qualified countermeasure

(2) Definitions In this section: (A) Qualified countermeasure The term “qualified countermeasure” means a drug (as that term is defined by section 321(g)(1) of title 21 ), biological product (as that term is defined by section 262(i) of this title ), or device (as that term is defined by section 321(h) of title 21 ), that the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6)— (i) to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security; (ii) 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 that is used as described in this subparagraph; or (iii) is a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii). (B) Infectious disease The term “infectious disease” means a disease potentially caused by a pathogenic organism (including a bacteria, virus, fungus, or parasite) that is acquired by a person and that reproduces in that person.

Source

42 USC § 247d-6a(a)(2)


Scoping language

In this section
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