in a distressed zone). (2) Qualified pharmaceutical or medical device production business (A) In general The term qualified pharmaceutical or medical device production business means the trade or business of producing pharmaceuticals, excipients, active pharmaceutical ingredients, medical diagnostic devices, or personal protective equipment. (B) Active pharmaceutical ingredient The term active pharmaceutical ingredients has the meaning given to such term in section 207.1 of title 21, Code of Federal Regulations (and any successor regulations). (C) Excipient The term excipient — (i) means any inactive ingredient that is intentionally added to a pharmaceutical that is not intended to exert therapeutic effects at the intended dosage, other than by acting to improve product delivery