Precision Dose, a maker of liquid generic drugs in unit-dose syringes and cups, and Tagi Pharma, a wholly owned subsidiary that makes generic oral and injectable drugs, will have to repay 340B covered entities for overcharges following an 340B program compliance audit.
Four of the five manufacturers that HRSA audited in fiscal year 2021 had adverse findings and were required to repay entities for overcharges. HRSA began auditing five manufacturers per year in fiscal year 2016. That year and in 2017, none of the manufacturers had an adverse finding. One had an adverse finding in 2018, four in 2019, and two in 2020.
The U.S. Health Resources and Services Administration (HRSA) posted the audit findings on the Office of Pharmacy Affairs (OPA) website on Nov. 24. Auditors found that Precision Dose charged more than the 340B ceiling price and did not determine the difference between new drug price estimates and actual 340B ceiling price and offer a refund. Tagi and Precision also did not submit quarterly pricing data to OPA. HRSA said the companies’ corrective action plan is pending.