Page:United States Statutes at Large Volume 117.djvu/2485

 117 STAT. 2466

Records.

Confidentiality.

VerDate 11-MAY-2000

13:59 Aug 30, 2004

PUBLIC LAW 108–173—DEC. 8, 2003

‘‘(ii) In the case of a prescription drug that is not shipped directly from the first foreign recipient of the prescription drug from the manufacturer, documentation demonstrating that each batch in each shipment offered for importation into the United States was statistically sampled and tested for authenticity and degradation. ‘‘(K) Certification from the importer or manufacturer of the prescription drug that the prescription drug— ‘‘(i) is approved for marketing in the United States and is not adulterated or misbranded; and ‘‘(ii) meets all labeling requirements under this Act. ‘‘(L) Laboratory records, including complete data derived from all tests necessary to ensure that the prescription drug is in compliance with established specifications and standards. ‘‘(M) Documentation demonstrating that the testing required by subparagraphs (J) and (L) was conducted at a qualifying laboratory. ‘‘(N) Any other information that the Secretary determines is necessary to ensure the protection of the public health. ‘‘(2) MAINTENANCE BY THE SECRETARY.—The Secretary shall maintain information and documentation submitted under paragraph (1) for such period of time as the Secretary determines to be necessary. ‘‘(e) TESTING.—The regulations under subsection (b) shall require— ‘‘(1) that testing described in subparagraphs (J) and (L) of subsection (d)(1) be conducted by the importer or by the manufacturer of the prescription drug at a qualified laboratory; ‘‘(2) if the tests are conducted by the importer— ‘‘(A) that information needed to— ‘‘(i) authenticate the prescription drug being tested; and ‘‘(ii) confirm that the labeling of the prescription drug complies with labeling requirements under this Act; be supplied by the manufacturer of the prescription drug to the pharmacist or wholesaler; and ‘‘(B) that the information supplied under subparagraph (A) be kept in strict confidence and used only for purposes of testing or otherwise complying with this Act; and ‘‘(3) may include such additional provisions as the Secretary determines to be appropriate to provide for the protection of trade secrets and commercial or financial information that is privileged or confidential. ‘‘(f) REGISTRATION OF FOREIGN SELLERS.—Any establishment within Canada engaged in the distribution of a prescription drug that is imported or offered for importation into the United States shall register with the Secretary the name and place of business of the establishment and the name of the United States agent for the establishment. ‘‘(g) SUSPENSION OF IMPORTATION.—The Secretary shall require that importations of a specific prescription drug or importations by a specific importer under subsection (b) be immediately suspended on discovery of a pattern of importation of that specific

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