dreamproit/uscode huggingface dataset:
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: 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 262(i) of title 42.
(c) Savings clause
Nothing in this section shall alter the criteria for evaluating the safety or effectiveness of a medical product under this chapter.
(June 25, 1938, ch. 675, § 569A, as added Pub. L. 112–144, title XI, § 1123, July 9, 2012, 126 Stat. 1113.)
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 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 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 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.)
21 U.S.C. § 360bbb–8c (FOOD AND DRUGS)
§ 360bbb–8c. Patient participation in medical product discussion
(a) In general
The Secretary shall develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions, including by—
(1) fostering participation of a patient representative who may serve as a special government employee in appropriate agency meetings with medical product sponsors and investigators; and
(2) exploring means to provide for identification of patient representatives who do not have any, or have minimal, financial interests in the medical products industry.
(b) Protection of proprietary information
Nothing in this section shall be construed to alter the protections offered by laws, regulations, or policies governing disclosure of confidential commercial or trade secret information and any other information exempt from disclosure pursuant to section 552(b) of title 5 as such laws, regulations, or policies would apply to consultation with individuals and organizations prior to July 9, 2012.
(c) Other consultation
Nothing in this section shall be construed to limit the ability of the Secretary to consult with individuals and organizations as authorized prior to July 9, 2012.
(d) No right or obligation
Nothing in this section shall be construed to create a legal right for a consultation on any matter or require the Secretary to meet with any particular expert or stakeholder. Nothing in this section shall be construed to alter agreed upon goals and procedures identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012. Nothing in this section is intended to increase the number of review cycles as in effect before July 9, 2012.
(e) Financial interest
In this section, the term “financial interest” means a financial interest under section 208(a) of title 18.
(June 25, 1938, ch. 675, § 569C, as added Pub. L. 112–144, title XI, § 1137, July 9, 2012, 126 Stat. 1124.)
heading: References in Text
text: Section 101(b) of the Prescription Drug User Fee Amendments of 2012, referred to in subsec. (d), is section 101(b) of Pub. L. 112–144, which is set out as a note under section 379g of this title.
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) 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.)
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: 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: 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: 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: 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: 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: 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: Amendments
text: 2009—Subsec. (b). Pub. L. 111–31 inserted “tobacco products,” after “devices,”.
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 this chapter, 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: 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: 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: 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: 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. § 379b (FOOD AND DRUGS)
§ 379b. Consolidated administrative and laboratory facility
(a) Authority
The Secretary, in consultation with the Administrator of the General Services Administration, shall enter into contracts for the design, construction, and operation of a consolidated Food and Drug Administration administrative and laboratory facility.
(b) Awarding of contract
The Secretary shall solicit contract proposals under subsection (a) of this section from interested parties. In awarding contracts under such subsection, the Secretary shall review such proposals and give priority to those alternatives that are the most cost effective for the Federal Government and that allow for the use of donated land, federally owned property, or lease-purchase arrangements. A contract under this subsection shall not be entered into unless such contract results in a net cost savings to the Federal Government over the duration of the contract, as compared to the Government purchase price including borrowing by the Secretary of the Treasury.
(c) Donations
In carrying out this section, the Secretary shall have the power, in connection with real property, buildings, and facilities, to accept on behalf of the Food and Drug Administration gifts or donations of services or property, real or personal, as the Secretary determines to be necessary.
(d) Authorization of appropriations
There are authorized to be appropriated to carry out this section $100,000,000 for fiscal year 1991, and such sums as may be necessary for each of the subsequent fiscal years, to remain available until expended.
(June 25, 1938, ch. 675, § 710, as added Pub. L. 101–635, title I, § 101, Nov. 28, 1990, 104 Stat. 4583.)
21 U.S.C. § 379c (FOOD AND DRUGS)
§ 379c. Transferred
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: 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.
