of manufacturing the bulk vaccine will be shipped, as well as the shipping and packaging controls and the labeling that will accompany the shipment. The labeling must specify that the bulk vaccine is "For Further Manufacturing Only." The license amendment must also include a written agreement, signed by the foreign consignee, stating that labeling of the finished filled containers of vaccine will not bear the U.S. license number of the bulk manufacturer nor make such reference in the labeling. Since U.S. Customs will detain a biological product from entering the country without a license number, the agreement effectively bars the product from being returned to the United States.

Distribution

A vaccine must be packaged to withstand the handling and storage to which it will be subjected in transit; therefore, the manufacturer must, as far as possible, control the route and shipment method. In addition, the manufacturer must maintain destination records of the vaccine, to initiate a rapid and efficient recall should it be necessary. Also, it is the manufacturer's responsibility to ensure that only approved labeling is used in any labeling or packaging operation (Weber, 1991). Finally, through the Vaccine Adverse Events Reporting System (see Chapter 6), the FDA, along with the Centers for Disease Control and Prevention, is responsible for monitoring adverse reactions to vaccines.

THE DRUG EXPORT AMENDMENTS ACT OF 1986

In addition to the export of vaccines under the licensing provisions of the Public Health Service Act, the Drug Export Amendments Act of 1986 (P.L. 99–660) permits the export of unlicensed biological products under certain specified conditions. The Drug Export Amendments establish three separate tracks for the export of unapproved drugs and unlicensed biological products. Under track 1, the FDA is authorized to approve the export of finished products that are not approved for marketing in the United States, but that have the same active ingredients as a product for which marketing approval is actively being sought in the United States. Export under track 1 is limited to 21 specified industrialized countries.

The FDA is also authorized to approve the export of drugs and biologics intended for the treatment of tropical diseases. Congress drafted this provision to enable the export of drugs and biologics intended for diseases and conditions in developing countries but that do not exist to a



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