The Health Resources and Services Administration (HRSA) released a proposed rule delaying the implementation of the 340B Drug Pricing Program ceiling price and manufacturer civil monetary penalties final rule to July 1, 2019. The regulation was initially set to take effect on March 6, 2017, but HRSA has delayed implementation of this final regulation numerous times, with the latest implementation date of July 1, 2018 [see Washington Highlights, Sept. 29, 2017].
The final rule, published in the Jan. 2, 2017 Federal Register (82 Fed. Reg. 1210), sets forth the calculation of the ceiling price and application of civil monetary penalties, and applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B program. The provisions of this final rule were initially set to take effect on March 6, 2017.
HRSA will accept stakeholder comments on this proposal until May 22.