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January 31, 2017

HRSA Withdraws 340B Program Omnibus Guidance

Jan. 31, 2017:  HRSA has withdrawn its 340B Program Omnibus Guidelines. HRSA’s Office of Pharmacy Affairs (OPA) first issued the guidance, which would have dramatically restricted key elements of the program, in August 2015. OPA submitted the final version of the guidance for review by the OMB Office of Information and Regulatory Affairs in September of last year.  As a result, the notice was subject to a January 20, 2017 Presidential Memorandum under which agencies were prohibited from sending pending regulations to be published until a department or agency head appointed or designated by the President reviews and approves the regulation. It is unclear at this time whether HRSA has pulled the Notice entirely, or just the final version, and whether HRSA will choose to reissue all or parts of the guidance.  See our 340B Drug Discount Program Resources for more information.