117 STAT. 2468
PUBLIC LAW 108–173—DEC. 8, 2003
‘‘(E) is in the form of a final finished dosage that was manufactured in an establishment registered under section 510; and ‘‘(F) is imported under such other conditions as the Secretary determines to be necessary to ensure public safety. ‘‘(k) CONSTRUCTION.—Nothing in this section limits the authority of the Secretary relating to the importation of prescription drugs, other than with respect to section 801(d)(1) as provided in this section. ‘‘(l) EFFECTIVENESS OF SECTION.— ‘‘(1) COMMENCEMENT OF PROGRAM.—This section shall become effective only if the Secretary certifies to the Congress that the implementation of this section will— (A) pose no additional risk to the public’s health and safety; and (B) result in a significant reduction in the cost of covered products to the American consumer. ‘‘(2) TERMINATION OF PROGRAM.— ‘‘(A) IN GENERAL.—If, after the date that is 1 year after the effective date of the regulations under subsection (b) and before the date that is 18 months after the effective date, the Secretary submits to Congress a certification that, in the opinion of the Secretary, based on substantial evidence obtained after the effective date, the benefits of implementation of this section do not outweigh any detriment of implementation of this section, this section shall cease to be effective as of the date that is 30 days after the date on which the Secretary submits the certification. ‘‘(B) PROCEDURE.—The Secretary shall not submit a certification under subparagraph (A) unless, after a hearing on the record under sections 556 and 557 of title 5, United States Code, the Secretary— ‘‘(i)(I) determines that it is more likely than not that implementation of this section would result in an increase in the risk to the public health and safety; ‘‘(II) identifies specifically, in qualitative and quantitative terms, the nature of the increased risk; ‘‘(III) identifies specifically the causes of the increased risk; and ‘‘(IV)(aa) considers whether any measures can be taken to avoid, reduce, or mitigate the increased risk; and ‘‘(bb) if the Secretary determines that any measures described in item (aa) would require additional statutory authority, submits to Congress a report describing the legislation that would be required; ‘‘(ii) identifies specifically, in qualitative and quantitative terms, the benefits that would result from implementation of this section (including the benefit of reductions in the cost of covered products to consumers in the United States, allowing consumers to procure needed medication that consumers might not otherwise be able to procure without foregoing other necessities of life); and
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