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Code · U.S. Code · Title 21 - FOOD AND DRUGS · CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT · SUBCHAPTER VI— COSMETICS · § 364b

§ 364b. Good manufacturing practice

350 words·~2 min read·/usc/title-21/section-364b

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(a)In general 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 section 361 of this title. 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 1 during an inspection conducted under section 374 of this title.
(b)Considerations 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.
(c)Timeframe The Secretary shall publish a notice of proposed rulemaking not later than 2 years after December 29, 2022, and shall publish a final such rule not later than 3 years after December 29, 2022.
(June 25, 1938, ch. 675, § 606, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5850.)
Connections3 cite this · traces to 7
3 references not yet in our index
  • 1
  • June 25, 1938, ch. 675, § 606
  • 136 Stat. 5850
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cites case law
§ 364b
Good manufacturing practice
Pub. L.×1
Stat.×1
U.S.C.×1
U.S.C.§ 361
U.S.C.§ 374
Pub. L.Public Law 117-328
U.S.C.§ 331
U.S.C.§ 1905
U.S.C.§ 552
U.S.C.§ 364
Cite1
ActJune 25, 1938, ch. 675, § 606
Stat.136 Stat. 5850
Cites 10Cited by 3 across 3 sources
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