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Title 21, Food and DrugsRelease 119-110

§364b Good Manufacturing Practice

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER VI — COSMETICS › § 364b

Last updated Sep 23, 2026|Official source

Summary

The Secretary must write rules for good manufacturing practices for places that make cosmetics. The rules should follow national and international standards when practical under section 361. They must protect public health and keep cosmetics from being adulterated. The rules may let the Secretary inspect records needed to show compliance during inspections under section 374. When making the rules, the Secretary must consider business size and health risks. The rules must be flexible, include simpler requirements, and may give small businesses more time. The Secretary must consult manufacturers (including small ones), consumer groups, and experts. A proposed rule must be published by December 29, 2024, and a final rule by December 29, 2025.

Full Legal Text

Title 21, §364b

Food and Drugs, Source: USLM XML via OLRC

(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 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.

Legislative History

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 364b

Title 21, Food and Drugs

Last Updated

Sep 23, 2026

Release point: 119-110