security countermeasure
(1) In general (A) Use of fund A security countermeasure may, in accordance with this subsection, be procured with amounts in the special reserve fund as defined in subsection (h). (B) Security countermeasure For purposes of this subsection, the term “security countermeasure” means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) )), biological product (as that term is defined by section 262(i) of this title ), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(h) )) that— (i) (I) the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6) to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material threat under paragraph (2)(A)(ii), or to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent; (II) the Secretary determines under paragraph (2)(B)(ii) to be a necessary countermeasure; and (III) (aa) is approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 351 et seq.] or licensed under section 262 of this title ; or (bb) is a countermeasure for which the Secretary determines that sufficient and satisfactory clinical experience or research data (including data, if available, from pre-clinical and clinical trials) support a reasonable conclusion that the countermeasure will qualify for approval or licensing within 10 years after the date of a determination under paragraph (5); or (ii) is authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 360bbb–3 ].