On August 28, 2015, the Health Services Resources Administration (HRSA) published long-awaited 340B Drug Pricing Program Omnibus Guidance.  Although many aspects of the notice reiterate previous HRSA guidance, several elements will generate significant debate among program stakeholders regarding the scope of the 340B program, particularly because of its potential to narrow the scope of permissible 340B purchasing and dispensing.  The notice also presages a more robust – if somewhat ill-defined – oversight and enforcement environment for covered entities and manufacturers participating in the program.  HRSA will accept public comments through October 27, 2015. Reed Smith has prepared a Client Alert that provides an overview of the notice, highlights significant policy issues, and identifies potential areas for public comment. To view the full client alert click here.