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

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

Below is an excerpt:

On August 28, 2015 the U.S. Department of Health and Human Services (HHS), published the proposed 340B Drug Pricing Program Omnibus Guidance (Guidance). This article, the first in a two-part series, will provide a guide to the basic framework of the 340B Program and explore how the Guidance manipulates the cornerstones of the Program. Part Two will hone in on items in the Guidance particularly applicable to manufacturers and summarize wins and losses for various stakeholders.

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