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340B Mega Guidance Withdrawn

    Client Alerts
  • February 02, 2017

On January 31, 2017, the Health Resources and Services Administration (“HRSA”) withdrew the 340B Program Omnibus Guidance (often referred to as the Mega Guidance).   The guidance addressed a number of significant issues under the 340B Program, including the definition of eligible patient and contract pharmacy arrangements.   The Mega Guidance was issued by HRSA in August 2015 after a HRSA “Mega Rule” was withdrawn in response to concerns that the issuance of the issuance of the “Mega Rule” exceeded HRSA’s regulatory authority.