The U.S. Health Resources and Services Administration (HRSA) is requiring Pharmaceutical Associates, Inc. (PAI), a South Carolina-based generic liquid drug manufacturer, to repay 340B covered entities for charges on its products above the 340B ceiling price discovered during a fiscal year 2020 audit. The affected PAI products have not yet been identified. The company website says it offers “more than 60 prescription and over-the-counter therapies.”
Auditors also cited PAI for having an incorrect record in 340B OPAIS, HRSA’s 340B program database. HRSA’s FY 2020 manufacturer audits webpage, updated Jan. 15, shows that the agency approved PAI’s corrective action plan. PAI has not posted a notice to covered entities about refunds for overcharges on HRSA’s manufacturer notices to covered entities webpage.