21 U.S.C. § 379d–2 (FOOD AND DRUGS)
§ 379d–2. Policy on the review and clearance of scientific articles published by FDA employees
(a) Definition
In this section, the term “article” means a paper, poster, abstract, book, book chapter, or other published writing.
(b) Policies
The Secretary, through the Commissioner of Food and Drugs, shall establish and make publicly available clear written policies to implement this section and govern the timely submission, review, clearance, and disclaimer requirements for articles.
(c) Timing of submission for review
If an officer or employee, including a Staff Fellow and a contractor who performs staff work, of the Food and Drug Administration is directed by the policies established under subsection (b) to submit an article to the supervisor of such officer or employee, or to some other official of the Food and Drug Administration, for review and clearance before such officer or employee may seek to publish or present such an article at a conference, such officer or employee shall submit such article for such review and clearance not less than 30 days before submitting the article for publication or presentation.
(d) Timing for review and clearance
The supervisor or other reviewing official shall review such article and provide written clearance, or written clearance on the condition of specified changes being made, to such officer or employee not later than 30 days after such officer or employee submitted such article for review.
(e) Non-timely review
If, 31 days after such submission under subsection (c), the supervisor or other reviewing official has not cleared or has not reviewed such article and provided written clearance, such officer or employee may consider such article not to have been cleared and may submit the article for publication or presentation with an appropriate disclaimer as specified in the policies established under subsection (b).
(f) Effect
Nothing in this section shall be construed as affecting any restrictions on such publication or presentation provided by other provisions of law.
(June 25, 1938, ch. 675, § 713, as added Pub. L. 110–85, title XI, § 1101, Sept. 27, 2007, 121 Stat. 971.)
21 U.S.C. § 379d–3 (FOOD AND DRUGS)
§ 379d–3. Streamlined hiring authority
(a) In general
In addition to any other personnel authorities under other provisions of law, the Secretary may, without regard to the provisions of title 5 governing appointments in the competitive service, appoint employees to positions in the Food and Drug Administration to perform, administer, or support activities described in subsection (b), if the Secretary determines that such appointments are needed to achieve the objectives specified in subsection (c).
(b) Activities described
The activities described in this subsection are—
(1) activities under this chapter related to the process for the review of device applications (as defined in section 379i(8) of this title); and
(2) activities under this chapter related to human generic drug activities (as defined in section 379j–41 of this title).
(c) Objectives specified
The objectives specified in this subsection are—
(1) with respect to the activities under subsection (b)(1), the goals referred to in section 379j–1(a)(1) of this title; and
(2) with respect to the activities under subsection (b)(2), the goals referred to in section 379j–43(a) of this title.
(d) Internal controls
The Secretary shall institute appropriate internal controls for appointments under this section.
(e) Sunset
The authority to appoint employees under this section shall terminate on the date that is 3 years after July 9, 2012.
(June 25, 1938, ch. 675, § 714, as added and amended Pub. L. 112–144, title II, § 208, title III, § 307, July 9, 2012, 126 Stat. 1007, 1025.)
heading: Amendments
text: 2012—Subsec. (b). Pub. L. 112–144, § 307(1), amended subsec. (b) generally. Prior to amendment, text read as follows: “The activities described in this subsection are activities under this chapter related to the process for the review of device applications (as defined in section 379i(8) of this title).”
Subsec. (c). Pub. L. 112–144, § 307(2), amended subsec. (c) generally. Prior to amendment, text read as follows: “The objectives specified in this subsection are with respect to the activities under subsection (b), the goals referred to in section 379j–1(a)(1) of this title.”
heading: Effective Date of 2012 Amendment
text: Amendment by section 307 of Pub. L. 112–144 effective Oct. 1, 2012, see section 305 of Pub. L. 112–144, set out as an Effective and Termination Dates note under section 379j–41 of this title.
heading: Effective Date
text: Section effective Oct. 1, 2012, see section 206 of Pub. L. 112–144, set out as an Effective Date of 2012 Amendment note under section 379i of this title.