Sec. 6. Definitions
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In this Act: The term covered pediatric cancer drug means a drug— that is included on the essential pediatric cancer drug list established under section 3; that may be at risk of a meaningful disruption (as defined in section 506J(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356j(j) )) in the supply of the drug; and whose final dosage form is manufactured at an eligible source facility. The term drug — means a drug (as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g) )); and includes a biological product (as defined in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) )).
The term eligible source facility means a facility— registered under section 510 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360 ); lawfully manufacturing a covered pediatric cancer drug; and located in— the United States; or a country that is a member of the Organisation for Economic Co-operation and Development. The term essential pediatric cancer drug list means the list under section 3(a). The term Secretary means the Secretary of Health and Human Services. The term United States means each of the several States and the territories and possessions of the United States.
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