Page:United States Statutes at Large Volume 110 Part 2.djvu/462

 110 STAT. 1321-315 PUBLIC LAW 104-134—APR. 26, 1996 labeling requirements or conditions for use and such country requires the drug to be labeled in accordance with those requirements or uses, such drug may be labeled in accordance with such requirements and conditions for use in the country to which such drug is being exported if it also is labeled in accordance with the requirements of this Act. "(2) If, pursuant to paragraph (1), the labeling of an exported drug includes conditions for use that have not been approved under this Act, the labeling must state that such conditions for use have not been approved under this Act.". (d) EXPORT OF CERTAIN UNAPPROVED DRUGS AND DEVICES. — (1) AMENDMENT.— Section 802 (21 U.S.C. 382) is amended to read as follows: " E XPORTS OF CERTAIN UNAPPROVED PRODUCTS "SEC. 802. (a) A drug or device— "(1) which, in the case of a drug— "(A)(i) requires approval by the Secretary under section 505 before such drug may be introduced or delivered for introduction into interstate commerce; or "(ii) requires licensing by the Secretary under section 351 of the Public Health Service Act or by the Secretary of Agriculture under the Act of March 4, 1913 (known as the Virus-Serum Toxin Act) before it may be introduced or delivered for introduction into interstate commerce; "(B) does not have such approval or license; and "(C) is not exempt from such sections or Act; and "(2) which, in the case of a device— "(A) does not comply with an applicable requirement under section 514 or 515; "(B) under section 520(g) is exempt from either such section; or "(C) is a banned device under section 516, is adulterated, misbranded, and in violation of such sections or Act unless the export of the drug or device is, except as provided in subsection (f), authorized under subsection (b), (c), (d), or (e) or section 801(e)(2). If a drug or device described in paragraphs (1) and (2) may be exported under subsection (b) and if an application for such drug or device under section 505 or 515 or section 351 of the Public Health Service Act was disapproved, the Secretary shall notify the appropriate public health official of the country to which such drug will be exported of such disapproval. "(b)(1)(A) A drug or device described in subsection (a) may be exported to any country, if the drug or device complies with the laws of that country and has valid marketing authorization by the appropriate authority— "(i) in Australia, Canada, Israel, Japan, New Zealand, Switzerland, or South Africa; or "(ii) in the European Union or a country in the European Economic Area (the countries in the European Union and the European Free Trade Association) if the drug or device is marketed in that country or the drug or device is authorized for general marketing in the European Economic Area. "(B) The Secretary may designate an additional country to be included in the list of countries described in clauses (i) and

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