; and (B) is licensed to operate and dispense prescription drugs to individuals in Canada, or, subject to subsection (e), the permitted country in which the pharmacy is located. (5) Qualifying prescription drug The term qualifying prescription drug — (A) means a prescription drug that— (i) is approved for use in patients, and marketed, in Canada, or subject to subsection (e), approved for use in patients, and marketed, in another permitted country; (ii) is manufactured in a facility registered under subsection (b)(1) or (i) of section 510 that is in compliance with good manufacturing practices regulations of the Food and Drug Administration; (iii) has the same active ingredient or ingredients, route of administration, and strength as a prescription drug approved under chapter V, or, for purposes of subparagraph (B)(iv), is biosimilar to an approved biological product and has the same route of administration and strength as the approved biological product; and (iv) is labeled in accordance with— (I) the laws of Canada, or another country from which importation is permitted pursuant to subsection (e); and (II) the requirements promulgated by the Secretary, which shall include labeling in English; (B) with respect to importers only, includes— (i) peritoneal dialysis solution; (ii) insulin; (iii) a drug for which a risk evaluation and mitigation strategy is required under section 505–1; (iv) biological products, as defined in section 351 of the Public Health Service Act that are proteins (except any chemically synthesized polypeptides) or analogous products; and (v) intravenously infused drugs; and (C) does not include— (i) a controlled substance (as defined in section 102 of the Controlled Substances Act); (ii) an anesthetic drug inhaled during surgery