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Federal district court upholds authority of HHS to pre-approve 340B rebate programs; HRSA submits proposed 340B rebate guidance

By The National Law Review  
   June 05, 2025

A federal judge in D.C. recently ruled in favor of the U.S. Health Resources and Services Administration, an administrative agency under the U.S. Department of Health and Human Services, by finding that drug manufacturers must obtain pre-approval from HRSA before implementing rebate models under the 340B Program.

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