antimicrobial drug
(4) (A) The term “antimicrobial drug” means, subject to subparagraph (B), a systemic antibacterial or antifungal drug that— (i) is intended for human use in the treatment of a disease or condition caused by a bacterium or fungus; (ii) may include a qualified infectious disease product designated under section 355f(d) of this title ; and (iii) is subject to section 353(b)(1) of this title . (B) If provided by the Secretary through regulations, such term may include— (i) drugs other than systemic antibacterial and antifungal drugs; and (ii) biological products (as such term is defined in section 262 of title 42 ) to the extent such products exhibit antimicrobial activity.