screenshot of HRSA FY 2022 manufacturer audit results page
HRSA released findings from its audit of drug company VistaPharm.

Generic/OTC Drug Maker Owes Refunds to 340B Providers, HRSA Audit Shows

The U.S. Health Resources Services Administration (HRSA) has ordered South Carolina-based VistaPharm, a manufacturer of generic and over-the-counter (OTC) drugs to repay overcharges to 340B covered entities after a HRSA audit showed the company did not offer its products at the statutory ceiling price.

HRSA’s audit of VistaPharm also found that the company had an incorrect 340B Office of Pharmacy Affairs Information System (OPAIS) record. VistaPharm’s corrective action plan is still pending, HRSA said. 340B Report reached out to the company to see if it wanted to elaborate on the findings but a spokesperson declined to comment. 

VistaPharm is a division of Greenville, South Carolina-based PAI Pharma that specializes in making liquid pharmaceuticals and opioid treatment program (OTP) products. The company manufactures generic drugs including generic equivalents of Keppra and Reglan oral solutions, and Megace and Milk of Magnesia oral suspensions.

Separately, HRSA said its audit of Jersey City, New Jersey-based Mitsubishi Tanabe Pharma America showed no adverse findings. Mitsubishi Tanabe, whose parent company is Mitsubishi Tanabe Pharma Corp. headquartered in Osaka, Japan, makes therapies including Radicava to treat amyotrophic lateral sclerosis.

HRSA posted the findings of its VistaPharm and Mitsubishi audits on September 16 and noted that remaining audits are still under review. The agency posts on its website the results of audits where the findings have been finalized and provides updates on corrective action plans and sanctions once they are HRSA-approved.