Page:United States Statutes at Large Volume 100 Part 5.djvu/270

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PUBLIC LAW 99-000—MMMM. DD, 1986

100 STAT. 3744

PUBLIC LAW 99-660—NOV. 14, 1986

"(I) which has an exemption under section 505(i), and "(II) for which approval is actively being pursued by the person who has the exemption, "(ii) biological product for human use— "(I) which has an exemption under section 505(i), and n; tiQj^ Qj. ^jjjgjj licensing of the biological product 42 USC 262. under section 351 of the Public Health Service Act is v. actively being pursued by the person who has the exemption, "(iii) biological product for animal use— "(I) for which authority heis been granted under the Virus-Serum Toxin Act for the preparation of an 21 USC 151 note. experimental drug product, and "(II) for which the licensing of the biological product under such Act is actively being pursued by the person who has the authority, or ^ "(iv) new animal drug— . *. "(I) which has an exemption under section 512(j), and 21 USC 360b. "(II) for which approval is actively being pursued by the person who has the exemption, "(B) except as provided in paragraph (2), the drug is exported to a country which is listed under paragraph (4) and in which the drug is approved and has not been withdrawn from sale, "(C) an application for the drug under section 505 or 512, section 351 of the Public Health Service Act, or the VirusSerum Toxin Act has not been disapproved by an order of the Secretary under section 505(d) or 512(d) or 351 of the Public Health Service Act or by the Secretary of Agriculture in the case of an application under the Virus-Serum Toxin Act, "(D) 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, 21 USC 351. Labeling. "(E) the outside of the shipping package is labeled with the 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, "(F) the drug is not the subject of a notice by the Secretary or Safety. 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, "(G) the requirements of subparagraphs (A) through (D) of section 801(d)(l) have been met. 21 USC 381. The Secretary shall determine that an applicant is actively pursuing the approval or licensing of a drug if the applicant has demonstrated that degree of attention and continuous directed effort as may reasonably be expected from, and are ordinarily exercised by, a person before approval or licensing of a drug, such as the preparation for and the conduct of preclinical or clinical investigations, the analysis of the results of such investigations, conferences on such investigations with government officials, and the preparation of an application of approval or licensing for the drug. "(2) The Secretary may permit the export of a drug under paragraph (1) to a country which is listed under paragraph (4) and in which the drug is not approved if the drug is exported to such 21 USC 355.