Fabio
76b8ec33a7
Ingested titles 12–51 and 54 from OLRC USLM XML @119-100 (the whole Code now, uniform edition; Title 53 is reserved/empty). LegalText 11,221 -> 59,740; repo total 105,704 records. Deterministic (byte-identical rerun, verified on Title 42's 8,356 sections); make check green. make legal-us-code default now covers every title. Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
46 lines
3.3 KiB
Markdown
46 lines
3.3 KiB
Markdown
---
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type: "LegalText"
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title: "21 U.S.C. § 364b"
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description: "Good manufacturing practice"
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jurisdiction: "us"
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corpus: "united_states_code"
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kind: "code_section"
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title_number: 21
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title_name: "FOOD AND DRUGS"
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chapter_number: "9"
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chapter_name: "FEDERAL FOOD, DRUG, AND COSMETIC ACT"
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section: "364b"
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citation: "21 U.S.C. § 364b"
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status: "current"
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release_point: "119-100"
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release_date: "2026-06-26"
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source: "official"
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source_url: "https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip"
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source_identifier: "/us/usc/t21/s364b"
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source_file: "data/legal/raw/us/code/title-21/usc21.xml"
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source_hash: "49d78243e2f26b56ac63c251de2e7a38fb34e320462881010f8c06c7c3c77b92"
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raw_snapshot_hash: "3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1"
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text_hash: "209d8811807472989de5c34e92426f2a0ae691093a0275bce2700ad848b1aec8"
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retrieved_at: "2026-07-04"
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confidence: "official"
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tags: ["legal", "us-code"]
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---
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# 21 U.S.C. § 364b - Good manufacturing practice
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## Text
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(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 11 So in original. Probably should be “this subsection”. during an inspection conducted under section 374 of this title.
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(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.
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(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.
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(June 25, 1938, ch. 675, § 606, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5850.)
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## Notes
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Statutory Notes and Related Subsidiaries
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Construction; ConfidentialityNothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.
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