340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
other · US Department of Health and Human Services · Rule · Published 2018-06-05 · Effective 2017-01-05 · 83 FR 25943
Document
Document number
2018-12103
Federal Register citation
83 FR 25943
CFR reference
42 CFR 10
Type
Rule
Action
Final rule; further delay of effective date.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
2018-06-05
Effective date
2017-01-05
Abstract
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), known as the "340B Drug Pricing Program" or the "340B Program." HRSA published a final rule on January 5, 2017, that set forth the calculation of the ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. On May 7, 2018, HHS solicited comments on further delaying the effective date of the January 5, 2017, final rule to July 1, 2019. HHS proposed this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for any 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, 2019.