Page:United States Statutes at Large Volume 114 Part 2.djvu/851

 PUBLIC LAW 106-387 —APPENDIX 114 STAT. 1549A-37 "(3) Documentation from the foreign seller specifying the original source of the product and the amount of each lot of the product originally received. "(4) The manufacturer's lot or control number of the product imported. "(5) The name, address, and telephone number of the importer, including the professional license number of the importer, if any. "(6) For a product that is coming directly from the first foreign recipient of the product from the manufacturer: "(A) Documentation demonstrating that such product came from such recipient and was received by the recipient from such manufacturer. "(B) Documentation of the amount of each lot of the product received by such recipient to demonstrate that the amount being imported into the United States is not more than the amount that was received by the recipient. "(C) In the case of the initial imported shipment, documentation demonstrating that each batch of such shipment was statistically sampled and tested for authenticity and degradation. "(D) In the case of all subsequent shipments from such recipient, documentation demonstrating that a statistically valid sample of such shipments was tested for authenticity and degradation. "(E) Certification from the importer or manufacturer of such product that the product is approved for marketing in the United States and meets all labeling requirements under this Act. "(7) For a product that is not coming directly from the first foreign recipient of the product from the manufacturer: "(A) Documentation demonstrating that each batch in all shipments offered for importation into the United States was statistically sampled and tested for authenticity and degradation. "(B) Certification from the importer or manufacturer of such product that the product is approved for marketing in the United States and meets all labeling requirements under this Act. "(8) Laboratory records, including complete data derived from all tests necessary to assure that the product is in compliance with established specifications and standards. "(9) Documentation demonstrating that the testing required by paragraphs (6) through (8) was performed at a qualifying laboratory (as defined in subsection (k)). "(10) Any other information that the Secretary determines is necessary to ensure the protection of the public health. "(e) TESTING.— Regulations under subsection (a)— "(1) shall require that testing referred to in paragraphs (6) through (8) of subsection (d) be conducted by the importer of the covered product pursuant to subsection (a), or the manufacturer of the product; "(2) shall require that if such tests are conducted by the importer, information needed to authenticate the product being tested, and to confirm that the labeling of such product complies with labeling requirements under this Act, be supplied by the manufacturer of such product to the pharmacist or wholesaler,

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