Fed Regist. 1999 Dec 3;64(232):67720-63.
The Food and Drug Administration (FDA) is issuing a final rule to set forth procedures and requirements implementing the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA) and the FDA Modernization Act of 1997 (the Modernization Act). The final rule sets forth requirements for the reimportation and wholesale distribution of prescription drugs; the sale, purchase, or trade of, or the offer to sell, purchase, or trade, prescription drugs that were purchased by hospitals or health care entities, or donated to charitable organizations; and the distribution of prescription drug samples. FDA is also amending certain sections of the regulations entitled "Guidelines for State Licensing of Wholesale Prescription Drug Distributors" to make them consistent with this final regulation.
美国食品药品监督管理局（FDA）正在发布一项最终规则，以阐明实施经1992年《处方药修正案》（PDA）和1997年《FDA现代化法案》（《现代化法案》）修订的1987年《处方药销售法案》（PDMA）的程序和要求。该最终规则规定了处方药再进口和批发分销的要求；医院或医疗保健机构购买的或捐赠给慈善组织的处方药的销售、购买或交易，或出售、购买或交易的要约；以及处方药样品的分发。FDA还正在修订题为《批发处方药经销商州许可指南》的法规的某些部分，使其与本最终法规保持一致。
