Page:United States Statutes at Large Volume 114 Part 2.djvu/853

 PUBLIC LAW 106-387 —APPENDIX 114 STAT. 1549A-39 (a), the Comptroller General shall prepare and submit to the Congress a report describing the findings of such study. "(j) CONSTRUCTION.— Nothing in this section shall be construed to limit the statutory, regulatory, or enforcement authority of the Secretary relating to the importation of covered products, other than with respect to section 801(d)(1) as provided in this section. " (k) DEFINITIONS.— "(1) COVERED PRODUCT.— " (A) IN GENERAL.—For purposes of this section, the term 'covered product' means a prescription drug, except that such term does not include a controlled substance in schedule I, II, or III under section 202(c) of the Controlled Substances Act or a biological product as defined in section 351 of the Public Health Service Act. " (B) CHARITABLE CONTRIBUTIONS; PARENTERAL DRUGS. — Notwithstanding any other provision of this section, section 801(d)(1)— "(i) continues to apply to a covered product donated or otherwise supplied for free by the manufacturer of the drug to a charitable or humanitarian organization, including the United Nations and affiliates, or to a government of a foreign country; and "(ii) continues to apply to a covered product that is a parenteral drug the importation of which pursuant to subsection (a) is determined by the Secretary to pose a threat to the public health. "(2) OTHER TERMS.— For purposes of this section: "(A) The term 'importer' means a pharmacist or wholesaler. "(B) The term 'pharmacist' means a person licensed by a State to practice pharmacy, including the dispensing and selling of prescription drugs. "(C) The term 'prescription drug' means a drug subject to section 503(b). "(D) The term 'qualifying laboratory' means a laboratory in the United States that has been approved by the Secretary for purposes of this section. "(E) The term 'wholesaler' means a person licensed as a wholesaler or distributor of prescription drugs in the United States pursuant to section 503(e)(2)(A). Such term does not include a person authorized to import drugs under section 801(d)(1). "(1) CONDITIONS.— Th is section shall become effective only if the Secretary demonstrates to the Congress that the implementation of this section will— "(1) pose no additional risk to the public's health and safety; and "(2) result in a significant reduction in the cost of covered products to the American consumer. "(m) SUNSET.—Effective upon the expiration of the 5-year period beginning on the effective date of final regulations under subsection (a), this section ceases to have any legal effect.", (d) PROHIBITED ACT. — (1) IN GENERAL.— Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:

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