Fact Sheet | Pricing

340B Drug Pricing Program Proposed Guidance Summary

Fact Sheet | Pricing

340B Drug Pricing Program Proposed Guidance Summary

This executive summary highlights important components of the Health Resources and Services Administration’s (HRSA) proposed 340B “Mega-Guidance.”

On August 27, 2015, the Health Resources and Services Administration (“HRSA”) released its long-awaited, proposed Omnibus Guidance on the 340B Drug Pricing Program (“Proposed Guidance”).  80 Fed. Reg. 52300 (Aug. 28, 2015). The 340B Program provides significant discounts to various types of hospitals and non-hospital, nonprofit healthcare organizations that have certain Federal designations or receive certain Federal grants (collectively, “covered entities”) on the purchase of “covered outpatient drugs” that are furnished to eligible patients. 42 U.S.C. § 256b.

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