On August 28, 2015, the Health Services Resources Administration (“HRSA”) published its 340B Drug Pricing Program Omnibus Guidance Notice in the Federal Register. 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.  In addition, the Notice presages a more robust – if still somewhat ill-defined – oversight and enforcement environment for both covered entities and manufacturers participating in the program.

For more details on this Notice, the significant policy issues that it raises, and the potential areas that 340B program stakeholders may wish to comment on through October 27, 2015, read the Client Alert written by Joe Metro, Julia Krebs- Markrich, Salvatore Rotella, Jacquelyn Godin, and Zachary Portin.