Federal Judge Invalidates 340B Orphan Drug Regulation

by Admin | May 23, 2014 7:32 pm

May 23, 2014—A federal district judge ruled today that the Department of Health and Human Services has no authority under the 340B statute to promulgate regulations implementing the Affordable Care Act’s 340B orphan drug exclusion[1], which applies to hospitals registered in 340B as critical access hospitals, sole community hospitals, rural referral centers, and free-standing cancer hospitals. 

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Endnotes:
  1. 340B orphan drug exclusion: https://340binformed.org/2014/01/phrma-doj-file-final-briefs-in-340b-orphan-drug-case/
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Source URL: https://340binformed.org/2014/05/federal-judge-invalidates-340b-orphan-drug-regulation/

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