Which organization is primarily responsible for overseeing the 340B program?

The Health Resources and Services Administration (HRSA) is the organization primarily responsible for overseeing the 340B program. This program, established in 1992, is designed to allow eligible healthcare providers to purchase outpatient drugs at reduced prices, thereby enabling them to better serve vulnerable populations, including low-income and uninsured patients.

HRSA administers the program and ensures compliance with its guidelines, monitoring the eligibility of participating entities and the integrity of the program as a whole. As the governing body, HRSA plays a critical role in providing guidance, technical assistance, and enforcement actions related to the program. This oversight ensures that participating organizations are using the 340B savings to expand their services and provide care to the communities that need it most, fulfilling the program's mission.

In contrast, the other organizations listed have different roles: the Centers for Disease Control and Prevention (CDC) primarily focuses on public health and disease control, Medicaid is a state and federally funded program that provides health coverage to eligible low-income individuals, and the Food and Drug Administration (FDA) is responsible for approving drugs and ensuring their safety and efficacy. None of these agencies are tasked with the same level of operational oversight and administration of the 340B program that HRSA has.