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May 18, 2017

HRSA Opts to Delay 340B Ceiling Price and Manufacturer Overcharging Penalty Rules until October 1, 2017

HRSA issued a rule further delaying until October 1, 2017, the implementation of a January 5th final rule codifying the calculation of the 340B ceiling price, and implementing civil monetary penalties for manufacturers that knowingly and intentionally overcharge 340B providers. A number of 340B provider groups had urged HRSA not to further delay the effective date of the rule, which has already been reopened for comment and then delayed twice since its publication in January.  HRSA cited the need to provide manufacturers sufficient time to make needed changes to facilitate compliance.