dreamproit/uscode huggingface dataset:
21 U.S.C. § 336 (FOOD AND DRUGS)
§ 336. Report of minor violations
Nothing in this chapter shall be construed as requiring the Secretary to report for prosecution, or for the institution of libel or injunction proceedings, minor violations of this chapter whenever he believes that the public interest will be adequately served by a suitable written notice or warning.
(June 25, 1938, ch. 675, § 309, formerly § 306, 52 Stat. 1045; renumbered § 309, Pub. L. 102–282, § 2, May 13, 1992, 106 Stat. 150.)
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. § 337 (FOOD AND DRUGS)
§ 337. Proceedings in name of United States; provision as to subpoenas
(a) Except as provided in subsection (b), all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States. Subpoenas for witnesses who are required to attend a court of the United States, in any district, may run into any other district in any proceeding under this section.
(b)
(1) A State may bring in its own name and within its jurisdiction proceedings for the civil enforcement, or to restrain violations, of section 341, 343(b), 343(c), 343(d), 343(e), 343(f), 343(g), 343(h), 343(i), 343(k), 343(q), or 343(r) of this title if the food that is the subject of the proceedings is located in the State.
(2) No proceeding may be commenced by a State under paragraph (1)—
(A) before 30 days after the State has given notice to the Secretary that the State intends to bring such proceeding,
(B) before 90 days after the State has given notice to the Secretary of such intent if the Secretary has, within such 30 days, commenced an informal or formal enforcement action pertaining to the food which would be the subject of such proceeding, or
(C) if the Secretary is diligently prosecuting a proceeding in court pertaining to such food, has settled such proceeding, or has settled the informal or formal enforcement action pertaining to such food.
In any court proceeding described in subparagraph (C), a State may intervene as a matter of right.
(June 25, 1938, ch. 675, § 310, formerly § 307, 52 Stat. 1046; Sept. 3, 1954, ch. 1263, § 37, 68 Stat. 1239; Pub. L. 101–535, § 4, Nov. 8, 1990, 104 Stat. 2362; renumbered § 310, Pub. L. 102–282, § 2, May 13, 1992, 106 Stat. 150.)
heading: Editorial Notes
heading: Amendments
text: 1990—Pub. L. 101–535 substituted “(a) Except as provided in subsection (b), all” for “All” and “any proceeding under this section” for “any such proceeding” and added subsec. (b).
1954—Act Sept. 3, 1954, struck out reference to section 654 of title 28.
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date of 1990 Amendment
text: Amendment by Pub. L. 101–535 effective 24 months after Nov. 8, 1990, except that such amendment effective Dec. 31, 1993, with respect to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances, see section 10(a)(1)(C) of Pub. L. 101–535, set out as a note under section 343 of this title.
heading: Construction of Amendments by Pub. L. 101–535
text: Amendments by Pub. L. 101–535 not to be construed to alter authority of Secretary of Health and Human Services and Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title.
21 U.S.C. § 343–3 (FOOD AND DRUGS)
§ 343–3. Disclosure
(a) No provision of section 321(n), 343(a), or 348 of this title shall be construed to require on the label or labeling of a food a separate radiation disclosure statement that is more prominent than the declaration of ingredients required by section 343(i)(2) of this title.
(b) In this section, the term “radiation disclosure statement” means a written statement that discloses that a food has been intentionally subject to radiation.
(June 25, 1938, ch. 675, § 403C, as added Pub. L. 105–115, title III, § 306, Nov. 21, 1997, 111 Stat. 2353.)
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. § 344 (FOOD AND DRUGS)
§ 344. Emergency permit control
(a) Conditions on manufacturing, processing, etc., as health measure
Whenever the Secretary finds after investigation that the distribution in interstate commerce of any class of food may, by reason of contamination with micro-organisms during the manufacture, processing, or packing thereof in any locality, be injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered interstate commerce, he then, and in such case only, shall promulgate regulations providing for the issuance, to manufacturers, processors, or packers of such class of food in such locality, of permits to which shall be attached such conditions governing the manufacture, processing, or packing of such class of food, for such temporary period of time, as may be necessary to protect the public health; and after the effective date of such regulations, and during such temporary period, no person shall introduce or deliver for introduction into interstate commerce any such food manufactured, processed, or packed by any such manufacturer, processor, or packer unless such manufacturer, processor, or packer holds a permit issued by the Secretary as provided by such regulations.
