Generic drug manufacturer Unichem Pharmaceuticals USA must repay 340B covered entities for overcharges found during a 340B program compliance audit, the U.S. Health Resources and Services Administration (HRSA) said yesterday.
HRSA has been auditing five drug manufacturers per year for 340B compliance since 2016. The number of drug company audit findings has increased over the years with four companies cited in fiscal year 2021, tying the record set in 2019. HRSA audits 200 covered entities each fiscal year for 340B program compliance. Of the 86 entity audit results for FY 2022 posted to date, 18 had adverse findings either requiring repayments to manufacturers or termination of ineligible sites or contract pharmacies.
Generic drug manufacturer Unichem Pharmaceuticals USA must repay 340B covered entities for overcharges found during a 340B program compliance audit, the U.S. Health Resources and Services Administration (HRSA) said yesterday.
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