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21 U.S.C. § 372 — Examinations and investigations

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

21 U.S.C. § 372 — Examinations and investigations

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Stable record: federal_law:legal_authorities:record_usc_0ad721f936ef6a49e521c6c3
Source file: Laws/federal/codes/united-states-code/title-21/section-372-examinations-and-investigations--0ad08bc60e.md
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Source location: Title 21, Chapter 9, § 372; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(a) Authority to conduct** (1) (A) The Secretary is authorized to conduct examinations and investigations for the purposes of this chapter through officers and employees of the Department or through any health, food, or drug officer or employee of any State, Territory, or political subdivision thereof, duly commissioned by the Secretary as an officer of the Department. (B) (i) For a tobacco product, to the extent feasible, the Secretary shall contract with the States in accordance with this paragraph to carry out inspections of retailers within that State in connection with the enforcement of this chapter. (ii) The Secretary shall not enter into any contract under clause (i) with the government of any of the several States to exercise enforcement authority under this chapter on Indian country without the express written consent of the Indian tribe involved. (2) (A) In addition to the authority established in paragraph (1), the Secretary, pursuant to a memorandum of understanding between the Secretary and the head of another Federal department or agency, is authorized to conduct examinations and investigations for the purposes of this chapter through the officers and employees of such other department or agency, subject to subparagraph (B). Such a memorandum shall include provisions to ensure adequate training of such officers and employees to conduct the examinations and investigations. The memorandum of understanding shall contain provisions regarding reimbursement. Such provisions may, at the sole discretion of the head of the other department or agency, require reimbursement, in whole or in part, from the Secretary for the examinations or investigations performed under this section by the officers or employees of the other department or agency. (B) A memorandum of understanding under subparagraph (A) between the Secretary and another Federal department or agency is effective only in the case of examinations or inspections at facilities or other locations that are jointly regulated by the Secretary and such department or agency. (C) For any fiscal year in which the Secretary and the head of another Federal department or agency carries out one or more examinations or inspections under a memorandum of understanding under subparagraph (A), the Secretary and the head of such department or agency shall with respect to their respective departments or agencies submit to the committees of jurisdiction (authorizing and appropriating) in the House of Representatives and the Senate a report that provides, for such year— (i) the number of officers or employees that carried out one or more programs, projects, or activities under such memorandum; (ii) the number of additional articles that were inspected or examined as a result of such memorandum; and (iii) the number of additional examinations or investigations that were carried out pursuant to such memorandum. (3) In the case of food packed in the Commonwealth of Puerto Rico or a Territory the Secretary shall attempt to make inspection of such food at the first point of entry within the United States when, in his opinion and with due regard to the enforcement of all the provisions of this chapter, the facilities at his disposal will permit of such inspection. (4) For the purposes of this subsection, the term “United States” means the States and the District of Columbia. **(b) Availability to owner of part of analysis samples** Where a sample of a food, drug, or cosmetic is collected for analysis under this chapter the Secretary shall, upon request, provide a part of such official sample for examination or analysis by any person named on the label of the article, or the owner thereof, or his attorney or agent; except that the Secretary is authorized, by regulations, to make such reasonable exceptions from, and impose such reasonable terms and conditions relating to, the operation of this subsection as he finds necessary for the proper administration of the provisions of this chapter. **(c) Records of other departments and agencies** For purposes of enforcement of this chapter, records of any department or independent establishment in the executive branch of the Government shall be open to inspection by any official of the Department duly authorized by the Secretary to make such inspection. **(d) Information on patents for drugs** The Secretary is authorized and directed, upon request from the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, to furnish full and complete information with respect to such questions relating to drugs as the Director may submit concerning any patent application. The Secretary is further authorized, upon receipt of any such request, to conduct or cause to be conducted, such research as may be required. **(e) Powers of enforcement personnel** Any officer or employee of the Department designated by the Secretary to conduct examinations, investigations, or inspections under this chapter relating to counterfeit drugs may, when so authorized by the Secretary— (1) carry firearms; (2) execute and serve search warrants and arrest warrants; (3) execute seizure by process issued pursuant to libel under [section 334 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section334&num=0&edition=prelim); (4) make arrests without warrant for offenses under this chapter with respect to such drugs if the offense is committed in his presence or, in the case of a felony, if he has probable cause to believe that the person so arrested has committed, or is committing, such offense; and (5) make, prior to the institution of libel proceedings under [section 334(a)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section334/a/2&num=0&edition=prelim), seizures of drugs or containers or of equipment, punches, dies, plates, stones, labeling, or other things, if they are, or he has reasonable grounds to believe that they are, subject to seizure and condemnation under such section 334(a)(2). In the event of seizure pursuant to this paragraph (5), libel proceedings under [section 334(a)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section334/a/2&num=0&edition=prelim) shall be instituted promptly and the property seized be placed under the jurisdiction of the court.

