Sec. 103. Good manufacturing practices for cosmetics
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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 102, is further amended by adding at the end the following: The Secretary shall— review national and international standards for cosmetic good manufacturing practices that are in effect on the date of enactment of the Cosmetic Safety Enhancement Act of 2019 ; and issue a rule establishing current good manufacturing standards consistent, to the extent the Secretary determines practicable and appropriate, with such national and international standards.
The regulations issued pursuant to subsection (a)(2)— may specify requirements for the use of certain analytical or recordkeeping methods by a manufacturer as may be necessary to ensure that a cosmetic product or cosmetic formulation is not injurious to health under the recommended or suggested conditions of use, or customary or usual use of the product or formulation; and shall not— impose standards for which there is no current and generally available analytic method; or apply to facilities meeting the criteria to be considered a facility under section 604(6), including retail stores or counters offering customized or personalized cosmetics to consumers, or to entities that are in compliance with the good manufacturing practice regulations specified in parts 210 and 211 of title 21, Code of Federal Regulations (or any successor regulations).
The Secretary shall publish a proposed rule described in subsection
(a)not later than 24 months after the date of enactment of the Cosmetic Safety Enhancement Act of 2019 and shall publish a final such rule not later than 36 months after such date of enactment. . Regulations issued pursuant to section 610 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) shall apply with respect to— large manufacturers (as defined in section 744L of such Act (as added by section 202 of this Act)), beginning 180 days after the date on which the final rule described in subsection
(a)is effective; midsize manufacturers (as defined in section 744L of such Act (as added by section 202 of this Act)), beginning 210 days after such date; and small manufacturers (as defined in section 744L of such Act (as added by section 202 of this Act)), beginning 2 years after such date. 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 the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to current good manufacturing practice, as prescribed by the Secretary. .
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Sec. 103
Good manufacturing practices for cosmetics
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