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21 U.S.C. § 331 — Prohibited acts
Federal law — U.S. Code and appendices · legal_authorities
The following acts and the causing thereof are prohibited:
**(a)** The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
**(b)** The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.
**(c)** The receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
**(d)** The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 350d, 355,,11 So in original. 360bbb–3, or 364c of this title.
**(e)** The refusal to permit access to or copying of any record as required by section 350a, 350c, 350f(j), 350e, 354, 360bbb–3, 364a, 373, 374(a), 379aa, or 379aa–1 of this title; or the failure to establish or maintain any record, or make any report, required under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 364a, 364g, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit access to or verification or copying of any such required record; or the violation of any recordkeeping requirement under section 2223 22 See References in Text note below. of this title (except when such violation is committed by a farm).
**(f)** The refusal to permit entry or inspection as authorized by [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim).
**(g)** The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
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Source location: Title 21, Chapter 9, § 331; chapter-009-federal-food-drug-and-cosmetic-act.md
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The following acts and the causing thereof are prohibited:
**(a)** The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
**(b)** The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.
**(c)** The receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
**(d)** The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 350d, 355,,11 So in original. 360bbb–3, or 364c of this title.
**(e)** The refusal to permit access to or copying of any record as required by section 350a, 350c, 350f(j), 350e, 354, 360bbb–3, 364a, 373, 374(a), 379aa, or 379aa–1 of this title; or the failure to establish or maintain any record, or make any report, required under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 364a, 364g, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit access to or verification or copying of any such required record; or the violation of any recordkeeping requirement under section 2223 22 See References in Text note below. of this title (except when such violation is committed by a farm).
**(f)** The refusal to permit entry or inspection as authorized by [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim).
**(g)** The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
**(h)** The giving of a guaranty or undertaking referred to in [section 333(c)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section333/c/2&num=0&edition=prelim), which guaranty or undertaking is false, except by a person who relied upon a guaranty or undertaking to the same effect signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith the food, drug, device, tobacco product, or cosmetic; or the giving of a guaranty or undertaking referred to in [section 333(c)(3) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section333/c/3&num=0&edition=prelim), which guaranty or undertaking is false.
**(i)**
(1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification device authorized or required by regulations promulgated under the provisions of section 344 or 379e of this title.
(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any drug or container or labeling thereof so as to render such drug a counterfeit drug.
(3) The doing of any act which causes a drug to be a counterfeit drug, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit drug.
**(j)** The using by any person to his own advantage, or revealing, other than to the Secretary or officers or employees of the Department, or to the courts when relevant in any judicial proceeding under this chapter, any information acquired under authority of section 344, 348, 350a, 350c, 355, 360, 360b, 360c, 360d, 360e, 360f, 360h, 360i, 360j, 360ccc, 360ccc–1, 360ccc–2, 374, 379, 379e, 387d, 387e, 387f, 387g, 387h, 387i, or 387t(b) of this title concerning any method or process which as a trade secret is entitled to protection; or the violating of [section 346a(i)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section346a/i/2&num=0&edition=prelim) or any regulation issued under that section..1This paragraph does not authorize the withholding of information from either House of Congress or from, to the extent of matter within its jurisdiction, any committee or subcommittee of such committee or any joint committee of Congress or any subcommittee of such joint committee.
**(k)** The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, tobacco product, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.
**(l)** Repealed. Pub. L. 105–115, title IV, § 421, Nov. 21, 1997, 111 Stat. 2380.
**(m)** The sale or offering for sale of colored oleomargarine or colored margarine, or the possession or serving of colored oleomargarine or colored margarine in violation of subsections (b) or (c) of [section 347 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section347&num=0&edition=prelim).
**(n)** The using, in labeling, advertising or other sales promotion of any reference to any report or analysis furnished in compliance with [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim).
**(o)** In the case of a prescription drug distributed or offered for sale in interstate commerce, the failure of the manufacturer, packer, or distributor thereof to maintain for transmittal, or to transmit, to any practitioner licensed by applicable State law to administer such drug who makes written request for information as to such drug, true and correct copies of all printed matter which is required to be included in any package in which that drug is distributed or sold, or such other printed matter as is approved by the Secretary. Nothing in this paragraph shall be construed to exempt any person from any labeling requirement imposed by or under other provisions of this chapter.
