21 U.S.C. § 364b — Good manufacturing practice

FEDERAL · 21 U.S.C. · Chapter 9

Good manufacturing practice

Current through Pub. L. 119-102

Title 21 — Food and Drugs·Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT·Subch. VI

(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 busines

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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 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.

21 U.S.C. § 364b (Good manufacturing practice) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

Source Credit

History

(June 25, 1938, ch. 675, §606, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5850.)

Editorial Notes

Statutory Notes and Related Subsidiaries

Construction; Confidentiality
Nothing 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.