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340B Compliance Cornerstones

Join us for a webinar designed to help covered entities understand and apply the core compliance requirements of the 340B Drug Pricing Program. Participants will learn how to put these core principles into practice through everyday scenarios, use available tools, better identify potential compliance risks, and know how to effectively respond to risks.

Objectives:

  1. Identify the fundamental compliance requirements of the 340B Drug Pricing Program, including manufacturer responsibilities, preventing diversion and duplicate discounts, Group Purchasing Organization (GPO) Prohibition, and orphan drug exclusion.
  2. Apply these principles to real-world scenarios, enhancing your ability to identify and address compliance concerns.
  3. Review the 340B Prime Vendor Program (PVP) tools and resources available to help you maintain a compliant 340B program, ensuring ongoing adherence to program requirements.

Why Attend?

Participants will learn key requirements, common pitfalls, and best practices for maintaining 340B program integrity. Attendees will apply practical tools to strengthen oversight and audit readiness.

Key Benefits Include:

  • Recognizing and managing potential compliance issues in day-to-day operations
  • Gaining familiarity with PVP tools and resources to streamline processes and support compliance
  • Receiving live answers to specific 340B compliance questions from experienced 340B University faculty
  • Accessing presentation slides for future reference and team learning

Participant Knowledge Level: Basic/Intermediate

Target Audience: All 340B Stakeholders

Event Date: Wednesday, August 13, 12:00–1:00 p.m. CT

The webinar will not be recorded.

Presenters:

Xan Janiga, PharmD, BCPS, 340B ACE
Director, 340B Compliance
Apexus

Natalie Russell, PharmD, MBA, MSHA, BCPS, 340B ACE
Director, 340B Compliance
Apexus

340B Prime Vendor Program (PVP) Tools

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

Use this sample data request list (DRL) to prepare for a HRSA 340B audit.

Self-Audit: Prevention of Diversion (CHC/FQHC) >

Outlines a sample self-audit method for CHCs/FQHCs to ensure that diversion safeguards are in place under 340B.

Self-Audit: Prevention of Duplicate Discounts (DSH/PED/CAN) >

Highlights a sample self-audit approach to assist hospitals in monitoring compliance with 340B duplicate discount requirements under the GPO Prohibition.

Self-Audit: Prevention of Duplicate Discounts (CAH/RRC/SCH) >

Illustrates how rural hospitals can structure internal reviews to address duplicate discount risks.

Self-Audit: Prevention of Diversion and GPO Violation (DSH/PED/CAN) >

Provides a sample self-audit framework to help hospitals address diversion risks and maintain compliance with the GPO Prohibition under 340B.

Self-Audit: Prevention Duplicate Discounts (CHC/FQHC) >

Guides CHCs/FQHCs through a sample review to ensure that safeguards against duplicate discounts are in place.

Self-Disclosure to HRSA and Manufacturer Template >

Inform HRSA and manufacturer of 340B noncompliance and provide corrective action plan.