Health Resources and Services Administration September 1, 2009 – Federal Register Recent Federal Regulation Documents

Section 340B of the Public Health Service Act (section 340B) and section 1927(a) of the Social Security Act (section 1927(a)) implement a drug pricing program in which manufacturers who sell covered outpatient drugs to covered entities must agree to charge a price that will not exceed an amount determined under a statutory formula. Section 6004 of the Deficit Reduction Act of 2005 (Pub. L. 109-171) (section 6004) added certain qualifying children's hospitals to the list of covered entities eligible to access 340B discounted drugs. The purpose of this notice is to inform interested parties of final guidelines regarding the addition of children's hospitals that meet certain requirements, specifically: (1) The process for the registration of children's hospitals to the 340B Program; and (2) the obligation of manufacturers to provide the statutorily mandated discount to those children's hospitals.