dreamproit/uscode huggingface dataset:
21 U.S.C. § 360bbb–2 (FOOD AND DRUGS)
§ 360bbb–2. Classification of products
(a) Request
A person who submits an application or submission (including a petition, notification, and any other similar form of request) under this chapter for a product, may submit a request to the Secretary respecting the classification of the product as a drug, biological product, device, or a combination product subject to section 353(g) of this title or respecting the component of the Food and Drug Administration that will regulate the product. In submitting the request, the person shall recommend a classification for the product, or a component to regulate the product, as appropriate.
(b) Statement
Not later than 60 days after the receipt of the request described in subsection (a), the Secretary shall determine the classification of the product under subsection (a), or the component of the Food and Drug Administration that will regulate the product, and shall provide to the person a written statement that identifies such classification or such component, and the reasons for such determination. The Secretary may not modify such statement except with the written consent of the person, or for public health reasons based on scientific evidence.
(c) Inaction of Secretary
If the Secretary does not provide the statement within the 60-day period described in subsection (b), the recommendation made by the person under subsection (a) shall be considered to be a final determination by the Secretary of such classification of the product, or the component of the Food and Drug Administration that will regulate the product, as applicable, and may not be modified by the Secretary except with the written consent of the person, or for public health reasons based on scientific evidence.
(June 25, 1938, ch. 675, § 563, as added Pub. L. 105–115, title IV, § 416, Nov. 21, 1997, 111 Stat. 2378.)
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date
text: Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.
21 U.S.C. § 360bbb–3b (FOOD AND DRUGS)
§ 360bbb–3b. Products held for emergency use
It is not a violation of any section of this chapter or of the Public Health Service Act [42 U.S.C. 201 et seq.] for a government entity (including a Federal, State, local, or tribal government entity), or a person acting on behalf of such a government entity, to introduce into interstate commerce a product (as defined in section 360bbb–3(a)(4) of this title) intended for emergency use, if that product—
(1) is intended to be held and not used; and
(2) is held and not used, unless and until that product—
(A) is approved, cleared, or licensed under section 355, 360(k), 360b, or 360e of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] or conditionally approved under section 360ccc of this title;
(B) is authorized for investigational use under section 355, 360b, or 360j of this title or section 351 of the Public Health Service Act [42 U.S.C. 262]; or
(C) is authorized for use under section 360bbb–3 of this title or section 360bbb–3a of this title.
(June 25, 1938, ch. 675, § 564B, as added Pub. L. 113–5, title III, § 302(d), Mar. 13, 2013, 127 Stat. 185; amended Pub. L. 114–255, div. A, title III, § 3088(d), Dec. 13, 2016, 130 Stat. 1149; Pub. L. 116–22, title VII, § 705(d), June 24, 2019, 133 Stat. 964.)
heading: Editorial Notes
heading: References in Text
text: The Public Health Service Act, referred to in text, is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.
heading: Amendments
text: 2019—Par. (2)(B). Pub. L. 116–22, § 705(d)(1), inserted comma after “355”.
Par. (2)(C). Pub. L. 116–22, § 705(d)(2), inserted “or section 360bbb–3a of this title” before period at end.
2016—Par. (2)(A). Pub. L. 114–255, § 3088(d)(1), substituted “360b, or 360e of this title” for “or 360e of this title” and inserted “or conditionally approved under section 360ccc of this title” after “Public Health Service Act”.
Par. (2)(B). Pub. L. 114–255, § 3088(d)(2), substituted “360b, or 360j of this title” for “or 360j of this title”.
21 U.S.C. § 360bbb–6 (FOOD AND DRUGS)
§ 360bbb–6. Risk communication
(a) Advisory Committee on Risk Communication
(1) In general
The Secretary shall establish an advisory committee to be known as the “Advisory Committee on Risk Communication” (referred to in this section as the “Committee”).
(2) Duties of Committee
The Committee shall advise the Commissioner on methods to effectively communicate risks associated with the products regulated by the Food and Drug Administration.
(3) Members
The Secretary shall ensure that the Committee is composed of experts on risk communication, experts on the risks described in subsection (b), and representatives of patient, consumer, and health professional organizations.
(4) Permanence of Committee
Section 14 of the Federal Advisory Committee Act shall not apply to the Committee established under this subsection.
(b) Partnerships for risk communication
(1) In general
The Secretary shall partner with professional medical societies, medical schools, academic medical centers, and other stakeholders to develop robust and multi-faceted systems for communication to health care providers about emerging postmarket drug risks.
