Sec. 6. Good manufacturing practices
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Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq.), as amended by section 5, is further amended by adding at the end the following: The Secretary shall by regulation establish good manufacturing practices for cosmetics in accordance with paragraphs
(a)and
(d)of section 601. Such regulations— shall be modeled after comparable good manufacturing practice standards for cosmetics in effect at the time of promulgation; may not impose standards for which there is no current and generally available analytical methodology; may ensure that cosmetics do not cause serious adverse health consequences or death; shall be intended to protect the public health; and shall not apply to entities described in clauses
(i)and
(ii)of section 604(c)(1)(B). In promulgating regulations under paragraph (1), the Secretary shall consider facilities that are subject to other, similar regulations, as appropriate. A regulation under subsection
(a)shall be promulgated only after providing notice and an opportunity for comment in accordance with chapter 5 of title 5, United States Code. The Secretary shall provide for an additional year after the effective date of the regulations under subsection
(a)for small businesses (as described in section 604(c)(1)(B)(iii)) to comply with the good manufacturing practices established in accordance with subsection (a), and issue guidance for small businesses for purposes of compliance with this section. In establishing good manufacturing practices under this section, the Secretary shall take into account the practices of small business, including the size and scope of the business, and consult with the Small Business Administration, as appropriate. No State or political subdivision of a State may establish or continue in effect any law, regulation, order, or other requirement with respect to good manufacturing practice standards for cosmetics that is different from the requirements under this section. . Section 601 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 ) is amended by adding at the end the following: If it has been manufactured under conditions that do not meet current good manufacturing practice regulations established under section 605. .
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Sec. 6
Good manufacturing practices
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