Lilly is providing refunds for 340B overcharges during Q1 2020 on Humalog and Trulicity.

HRSA Posts Four Manufacturer Notices to 340B Entities

The U.S. Health Resources and Services Administration yesterday posted notices of refunds for 340B overcharges from drug manufacturers Lilly, Novo Nordisk, and Neurocrine and a notice from Amneal about product NDC changes.


Lilly’s May 30 notice covers purchases during Q1 2020. It is providing refunds for overcharges on one NDC for its insulin Humalog and two NDCs for its injectable diabetes medicine Trulicity. Continuing a recent practice, the notice includes four NDCs for Lilly’s human growth hormone injection Humatrope for which, Lilly said, routine price restatements should have resulted in covered entities repaying Lilly for 340B underpayments. “Lilly has elected not to seek recoupment of these underpayments from covered entities,” the notice said.

Novo Nordisk

Novo Nordisk’s undated notice covers purchases during Q3 2020. It is providing refunds for 340B overcharges on one NDC for its insulin Tresiba, an NDC for its weight-loss injectable medicine Saxenda, and two NDCs for its injectable diabetes and weight-loss medicine Ozempic.


Neurocrene’s undated notice covers purchases from Q3 2022 to Q2 2023. It is issuing refunds for overcharged on an NDC for Ingrezza, a medicine to treat tardive dyskinesia, a condition affecting the nervous system.


Amneal’s June 1 notice is about six new NDCs beginning in March for Lioresal Intrathecal Baclofen, a muscle relaxant and antispastic medication.

“Because the new Lioresal NDCs are for the same product (drug, dose, or formulation) and have the same 340B price as the corresponding old NDC, Amneal will allow eligible 340B covered entities that use a 340B compliant inventory replenishment model to count accumulations of the old NDCs toward replenishment of equal quantities of the corresponding new NDCs,” the notice said. “Amneal wishes to emphasize that 340B pricing for the new NDCs will remain the same as for the old NDCs.”

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