(2) Partnerships
The systems developed under paragraph (1) shall—
(A) account for the diversity among physicians in terms of practice, willingness to adopt technology, and medical specialty; and
(B) include the use of existing communication channels, including electronic communications, in place at the Food and Drug Administration.
(June 25, 1938, ch. 675, § 567, as added Pub. L. 110–85, title IX, § 917, Sept. 27, 2007, 121 Stat. 960.)
heading: Editorial Notes
heading: References in Text
text: Section 14 of the Federal Advisory Committee Act, referred to in subsec. (a)(4), is section 14 of Pub. L. 92–463, which is set out in the Appendix to Title 5, Government Organization and Employees.
21 U.S.C. § 360bbb–7 (FOOD AND DRUGS)
§ 360bbb–7. Notification
(a) Notification to Secretary
With respect to a drug, the Secretary may require notification to the Secretary by a regulated person if the regulated person knows—
(1) that the use of such drug in the United States may result in serious injury or death;
(2) of a significant loss or known theft of such drug intended for use in the United States; or
(3) that—
(A) such drug has been or is being counterfeited; and
(B)
(i) the counterfeit product is in commerce in the United States or could be reasonably expected to be introduced into commerce in the United States; or
(ii) such drug has been or is being imported into the United States or may reasonably be expected to be offered for import into the United States.
(b) Manner of notification
Notification under this section shall be made in such manner and by such means as the Secretary may specify by regulation or guidance.
(c) Savings clause
Nothing in this section shall be construed as limiting any other authority of the Secretary to require notifications related to a drug under any other provision of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.].
(d) Definition
In this section, the term “regulated person” means—
(1) a person who is required to register under section 360 or 381(s) of this title;
(2) a wholesale distributor of a drug product; or
(3) any other person that distributes drugs except a person that distributes drugs exclusively for retail sale.
(June 25, 1938, ch. 675, § 568, as added Pub. L. 112–144, title VII, § 715(b), July 9, 2012, 126 Stat. 1075.)
heading: Editorial Notes
heading: References in Text
text: The Public Health Service Act, referred to in subsec. (c), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.
21 U.S.C. § 360bbb–8a (FOOD AND DRUGS)
§ 360bbb–8a. Optimizing global clinical trials
(a) In general
The Secretary shall—
(1) work with other regulatory authorities of similar standing, medical research companies, and international organizations to foster and encourage uniform, scientifically driven clinical trial standards with respect to medical products around the world; and
(2) enhance the commitment to provide consistent parallel scientific advice to manufacturers seeking simultaneous global development of new medical products in order to—
(A) enhance medical product development;
(B) facilitate the use of foreign data; and
(C) minimize the need to conduct duplicative clinical studies, preclinical studies, or nonclinical studies.
(b) Medical product
In this section, the term “medical product” means a drug, as defined in subsection (g) of section 321 of this title, a device, as defined in subsection (h) of such section, or a biological product, as defined in section 351(i) of the Public Health Service Act [42 U.S.C. 262(i)].
(c) Savings clause
Nothing in this section shall alter the criteria for evaluating the safety or effectiveness of a medical product under this chapter or under the Public Health Service Act [42 U.S.C. 201 et seq.].
(June 25, 1938, ch. 675, § 569A, as added Pub. L. 112–144, title XI, § 1123, July 9, 2012, 126 Stat. 1113; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(P), Dec. 13, 2016, 130 Stat. 1154.)
heading: Editorial Notes
heading: References in Text
text: The Public Health Service Act, referred to in subsec. (c), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.
heading: Amendments
text: 2016—Subsec. (c). Pub. L. 114–255 inserted “or under the Public Health Service Act” before period at end.
21 U.S.C. § 360bbb–8b (FOOD AND DRUGS)
§ 360bbb–8b. Use of clinical investigation data from outside the United States
(a) In general
In determining whether to approve, license, or clear a drug, biological product, or device pursuant to an application submitted under this subchapter, the Secretary shall accept data from clinical investigations conducted outside of the United States, including the European Union, if the applicant demonstrates that such data are adequate under applicable standards to support approval, licensure, or clearance of the drug, biological product, or device in the United States.
(b) Notice to sponsor
If the Secretary finds under subsection (a) that the data from clinical investigations conducted outside the United States, including in the European Union, are inadequate for the purpose of making a determination on approval, clearance, or licensure of a drug, biological product, or device pursuant to an application submitted under this subchapter, the Secretary shall provide written notice to the sponsor of the application of such finding and include the rationale for such finding.