(b) Violation of permit; suspension and reinstatement
The Secretary is authorized to suspend immediately upon notice any permit issued under authority of this section if it is found that any of the conditions of the permit have been violated. The holder of a permit so suspended shall be privileged at any time to apply for the reinstatement of such permit, and the Secretary shall, immediately after prompt hearing and an inspection of the establishment, reinstate such permit if it is found that adequate measures have been taken to comply with and maintain the conditions of the permit, as originally issued or as amended.
(c) Inspection of permit-holding establishments
Any officer or employee duly designated by the Secretary shall have access to any factory or establishment, the operator of which holds a permit from the Secretary, for the purpose of ascertaining whether or not the conditions of the permit are being complied with, and denial of access for such inspection shall be ground for suspension of the permit until such access is freely given by the operator.
(June 25, 1938, ch. 675, § 404, 52 Stat. 1048.)
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. § 345 (FOOD AND DRUGS)
§ 345. Regulations making exemptions
The Secretary shall promulgate regulations exempting from any labeling requirement of this chapter (1) small open containers of fresh fruits and fresh vegetables and (2) food which is, 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 food is not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment. This section does not apply to the labeling requirements of sections 343(q) and 343(r) of this title.
(June 25, 1938, ch. 675, § 405, 52 Stat. 1049; Pub. L. 101–535, § 5(a), Nov. 8, 1990, 104 Stat. 2362.)
heading: Editorial Notes
heading: Amendments
text: 1990—Pub. L. 101–535 inserted at end “This section does not apply to the labeling requirements of sections 343(q) and 343(r) of this title.”
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date of 1990 Amendment
text: Amendment by Pub. L. 101–535 effective six months after the date of the promulgation of final regulations to implement section 343(r) of this title, or if such regulations are not promulgated, the date proposed regulations are to be considered as such final regulations (Nov. 8, 1992), with exception for persons marketing food the brand name of which contains a term defined by the Secretary under section 343(r)(2)(A)(i) of this title, see section 10(a) of Pub. L. 101–535, set out as a note under section 343 of this title.
heading: Construction of Amendments by Pub. L. 101–535
text: Amendments by Pub. L. 101–535 not to be construed to alter authority of Secretary of Health and Human Services and Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title.
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. § 346b (FOOD AND DRUGS)
§ 346b. Authorization of appropriations
There are authorized to be appropriated, out of any moneys in the Treasury not otherwise appropriated, such sums as may be necessary for the purpose and administration of sections 321(q), (r), 342(a)(2), and 346a of this title.
(July 22, 1954, ch. 559, § 4, 68 Stat. 517.)
heading: Editorial Notes
heading: Codification
text: Section was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
21 U.S.C. § 347a (FOOD AND DRUGS)
§ 347a. Congressional declaration of policy regarding oleomargarine sales
The Congress hereby finds and declares that the sale, or the serving in public eating places, of colored oleomargarine or colored margarine without clear identification as such or which is otherwise adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] depresses the market in interstate commerce for butter and for oleomargarine or margarine clearly identified and neither adulterated nor misbranded, and constitutes a burden on interstate commerce in such articles. Such burden exists, irrespective of whether such oleomargarine or margarine originates from an interstate source or from the State in which it is sold.
(Mar. 16, 1950, ch. 61, § 3(a), 64 Stat. 20.)
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 not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date
text: Section effective July 1, 1950, see section 7 of act Mar. 16, 1950, set out as a note under section 347 of this title.
21 U.S.C. § 347b (FOOD AND DRUGS)
§ 347b. Contravention of State laws
Nothing in this Act shall be construed as authorizing the possession, sale, or serving of colored oleomargarine or colored margarine in any State or Territory in contravention of the laws of such State or Territory.
(Mar. 16, 1950, ch. 61, § 6, 64 Stat. 22.)
heading: Editorial Notes
heading: References in Text
text: This Act, referred to in text, is act Mar. 16, 1950, ch. 61, 64 Stat. 20, which is classified to sections 331, 342, 347 to 347b of this title, and sections 45 and 55 of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Tables.
heading: Codification
text: Section was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date
text: Section effective July 1, 1950, see section 7 of act Mar. 16, 1950, set out as a note under section 347 of this title.
21 U.S.C. § 350l–1 (FOOD AND DRUGS)
§ 350l–1. Annual report to Congress
(1) In general
Not later than 2 years after January 4, 2011, and annually thereafter, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the use of recall authority under section 350l of this title (as added by subsection (a)) 1 and any public health advisories issued by the Secretary that advise against the consumption of an article of food on the ground that the article of food is adulterated and poses an imminent danger to health.
