Page:United States Statutes at Large Volume 100 Part 5.djvu/275

 PUBLIC LAW 99-660—NOV. 14, 1986

100 STAT. 3749

tunity for an informal hearing on such evidence. Upon the expiration of such 60 days the Secretary shall prohibit the export of such drug to such country if the Secretary determines that the holder of the application is exporting the drug to a country which is not listed under subsection (b)(4). "(6) If the Secretary receives credible evidence that an importer is exporting a drug to a country which is not listed under subsection (b)(4), the Secretary shall notify the holder of the application authorizing the export of such drug of such evidence and shall require the holder to investigate the export by such importer and to report to the Secretary within 14 days of the receipt of such notice the findings of the holder. If the Secretary determines that the importer has exported a drug to such a country, the Secretary shall prohibit such holder from exporting such drug to the importer unless the Secretary determines that the export by the importer was unintentional. "(fKl) A drug (including a biological product) which is to be used in the prevention or treatment of a tropical disease may, upon approval of an application submitted under paragraph (2), be exported if— "(A) the Secretary finds, based on credible scientific evidence, including clinical investigations, that the drug is safe and effec'• tive in the country to which it is to be exported in the prevention or treatment of a tropical disease in such country, "(B) the drug is manufactured, processed, packaged, and held in conformity with current good manufacturing practice and is not adulterated under paragraph (a)(D, (a)(2)(A), (a)(3), (c), or (d) of section 501, "(C) the outside of the shipping package is labeled with the ^i^ following statement: 'This drug may be sold or offered for sale only in the following countries: ', the blank space being filled with a list of the countries to which export of the drug is authorized under this subsection, "(D) the drug is not the subject of a notice by the Secretary or the Secretary of Agriculture of a determination that the manufacture of the drug in the United States for export to a country is contrary to the public health and safety of the United States, and "(E) the requirements of subparagraphs (A) through (D) of section 801(d)(l) have been met. "(2) Any person may apply to have a drug exported under paragraph (1). The application shall— "(A) describe the drug to be exported, "(B) list each country to which the drug is to be exported, "(C) contain a certification by the applicant that the drug will not be exported to a country for which the Secretary cannot make a finding described in paragraph (I)(A), "(D) identify the establishments in which the drug is manufactured, and "(E) demonstrate to the Secretary that the drug meets the requirements of paragraph (1). "(3) The holder of an approved application for the export of a drug under this subsection shall report to the Secretary— "(A) the receipt of any information indicating that the drug is being or may have been exported from a country for which the Secretary made a finding under paragraph (I)(A) to a country for which the Secretary cannot make such a finding, and

Reports,

Safety.

21 USC 351. Labeling.

Safety.

21 USC 381.

Reports.

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