A strong 340B program depends on consistent compliance, clear internal controls, and ongoing oversight. HRSA audits covered entities to assess compliance with eligibility requirements, the prohibition on duplicate discounts, the GPO prohibition when applicable, and the prevention of diversion.

Only one audit of a covered entity is allowed at a time under HRSA guidelines. However, any audit can uncover compliance gaps that may result in corrective action, repayment to drug manufacturers, or, in serious circumstances, removal from the 340B Program. Building a dedicated 340B compliance team helps your organization remain audit-ready while protecting the savings that support patient care and your broader organizational mission.

Why a 340B Compliance Team Matters

HRSA conducts official 340B Program audits using contracted auditors. Audits may be performed onsite or remotely and include reviews of policies and procedures, internal controls, eligibility, program data, and selected 340B drug transactions.

Following an audit, HRSA reviews the auditor’s preliminary report and issues a Final Report. When corrective action is required, a covered entity that agrees with the findings must submit a corrective action plan, or CAP, within 60 calendar days for HRSA approval. Covered entities that disagree with findings generally have 30 calendar days from the Final Report to submit written disagreement and supporting documentation.

Unless otherwise approved by HRSA, full implementation of an approved CAP and applicable settlement with manufacturers is generally expected within six months of CAP approval.

A well-structured compliance team helps ensure that your organization has the documentation, processes, monitoring, and leadership oversight necessary to respond effectively throughout the audit process.

Key Components of a 340B Compliance Team

An effective 340B compliance structure combines written policies, operational procedures, internal controls, data oversight, and clearly assigned responsibilities.

Your compliance team should include individuals who understand 340B requirements as well as the day-to-day operations that affect program eligibility and compliance.

Common roles may include:

• 340B Coordinator or Compliance Lead – Oversees the overall compliance program, policies, monitoring activities, audit preparation, and corrective actions.

• Pharmacy Leadership – Provides oversight of dispensing operations, purchasing, inventory, accumulator activity, and pharmacy-related compliance controls.

• Pharmacy Staff – Helps ensure that operational processes are consistently followed and supporting documentation is maintained.

• Data and Analytics Support – Reviews claims, eligibility logic, duplicate discount risks, accumulator activity, and other data used to support compliance.

• Finance Representatives – Assists with purchasing reconciliation, financial controls, repayment calculations, and program oversight.

• Clinical or Health Information Representatives – Helps validate patient eligibility, provider relationships, encounter documentation, and related medical record requirements.

• Executive Leadership – Provides governance, organizational accountability, resources, and support for compliance initiatives.

The exact structure will depend on the size and complexity of the covered entity. Smaller organizations may have one individual responsible for several functions, while larger programs may require a broader cross-functional committee.

Internal vs. External Compliance Support

Not every covered entity has the internal resources or specialized expertise required to manage every aspect of 340B compliance independently.

Some organizations maintain a fully internal compliance structure, while others use a hybrid approach that combines internal program leadership with specialized external support.

External 340B compliance support may be particularly valuable for:

Service Type	Purpose
Mock HRSA Audits	Simulate the audit process, test documentation and transaction samples, and identify potential compliance gaps before an official audit.
Ongoing Compliance Monitoring	Provide recurring review of program operations, transactions, eligibility, and internal controls.
Coordinator & Staff Training	Strengthen staff understanding of 340B requirements, operational procedures, and documentation expectations.
Policy & Procedure Review	Evaluate whether written policies accurately reflect current operations and establish appropriate internal controls.
Program Governance	Review organizational oversight, responsibilities, accountability, and escalation processes.
Corrective Action Support	Help investigate identified issues, determine root causes, develop corrective actions, and monitor remediation.
Audit Preparation & Support	Organize documentation, review requested data, prepare staff, and coordinate activities associated with a HRSA audit.

The goal of external support should not be to replace internal ownership. Instead, outside expertise can strengthen the covered entity’s internal compliance infrastructure and provide an additional level of independent review.

Preparing for a HRSA Audit

Your compliance team should operate under the assumption that the organization could be selected for an audit at any time.

HRSA auditors may review written policies and procedures, internal controls, covered entity eligibility, outpatient facility eligibility, the GPO prohibition when applicable, Medicaid Exclusion File designations, 340B OPAIS records, contract pharmacy arrangements, and controls designed to prevent diversion and duplicate discounts.

Auditors also test selected 340B drug transaction records.

To maintain audit readiness, your compliance team should routinely:

• Maintain current and accurate 340B policies and procedures.

• Verify that 340B OPAIS information remains accurate.

• Review Medicaid carve-in and carve-out arrangements.

• Monitor controls designed to prevent duplicate discounts.

