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

Federal law — U.S. Code and appendices · legal_authorities

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

**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section361&num=0&edition=prelim). 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim). **(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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Source file: Laws/federal/codes/united-states-code/title-21/section-364b-good-manufacturing-practice--5d8a310c1a.md
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Source location: Title 21, Chapter 9, § 364b; chapter-009-federal-food-drug-and-cosmetic-act.md

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 364 — Definitions

In this subchapter: (1) **Adverse event** — The term “adverse event” means any health-related event associated with the use of a cosmetic product that is adverse. (2) **Cosmetic product** — The term “cosmetic product” means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product. (3) **Facility** (A) *In general.—* — The term “facility” includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States. (B) Such term does not include any of the following: (i) Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location. (ii) Cosmetic product retailers, including individual sales representatives, direct sellers (as defined in [section 3508(b)(2) of title 26](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title26-section3508/b/2&num=0&edition=prelim)), retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location. (iii) Hospitals, physicians’ offices, and health care clinics. (iv) Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer. (v) Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services. (vi) Trade shows and other venues where cosmetic product samples are provided free of charge. (vii) An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale. (vii

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 361 — Adulterated cosmetics

A cosmetic shall be deemed to be adulterated— **(a)** If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual, except that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: “Caution—This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.”, and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term “hair dye” shall not include eyelash dyes or eyebrow dyes. **(b)** If it consists in whole or in part of any filthy, putrid, or decomposed substance. **(c)** If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. **(d)** If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health. **(e)** If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe within the meaning of [section 379e(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379e/a&num=0&edition=prelim). **(f)** If it has been manufactured or processed under conditions that do not meet the good manufacturing practice requirements of [section 364b of this title](https://uscode.house.gov/view.xhtml?r

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Federal law — U.S. Code and appendices · legal_authorities

18 U.S.C. § 1905 — Disclosure of confidential information generally

Whoever, being an officer or employee of the United States or of any department or agency thereof, any person acting on behalf of the Federal Housing Finance Agency, or agent of the Department of Justice as defined in the Antitrust Civil Process Act ([15 U.S.C. 1311–131](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1311–131&num=0&edition=prelim)4), or being an employee of a private sector organization who is or was assigned to an agency under chapter 37 of title 5, publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties or by reason of any examination or investigation made by, or return, report or record made to or filed with, such department or agency or officer or employee thereof, which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof to be seen or examined by any person except as provided by law; shall be fined under this title, or imprisoned not more than one year, or both; and shall be removed from office or employment.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 374 — Inspection

**(a) Right of agents to enter; scope of inspection; notice; promptness; exclusions** (1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in [section 350c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c&num=0&edition=prelim), when the standard for records inspection under paragraph (1) or (2) of [section 350c(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c/a&num=0&edition=prelim) applies, subject to the limitations established in [section 350c(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c/d&num=0&edition=prelim). In the case of a facility (as defined in [section 364 of this title](https://uscode.house.gov/vi

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Federal law — U.S. Code and appendices · legal_authorities

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

Page 484 TITLE 21—FOOD AND DRUGS § 364b 1 So in original. Probably should be ‘‘this subsection’’. submitted to the Secretary within 30 days of such request. In response to a request under sec- tion 552 of title 5, information submitted to the Secretary under this subsection shall be with- held under section 552(b)(3) of title 5. (g) Protected information A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under sub- section (b)(2), or an adverse event report, or any new information, voluntarily submitted to the Secretary shall be considered to be— (1) a safety report under section 379v of this title and may be accompanied by a statement, which shall be a part of any report that is re- leased for public disclosure, that denies that the report or the records constitute an admis- sion that the product involved caused or con- tributed to the adverse event; and (2) a record about an individual under sec- tion 552a of title 5 (commonly referred to as the ‘‘Privacy Act of 1974’’) and a medical or similar file the disclosure of which would con- stitute a violation of section 552 of such title 5 (commonly referred to as the ‘‘Freedom of Information Act’’), and shall not be publicly disclosed unless all personally identifiable in- formation is redacted. (h) Effect of section (1) In general Nothing in this section shall affect the au- thority of the Secretary to provide adverse event reports and information to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, under a memorandum of under- standing between the Secretary and such State, territory, or political subdivision. (2) Personally identifiable information

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