340B Freeze: 'Mega-Guidance' Withdrawn; Clarity On Program Boundaries Delayed Again

Long-delayed effort to define key boundaries for 340B drug discount program is on hold once again – and it may now take legislation to enable HRSA to move forward with plans to better define who is eligible for the discount.

Blister Packs

The decision of when and how to proceed on defining key parameters of the 340B drug discount program now rests with the Trump Administration.

HRSA formally withdrew the final version of the 340B “mega-guidance” from review at the Office of Management & Budget on January 31, following the regulatory freeze directive from the incoming...

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