The Health Resources and Services Administration (HRSA) has adopted its proposal to delay the effective date of its final rule revising the calculation of the 340B "ceiling price" that may be charged to covered entities and related civil money penalties.  As previously reported, while implementation of the January 5, 2017 rule was already delayed until October 1, 2017, HRSA has now pushed back the effective date to July 1, 2018.  HRSA states that this delay "provides regulated entities sufficient time to implement the requirements of the rule, as well as allowing a more deliberate process of considering alternative and supplemental regulatory provisions, and to allow for sufficient time for additional rulemaking."  In fact, this new rulemaking is already in the works; HRSA sent a new 340B drug pricing/CMP proposed rule to the White House Office of Management and Budget for regulatory review on October 6, 2017. 

This article is presented for informational purposes only and is not intended to constitute legal advice.