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June 18, 2021

HRSA Withdraws Contract Pharmacy Advisory Opinion But Will Continue Enforcement of Statute, Including Pursuant to May 17 Letters

The Health and Resource Service Administration (HRSA) announced June 18, in connection with the ongoing AstraZeneca case, that is withdrawing its December 2020 contract pharmacy Advisory Opinion “to avoid confusion and unnecessary litigation.” Despite withdrawal of the informal guidance, HRSA intends to continue enforcement of the 340B statute, which it views as independent from the issuance of the Advisory Opinion and consistent with the AstraZeneca district court’s recent ruling. Specifically, HRSA has indicated it will continue to pursue enforcement through a series of May 17 letters issued to drug manufacturers.