110 STAT. 1321-319 PUBLIC LAW 104-134—APR. 26, 1996 Records. of limiting the hazard is to prohibit the export of the drug or device; or "(B) if the drug or device presents an imminent hazard to the public health of the country to which the drug or device would be exported; "(5) if the drug or device is not labeled— "(A) in accordance with the requirements and conditions for use in— "(i) the country in which the drug or device received valid marketing authorization under subsection (b); and "(ii) the country to which the drug or device would be exported; and "(B) in the language and units of measurement of the country to which the drug or device would be exported or in the language designated by such country; or "(6) if the drug or device is not promoted in accordance with the labeling requirements set forth in paragraph (5). In making a finding under paragraph (4)(B), (5), or (6) the Secretary shall consult with the appropriate public health official in the affected country. "(g) The exporter of a drug or device exported under subsection (b)(1) shall provide a simple notification to the Secretary identifying the drug or device when the exporter first begins to export such drug or device to any country listed in clause (i) or (ii) of subsection (b)(1)(A). When an exporter of a drug or device first begins to export a drug or device to a country which is not listed in clause (i) or (ii) of subsection (b)(l)A), the exporter shall provide a simple notification to the Secretary identifying the drug or device and the country to which such drug or device is being exported. Any exporter of a drug or device shall maintain records of all drugs or devices exported and the countries to which they were exported. "(h) For purposes of this section— "(1) a reference to the Secretary shall in the case of a biological product which is required to be licensed under the Act of March 4, 1913 (37 Stat. 832-833) (commonly known as the Virus-Serum Toxin Act) be considered to be a reference to the Secretary of Agriculture, and "(2) the term 'drug' includes drugs for human use as well as biologicals under section 351 of the Public Health Service Act or the Act of March 4, 1913 (37 Stat. 832-833) (commonly known as the Virus-Serum Toxin Act).". (2) CONFORMING AMENDMENTS.^^ection 351(h) of the Public Health Service Act (42 U.S.C. 262(h)) is amended by striking " 802(b)(A)" and inserting "802(b)(1)" and by striking "802(b)(4)" and inserting "802(b)(1)". SEC. 2103. PROHIBITED ACT. Section 301 (21 U.S.C. 331) is amended— (1) by redesignating the second subsection (u) as subsection (v); and (2) by adding at the end thereof the following: "(w) The making of a knowingly false statement in any record or report required or requested under subparagraph (A) or (B) of section 801(d)(3), the failure to submit or maintain records as required by sections 801(d)(3)(A) and 801(d)(3)(B), the release into interstate commerce of any article imported into the United States
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