Page:United States Statutes at Large Volume 117.djvu/1703

 117 STAT. 1684

PUBLIC LAW 108–136—NOV. 24, 2003

as may be necessary for the costs incurred by the Secretary in the procurement of countermeasures under this section. SEC. 1603. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.

(a) IN GENERAL.—Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the following section: 21 USC 360bbb– 3.

‘‘SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.

‘‘(a) IN GENERAL.— ‘‘(1) EMERGENCY USES.—Notwithstanding sections 505, 510(k), and 515 of this Act and section 351 of the Public Health Service Act, and subject to the provisions of this section, the Secretary may authorize the introduction into interstate commerce, during the effective period of a declaration under subsection (b), of a drug, device, or biological product intended for use in an actual or potential emergency (referred to in this section as an ‘emergency use’). ‘‘(2) APPROVAL STATUS OF PRODUCT.—An authorization under paragraph (1) may authorize an emergency use of a product that— ‘‘(A) is not approved, licensed, or cleared for commercial distribution under a provision of law referred to in such paragraph (referred to in this section as an ‘unapproved product’); or ‘‘(B) is approved, licensed, or cleared under such a provision, but which use is not under such provision an approved, licensed, or cleared use of the product (referred to in this section as an ‘unapproved use of an approved product’). ‘‘(3) RELATION TO OTHER USES.—An emergency use authorized under paragraph (1) for a product is in addition to any other use that is authorized for the product under a provision of law referred to in such paragraph. ‘‘(4) DEFINITIONS.—For purposes of this section: ‘‘(A) The term ‘biological product’ has the meaning given such term in section 351 of the Public Health Service Act. ‘‘(B) The term ‘emergency use’ has the meaning indicated for such term in paragraph (1). ‘‘(C) The term ‘product’ means a drug, device, or biological product. ‘‘(D) The term ‘unapproved product’ has the meaning indicated for such term in paragraph (2)(A). ‘‘(E) The term ‘unapproved use of an approved product’ has the meaning indicated for such term in paragraph (2)(B). ‘‘(b) DECLARATION OF EMERGENCY.— ‘‘(1) IN GENERAL.—The Secretary may declare an emergency justifying the authorization under this subsection for a product on the basis of a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a specified biological, chemical, radiological, or nuclear agent or agents. ‘‘(2) TERMINATION OF DECLARATION.—

VerDate 11-MAY-2000

10:15 Aug 27, 2004

Jkt 019194

PO 00000

Frm 00636

Fmt 6580

Sfmt 6581

D:\STATUTES\2003\19194PT2.001

APPS10

PsN: 19194PT2

