HRSA Finds Two Drugmakers Overcharged Covered Entities for 340B Drugs

HRSA’s fiscal year 2025 manufacturer audit results show that Cycle Pharmaceuticals Ltd. and Rhodes Pharmaceuticals L.P. overcharged covered entities for their 340B drugs. HRSA sanctioned both companies; requiring that they repay covered entities as part of their corrective action plan. Three manufacturer audits are still under review.

HRSA audits five manufacturers per year. This paltry number is in stark contrast to the 200 covered entities that the agency audits every year. Despite the dismal number of manufacturer audits that HRSA conducts, 60% of HRSA manufacturer audits resulted in repayments to covered entities between 2020 and 2024.