Generic Drug Manufacturer Posts 340B Refund Notice

Generic liquid drug manufacturer Pharmaceutical Associates, Inc. (PAI), has notified 340B covered entities on the U.S. Health Resources and Services Administration (HRSA) website about 340B overcharges and potential credit/rebill repayments regarding all of its products covering the first through third quarters of 2019.

A HRSA audit in fiscal year 2020 found that PAI charged more than the 340B ceiling price and had an incorrect record in 340B OPAIS, the 340B program database. HRSA required PAI to repay covered entities for the overcharges. PAI’s public notice to covered entities, dated Jan. 25, does not mention the audit.

PAI is a subsidiary of Beach Products Inc., which earlier this month posted a separate notice about the availability of potential payments for overcharges covering the same period in 2019. That notice also did not address HRSA’s audit findings.

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