Page:United States Statutes at Large Volume 100 Part 5.djvu/273

 PUBLIC LAW 99-660—NOV. 14, 1986

100 STAT. 3747

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"(ii) Statutory or regulatory requirements that the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of drugs in the country are adequate to preserve their identity, quality, purity, and strength, "(iii) Statutory or regulatory requirements for the reporting of adverse reactions to drugs and procedures to withdraw approval and remove drugs found not to be safe or effective, "(iv) Statutory or regulatory requirements that the labeling and promotion of drugs must be in accordance with the approval of the drug. "(c)(1) The holder of an approved application under subsection Qi) authorizing the export of a drug shall report to the Secretary— "(A) any withdrawal of an approval of the drug by any country to which it has been exported, "(B) any withdrawal of the drug from sale in any such country, "(C) the withdrawal of an application by the holder under section 505 or 512, section 351 of the Public Health Service Act, or the Virus-Serum Toxin Act, and "(D) the receipt of any credible information indicating that the drug is being or may have been exported from a country listed under subsection (b)(4) to a country which is not listed under such subsection. The reporting of an event described in subparagraph (A), (B), or (C) shall be made within 15 days of the occurrence of the event and the reporting of the receipt of information under subparagraph (D) shall be made within 15 days of the receipt of such information. "(2) The holder of an approved application under subsection (b) authorizing the export of a drug shall report annually to the Secretary after the date of the approval of the application of the actions taken by the holder in pursuit of the approval of such drug during the yeai reported on. Not later than 90 days from the date of the receipt of a report under this paragraph the Secretary shall determine if the holder is actively pursuing the approval of such drug. "(d) A drug authorized to be exported to a country under an application approved under subsection (b) may not be exported to such country if— "(1) an approval of such drug is withdrawn by such country, "(2) the drug is withdrawn from sale in such country, ^^ "(3) the Secretary issues an order refusing to approve an application of the holder of such application under section 505 or 512, section 351 of the Public Health Service Act, or the Virus-Serum Toxin Act, or "(4) an application for such drug under such section or Act is withdrawn or if an exemption for such drug under section 505(i) or 512(j) or the authority granted for such drug to prepare an experimental drug product under the Virus-Serum Toxin Act is withdrawn and no application for approval of such drug has been submitted under section 505 or 512, section 351 of the Public Health Service Act, or the Virus-Serum Toxin Act. "(e)(1) If the Secretary determines that— "(A) a drug for which an application was approved under subsection (b) no longer complies with subparagraphs (A), (D), (E), and (G) of paragraph (1) of such subsection or with paragraph (2) of such subsection or the holder of such application has not made the reports required by subsection (c), or

Safety.

Labeling. Marketing. Reports.

21 USC 355, 3606; 42 USC 262. 21 USC 151 note.

Reports.

Reports.

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