Notice regarding HRSA grant requirement--participation in the 340B drug pricing program--HRSA. Notice.

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992," enacted section 340B of the Public Health Service (PHS) Act, "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of HHS in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed that amount determined under a statutory formula. The purpose of this notice is to request comments on a proposed grant award requirement in which all entities, except those entities which fall within excepted categories, that receive HRSA grants listed in section 340B(a)(4) and that purchase or reimburse for covered outpatient drugs must participate in the 340B Drug Pricing Program, or demonstrate good cause for nonparticipation. When the Prime Vendor program is operational, HRSA intends to publish a second Federal Register notice proposing an expansion of the grant award requirement to include participation in the Prime Vendor Program.