The Health Resources and Services Administration (HRSA) has announced that it will implement its January 5, 2017 340B drug pricing program rule on January 1, 2019.  The oft-delayed final rule addresses:  (i) the calculation of the 340B “ceiling price” that may be charged to covered entities; (ii) the substantive standards applicable to civil monetary penalties (CMPs); and (iii) the procedures applicable to the imposition of CMPs.  In the preamble, HRSA indicated that it will “assess the need for further rulemaking and guidance after the rule is in effect.” HRSA also stated that it plans to release the 340B ceiling pricing reporting system “shortly,” and the agency will ensure all impacted stakeholders receive education and training on the reporting system.  Separately, HRSA projects that it will publish 340B ceiling prices on April 1, 2019.