November 17, 2014

On November 13, 2014, HRSA formally withdrew its much-anticipated 340B Mega-Reg from the rulemaking process, effectively abandoning its effort to overhaul existing 340B program guidance through new regulations. Commander Krista Pedley, the director of the Office of Pharmacy Affairs in HRSA, indicated that HRSA no longer believes it has sufficient rulemaking authority to proceed with the Mega-Reg. HRSA’s rulemaking authority was called into question by a federal court that ruled against HRSA in a recent orphan drug rule case.

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