340B “Mega-Guidance” Delayed To December (Or Beyond)

HRSA official stresses importance “good faith” by manufacturers and purchasers to assure program integrity while key definitions remain in limbo.

The HHS Health Resources & Services Administration is now working towards a December deadline to issue a final guidance on the 340B program, Office of Pharmacy Affairs Director Krista Pedley told the 340B Coalition annual summer conference on July 11.

HRSA issued the draft “mega-guidance” defining many key components of the 340B drug discount program in August 2015. (Also see...

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