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“The 340B Drug Pricing Program Omnibus Guidance – Part Two”

Pharmaceutical Compliance Monitor By Alyce C. Katayama and Elizabeth R. Gebarski

Below is an excerpt:

This is Part Two in a two-part series exploring the proposed 340B Drug Pricing Program Omnibus Guidance (Guidance). This article delves into the Guidance’s impact on manufacturers and in Figure 1, summarizes wins and losses for various stakeholders.

Background

Manufacturers have one statutory obligation under the 340B Program: to provide covered outpatient drugs to participating covered entities (CEs) at no greater than the 340B-ceiling price (i.e., the maximum price manufacturers can charge for a 340B-purchased drug). Just how a manufacturer ensures and the Health Resources and Services Administration (HRSA) monitors compliance under the Guidance is the focus of this article.

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