PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2323 SEC. 123. MODERNIZATION OF REGULATION. (a) LICENSES. — (1) IN GENERAL.— Section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) is amended to read as follows: "(a)(1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless— "(A) a biologies license is in effect for the biological product; and " (B) each package of the biological product is plainly marked with— "(i) the proper name of the biological product contained in the package; "(ii) the name, address, and applicable license number of the manufacturer of the biological product; and "(iii) the expiration date of the biological product. "(2)(A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologies licenses. "(B) The Secretary shall approve a biologies license application— "(i) on the basis of a demonstration that— "(I) the biological product that is the subject of the application is safe, pure, and potent; and "(II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and "(ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c). "(3) The Secretary shall prescribe requirements under which a biological product undergoing investigation shall be exempt from the requirements of paragraph (1).". (2) ELIMINATION OF EXISTING LICENSE REQUIREMENT.—Section 351(d) of the Public Health Service Act (42 U.S.C. 262(d)) is amended— (A) by striking "(d)(1)" and all that follows through "of this section."; (B) in paragraph (2)— (i) by striking "(2)(A) Upon" and inserting "(d)(1) Upon"and (ii) by redesignating subparagraph (B) as paragraph (2); and (C) in paragraph (2) (as so redesignated by subparagraph (B)(ii))— (i) by striking "subparagraph (A)" and inserting "paragraph (1)"; and (ii) by striking "this subparagraph" each place it appears and inserting "this paragraph". (b) LABELING.— Section 351(b) of the Public Health Service Act (42 U.S.C. 262(b)) is amended to read as follows: "(b) No person shall falsely label or mark any package or container of any biological product or alter any label or mark on the package or container of the biological product so as to falsify the label or mark.".
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