The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This proposed rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. The proposed rule sets forth the calculation of the ceiling price and application of civil monetary penalties.
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340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program...
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80 FR 34583
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“340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation,” thefederalregister.org (June 17, 2015), https://thefederalregister.org/documents/2015-14648/340b-drug-pricing-program-ceiling-price-and-manufacturer-civil-monetary-penalties-regulation.