What is the 340B Program? Why does it matter today?

The 340B Drug Pricing Program is one of the most important cost-saving mechanisms in the U.S. healthcare system. Established by Congress in 1992, it enables eligible healthcare organizations — known as covered entities — to purchase outpatient drugs at significantly reduced prices. The intent is simple but powerful: stretch federal resources to reach more patients and deliver more comprehensive services, especially to underserved populations.

But while the program offers huge opportunities, it also carries complex compliance responsibilities. With increased audit activity from the Health Resources and Services Administration (HRSA) and growing scrutiny from drug manufacturers, pharmacies and covered entities must not only participate but also prove they are managing the program responsibly.

Why Does the 340B Program Matter Today?

The 340B program has become a critical financial lifeline for many healthcare providers. Discounts can reach 25–50% off drug costs, allowing organizations to:

• Expand pharmacy services

• Improve medication adherence programs

• Fund outreach clinics, counseling, or case management

• Provide discounted prescriptions to patients

However, in recent years, manufacturers have restricted contract pharmacy participation or added conditions for 340B pricing. Meanwhile, HRSA has stepped up enforcement — meaning entities need strong documentation and audit readiness to retain program benefits.

The 340B Program was built to empower healthcare providers serving those most in need. Today, its value is greater than ever — but so are the risks of non-compliance. Pharmacies and covered entities that invest in strong oversight and audit readiness not only protect their participation but also maximize the impact of 340B savings for their patients.

At Concordia Pharma Solutions, we help covered entities and pharmacies strengthen their 340B compliance framework, prepare for HRSA audits, and ensure continuous readiness. Contact us today to schedule a consultation and take the first step toward confident 340B program management.