(2) Content
The report under paragraph (1) shall include, with respect to the report year—
(A) the identity of each article of food that was the subject of a public health advisory described in paragraph (1), an opportunity to cease distribution and recall under subsection (a) of section 350l of this title, or a mandatory recall order under subsection (b) of such section;
(B) the number of responsible parties, as defined in section 350f of this title, formally given the opportunity to cease distribution of an article of food and recall such article, as described in section 350l(a) of such title;
(C) the number of responsible parties described in subparagraph (B) who did not cease distribution of or recall an article of food after given the opportunity to cease distribution or recall under section 350l(a) of this title;
(D) the number of recall orders issued under section 350l(b) of this title; and
(E) a description of any instances in which there was no testing that confirmed adulteration of an article of food that was the subject of a recall under section 350l(b) of this title or a public health advisory described in paragraph (1).
(Pub. L. 111–353, title II, § 206(f), Jan. 4, 2011, 124 Stat. 3943.)
heading: Editorial Notes
heading: References in Text
text: Subsection (a), referred to in par. (1), means subsec. (a) of section 206 of Pub. L. 111–353.
heading: Codification
text: Section was enacted as part of the FDA Food Safety Modernization Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
heading: Statutory Notes and Related Subsidiaries
heading: Construction
text: Nothing in this section to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title.
21 U.S.C. § 353a–1 (FOOD AND DRUGS)
§ 353a–1. Enhanced communication
(a) Submissions from State boards of pharmacy
In a manner specified by the Secretary of Health and Human Services (referred to in this section as the “Secretary”), the Secretary shall receive submissions from State boards of pharmacy—
(1) describing actions taken against compounding pharmacies, as described in subsection (b); or
(2) expressing concerns that a compounding pharmacy may be acting contrary to section 353a of this title.
(b) Content of submissions from State boards of pharmacy
An action referred to in subsection (a)(1) is, with respect to a pharmacy that compounds drugs, any of the following:
(1) The issuance of a warning letter, or the imposition of sanctions or penalties, by a State for violations of a State’s pharmacy regulations pertaining to compounding.
(2) The suspension or revocation of a State-issued pharmacy license or registration for violations of a State’s pharmacy regulations pertaining to compounding.
(3) The recall of a compounded drug due to concerns relating to the quality or purity of such drug.
(c) Consultation
The Secretary shall implement subsection (a) in consultation with the National Association of Boards of Pharmacy.
(d) Notifying State boards of pharmacy
The Secretary shall immediately notify State boards of pharmacy when—
(1) the Secretary receives a submission under subsection (a)(1); or
(2) the Secretary makes a determination that a pharmacy is acting contrary to section 353a of this title.
(Pub. L. 113–54, title I, § 105, Nov. 27, 2013, 127 Stat. 597.)
heading: Editorial Notes
heading: Codification
text: Section was enacted as part of the Compounding Quality Act and also as part of the Drug Quality and Security Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
21 U.S.C. § 355d (FOOD AND DRUGS)
§ 355d. Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
The Secretary shall establish an internal committee within the Food and Drug Administration to carry out the activities as described in sections 355a(f) and 355c(f) of this title. Such internal committee shall include employees of the Food and Drug Administration, with expertise in pediatrics (including representation from the Office of Pediatric Therapeutics), biopharmacology, statistics, chemistry, legal issues, pediatric ethics, neonatology, and the appropriate expertise pertaining to the pediatric product under review, such as expertise in child and adolescent psychiatry or pediatric rare diseases, and other individuals designated by the Secretary.
(June 25, 1938, ch. 675, § 505C, as added Pub. L. 110–85, title IV, § 403, Sept. 27, 2007, 121 Stat. 875; amended Pub. L. 112–144, title V, § 509(c), July 9, 2012, 126 Stat. 1049; Pub. L. 115–52, title V, § 505(f), Aug. 18, 2017, 131 Stat. 1047.)
heading: Editorial Notes
heading: Amendments
text: 2017—Pub. L. 115–52 inserted “or pediatric rare diseases” after “psychiatry”.
2012—Pub. L. 112–144 inserted “deferral extensions,” after “deferrals,” in section catchline and “neonatology,” after “pediatric ethics,” in text.
