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Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
2026-07-06 10:51:44 -04:00

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LegalText 21 U.S.C. § 364i Exemption for certain products and facilities us united_states_code code_section 21 FOOD AND DRUGS 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT 364i 21 U.S.C. § 364i current 119-100 2026-06-26 official https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip /us/usc/t21/s364i data/legal/raw/us/code/title-21/usc21.xml 2791e9dcd87d05cc7270215a5c7a25190fc367a8157ecdb337af931ea9bfda46 3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1 457cd86b99973ae07cecf7bfdd1306f5b656d7f88b196a4c5a6620dd270eb441 2026-07-04 official
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21 U.S.C. § 364i - Exemption for certain products and facilities

Text

(a) In general Notwithstanding any other provision of law, except as provided in subsection (b), a cosmetic product or facility that is also subject to the requirements of subchapter V shall be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title.

(b) Exception A facility described in subsection (a) that also manufactures or processes cosmetic products that are not subject to the requirements of subchapter V shall not be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title, with respect to such cosmetic products.

(June 25, 1938, ch. 675, § 613, as added Pub. L. 117328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5857.)

Notes

Statutory Notes and Related Subsidiaries

Construction; ConfidentialityNothing in section 3502 of Pub. L. 117328, 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. 117328, set out as a note under section 364 of this title.