antimicrobial drug
Defined in 1 place of the United States Code.
(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.
Source
- 2016–202621 U.S.C. § 360a-2Food and Drugs · Susceptibility test interpretive criteria for microorganisms · in this section
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.
Source
- 2026–present21 U.S.C. § 360a-2Food and Drugs · Susceptibility test interpretive criteria for microorganisms · in this section