Navigating 340B Manufacturer Inquiries and Audits

Healthcare Policy Update
Article Background

What’s happening

Continued concerns among drug manufacturers about the size of the 340B program are driving a surge in 340B program audits and manufacturer good faith inquiries to 340B covered entities.

Of interest

Our partners at McDermott Will & Schulte (MWS), one of healthcare’s most trusted and respected healthcare law firms, are hosting a webinar for 340B covered entities on appropriately responding to and managing good faith inquiries and audit notices. The program will explore:

Why manufacturers are reaching out and what it means for your organization
Office of Pharmacy Affairs’ (OPA’s) views on good faith outreach
How good faith inquiries escalate into audits—and how to navigate both
Risks of mismanaging the process
340B program operational elements that may increase the risk of a manufacturer good faith inquiry or audit

Why you should care

Knowing how to respond to good faith inquiries and audit notices is essential to safeguard program integrity and continued participation—especially with the 340B rebate pilot model launching in 2026 and expanding manufacturer policies limiting purchasing of 340B drugs.

Looking to learn more?

Register here for the webinar and tune in on November 20, 2025, at 3pm ET to learn more.