January 2017
Drug Manufacturer Pricing Under the Microscope: HRSA’s 340B Civil Monetary Penalty and
Drug Pricing Final Rule

The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary penalties.

HRSA's new rule, titled "340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation" (Final Rule), 82 Fed. Reg. 1210 (January 5, 2017), is available here. The Final Rule addresses the calculation of the 340B ceiling price and establishes the rules by which significant CMPs would be imposed on a manufacturer who knowingly and intentionally overcharges a covered entity. It replaces all former HRSA guidance on Penny Pricing and New Drug Pricing, and the Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 New Drug Pricing.

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