Two New Manufacturer Notices to 340B Entities on HRSA Website

The generic drug manufacturer recently required to repay covered entities for charging above the ceiling price following an audit has posted a notice on the U.S. Health Services and Resources Administration (HRSA) website about recalculation of ceiling prices and “potential payment” of “eligible refunds.”

The notice, dated Jan. 25, was posted by Beach Products Inc. and does not address the audit. Pharmaceutical Associates Inc. (PAI) was the manufacturer that HRSA audited. A company contact listed on both the PAI audit results webpage and the Beach notice to covered entities is the same person with the same Beach email address.

The potential repayments are for five formulations of a urinary acidifier in oral tablet form. The overcharges were during the first three quarters of 2019. Beach said it has identified entities “that may be eligible for potential payment based on recalculated 340B ceiling prices.” It said a notification was distributed to wholesalers “offering a credit/rebill repayment” and that “eligible refunds must be processed by June 17, 2021.”

Verity Pharmaceuticals Supply Allocation Notice

Verity Pharmaceuticals, a specialty pharmacy specializing in genitourinary products, posted a supply allocation plan dated Jan. 8 for two NDCs of Trelstar, a palliative treatment for advanced prostate cancer. Verity said in the notice it expects the 340B price of Trelstar will drop to $0.01, creating “challenges with equitable market distribution.” It is limiting purchases “based on available supply and prior purchasing history.”

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