; (B) is dispensed by a pharmacist licensed to practice pharmacy and dispense prescription drugs in Canada; (C) is purchased for personal use by the individual, not for resale, in quantities that do not exceed a 90-day supply; (D) is filled using a valid prescription issued by a physician licensed to practice in a State in the United States; and (E) has the same active ingredient or ingredients, route of administration, dosage form, and strength as a prescription drug approved by the Secretary under chapter V; and (2) does not include— (A) a controlled substance (as defined in section 102 of the Controlled Substances Act); (B) a biological product (as defined in section 351 of the Public Health Service Act); (C) an infused drug (including a peritoneal dialysis solution); (D) an intravenously injected drug; (E) a drug that is inhaled during surgery; (F) a parenteral drug; (G) a drug manufactured through one or more biotechnology processes, including— (i) a therapeutic DNA plasmid product; (ii) a therapeutic synthetic peptide product of not more than 40 amino acids; (iii) a monoclonal antibody product for in vivo use; and (iv) a therapeutic recombinant DNA-derived product; (H) a drug required to be refrigerated at any time during manufacturing, packing, processing, or holding; or (I) a photoreactive drug. (c) Approved Canadian pharmacy (1) In general In this section, an approved Canadian pharmacy is a pharmacy that— (A) is located in Canada; and (B) the Secretary certifies— (i) is licensed to operate and dispense prescription drugs to individuals in Canada