Which organization is responsible for overseeing 340B audits?

The Health Resources and Services Administration (HRSA) is the organization responsible for overseeing 340B audits. HRSA administers the 340B Drug Pricing Program, which includes ensuring compliance among covered entities and manufacturers. Their regulatory oversight helps to maintain the integrity of the program, ensuring that eligible entities are using the savings from discounted drugs to benefit their patients as intended.

HRSA also develops guidance on the program and conducts audits to assess adherence to the program's requirements. This auditing function is crucial for maintaining accountability and ensuring the program serves its purpose of improving access to affordable medications for vulnerable populations.

Other organizations mentioned, such as the FDA and CMS, have their specific roles within the healthcare system but do not oversee the 340B audits directly. The National Association of Community Health Centers (NACHC) represents community health centers and advocates for their interests but is not the regulatory body responsible for auditing compliance within the 340B Program.