MODERNIZATION OF REGULATION.

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 biologics 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 biologics licenses. “(B) The Secretary shall approve a biologics 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.”. 111 STAT. 2324 (c) Inspection.—Section 351(c) of the Public Health Service Act (42 U.S.C. 262(c)) is amended by striking “virus, serum,” and all that follows and inserting “biological product.”. (d) Definition; Application.—Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended by adding at the end the following: “(i) In this section, the term ‘biological product’ means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphen-amine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.”. (e) Conforming Amendment.—Section 503(g)(4) (21 U.S.C. 353(g)(4)) is amended— (1) in subparagraph (A)— (A) by striking “section 351(a)” and inserting “section 351(i)”; and (B) by striking “262(a)” and inserting “262(i)”; and (2) in subparagraph (B)(iii), by striking “product or establishment license under subsection (a) or (d)” and inserting “biologics license application under subsection (a)”. (f) Special Rule.—The Secretary of Health and Human Services shall take measures to minimize differences in the review and approval of products required to have approved biologics license applications under section 351 of the Public Health Service Act (42 U.S.C. 262) and products required to have approved new drug applications under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)). (g) Application of Federal Food, Drug, and Cosmetic Act.—Section 351 of the Public Health Service Act (42 U.S.C. 262), as amended by subsection (d), is further amended by adding at the end the following: “(j) The Federal Food, Drug, and Cosmetic Act applies to a biological product subject to regulation under this section, except that a product for which a license has been approved under subsection (a) shall not be required to have an approved application under section 505 of such Act.”. (h) Examinations and Procedures.—Paragraph (3) of section 353(d) of the Public Health Service Act (42 U.S.C. 263a(d)) is amended to read as follows: “(3) Examinations and procedures.—The examinations and procedures identified in paragraph (2) are laboratory examinations and procedures that have been approved by the Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that— “(A) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or “(B) the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly.”.