**(p)** The failure to register in accordance with section 360 or 387e of this title, the failure to provide any information required by section 360(j), 360(k), 387e(i), or 387e(j) of this title, or the failure to provide a notice required by section 360(j)(2) or 387e(i)(3) of this title.
**(q)**
(1) The failure or refusal—
(A) to comply with any requirement prescribed under section 360h, 360j(g), 387c(b), 387g, 387h, or 387o of this title;
(B) to furnish any notification or other material or information required by or under section 360i, 360j(g), 387d, 387i, or 387t of this title; or
(C) to comply with a requirement under section 360l or 387m of this title.
(2) With respect to any device or tobacco product, the submission of any report that is required by or under this chapter that is false or misleading in any material respect.
(3) The failure to comply with any requirement under [section 360n–2(b)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360n–2/b/2&num=0&edition=prelim) (relating to ensuring device cybersecurity).
**(r)** The movement of a device, drug, or tobacco product in violation of an order under [section 334(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section334/g&num=0&edition=prelim) or the removal or alteration of any mark or label required by the order to identify the device, drug, or tobacco product as detained.
**(s)** The failure to provide the notice required by section 350a(c) or 350a(e) of this title, the failure to make the reports required by [section 350a(f)(1)(B) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350a/f/1/B&num=0&edition=prelim), the failure to retain the records required by [section 350a(b)(4) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350a/b/4&num=0&edition=prelim), or the failure to meet the requirements prescribed under [section 350a(f)(3) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350a/f/3&num=0&edition=prelim).
**(t)** The importation of a drug in violation of [section 381(d)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/d/1&num=0&edition=prelim), the sale, purchase, or trade of a drug or drug sample or the offer to sell, purchase, or trade a drug or drug sample in violation of [section 353(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/c&num=0&edition=prelim), the sale, purchase, or trade of a coupon, the offer to sell, purchase, or trade such a coupon, or the counterfeiting of such a coupon in violation of [section 353(c)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/c/2&num=0&edition=prelim), the distribution of a drug sample in violation of [section 353(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/d&num=0&edition=prelim) or the failure to otherwise comply with the requirements of [section 353(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/d&num=0&edition=prelim), the distribution of drugs in violation of [section 353(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/e&num=0&edition=prelim), failure to comply with the requirements under [section 360eee–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360eee-1&num=0&edition=prelim), the failure to comply with the requirements under [section 360eee–3 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360eee-3&num=0&edition=prelim), as applicable, or the failure to otherwise comply with the requirements of [section 353(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/e&num=0&edition=prelim).
**(u)** The failure to comply with any requirements of the provisions of, or any regulations or orders of the Secretary, under section 360b(a)(4)(A), 360b(a)(4)(D), or 360b(a)(5) of this title.
**(v)** The introduction or delivery for introduction into interstate commerce of a dietary supplement that is unsafe under [section 350b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350b&num=0&edition=prelim).
**(w)** The making of a knowingly false statement in any statement, certificate of analysis, record, or report required or requested under [section 381(d)(3) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/d/3&num=0&edition=prelim); the failure to submit a certificate of analysis as required under such section; the failure to maintain records or to submit records or reports as required by such section; the release into interstate commerce of any article or portion thereof imported into the United States under such section or any finished product made from such article or portion, except for export in accordance with section 381(e) or 382 of this title, or with [section 262(h) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/h&num=0&edition=prelim); or the failure to so export or to destroy such an article or portions thereof, or such a finished product.
**(x)** The falsification of a declaration of conformity submitted under [section 360d(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360d/c&num=0&edition=prelim) or the failure or refusal to provide data or information requested by the Secretary under paragraph (3) of such section.
**(y)** In the case of a drug, device, or food—
(1) the submission of a report or recommendation by a person accredited under [section 360m of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360m&num=0&edition=prelim) that is false or misleading in any material respect;
(2) the disclosure by a person accredited under [section 360m of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360m&num=0&edition=prelim) of confidential commercial information or any trade secret without the express written consent of the person who submitted such information or secret to such person; or
(3) the receipt by a person accredited under [section 360m of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360m&num=0&edition=prelim) of a bribe in any form or the doing of any corrupt act by such person associated with a responsibility delegated to such person under this chapter.
**(z)** Omitted.
**(aa)** The importation of a prescription drug in violation of [section 384 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section384&num=0&edition=prelim), the falsification of any record required to be maintained or provided to the Secretary under such section, or any other violation of regulations under such section.
