Earlier today, HRSA published online its long-awaited final regulation 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 in most ways, with some key changes and clarifications, and will appear in tomorrow’s Federal Register.
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