[20010110]RS20750_《2001财年农业拨款法》的处方药进口规定P.L106-387.pdf

Congressional Research Service ? The Library of CongressCRS Report for CongressReceived through the CRS WebOrder Code RS20750Updated January 10, 2001The Prescription Drug Import Provisions of the FY2001 Agriculture Appropriations Act, P.L. 106-387Donna U. Vogt Blanchard Randall IVDomestic Social Policy DivisionSummaryThe FY2001 Agricultural Appropriations bill P.L. 106-387 included twoamendments to the Federal Food Drug and Cosmetic Act (FFDCA): one that wouldhave required the Food and Drug Administration (FDA) to establish a 5-year drug importprogram that would allow pharmacists and wholesalers to import FDA-approvedprescription drugs into the United States; and a second that placed conditions on FDAsending warning letters regarding the importation of drugs for personal use. Whenthe106th Congress was unable to reach a consensus on a new a prescription drug benefitunder Medicare, it looked for other ways to increase the availability of lower costprescription drugs. Under the new law, pharmacists and drug wholesalers who importdrugs would have to provide FDA with specific information that would allow the agencyto monitor the program. All imported drugs would have to be FDA-approved,