HRSA Issues Final Rule on Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program

On July 23, 2013, the Health Resources and Services Administration (HRSA) issued its final rule regarding the exclusion of orphan drugs for certain covered entities from the 340B Program. This is the first regulation that HRSA has issued in connection with the 340B Program.  It establishes a new Part 10 of Chapter 42 of the Code of Federal Regulations, which will address implementation of certain requirements of the 340B law, as modified by the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act (together, PPACA).  According to HRSA, additional 340B Program regulations may be published in the future and would be incorporated into the new 42 C.F.R. part 10.  The final rule is effective October 1, 2013.