**(bb)** The transfer of an article of food in violation of an order under [section 334(h) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section334/h&num=0&edition=prelim), or the removal or alteration of any mark or label required by the order to identify the article as detained.
**(cc)** The importing or offering for import into the United States of an article of food or a drug by, with the assistance of, or at the direction of, a person debarred from such activity under [section 335a(b)(3) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section335a/b/3&num=0&edition=prelim).
**(dd)** The failure to register in accordance with [section 350d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350d&num=0&edition=prelim).
**(ee)** The importing or offering for import into the United States of an article of food in violation of the requirements under [section 381(m) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/m&num=0&edition=prelim).
**(ff)** The importing or offering for import into the United States of a drug or device with respect to which there is a failure to comply with a request of the Secretary to submit to the Secretary a statement under section 381(o) of this title.
**(gg)** The knowing failure to comply with paragraph (7)(E) of [section 374(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374/g&num=0&edition=prelim); the knowing inclusion by a person accredited under paragraph (2) of such section of false information in an inspection report under paragraph (7)(A) of such section; or the knowing failure of such a person to include material facts in such a report.
**(hh)** The failure by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food to comply with the sanitary transportation practices prescribed by the Secretary under [section 350e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350e&num=0&edition=prelim).
**(ii)** The falsification of a report of a serious adverse event submitted to a responsible person (as defined under section 364, 379aa, or 379aa–1 of this title) or the falsification of a serious adverse event report (as defined under section 379aa or 379aa–1 of this title or required under [section 364a(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section364a/a&num=0&edition=prelim)) submitted to the Secretary.
**(jj)**
(1) The failure to submit the certification required by [section 282(j)(5)(B) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section282/j/5/B&num=0&edition=prelim), or knowingly submitting a false certification under such section.
(2) The failure to submit clinical trial information required under subsection (j) of [section 282 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section282&num=0&edition=prelim).
(3) The submission of clinical trial information under subsection (j) of [section 282 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section282&num=0&edition=prelim) that is false or misleading in any particular under paragraph (5)(D) of such subsection (j).
**(kk)** The dissemination of a television advertisement without complying with section 353c 2 of this title.
**(ll)** The introduction or delivery for introduction into interstate commerce of any food to which has been added a drug approved under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), a biological product licensed under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, unless—
(1) such drug or such biological product was marketed in food before any approval of the drug under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), before licensure of the biological product under such [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), and before any substantial clinical investigations involving the drug or the biological product have been instituted;
(2) the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, approving the use of such drug or such biological product in the food;
(3) the use of the drug or the biological product in the food is to enhance the safety of the food to which the drug or the biological product is added or applied and not to have independent biological or therapeutic effects on humans, and the use is in conformity with—
(A) a regulation issued under [section 348 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section348&num=0&edition=prelim) prescribing conditions of safe use in food;
(B) a regulation listing or affirming conditions under which the use of the drug or the biological product in food is generally recognized as safe;
(C) the conditions of use identified in a notification to the Secretary of a claim of exemption from the premarket approval requirements for food additives based on the notifier’s determination that the use of the drug or the biological product in food is generally recognized as safe, provided that the Secretary has not questioned the general recognition of safety determination in a letter to the notifier;
(D) a food contact substance notification that is effective under [section 348(h) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section348/h&num=0&edition=prelim); or
(E) such drug or biological product had been marketed for smoking cessation prior to September 27, 2007; or
(4) the drug is a new animal drug whose use is not unsafe under [section 360b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b&num=0&edition=prelim).
**(mm)** The failure to submit a report or provide a notification required under [section 350f(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350f/d&num=0&edition=prelim).
**(nn)** The falsification of a report or notification required under [section 350f(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350f/d&num=0&edition=prelim).
**(oo)** The sale of tobacco products in violation of a no-tobacco-sale order issued under [section 333(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section333/f&num=0&edition=prelim).
**(pp)** The introduction or delivery for introduction into interstate commerce of a tobacco product in violation of [section 387k of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387k&num=0&edition=prelim).
**(qq)**
(1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp (including tax stamp), tag, label, or other identification device upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product.
(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other item that is designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product.
(3) The doing of any act that causes a tobacco product to be a counterfeit tobacco product, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit tobacco product.
