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This rule changed the effective date of the January 5, 2017, final rule (82 FR 1210; RIN 0906-AA89) that sets forth the calculation of the 340B ceiling price and application of civil monetary penalties to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. The new effective date was changed to January 1, 2019. The January 5, 2017, final rule was required under the Affordable Care Act and imposes monetary sanctions (not to exceed $5,000 per instance) on drug manufacturers who intentionally charge a covered entity a price above the ceiling price established under the procedures of the 340B Program and also defines standards and methodology for the calculation of ceiling prices for purposes of the 340B Program.