114 STAT. 1549A-36 PUBLIC LAW 106-387 —APPENDIX (2) Millions of Americans, including Medicare beneficiaries on fixed incomes, face a daily choice between purchasing lifesustaining prescription drugs, or paying for other necessities, such as food and housing. (3) Many life-saving prescription drugs are available in countries other than the United States at substantially lower prices, even though such drugs were developed and are approved for use by patients in the United States. (4) Many Americans travel to other countries to purchase prescription drugs because the medicines that they need are unaffordable in the United States. (5) Americans should be able to purchase medicines at prices that are comparable to prices for such medicines in other countries, but efforts to enable such purchases should not endanger the gold standard for safety and effectiveness that has been established and maintained in the United States, (c) AMENDMENT.—Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) is amended— (1) in section 801(d)(1), by inserting "and section 804" after "paragraph (2)"; and (2) by adding at the end the following: "IMPORTATION OF COVERED PRODUCTS "SEC. 804. (a) REGULATIONS. — The Secretary, after consultation with the United States Trade Representative and the Commissioner of Customs, shall promulgate regulations permitting pharmacists and wholesalers to import into the United States covered products. "(b) LIMITATION.— Regulations under subsection (a) shall— "(1) require that safeguards be in place to ensure that each covered product imported pursuant to such subsection complies with section 505 (including with respect to being safe and effective for its intended use), with sections 501 and 502, and with other applicable requirements of this Act; "(2) require that an importer of a covered product pursuant to subsection (a) comply with the applicable provisions of this section, including subsection (d); and "(3) contain any additional provisions determined by the Secretary to be appropriate as a safeguard to protect the public health or as a means to facilitate the importation of such products. "(c) RECORDS.—Regulations under subsection (a) shall require that records regarding the importation of covered products pursuant to such subsection be provided to and maintained by the Secretary for a period of time determined to be necessary by the Secretary. "(d) IMPORTATION. — Regulations under subsection (a) shall require an importer of a covered product pursuant to such subsection to provide to the Secretary the following information and records: "(1) The name and amount of the active ingredient of such product and description of the dosage form. "(2) The date that the product is shipped and the quantity of the product that is shipped, points of origin and destination for the product, the price paid for the product by the importer, and (once the product is distributed) the price for which such product is sold by the importer.
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