The Health Resources and Services Administration (HRSA) further delayed implementation of a final rule on ceiling prices and manufacturer civil monetary policies in the 340B Drug Pricing Program.
In the final rule, issued earlier this year, HRSA gives additional guidance on the calculation of ceiling prices for 340B drugs supplied to covered entities. The rule also imposes civil monetary penalties for manufacturers who knowingly and intentionally charge covered entities more than the ceiling price for covered outpatient drugs.
HRSA has repeatedly delayed implementation of the final rule. The most recent delay to July 1, 2018, comes after HRSA issued a proposed rule soliciting feedback from stakeholders.
HRSA will continue to examine issues raised by commenters about the implementation of the final rule and release further rulemaking in coming months.
Contact Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions