Page:United States Statutes at Large Volume 110 Part 2.djvu/465

 PUBLIC LAW 104-134—APR. 26, 1996 110 STAT. 1321-318 "(e)(1) A drug or device which is used in the diagnosis, prevention, or treatment of a tropical disease or another disease not of significant prevalence in the United States and which does not otherwise qualify for export under this section shall, upon approval of an application, be permitted to be exported if the Secretary finds that the drug or device will not expose patients in such country to an unreasonable risk of illness or injury and the probable benefit to health from the use of the drug or device (under conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling of the drug or device) outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available drug or device treatment. "(2) The holder of an approved application for the export of Reports. a drug or device under this subsection shall report to the Secretary— "(A) the receipt of any credible information indicating that the drug or device is being or may have been exported from a country for which the Secretary made a finding under paragraph (1)(A) to a country for which the Secretary cannot make such a finding; and "(B) the receipt of any information indicating adverse reactions to such drug. "(3)(A) If the Secretary determines that— "(i) a drug or device for which an application is approved under paragraph (1) does not continue to meet the requirements of such paragraph; or "(ii) the holder of an approved application under paragraph (1) has not made the report required by paragraph (2), the Secretary may, after providing the holder of the application an opportunity for an informal hearing, withdraw the approved application. "(B) If the Secretary determines that the holder of an approved application under paragraph (1) or an importer is exporting a drug or device from the United States to an importer and such importer is exporting the drug or device to a country for which the Secretary cannot make a finding under paragraph (1) and such export presents an imminent hazard, the Secretary shall immediately prohibit the export of the drug or device to such importer, provide the person exporting the drug or device from the United States prompt notice of the prohibition, and afford such person an opportunity for an expedited hearing. "(f) A drug or device may not be exported under this section— "(1) if the drug or device is not manufactured, processed, packaged, and held in substantial conformity with current good manufacturing practice requirements or does not meet international standards as certified by an international standards organization recognized by the Secretary; "(2) if the drug or device is adulterated under clause (1), (2)(A), or (3) of section 501(a) or subsection (c) or (d) of section 501; "(3) if the requirements of subparagraphs (A) through (D) of section 801(e)(1) have not been met; "(4)(A) if the diTig or device is the subject of a notice by the Secretary or the Secretary of Agriculture of a determination that the probability of reimportation of the exported drug or device would present an imminent hazard to the public health and safety of the United States and the only means