**(rr)** The charitable distribution of tobacco products.
**(ss)** The failure of a manufacturer or distributor to notify the Attorney General and the Secretary of the Treasury of their knowledge of tobacco products used in illicit trade.
**(tt)** Making any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that—
(1) the product is approved by the Food and Drug Administration;
(2) the Food and Drug Administration deems the product to be safe for use by consumers;
(3) the product is endorsed by the Food and Drug Administration for use by consumers; or
(4) the product is safe or less harmful by virtue of—
(A) its regulation or inspection by the Food and Drug Administration; or
(B) its compliance with regulatory requirements set by the Food and Drug Administration;
including any such statement or representation rendering the product misbranded under [section 387c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387c&num=0&edition=prelim).
**(uu)** The operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with [section 350g of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350g&num=0&edition=prelim).
**(vv)** The failure to comply with the requirements under [section 350h of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350h&num=0&edition=prelim).
**(ww)** The failure to comply with [section 350i of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350i&num=0&edition=prelim).
**(xx)** The refusal or failure to follow an order under section 350l of this title.
**(yy)** The knowing and willful failure to comply with the notification requirement under [section 350f(h) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350f/h&num=0&edition=prelim).
**(zz)** The importation or offering for importation of a food if the importer (as defined in [section 384a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section384a&num=0&edition=prelim)) does not have in place a foreign supplier verification program in compliance with such [section 384a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section384a&num=0&edition=prelim).
**(aaa)** The failure to register in accordance with [section 381(s) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/s&num=0&edition=prelim).
**(bbb)** The failure to notify the Secretary in violation of [section 360bbb–7 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb-7&num=0&edition=prelim).
**(ccc)**
(1) The resale of a compounded drug that is labeled “not for resale” in accordance with [section 353b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353b&num=0&edition=prelim).
(2) With respect to a drug to be compounded pursuant to section 353a or 353b of this title, the intentional falsification of a prescription, as applicable.
(3) The failure to report drugs or adverse events by an entity that is registered in accordance with subsection (b) of [section 353b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353b&num=0&edition=prelim).
**(ddd)**
(1) The manufacture or the introduction or delivery for introduction into interstate commerce of a rinse-off cosmetic that contains intentionally-added plastic microbeads.
(2) In this paragraph—
(A) the term “plastic microbead” means any solid plastic particle that is less than five millimeters in size and is intended to be used to exfoliate or cleanse the human body or any part thereof; and
(B) the term “rinse-off cosmetic” includes toothpaste.
**(eee)** The failure to comply with any order issued under [section 360bbb–8d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb-8d&num=0&edition=prelim).
**(fff)**
(1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification upon any device or container, packaging, or labeling thereof so as to render such device a counterfeit device.
(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark or imprint of another or any likeness of any of the foregoing upon any device or container, packaging, or labeling thereof so as to render such device a counterfeit device.
(3) The doing of any act which causes a device to be a counterfeit device, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit device.
**(ggg)** The failure of a sponsor of a product approved under accelerated approval pursuant to [section 356(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356/c&num=0&edition=prelim)—
(1) to conduct with due diligence any postapproval study required under [section 356(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356/c&num=0&edition=prelim) with respect to such product; or
(2) to submit timely reports with respect to such product in accordance with [section 356b(a)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356b/a/2&num=0&edition=prelim).
**(hhh)** The failure to register or submit listing information in accordance with [section 364c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section364c&num=0&edition=prelim).
**(iii)** The refusal or failure to follow an order under [section 364g of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section364g&num=0&edition=prelim).
Cross-references
Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.
Federal law — U.S. Code and appendices · legal_authorities
The Secretary, upon application of any packer of any sea food for shipment or sale within the jurisdiction of this chapter, may, at his discretion, designate inspectors to examine and inspect such food and the production, packing, and labeling thereof. If on such examination and inspection compliance is found with the provisions of this chapter and regulations promulgated thereunder, the applicant shall be authorized or required to mark the food as provided by regulation to show such compliance. Services under this section shall be rendered only upon payment by the applicant of fees fixed by regulation in such amounts as may be necessary to provide, equip, and maintain an adequate and efficient inspection service. Receipts from such fees shall be covered into the Treasury and shall be available to the Secretary for expenditures incurred in carrying out the purposes of this section, including expenditures for salaries of additional inspectors when necessary to supplement the number of inspectors for whose salaries Congress has appropriated. The Secretary is authorized to promulgate regulations governing the sanitary and other conditions under which the service herein provided shall be granted and maintained, and for otherwise carrying out the purposes of this section. Any person who forges, counterfeits, simulates, or falsely represents, or without proper authority uses any mark, stamp, tag, label, or other identification devices authorized or required by the provisions of this section or regulations thereunder, shall be guilty of a misdemeanor, and shall on conviction thereof be subject to imprisonment for not more than one year or a fine of not less than $1,000 nor more than $5,000, or both such imprisonment and fine.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 376
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.
