The following summarizes the provisions of the 340B drug pricing program omnibus guidance released by the Health Resources and Services Administration on August 28, 2015, and identifies key issues raised by it.  The Proposed Guidance is attached to this summary.  The Proposed Guidance touches on every area of the 340B Program and, in some areas, proposed substantial changes.  HRSA is soliciting public comments on the Proposed Guidance.  Comments are due on October 27, 2015.

Read More