(June 25, 1938, ch. 675, § 569B, as added Pub. L. 112–144, title XI, § 1123, July 9, 2012, 126 Stat. 1113; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(Q), Dec. 13, 2016, 130 Stat. 1155.)
heading: Editorial Notes
heading: Amendments
text: 2016—Pub. L. 114–255 substituted “drug, biological product, or device” for “drug or device” wherever appearing.
21 U.S.C. § 360ddd–2 (FOOD AND DRUGS)
§ 360ddd–2. Inapplicability of drug fees to designated medical gases
A designated medical gas, alone or in combination with another designated gas or gases (as medically appropriate) deemed under section 360ddd–1 of this title to have in effect an approved application shall not be assessed fees under section 379h(a) or 379j–12(a) of this title on the basis of such deemed approval.
(June 25, 1938, ch. 675, § 577, as added Pub. L. 112–144, title XI, § 1111, July 9, 2012, 126 Stat. 1111; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(T), Dec. 13, 2016, 130 Stat. 1155.)
heading: Editorial Notes
heading: Amendments
text: 2016—Pub. L. 114–255 inserted “or 379j–12(a)” after “section 379h(a)”.
21 U.S.C. § 361 (FOOD AND DRUGS)
§ 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.
(June 25, 1938, ch. 675, § 601, 52 Stat. 1054; Pub. L. 86–618, title I, § 102(c)(1), July 12, 1960, 74 Stat. 398; Pub. L. 102–571, title I, § 107(11), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, § 3(x), Aug. 13, 1993, 107 Stat. 778.)
heading: Editorial Notes
heading: Amendments
text: 1993—Subsec. (a). Pub. L. 103–80 substituted “usual, except that this” for “usual: Provided, That this”.
1992—Par. (e). Pub. L. 102–571 substituted “379e(a)” for “376(a)”.
1960—Par. (e). Pub. L. 86–618 substituted “and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 376(a) of this title” for “and it bears or contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 364 of this title”.
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date of 1960 Amendment
text: Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.
heading: Effective Date; Postponement
text: Par. (e) effective Jan. 1, 1940, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective Date; Postponement in Certain Cases note under section 301 of this title.
heading: Effective Date
text: Section effective twelve months after June 25, 1938, except par. (a), which, with certain exceptions, became effective on June 25, 1938, see section 1002(a) of act June 25, 1938, set out as a note under section 301 of this title.
21 U.S.C. § 363 (FOOD AND DRUGS)
§ 363. Regulations making exemptions
The Secretary shall promulgate regulations exempting from any labeling requirement of this chapter cosmetics which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such cosmetics are not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment.
(June 25, 1938, ch. 675, § 603, 52 Stat. 1054.)
heading: Statutory Notes and Related Subsidiaries
heading: Transfer of Functions
text: For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.
21 U.S.C. § 364 (FOOD AND DRUGS)
§ 364. Repealed. Pub. L. 86–618, title I, § 103(a)(3), July 12, 1960, 74 Stat. 398
text: Section, act June 25, 1938, ch. 675, § 604, 52 Stat. 1055, directed Secretary to promulgate regulations for listing of coal-tar colors for cosmetics. See section 379e of this title.
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date of Repeal
text: Repeal effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as an Effective Date of 1960 Amendment note under section 379e of this title.
21 U.S.C. § 372a (FOOD AND DRUGS)
§ 372a. Transferred
heading: Editorial Notes
heading: Codification
text: Section, act June 25, 1938, ch. 675, § 702A, formerly June 30, 1906, ch. 3915, § 10A, as added June 22, 1934, ch. 712, 48 Stat. 1204, and amended, which related to examination of sea food, was renumbered section 706 of act June 25, 1938, by Pub. L. 102–571, title I, § 106(3), Oct. 29, 1992, 106 Stat. 4498, and transferred to section 376 of this title.
21 U.S.C. § 374a (FOOD AND DRUGS)
§ 374a. Inspections relating to food allergens
The Secretary of Health and Human Services shall conduct inspections consistent with the authority under section 374 of this title of facilities in which foods are manufactured, processed, packed, or held—
(1) to ensure that the entities operating the facilities comply with practices to reduce or eliminate cross-contact of a food with residues of major food allergens that are not intentional ingredients of the food; and
(2) to ensure that major food allergens are properly labeled on foods.
