Page:United States Statutes at Large Volume 119.djvu/2846

 119 STAT. 2828

PUBLIC LAW 109–148—DEC. 30, 2005 ‘‘(C) a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), biological product (as such term is defined by section 351(i) of this Act), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)) that is authorized for emergency use in accordance with section 564 of the Federal Food, Drug, and Cosmetic Act. ‘‘(2) COVERED PERSON.—The term ‘covered person’, when used with respect to the administration or use of a covered countermeasure, means— ‘‘(A) the United States; or ‘‘(B) a person or entity that is— ‘‘(i) a manufacturer of such countermeasure; ‘‘(ii) a distributor of such countermeasure; ‘‘(iii) a program planner of such countermeasure; ‘‘(iv) a qualified person who prescribed, administered, or dispensed such countermeasure; or ‘‘(v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv). ‘‘(3) DISTRIBUTOR.—The term ‘distributor’ means a person or entity engaged in the distribution of drugs, biologics, or devices, including but not limited to manufacturers; repackers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies. ‘‘(4) MANUFACTURER.—The term ‘manufacturer’ includes— ‘‘(A) a contractor or subcontractor of a manufacturer; ‘‘(B) a supplier or licenser of any product, intellectual property, service, research tool, or component or other article used in the design, development, clinical testing, investigation, or manufacturing of a covered countermeasure; and ‘‘(C) any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer. ‘‘(5) PERSON.—The term ‘person’ includes an individual, partnership, corporation, association, entity, or public or private corporation, including a Federal, State, or local government agency or department. ‘‘(6) PROGRAM PLANNER.—The term ‘program planner’ means a State or local government, including an Indian tribe, a person employed by the State or local government, or other person who supervised or administered a program with respect to the administration, dispensing, distribution, provision, or use of a security countermeasure or a qualified pandemic or epidemic product, including a person who has established requirements, provided policy guidance, or supplied technical or scientific advice or assistance or provides a facility to administer or use a covered countermeasure in accordance with a declaration under subsection (b). ‘‘(7) QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT.—The term ‘qualified pandemic or epidemic product’ means a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), biological product (as such term is defined by section 351(i) of this Act), or

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