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

21 U.S.C. § 801 — Congressional findings and declarations: controlled substances

The Congress makes the following findings and declarations: (1) Many of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people. (2) The illegal importation, manufacture, distribution, and possession and improper use of controlled substances have a substantial and detrimental effect on the health and general welfare of the American people. (3) A major portion of the traffic in controlled substances flows through interstate and foreign commerce. Incidents of the traffic which are not an integral part of the interstate or foreign flow, such as manufacture, local distribution, and possession, nonetheless have a substantial and direct effect upon interstate commerce because— (A) after manufacture, many controlled substances are transported in interstate commerce, (B) controlled substances distributed locally usually have been transported in interstate commerce immediately before their distribution, and (C) controlled substances possessed commonly flow through interstate commerce immediately prior to such possession. (4) Local distribution and possession of controlled substances contribute to swelling the interstate traffic in such substances. (5) Controlled substances manufactured and distributed intrastate cannot be differentiated from controlled substances manufactured and distributed interstate. Thus, it is not feasible to distinguish, in terms of controls, between controlled substances manufactured and distributed interstate and controlled substances manufactured and distributed intrastate. (6) Federal control of the intrastate incidents of the traffic in controlled substances is essential to the effective control of the interstate incidents

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 801

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

21 U.S.C. § 334 — Seizure

**(a) Grounds and jurisdiction** (1) Any article of food, drug, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce or while held for sale (whether or not the first sale) after shipment in interstate commerce, or which may not, under the provisions of section 331(ll), 344, or 355 of this title, be introduced into interstate commerce, shall be liable to be proceeded against while in interstate commerce, or at any time thereafter, on libel of information and condemned in any district court of the United States or United States court of a Territory within the jurisdiction of which the article is found. No libel for condemnation shall be instituted under this chapter, for any alleged misbranding if there is pending in any court a libel for condemnation proceeding under this chapter based upon the same alleged misbranding, and not more than one such proceeding shall be instituted if no such proceeding is so pending, except that such limitations shall not apply (A) when such misbranding has been the basis of a prior judgment in favor of the United States, in a criminal, injunction, or libel for condemnation proceeding under this chapter, or (B) when the Secretary has probable cause to believe from facts found, without hearing, by him or any officer or employee of the Department that the misbranded article is dangerous to health, or that the labeling of the misbranded article is fraudulent, or would be in a material respect misleading to the injury or damage of the purchaser or consumer. In any case where the number of libel for condemnation proceedings is limited as above provided the proceeding pending or instituted shall, on application of the claimant, seasonably made, be removed for trial to any district agreed upon by stipu

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 334

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

21 U.S.C. § 321 — Definitions; generally

For the purposes of this chapter— **(a)** (1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico. (2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone. **(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body. **(c)** The term “Department” means Department of Health and Human Services. **(d)** The term “Secretary” means the Secretary of Health and Human Services. **(e)** The term “person” includes individual, partnership, corporation, and association. **(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. **(g)** (1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 321

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

35 U.S.C. § 1 — Establishment

**(a) Establishment.—** The United States Patent and Trademark Office is established as an agency of the United States, within the Department of Commerce. In carrying out its functions, the United States Patent and Trademark Office shall be subject to the policy direction of the Secretary of Commerce, but otherwise shall retain responsibility for decisions regarding the management and administration of its operations and shall exercise independent control of its budget allocations and expenditures, personnel decisions and processes, procurements, and other administrative and management functions in accordance with this title and applicable provisions of law. Those operations designed to grant and issue patents and those operations which are designed to facilitate the registration of trademarks shall be treated as separate operating units within the Office. **(b) Offices.—** The United States Patent and Trademark Office shall maintain its principal office in the metropolitan Washington, D.C., area, for the service of process and papers and for the purpose of carrying out its functions. The United States Patent and Trademark Office shall be deemed, for purposes of venue in civil actions, to be a resident of the district in which its principal office is located, except where jurisdiction is otherwise provided by law. The United States Patent and Trademark Office may establish satellite offices in such other places in the United States as it considers necessary and appropriate in the conduct of its business. **(c) Reference.—** For purposes of this title, the United States Patent and Trademark Office shall also be referred to as the “Office” and the “Patent and Trademark Office”.

