Page:United States Statutes at Large Volume 111 Part 3.djvu/236

 Ill STAT. 2324 PUBLIC LAW 105-115—NOV. 21, 1997 (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 arsphenamine 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 "biologies license application under subsection (a)". 21 USC 355 note. (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 biologies 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.". SEC. 124. PILOT AND SMALL SCALE MANUFACTURE. (a) HUMAN DRUGS. —Section 505(c) (21 U.S.C. 355(c)) is amended by adding at the end the following:

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