{"identifier":"/us/usc/t21/s364b","title":21,"num":"\u00a7\u202f364b.","heading":"Good manufacturing practice","text":"\u00a7\u202f364b.\nGood manufacturing practice\n(a)\nIn general\nThe Secretary shall by regulation establish good manufacturing practices for facilities that are consistent, to the extent practicable, and appropriate, with national and international standards, in accordance with\nsection 361 of this title\n1\n1 So in original. Probably should be \u201cthis subsection\u201d.\nsection 374 of this title\n(b)\nConsiderations\nIn establishing regulations for good manufacturing practices under this section, the Secretary shall take into account the size and scope of the businesses engaged in the manufacture of cosmetics, and the risks to public health posed by such cosmetics, and provide sufficient flexibility to be practicable for all sizes and types of facilities to which such regulations will apply. Such regulations shall include simplified good manufacturing practice requirements for smaller businesses, as appropriate, to ensure that such regulations do not impose undue economic hardship for smaller businesses, and may include longer compliance times for smaller businesses. Before issuing regulations to implement subsection (a), the Secretary shall consult with cosmetics manufacturers, including smaller businesses, consumer organizations, and other experts selected by the Secretary.\n(c)\nTimeframe\nThe Secretary shall publish a notice of proposed rulemaking not later than 2 years after\nDecember 29, 2022\nDecember 29, 2022","url":"https://projectusc.org/usc/t21/s364b.html","content":[{"t":"sec","id":"/us/usc/t21/s364b","children":[{"t":"num","text":"\u00a7\u202f364b."},{"t":"heading","text":"Good manufacturing practice"},{"t":"subsec","id":"/us/usc/t21/s364b/a","children":[{"t":"num","text":"(a)"},{"t":"heading","text":"In general"},{"t":"content","children":[{"t":"p","text":"The Secretary shall by regulation establish good manufacturing practices for facilities that are consistent, to the extent practicable, and appropriate, with national and international standards, in accordance with ","children":[{"t":"ref","text":"section 361 of this title","href":"/us/usc/t21/s361","tail":". Any such regulations shall be intended to protect the public health and ensure that cosmetic products are not adulterated. Such regulations may allow for the Secretary to inspect records necessary to demonstrate compliance with good manufacturing practices prescribed by the Secretary under this paragraph\u202f"},{"t":"ref","text":"1"},{"t":"num","text":"1","tail":"\u202fSo in original. Probably should be \u201cthis subsection\u201d."},{"t":"text","text":"\u202fSo in original. Probably should be \u201cthis subsection\u201d.","tail":" during an inspection conducted under "},{"t":"ref","text":"section 374 of this title","href":"/us/usc/t21/s374","tail":"."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s364b/b","children":[{"t":"num","text":"(b)"},{"t":"heading","text":"Considerations"},{"t":"content","children":[{"t":"p","text":"In establishing regulations for good manufacturing practices under this section, the Secretary shall take into account the size and scope of the businesses engaged in the manufacture of cosmetics, and the risks to public health posed by such cosmetics, and provide sufficient flexibility to be practicable for all sizes and types of facilities to which such regulations will apply. Such regulations shall include simplified good manufacturing practice requirements for smaller businesses, as appropriate, to ensure that such regulations do not impose undue economic hardship for smaller businesses, and may include longer compliance times for smaller businesses. Before issuing regulations to implement subsection (a), the Secretary shall consult with cosmetics manufacturers, including smaller businesses, consumer organizations, and other experts selected by the Secretary.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s364b/c","children":[{"t":"num","text":"(c)"},{"t":"heading","text":"Timeframe"},{"t":"content","children":[{"t":"p","text":"The Secretary shall publish a notice of proposed rulemaking not later than 2 years after ","children":[{"t":"text","text":"December 29, 2022","tail":", and shall publish a final such rule not later than 3 years after "},{"t":"text","text":"December 29, 2022","tail":"."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"text","text":"\n"},{"t":"text","text":"\n"}]}]}