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Virtue 340B Content Hub

Explore 340B Audit & Compliance Resources for Covered Entities

Educational resources and compliance guidance for healthcare professionals managing the 340B Drug Pricing Program. Five formats: a published book, a long-form blog, a video series, a professional newsletter, and a terminology glossary, produced under the direction of Virtue 340B’s credentialed experts.

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5

Resource formats

2

Credentialed experts

1

Independent advisory firm

The Five Resources

Five Formats, One Compliance Knowledge System

Each resource serves a specific stage of the 340B compliance learning journey, from foundational reference to ongoing analysis to real-time regulatory updates.

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Foundational

340B Mastery Book

Transforming Risk into Reward in Pharmacy Program Management

Authoritative guide to 340B program management by Edward Vargas, Founder and CEO of Virtue 340B. A complete strategic and operational framework covering risk identification, internal oversight design, audit preparation, and program leadership.

Learn More About the Book >

340B Audits Graphs and Results
Ongoing analysis

Blog

Topic-Specific Compliance Guidance from Credentialed Experts

In-depth articles on compliance challenges, audit requirements, and program management decisions that 340B professionals face most often. Topics include HRSA audit preparation, contract pharmacy compliance, data integrity, drug pricing, and ethical program management.

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In today’s 340B environment, how you communicate your program matters just as much as how you manage it. Organizations are increasingly expected to demonstrate not only compliance, but also the broader value their programs bring to patients and communities. In this episode, Katy Lees explores how to build and communicate a clear, credible 340B narrative across internal teams, lawmakers, and external stakeholders. She breaks down the importance of program stewardship, aligning internal voices, and translating social return on investment into language that resonates beyond pharmacy. This discussion is especially relevant for health system leaders, compliance professionals, and pharmacy teams working to strengthen oversight and organizational alignment. As Principal 340B Compliance Advisor at Virtue 340B, Katy brings a structured, practical perspective, helping organizations move from fragmented messaging to confident, consistent communication grounded in operational reality. Visit Virtue 340B’s episode landing page to watch this episode and explore additional viewing and listening options.
Ep 18 - Telling Your 340B Story: Defining and Communicating Value Clearly
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Expert video commentary

Katy’s 340B Compass

Conversational Guidance from a Principal 340B Compliance Advisor

Hosted by Katy Lees, Principal 340B Compliance Advisor at Virtue 340B. Each episode addresses a specific compliance question, regulatory development, or program management challenge in an accessible, expert-led format.

Watch the Latest Episode >

virtue-340b-blog
Real-time updates

Newsletter

Timely Regulatory Updates and Compliance Tools

Regulatory updates, compliance tools, and audit insights delivered directly to subscribers. Each edition covers timely changes in HRSA guidance, practical checklists drawn from real audit experience, and emerging compliance risks.

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Reference base

340B Glossary

Independent Definitions of 340B Program Terminology

Definitions of the terminology used throughout the 340B Drug Pricing Program: ceiling price calculations, duplicate discounts, diversion, contract pharmacy arrangements, HRSA audit procedures, and covered entity eligibility.

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How the Resources Connect

A Natural Progression for Building 340B Compliance Expertise

Organizations typically move through these resources as a learning journey: building foundational knowledge through the book and glossary, deepening expertise through the blog and vlog, and staying current through the newsletter.

01

Foundation

340B Mastery Book

Strategic framework for the entire program.

02

Reference base

340B Glossary

Shared terminology that runs through every other resource.

03

Ongoing analysis

Blog & Katy’s 340B Compass

Written articles and expert video commentary on specific compliance topics.

04

Stay current

Virtue 340B Newsletter

Bridges published content with real-time regulatory developments.

Resource Comparison

Choose the Right Resource for
Your Compliance Question

Each format serves a different stage of program management, from one-time strategic reading to recurring regulatory updates.

