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HRSA Finalizes Further Delay of 340B Rule

The Health Resources and Services Administration (HRSA) finalized a rule that will further delay implementation of a final rule on ceiling prices and manufacturer civil monetary penalties in the 340B Drug Pricing Program.

The final rule, issued in 2017, provides 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.

This is the latest of several delays in implementation of the final rule. Implementation will now be pushed back one year, from July 1, 2018, to July 1, 2019.

America’s Essential Hospitals issued a statement urging HRSA to reconsider its delay, citing the rule as a necessary step to ensure manufacturer accountability and transparency in the 340B program. The association in May also submitted comments on the proposed delay.

Contact Senior Director of Policy Erin O’Malley at or 202.585.0127 with questions.


About the Author

Rachel Schwartz is a former policy associate at America's Essential Hospitals.

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