HRSA Publishes Final 340B Orphan Drug Regulation

by Admin | July 22, 2013 1:01 pm

Earlier today, HRSA published online its long-awaited final regulation[1] to implement the 340B “orphan drug exclusion,” which limits 340B-purchasing for free-standing cancer hospitals, critical access hospitals, sole community hospitals, and rural referral centers participating in the 340B drug discount program. The final regulation mirrors HRSA’s May 2011 proposed rulemaking[2] in most ways, with some key changes and clarifications, and will appear in tomorrow’s Federal Register. 

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Endnotes:
  1. final regulation: https://s3.amazonaws.com/public-inspection.federalregister.gov/2013-17547.pdf
  2. proposed rulemaking: http://www.gpo.gov/fdsys/pkg/FR-2011-05-20/pdf/2011-12423.pdf
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