Source: Supplied U.S. Code snapshot — release unconfirmed · 35 U.S.C. § 1

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

21 U.S.C. § 399 — Grants to enhance food safety

**(a) In general** The Secretary is authorized to make grants to eligible entities to— (1) undertake examinations, inspections, and investigations, and related food safety activities under [section 372 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372&num=0&edition=prelim); (2) train to the standards of the Secretary for the examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as such examination, inspection, and investigation relate to retail food establishments; (3) build the food safety capacity of the laboratories of such eligible entity, including the detection of zoonotic diseases; (4) build the infrastructure and capacity of the food safety programs of such eligible entity to meet the standards as outlined in the grant application; and (5) take appropriate action to protect the public health in response to— (A) a notification under [section 398 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section398&num=0&edition=prelim), including planning and otherwise preparing to take such action; or (B) a recall of food under this chapter. **(b) Eligible entities; application** (1) **In general** — In this section, the term “eligible entity” means an entity— (A) that is— (i) a State; (ii) a locality; (iii) a territory; (iv) an Indian tribe (as defined in [section 5304(e) of title 25](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title25-section5304/e&num=0&edition=prelim)); or (v) a nonprofit food safety training entity that collaborates with 1 or more institutions of higher education; and (B) that submits an application to the Secretary at such time,

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 399

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

21 U.S.C. § 399c — Improving the training of State, local, territorial, and tribal food safety officials

**(a) Training** The Secretary shall set standards and administer training and education programs for the employees of State, local, territorial, and tribal food safety officials relating to the regulatory responsibilities and policies established by this chapter, including programs for— (1) scientific training; (2) training to improve the skill of officers and employees authorized to conduct inspections under sections 372 and 374 of this title; (3) training to achieve advanced product or process specialization in such inspections; (4) training that addresses best practices; (5) training in administrative process and procedure and integrity issues; (6) training in appropriate sampling and laboratory analysis methodology; and (7) training in building enforcement actions following inspections, examinations, testing, and investigations. **(b) Partnerships with State and local officials** (1) **In general** — The Secretary, pursuant to a contract or memorandum of understanding between the Secretary and the head of a State, local, territorial, or tribal department or agency, is authorized and encouraged to conduct examinations, testing, and investigations for the purposes of determining compliance with the food safety provisions of this chapter through the officers and employees of such State, local, territorial, or tribal department or agency. (2) **Content** — A contract or memorandum described under paragraph (1) shall include provisions to ensure adequate training of such officers and employees to conduct such examinations, testing, and investigations. The contract or memorandum shall contain provisions regarding reimbursement. Such provisions may, at the sole discretion of the head of the other department or agency, require reimbursement, in whole or in part,

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 399c

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

21 U.S.C. § 372 — Examinations and investigations

Page 493 TITLE 21—FOOD AND DRUGS § 372 ‘‘(d) COLLABORATION.—The Secretary shall implement programs and policies that will foster collaboration be- tween the Food and Drug Administration, the National Institutes of Health, professional medical and scientific societies, and other persons, to identify published and unpublished studies that may support a supplemental application, and to encourage sponsors to make supple- mental applications or conduct further research in sup- port of a supplemental application based, in whole or in part, on such studies.’’ HEARINGS PENDING ON APRIL 15, 1954, WITH RESPECT TO FOOD STANDARDS Provisions of this chapter in effect prior to Apr. 15, 1954, as applicable with respect to hearings begun prior to such date under subsection (e) of this section, re- garding food standards, see Savings Provisions note set out under section 341 of this title. Executive Documents TRANSFER OF FUNCTIONS For transfer of functions of Federal Security Admin- istrator 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. § 372. Examinations and investigations (a) Authority to conduct (1)(A) The Secretary is authorized to conduct examinations and investigations for the pur- poses of this chapter through officers and em- ployees of the Department or through any health, food, or drug officer or employee of any State, Territory, or political subdivision there- of, duly commissioned by the Secretary as an of- ficer of the Department. (B)(i) For a tobacco product, to the extent fea- sible, the Secretary shall contract with the States in accordance with this paragraph to ca

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 372

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