21 U.S.C. § 356c–1 (FOOD AND DRUGS)
§ 356c–1. Annual reporting on drug shortages
(a) Annual reports to Congress
Not later than March 31 of each calendar year, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report, with respect to the preceding calendar year, on drug shortages that—
(1) specifies the number of manufacturers that submitted a notification to the Secretary under section 356c(a) of this title during such calendar year;
(2) describes the communication between the field investigators of the Food and Drug Administration and the staff of the Center for Drug Evaluation and Research’s Office of Compliance and Drug Shortage Program, including the Food and Drug Administration’s procedures for enabling and ensuring such communication;
(3)
(A) lists the major actions taken by the Secretary to prevent or mitigate the drug shortages described in paragraph (7);
(B) in the list under subparagraph (A), includes—
(i) the number of applications and supplements for which the Secretary expedited review under section 356c(g)(1) of this title during such calendar year; and
(ii) the number of establishment inspections or reinspections that the Secretary expedited under section 356c(g)(2) of this title during such calendar year;
(4) describes the coordination between the Food and Drug Administration and the Drug Enforcement Administration on efforts to prevent or alleviate drug shortages;
(5) identifies the number of and describes the instances in which the Food and Drug Administration exercised regulatory flexibility and discretion to prevent or alleviate a drug shortage;
(6) lists the names of manufacturers that were issued letters under section 356c(f) of this title; and
(7) specifies the number of drug shortages occurring during such calendar year, as identified by the Secretary.
(b) Trend analysis
The Secretary is authorized to retain a third party to conduct a study, if the Secretary believes such a study would help clarify the causes, trends, or solutions related to drug shortages.
(c) Definition
In this section, the term “drug shortage” or “shortage” has the meaning given such term in section 356c of this title.
(June 25, 1938, ch. 675, § 506C–1, as added Pub. L. 112–144, title X, § 1002, July 9, 2012, 126 Stat. 1102; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(F), Dec. 13, 2016, 130 Stat. 1153.)
heading: Editorial Notes
heading: Amendments
text: 2016—Subsec. (a). Pub. L. 114–255, in introductory provisions, substituted “Not later than March 31 of each calendar year,” for “Not later than the end of calendar year 2013, and not later than the end of each calendar year thereafter,” and inserted “, with respect to the preceding calendar year,” after “a report”.
21 U.S.C. § 356e (FOOD AND DRUGS)
§ 356e. Drug shortage list
(a) Establishment
The Secretary shall maintain an up-to-date list of drugs that are determined by the Secretary to be in shortage in the United States.
(b) Contents
For each drug on such list, the Secretary shall include the following information:
(1) The name of the drug in shortage, including the National Drug Code number for such drug.
(2) The name of each manufacturer of such drug.
(3) The reason for the shortage, as determined by the Secretary, selecting from the following categories:
(A) Requirements related to complying with good manufacturing practices.
(B) Regulatory delay.
(C) Shortage of an active ingredient.
(D) Shortage of an inactive ingredient component.
(E) Discontinuance of the manufacture of the drug.
(F) Delay in shipping of the drug.
(G) Demand increase for the drug.
(4) The estimated duration of the shortage as determined by the Secretary.
(c) Public availability
(1) In general
Subject to paragraphs (2) and (3), the Secretary shall make the information in such list publicly available.
(2) Trade secrets and confidential information
Nothing in this section alters or amends section 1905 of title 18 or section 552(b)(4) of title 5.
(3) Public health exception
The Secretary may choose not to make information collected under this section publicly available under paragraph (1) or section 356c(c) of this title if the Secretary determines that disclosure of such information would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of drug products to patients).
(d) Interagency notification
Not later than 180 days after March 27, 2020, and every 90 days thereafter, the Secretary shall transmit a report regarding the drugs of the current drug shortage list under this section to the Administrator of the Centers for Medicare & Medicaid Services.
(June 25, 1938, ch. 675, § 506E, as added Pub. L. 112–144, title X, § 1004, July 9, 2012, 126 Stat. 1104; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(G), Dec. 13, 2016, 130 Stat. 1153; Pub. L. 116–136, div. A, title III, § 3112(c), Mar. 27, 2020, 134 Stat. 362.)
heading: Editorial Notes
heading: Amendments
text: 2020—Subsec. (d). Pub. L. 116–136 added subsec. (d).
2016—Subsec. (b)(3)(E). Pub. L. 114–255, which directed substitution of “discontinuance” for “discontinuation”, was executed by substituting “Discontinuance” for “Discontinuation” to reflect the probable intent of Congress.
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date of 2020 Amendment
text: Amendment by Pub. L. 116–136 effective 180 days after Mar. 27, 2020, see section 3112(g) of Pub. L. 116–136, set out as a note under section 356c of this title.