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340B Program Integrity: Self-Audits and Good-Faith Engagement

| 12:00–1:00 p.m. CT

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This virtual learning session highlights what manufacturers and covered entities need to efficiently navigate good-faith inquiries (GFIs). Join us to learn how strong self-audit practices and good-faith engagement strengthen 340B Program integrity. Both stakeholder types will gain expert compliance intel from the HRSA 340B Prime Vendor.

Objectives:

  • Review best practices for covered entities when conducting 340B self-audits.
  • Describe the self-disclosure and repayment processes from a covered entity perspective.
  • Explain the role of good-faith inquiries from both manufacturer and covered entity perspectives.
  • Discuss the 340B administrative dispute resolution (ADR) process, including questions and considerations.

Speakers:

Sara Dwivedi, PharmD, MS, 340B ACE

340B Compliance Associate Director

Apexus

Natalie Russell, PharmD, MSHA, MBA, BCPS, 340B ACE

340B Compliance Director

Apexus

Experienced 340B University faculty members will be available to answer your questions via a live Q&A during the event. Registrants will receive a link to access a copy of the slides; a recording will not be available.

Target Audience: All Stakeholders

Participant Knowledge Level: Intermediate

Event Date: Thursday, August 20, 2026 | 12:00–1:00 p.m. CT

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340B Prime Vendor Program (PVP) Tools

Sample HRSA 340B Audit Date Request List (DRL) for Covered Entities

This tool provides an example data request list (DRL) for a HRSA 340B audit. This is only a sample and may differ from an actual HRSA data request.