On Thursday, 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.
We expected the rule to address key areas including patient eligibility, compliance requirements for contract pharmacy arrangements, and hospital eligibility including criteria for off-site facilities.
Despite withdrawing the Mega-Reg, Commander Pedley indicated that HRSA would issue new interpretive guidance in many areas that the Mega-Reg was expected to address, such as the definition of patient, standards for contract pharmacy arrangements and other key 340B Program issues.
It appears that HRSA will not issue another broad set of proposed regulations until Congress provides HRSA with additional authority. In the interim, Commander Pedley indicated that HRSA will issue proposed regulations in areas where HRSA believes it has authority to act, such as civil monetary penalties for pharmaceutical manufacturers and the calculation of ceiling prices. Commander Pedley advised that there are no specific timelines in place yet, but the 340B community should expect some additional guidance next year.
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