**(b) Filing application; contents**
(1)
(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application—
(i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use;
(ii) a full list of the articles used as components of such drug;
(iii) a full statement of the composition of such drug;
(iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug;
(v) such samples of such drug and of the articles used as components thereof as the Secretary may require;
(vi) specimens of the labeling proposed to be used for such drug;
(vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and
(viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—
(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or
(II) claims a method of using such drug for which approv
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** Sections 352(f)(1), 355, and 360eee–1 of this title shall not apply to a drug compounded by or under the direct supervision of a licensed pharmacist in a facility that elects to register as an outsourcing facility if each of the following conditions is met:
(1) **Registration and reporting** — The drug is compounded in an outsourcing facility that is in compliance with the requirements of subsection (b).
(2) **Bulk drug substances** — The drug is compounded in an outsourcing facility that does not compound using bulk drug substances (as defined in section 207.3(a)(4) of title 21, Code of Federal Regulations (or any successor regulation)), unless—
(A)
(i) the bulk drug substance appears on a list established by the Secretary identifying bulk drug substances for which there is a clinical need, by—
(I) publishing a notice in the Federal Register proposing bulk drug substances to be included on the list, including the rationale for such proposal;
(II) providing a period of not less than 60 calendar days for comment on the notice; and
(III) publishing a notice in the Federal Register designating bulk drug substances for inclusion on the list; or
(ii) the drug compounded from such bulk drug substance appears on the drug shortage list in effect under [section 356e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356e&num=0&edition=prelim) at the time of compounding, distribution, and dispensing;
(B) if an applicable monograph exists under the United States Pharmacopeia, the National Formulary, or another compendium or pharmacopeia recognized by the Secretary for purposes of this paragraph, the bulk drug substances each comply with the monograph;
(C) the bulk drug substances a
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 353b
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Inspection Procedures.—**
(1) **In general.—** — The Secretary of Transportation, in consultation with the Secretary of Health and Human Services and the Secretary of Agriculture, shall establish procedures for transportation safety inspections for the purpose of identifying suspected incidents of contamination or adulteration of—
(A) food in violation of regulations promulgated under section 416 of the Federal Food, Drug, and Cosmetic Act;
(B) a carcass, part of a carcass, meat, meat food product, or animal subject to detention under section 402 of the Federal Meat Inspection Act ([21 U.S.C. 672](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section672&num=0&edition=prelim)); and
(C) poultry products or poultry subject to detention under section 19 of the Poultry Products Inspection Act ([21 U.S.C. 467a](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section467a&num=0&edition=prelim)).
(2) **Training.—**
(A) *In general.—* — The Secretary of Transportation shall develop and carry out a training program to conduct enforcement of this chapter and regulations prescribed under this chapter or compatible State laws and regulations.
(B) *Conduct.—* — In carrying out this paragraph, the Secretary of Transportation shall train inspectors, including Department of Transportation personnel, State employees described under subsection (c), or personnel paid with funds authorized under sections 31102 and 31104, in the recognition of adulteration problems associated with the transportation of cosmetics, devices, drugs, food, and food additives and in the procedures for obtaining assistance of the appropriate departments, agencies, and instrumentalities of the Government and State authorities to support the enforcemen
Source: Supplied U.S. Code snapshot — release unconfirmed · 49 U.S.C. § 5701
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Federal law — U.S. Code and appendices · legal_authorities
In this subchapter:
(1) **Adverse event** — The term “adverse event” means any health-related event associated with the use of a cosmetic product that is adverse.
(2) **Cosmetic product** — The term “cosmetic product” means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.
(3) **Facility**
(A) *In general.—* — The term “facility” includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.
(B) Such term does not include any of the following:
(i) Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location.
