HRSA’s Civil Monetary Penalties Rule Postponed (Again!)

The effective date for the 340B Drug Program Ceiling Price and Manufacturer Civil Monetary Penalties has been delayed once again, pushing the date to July 1, 2018.

A Final Rule was released today, stating: HHS proposed this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking. After consideration of the comments received on the proposed rule, HHS is delaying the effective date of the January 5, 2017, final rule, to July 1, 2018.

It is still unclear whether the rule will be reconsidered entirely during that time. We will continue to update as things change.