340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
other · US Department of Health and Human Services · Rule · Published 2017-01-05 · Effective 2017-03-06 · 82 FR 1210
Document
Document number
2016-31935
Federal Register citation
82 FR 1210
CFR reference
42 CFR 10
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
2017-01-05
Effective date
2017-03-06
Abstract
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the "340B Drug Pricing Program" or the "340B Program." This final rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This final rule sets forth the calculation of the 340B ceiling price and application of civil monetary penalties (CMPs).