(ii) Cosmetic product retailers, including individual sales representatives, direct sellers (as defined in [section 3508(b)(2) of title 26](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title26-section3508/b/2&num=0&edition=prelim)), retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location.
(iii) Hospitals, physicians’ offices, and health care clinics.
(iv) Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer.
(v) Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services.
(vi) Trade shows and other venues where cosmetic product samples are provided free of charge.
(vii) An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale.
(vii
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 364
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Adulteration** An infant formula, including an infant formula powder, shall be deemed to be adulterated if—
(1) such infant formula does not provide nutrients as required by subsection (i),
(2) such infant formula does not meet the quality factor requirements prescribed by the Secretary under subsection (b)(1), or
(3) the processing of such infant formula is not in compliance with the good manufacturing practices and the quality control procedures prescribed by the Secretary under subsection (b)(2).
**(b) Requirements for quality factors, good manufacturing practices, and retention of records**
(1) The Secretary shall by regulation establish requirements for quality factors for infant formulas to the extent possible consistent with current scientific knowledge, including quality factor requirements for the nutrients required by subsection (i).
(2)
(A) The Secretary shall by regulation establish good manufacturing practices for infant formulas, including quality control procedures that the Secretary determines are necessary to assure that an infant formula provides nutrients in accordance with this subsection and subsection (i) and is manufactured in a manner designed to prevent adulteration of the infant formula.
(B) The good manufacturing practices and quality control procedures prescribed by the Secretary under subparagraph (A) shall include requirements for—
(i) the testing, in accordance with paragraph (3) and by the manufacturer of an infant formula or an agent of such manufacturer, of each batch of infant formula for each nutrient required by subsection (i) before the distribution of such batch,
(ii) regularly scheduled testing, by the manufacturer of an infant formula or an agent of such manufacturer, of samples of infant formulas duri
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350a
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Federal law — U.S. Code and appendices · legal_authorities
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
**(a) Submission of registration**
(1) **Initial registration**
(A) *Existing facilities* — Every person that, on December 29, 2022, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with the Secretary not later than 1 year after December 29, 2022.
(B) *New facilities* — Every person that owns or operates a facility that first engages, after December 29, 2022, in manufacturing or processing of a cosmetic product for distribution in the United States, shall register with the Secretary such facility within 60 days of first engaging in such activity or 60 days after the deadline for registration under subparagraph (A), whichever is later.
(2) **Biennial renewal of registration** — A person required to register a facility under paragraph (1) shall renew such registrations with the Secretary biennially.
(3) **Contract manufacturers** — If a facility manufactures or processes cosmetic products on behalf of a responsible person, the Secretary shall require only a single registration for such facility even if such facility is manufacturing or processing its own cosmetic products or cosmetic products on behalf of more than one responsible person. Such single registration may be submitted to the Secretary by such facility or any responsible person whose products are manufactured or processed at such facility.
(4) **Updates to content** — A person that is required to register under subsection (a)(1) shall notify the Secretary within 60 days of any changes to information required under subsection (b)(2).
(5) **Abbreviated renewal registrations** — The Secretary shall provide for an abbreviated registration renewal process for any person that owns or operates
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 364c
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general**
(1) **Review and classification of devices** — Not later than 1 year after November 21, 1997, the Secretary shall, subject to paragraph (3), accredit persons for the purpose of reviewing reports submitted under [section 360(k) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360/k&num=0&edition=prelim) and making recommendations to the Secretary regarding the initial classification of devices under [section 360c(f)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/f/1&num=0&edition=prelim).
(2) **Requirements regarding review**
(A) *In general* — In making a recommendation to the Secretary under paragraph (1), an accredited person shall notify the Secretary in writing of the reasons for the recommendation.
(B) *Time period for review* — Not later than 30 days after the date on which the Secretary is notified under subparagraph (A) by an accredited person with respect to a recommendation of an initial classification of a device, the Secretary shall make a determination with respect to the initial classification.
(C) *Special rule* — The Secretary may change the initial classification under [section 360c(f)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/f/1&num=0&edition=prelim) that is recommended under paragraph (1) by an accredited person, and in such case shall provide to such person, and the person who submitted the report under [section 360(k) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360/k&num=0&edition=prelim) for the device, a statement explaining in detail the reasons for the change.
(3) **Certain devices**
(A) *In general* — An accredited
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360m
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