(Pub. L. 108–282, title II, § 205, Aug. 2, 2004, 118 Stat. 909.)
heading: Editorial Notes
heading: Codification
text: Section was enacted as a part of the Food Allergen Labeling and Consumer Protection Act of 2004, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
21 U.S.C. § 375 (FOOD AND DRUGS)
§ 375. Publicity
(a) Reports
The Secretary shall cause to be published from time to time reports summarizing all judgments, decrees, and court orders which have been rendered under this chapter, including the nature of the charge and the disposition thereof.
(b) Information regarding certain goods
The Secretary may also cause to be disseminated information regarding food, drugs, devices, tobacco products, or cosmetics in situations involving, in the opinion of the Secretary, imminent danger to health or gross deception of the consumer. Nothing in this section shall be construed to prohibit the Secretary from collecting, reporting, and illustrating the results of the investigations of the Department.
(June 25, 1938, ch. 675, § 705, 52 Stat. 1057; Pub. L. 111–31, div. A, title I, § 103(j), June 22, 2009, 123 Stat. 1837.)
heading: Editorial Notes
heading: Amendments
text: 2009—Subsec. (b). Pub. L. 111–31 inserted “tobacco products,” after “devices,”.
heading: Statutory Notes and Related Subsidiaries
heading: Transfer of Functions
text: For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.
21 U.S.C. § 377 (FOOD AND DRUGS)
§ 377. Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests
The Secretary, in carrying into effect the provisions of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], is authorized on and after July 12, 1943, to cooperate with associations and scientific societies in the revision of the United States Pharmacopoeia and in the development of methods of analysis and mechanical and physical tests necessary to carry out the work of the Food and Drug Administration.
(July 12, 1943, ch. 221, title II, 57 Stat. 500; 1953 Reorg. Plan No. 1, § 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631.)
heading: Editorial Notes
heading: References in Text
text: The Federal Food, Drug, and Cosmetic Act, referred to in text, is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.
heading: Codification
text: Section was enacted as part of the Labor-Federal Security Appropriation Act, 1944, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
heading: Statutory Notes and Related Subsidiaries
heading: Transfer of Functions
text: For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.
21 U.S.C. § 379a (FOOD AND DRUGS)
§ 379a. Presumption of existence of jurisdiction
In any action to enforce the requirements of this chapter respecting a device, tobacco product, food, drug, or cosmetic the connection with interstate commerce required for jurisdiction in such action shall be presumed to exist.
(June 25, 1938, ch. 675, § 709, as added Pub. L. 94–295, § 8, May 28, 1976, 90 Stat. 583; amended Pub. L. 105–115, title IV, § 419, Nov. 21, 1997, 111 Stat. 2379; Pub. L. 111–31, div. A, title I, § 103(k), June 22, 2009, 123 Stat. 1837.)
heading: Editorial Notes
heading: Amendments
text: 2009—Pub. L. 111–31 inserted “tobacco product,” after “device,”.
1997—Pub. L. 105–115 substituted “a device, food, drug, or cosmetic” for “a device”.
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date of 1997 Amendment
text: Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.
21 U.S.C. § 379c (FOOD AND DRUGS)
§ 379c. Transferred
heading: Editorial Notes
heading: Codification
text: Section, act June 25, 1938, ch. 675, § 711, as added Nov. 28, 1990, Pub. L. 101–635, title II, § 201, 104 Stat. 4584, which related to recovery and retention of fees for freedom of information requests, was renumbered section 731 of act June 25, 1938, by Pub. L. 102–571, title I, § 106(6), Oct. 29, 1992, 106 Stat. 4499, and transferred to section 379f of this title.
21 U.S.C. § 379d (FOOD AND DRUGS)
§ 379d. Automation of Food and Drug Administration
(a) In general
The Secretary, acting through the Commissioner of Food and Drugs, shall automate appropriate activities of the Food and Drug Administration to ensure timely review of activities regulated under this chapter.
(b) Authorization of appropriations
There are authorized to be appropriated each fiscal year such sums as are necessary to carry out this section.
(June 25, 1938, ch. 675, § 711, formerly § 712, as added Pub. L. 101–635, title IV, § 401, Nov. 28, 1990, 104 Stat. 4585; renumbered § 711, Pub. L. 102–571, title I, § 106(3), Oct. 29, 1992, 106 Stat. 4498.)
heading: Editorial Notes
heading: Prior Provisions
text: A prior section 711 of act June 25, 1938, was renumbered section 731 by Pub. L. 102–571 and is classified to section 379f of this title.