pharmaceutical or medical device production business means the trade or business of producing qualified pharmaceuticals in commercial quantities. (B) Qualified pharmaceuticals (i) In general The term qualified pharmaceuticals means pharmaceuticals, active pharmaceutical ingredients, excipients, medical diagnostic devices, or personal protective equipment. (ii) Pharmaceutical The term pharmaceuticals — (I) means any drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act), and (II) includes a biological product (as defined in section 351 of the Public Health Service Act). (iii) 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 (or any successor regulations). (iv) 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, and (II) includes any such filler, extenders, diluent, wetting agent, solvent, emulsifier, preservative, flavor, absorption enhancer, sustained release matrix, and coloring agent. (v) Medical diagnostic device The term medical diagnostic device means any device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act) intended for use in the diagnosis of disease or other conditions. (vi) Personal protective equipment The term personal protective equipment means— (I) any device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act) that is a face mask, filtering facepiece respirator, face shield, surgical mask, gown, other apparel, or glove that is intended for a medical purpose, and (II) any particulate filtering air purifying respiratory protective device that is approved by the National Institute for Occupational Safety and Health under part 84 of title 42, Code of Federal Regulations (or successor regulations). (3) Certain health plan expenses