Resource Format Primary Purpose Typical Use Case Key Benefit
340B Mastery Book Published Book Foundational program management guide Program managers seeking a comprehensive reference on 340B compliance strategy and risk management Complete framework for understanding and managing 340B program requirements Learn More >
Blog Long-Form Articles Topic-specific compliance guidance Compliance officers researching specific challenges, audit preparation, or regulatory changes Expert written analysis on the compliance topics organizations encounter most often Learn More >
Katy’s 340B Compass Video Series Expert video commentary on 340B compliance Compliance teams seeking accessible, conversational guidance on complex 340B topics Biweekly video insights from a Principal 340B Compliance Advisor Learn More >
Newsletter Email Subscription Timely regulatory updates and compliance tools 340B professionals who need to stay current on program changes and HRSA guidance Actionable updates, checklists, and monitoring guidance delivered to subscribers Learn More >
Glossary Reference Resource Program staff who need clear definitions of 340B-specific terms and concepts 340B terminology definitions Reliable, independent reference for the shared language of 340B compliance Learn More >

Meet the Experts

Independent, Credentialed
Authorship Across Every Resource

Every Content Hub resource is produced by or under the direction of Virtue 340B’s credentialed experts, not aggregated from third-party sources.

Edward Vargas

Founder and CEO, Virtue 340B

Edward brings nearly a decade of experience across the full spectrum of the 340B program: at the hospital level, as an independent consultant and auditor, as a health system specialist, and in the vendor space as a third-party administrator (TPA). Author of 340B Mastery: Transforming Risk into Reward in Pharmacy Program Management.

  • Certified Internal Auditor (CIA)
  • Minority Business Enterprise (MBE), New York State
  • Author, 340B Mastery

Contributes to

340B Mastery Book
Blog

Katy Lees

Principal 340B Compliance Advisor, Virtue 340B

Katy serves as Principal 340B Compliance Advisor and is the host of Katy’s 340B Compass, the company’s biweekly video series. Her work focuses on helping covered entities navigate program complexity with clarity and build compliance programs that are both sustainable and audit-ready.

  • Principal 340B Compliance Advisor
  • Host, Katy’s 340B Compass
  • 340B ACE certified

Contributes to

Katy’s 340B Compass
Newsletter
Meet the full Virtue 340B team

Who Uses the Content Hub

Built for Every Type of Covered Entity

Different covered entities draw on different resources first. Here’s where each audience starts.

Health Systems and Large Hospitals

Health systems managing complex 340B programs across multiple sites and contract pharmacy relationships use the Content Hub to support compliance governance, audit readiness, and team development.

Most relevant resources

Blog
340B Mastery Book

Rural Hospitals

Rural hospitals often operate with smaller compliance teams and fewer internal resources. Accessible, expert-driven guidance helps staff build and maintain compliance knowledge regardless of organizational size.

Most relevant resources

Newsletter
Glossary

FQHCs and Grantees

Federally Qualified Health Centers and grantee organizations stay current on program requirements, understand manufacturer restrictions, and prepare for HRSA audits with timely updates and clear guidance.

Most relevant resources

Katy’s 340B Compass
Newsletter

Topics Covered Across the Content Hub

Compliance Questions Covered Entities Face Most Often

The Content Hub addresses the operational, regulatory, and governance topics that come up at every level of 340B program management.

Browse the Blog by topic
  • HRSA audit preparation and audit readiness
  • Internal audit checklists and corrective action planning
  • Contract pharmacy compliance and opportunity analysis
  • Duplicate discount prevention and diversion controls
  • 340B ceiling price calculation and drug pricing compliance
  • Data integrity, data management, and reporting
  • Third-party administrator (TPA) configuration and oversight
  • Manufacturer restrictions management at contract pharmacies
  • Referral capture policy and patient eligibility
  • Staff training and organizational awareness
  • Automation and technology in 340B program management
  • Ethical compliance and program integrity
  • Regulatory changes, HRSA guidance, and legislative developments

The 340B Program and Compliance Context

Why Independent Oversight Matters

The 340B Drug Pricing Program is administered by the Health Resources and Services Administration (HRSA) under Section 340B of the Public Health Service Act. Participating organizations must maintain compliance with HRSA’s program requirements, including restrictions on diversion and duplicate discounts, accurate patient eligibility determinations, and proper contract pharmacy oversight.

HRSA conducts audits to verify compliance, and findings can result in corrective action requirements or, in serious cases, removal from the program and repayment obligations to manufacturers. The Content Hub builds the knowledge foundation that supports Virtue 340B’s audit, consulting, and continuous monitoring services.

Explore Virtue 340B’s Services

Understanding the 340B Program Is the First Step. Protecting Your Compliance Is the Next.

Virtue 340B works with covered entities of all types and sizes nationwide, providing independent audits, consulting support, and continuous monitoring to help organizations manage their programs with confidence.

Service

Independent 340B Audits

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Service

340B Consulting Services

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Service

340B Continuous Monitoring

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