• Validate patient, provider, and prescription eligibility.

• Reconcile purchasing, dispensing, and accumulator activity.

• Monitor contract pharmacy arrangements when applicable.

• Maintain documentation supporting 340B transactions.

• Conduct recurring internal audits or transaction testing.

• Document identified issues and corrective actions.

• Provide ongoing education to employees involved in the 340B Program.

Audit readiness should be an ongoing compliance process rather than an activity that begins only after receiving an audit engagement letter.

Building Your Team Step by Step

Start by identifying an individual who will have primary responsibility for 340B compliance. Depending on your organization, this may be a pharmacy director, compliance officer, 340B coordinator, or another appropriately qualified leader.

Next, build a cross-functional team representing the departments that affect your 340B Program. For many covered entities, this includes pharmacy, finance, information technology, compliance, clinical operations, revenue cycle, and organizational leadership.

Clearly define who is responsible for:

• Maintaining 340B policies and procedures.

• Reviewing eligibility.

• Monitoring duplicate discount exposure.

• Evaluating contract pharmacy activity.

• Reviewing transaction-level data.

• Conducting internal audits.

• Investigating compliance exceptions.

• Coordinating staff education.

• Maintaining audit documentation.

• Managing corrective actions.

• Communicating material compliance concerns to leadership.

Establish a recurring meeting structure so the team can review findings, operational changes, unresolved issues, and emerging compliance risks.

If internal resources are limited or additional expertise is needed, specialized 340B compliance support can supplement the internal team through mock audits, monitoring, training, policy review, analytics, and audit preparation.

Regardless of the structure, successful 340B compliance requires clear ownership, consistent monitoring, documented processes, and organizational accountability.

Frequently Asked Questions

What roles are essential on a 340B compliance team?

A typical compliance team may include a 340B coordinator or compliance lead, pharmacy leadership, pharmacy staff, data or analytics support, finance representatives, and clinical or health information representatives.

Executive leadership involvement is also important because leadership provides governance, resources, and organizational accountability.

The exact structure should reflect the size and complexity of the covered entity’s 340B operations.

How often should we conduct internal self-audits?

There is no single audit frequency appropriate for every covered entity. The frequency should reflect the organization’s transaction volume, number of locations, contract pharmacy relationships, Medicaid billing arrangements, identified risks, and overall program complexity.

Higher-volume or more complex programs may benefit from monthly transaction monitoring in addition to more comprehensive periodic internal audits.

The most important principle is that auditing should be recurring and risk-based, rather than performed only in preparation for a HRSA audit.

Do we need external 340B compliance support?

Not every covered entity requires ongoing external assistance. Organizations with experienced internal personnel, strong monitoring systems, and established compliance controls may manage many activities internally.

External support can be valuable when an organization needs additional expertise, an independent review, a mock HRSA audit, specialized analytics, policy development, staff training, corrective action assistance, or support preparing for an official audit.

The appropriate model may be fully internal, externally supported, or a combination of both.

What happens if HRSA finds non-compliance during an audit?

HRSA issues a Final Report identifying applicable findings and may request a corrective action plan.

If the covered entity agrees with the findings, the CAP must generally be submitted to HRSA within 60 calendar days. If the covered entity disagrees, it must generally notify HRSA in writing within 30 calendar days and provide supporting documentation.

Unless HRSA approves otherwise, full CAP implementation and settlement with affected manufacturers are generally expected within six months of CAP approval.

Depending on the nature and severity of the findings, consequences can include repayment to manufacturers or removal from the 340B Program. Repeated findings during subsequent audits can create additional compliance risk.

Make Audit Readiness an Ongoing Process

Building a 340B compliance team is an investment in the long-term sustainability of your program.

The strongest programs do not treat compliance as an annual project or wait until an audit notice arrives. They establish clear responsibilities, continuously monitor transactions and internal controls, maintain accurate documentation, educate staff, and address potential issues as they arise.

Whether your compliance structure is managed internally or supported by outside 340B expertise, the objective remains the same: maintain a defensible, well-documented 340B Program that protects program integrity, preserves 340B savings, and supports the patients and communities your organization serves.

Need Help Strengthening Your 340B Compliance Program?

GapRx 340B Consultants can help your organization strengthen compliance, improve audit readiness, and build a more sustainable 340B oversight process. Our support can include mock HRSA audits, compliance monitoring, policy and procedure review, staff training, data analysis, corrective action support, and ongoing 340B program guidance.

Whether you need an independent review of your current program or ongoing support for your internal compliance team, GapRx can provide practical, hands-on assistance tailored to your organization’s needs.

Ready to strengthen your 340B compliance program?
Schedule a 340B Strategy Call with GapRx 340B Consultants.