all contract pharmacy arrangements listed on 340B OPAIS. Audits of 340B covered entities include a covered entity’s outpatient f...
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FAQ ID: 1539

Last Modified: 01/10/2019

Q: How does HRSA define the term "breach" that is used in the recertification statements? (Ref: "the covered entity acknowledges its responsibility to contact OPA as soon as reasonably possible if there is a change in 340B eligibility and/or breach by the covered entity of any of the foregoing...")

A: The term breach in this context refers to an instance of non-compliance with any of the 340B Program requirements. The covered entity upon recertification attests to contact OPA when there is a breach of 340B requirements. To increase program transparency among all stakeholders and ensure that cove...
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FAQ ID: 1411

Last Modified: 10/09/2014

Q: In an audit, is it sufficient to demonstrate compliance through documentation of the procedures for administration of specific drugs or will we be asked to show medical records?

A: 340B covered entities will be audited for all 340B Program requirements, including the maintenance of auditable records. Auditable records include specific documentation that all 340B Program requirements are met for every 340B drug.

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340B Compliance Audits

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