117 STAT. 2464 21 USC 355 note.
PUBLIC LAW 108–173—DEC. 8, 2003
SEC. 1118. EFFECTIVE DATE.
This subtitle shall— (1) take effect 30 days after the date of the enactment of this Act; and (2) shall apply to agreements described in section 1112 that are entered into 30 days after the date of the enactment of this Act.
Subtitle C—Importation of Prescription Drugs SEC. 1121. IMPORTATION OF PRESCRIPTION DRUGS. 21 USC 384.
(a) IN GENERAL.—Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) is amended by striking section 804 and inserting the following: ‘‘SEC. 804. IMPORTATION OF PRESCRIPTION DRUGS.
‘‘(a) DEFINITIONS.—In this section: ‘‘(1) IMPORTER.—The term ‘importer’ means a pharmacist or wholesaler. ‘‘(2) PHARMACIST.—The term ‘pharmacist’ means a person licensed by a State to practice pharmacy, including the dispensing and selling of prescription drugs. ‘‘(3) PRESCRIPTION DRUG.—The term ‘prescription drug’ means a drug subject to section 503(b), other than— ‘‘(A) a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)); ‘‘(B) a biological product (as defined in section 351 of the Public Health Service Act (42 U.S.C. 262)); ‘‘(C) an infused drug (including a peritoneal dialysis solution); ‘‘(D) an intravenously injected drug; ‘‘(E) a drug that is inhaled during surgery; or ‘‘(F) a drug which is a parenteral drug, the importation of which pursuant to subsection (b) is determined by the Secretary to pose a threat to the public health, in which case section 801(d)(1) shall continue to apply. ‘‘(4) QUALIFYING LABORATORY.—The term ‘qualifying laboratory’ means a laboratory in the United States that has been approved by the Secretary for the purposes of this section. ‘‘(5) WHOLESALER.— ‘‘(A) IN GENERAL.—The term ‘wholesaler’ means a person licensed as a wholesaler or distributor of prescription drugs in the United States under section 503(e)(2)(A). ‘‘(B) EXCLUSION.—The term ‘wholesaler’ does not include a person authorized to import drugs under section 801(d)(1). ‘‘(b) 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 prescription drugs from Canada into the United States. ‘‘(c) LIMITATION.—The regulations under subsection (b) shall— ‘‘(1) require that safeguards be in place to ensure that each prescription drug imported under the regulations complies with section 505 (including with respect to being safe and
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