Fed Regist. 1995 Oct 2;60(190):51488-9.
Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992," enacted section 340B of the Public Health Service Act ("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 Health and Human Services in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula. The purpose of this notice is to inform interested parties of final guidelines regarding new drug pricing.
《1992年退伍军人医疗保健法》（公法102 - 585）第602节颁布了《公共卫生服务法》（“PHS法”）第340B节“受保实体购买药品的价格限制”。第340B节规定，向合格实体销售受保门诊药品的制造商必须与卫生与公众服务部部长签署药品定价协议，制造商在协议中同意对受保门诊药品收取不超过法定公式确定金额的价格。本通知的目的是向有关各方通报关于新药定价的最终指南。
