Generic drug manufacturers Lifestar Pharma and Chartwell Pharmaceuticals may owe refunds to 340B covered entities for overcharges on drugs purchased from the companies in the fourth quarter of 2022, according to recent notices posted on the U.S. Health Resources and Services Administration website.
Lifestar Pharma, based in Mahwah, N.J., “completed a minor restatement of government pricing values,” that impacted 340B pricing on certain drugs purchased between Oct. 1 and Nov. 17 of last year, according to a Lifestar notice dated April 17 and posted by HRSA late last week. The potential overcharges affect four NDCs.
Lifestar has identified all covered entities that may be owed a refund for purchases during the relevant timeframe and is in the process of directly contacting by mail any entity owed a refund greater than $50, the notice said. Covered entities overcharged on a 340B purchase during the stated time period whose overcharges amount to less than $50 are also eligible for refunds, it said.
Covered entities have until March 31, 2024, to email refund inquiries to Lifestar and must provide documentation of an overcharge, according to the HRSA notice.
Lifestar, a subsidiary of India-based Mankind Pharma, makes generic equivalents of brand drugs including Prevacid, a proton pump inhibitor used to treat gastrointestinal conditions, cholesterol-lowering drug Tricor and antibiotic Floxin.
Chartwell Refund Notice
HRSA also recently posted a similar notice regarding possible refunds to 340B covered entities for overcharges on Chartwell drugs purchased between Oct. 1 and Dec. 18, 2022. The notice covers a total of 43 NDCs. It was dated March 21 and posted by HRSA late last week.
Chartwell, headquartered in Congers, N.Y., was also contacting directly via mail those covered entities potentially owed refunds of more than $50, the posting said, but entities that can show overpayments totaling less than $50 for the stated time period are also eligible for refunds.
Covered entities have until March 31, 2024, to email refund inquiries to Chartwell, the HRSA notice said. Chartwell produces generic equivalents of brand products including antibiotics Cipro and Zithromax and arthritis treatment Celebrex.