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HRSA Releases Long-Awaited 340B Mega-Guidance, Elements Threaten RWCs

Congress, Mega-Guidance, Regulations, RWC-340BBy adminAugust 28, 2015

The Health Resources and Services Administration (HRSA) released its long-awaited 340B program omnibus guidance, often called the “Mega-Guidance” today.  RWC-340B has reviewed the Mega-Guidance and is quite troubled by proposed changes…

RWC-340B Comments on HRSA’s Proposed Regulations to Implement Civil Monetary Penalties on Drug Manufacturers That Overcharge

Regulations, RWC-340BBy adminAugust 17, 2015

On June 17, 2015, HRSA proposed regulations to implement elements of the Affordable Card Act that required the agency to develop guidelines for assessing civil monetary penalties on drug manufacturers…

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