Page:United States Statutes at Large Volume 100 Part 4.djvu/395

 PUBLIC LAW 99-570—OCT. 27, 1986

100 STAT. 3207-116

SEC. 4012. MENTAL HEALTH NEEDS OF THE ELDERLY. i Section 504(c) is amended by adding at the end thereof the follow- 42 USC 290aa-3. ing: "Special consideration shall be given to programs for training and research on the mental health needs of the elderly.". SEC. 4013. TECHNICAL AMENDMENT. Section 504(e) is amended by striking out the period at the end of 42 USC 290aa-3. paragraph (2)(A) and inserting in lieu thereof a semicolon. SEC. 4014. INFANT FORMULAS. (a) Section 412 of the Federal Food, Drug, and Cosmetic Act is 21 USC 350a. amended— (1) by redesignating subsections (e), (f), and (g) as subsections (g), (h), and (i), respectively, (2) by amending the last sentence of paragraph (1) of subsection (g) (as so redesignated) to read as follows: "Such records shall be retained for at least one year after the expiration of the shelf life of the infant formula.", (3) by striking out "(a) and (b)" in the first sentence of subsection (h)(l) (as so redesignated) and inserting in lieu thereof "(a), (b), and (c)", (4) by striking out "(c)(l)" in the second sentence of such subsection and inserting in lieu thereof "(e)(D", (5) by striking out "(e)(l)(B)" in such sentence and inserting in lieu thereof "(d)(l)(B)", (6) by striking out "(a) and (b)" in subsection (h)(2) (as so redesignated) and inserting in lieu thereof "(a), (b), and (c)", and (7) by striking out subsections (a) through (d) and inserting in lieu thereof the following: "(a) An infant formula, including an infant formula powder, shall be deemed to be adulterated if— "(1) such infant formula does not provide nutrients as re' quired by subsection (i), "(2) such infant formula does not meet the quality factor requirements prescribed by the Secretary under subsection (b)(D, or "(3) the processing of such infant formula is not in compliance with the good manufacturing practices and the quality control procedures prescribed by the Secretary under subsection (b)(2). "(b)(1) The Secretary shall by regulation establish requirements for quality factors for infant formulas to the extent possible consistent with current scientific knowledge, including quality factor requirements for the nutrients required by subsection (i). "(2)(A) The Secretary shall by regulation establish good manufacturing practices for infant formulas, including quality control procedures that the Secretary determines are necessary to assure that an infant formula provides nutrients in accordance with this subsection ^ ' -^ ^ ' and subsection (i) and is manufactured in a manner designed to prevent adulteration of the infant formula. "(B) The good manufacturing practices and quality control procedures prescribed by the Secretary under subparagraph (A) shall include requirements for— "(i) the testing, in accordance with paragraph (3) and by the manufacturer of an infant formula or an agent of such manufacturer, of each batch of infant formula for each nutrient required by subsection (i) before the distribution of such batch,

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