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21 U.S.C. § 331Prohibited acts

submitted 88 years ago by ch. 675 to r/title-21-FOOD-AND-DRUGS · 3,471 words · no verdicts yet

in plain englishAI-generated · not legal advice

This law lists dozens of actions that are illegal under federal food, drug, and cosmetic law. Most involve selling, shipping, or making adulterated or misbranded food, drugs, devices, tobacco products, or cosmetics. Others cover counterfeiting, false reports, blocked inspections, and breaking specific safety and registration rules.

The following acts, and causing them, are prohibited: (a) Bringing an adulterated or misbranded food, drug, device, tobacco product, or cosmetic into interstate commerce, or delivering one to be brought into interstate commerce. (b) Adulterating or misbranding any food, drug, device, tobacco product, or cosmetic while it is in interstate commerce. (c) Receiving an adulterated or misbranded food, drug, device, tobacco product, or cosmetic in interstate commerce, and delivering it (or offering to) for pay or otherwise. (d) Bringing an article into interstate commerce, or delivering it to be brought in, in violation of sections 344, 350d, 355, 360bbb-3, or 364c of this title. (e) Refusing to let someone access or copy records required under a list of sections (350a, 350c, 350f(j), 350e, 354, 360bbb-3, 364a, 373, 374(a), 379aa, or 379aa-1); failing to establish or maintain a required record or report under another long list of sections; or violating a recordkeeping requirement under section 2223 of this title, except when a farm commits the violation. (f) Refusing to permit entry or inspection authorized under section 374. (g) Manufacturing an adulterated or misbranded food, drug, device, tobacco product, or cosmetic within any U.S. Territory. (h) Giving a false guaranty or undertaking described in section 333(c)(2) -- except this does not apply to someone who relied in good faith on a matching guaranty signed by, and naming, the U.S.-based person who supplied them the product; or giving a false guaranty or undertaking described in section 333(c)(3). (i) (1) Forging, counterfeiting, simulating, or falsely using -- without proper authority -- any mark, stamp, tag, label, or identification device required by regulations under section 344 or 379e. (2) Making, selling, disposing of, keeping, or concealing any tool designed to reproduce someone else's trademark, trade name, or identifying mark on a drug or its container or labeling, so as to make it a counterfeit drug. (3) Doing anything that causes a drug to become counterfeit, or selling, dispensing, or holding a counterfeit drug for sale or dispensing. (j) Using for personal advantage, or revealing to anyone other than the Secretary, Department staff, or a relevant court, trade-secret information gathered under a long list of sections; or violating section 346a(i)(2) or a related regulation. A footnote clarifies this does not authorize withholding information from Congress or its committees. (k) Altering, mutilating, destroying, or removing all or part of a food, drug, device, tobacco product, or cosmetic's labeling -- or doing anything similar -- while it is held for sale after moving through interstate commerce, if that act makes the article adulterated or misbranded. (l) Repealed in 1997. (m) Selling or offering to sell colored oleomargarine or colored margarine, or possessing or serving it, in violation of section 347(b) or (c). (n) Referring, in labeling, advertising, or sales promotion, to a report or analysis submitted to comply with section 374. (o) For a prescription drug sold in interstate commerce: the manufacturer, packer, or distributor failing to keep or send -- to a licensed practitioner who requests it in writing -- true copies of printed material required in the drug's package, or other material the Secretary approved. This does not excuse anyone from other labeling requirements. (p) Failing to register under section 360 or 387e; failing to provide required information under section 360(j), 360(k), 387e(i), or 387e(j); or failing to provide a required notice under section 360(j)(2) or 387e(i)(3). (q) (1) Failing or refusing to (A) comply with requirements under sections 360h, 360j(g), 387c(b), 387g, 387h, or 387o; (B) provide notifications or material required under sections 360i, 360j(g), 387d, 387i, or 387t; or (C) comply with a requirement under section 360l or 387m. (2) Submitting a false or misleading report about a device or tobacco product. (3) Failing to comply with a device-cybersecurity requirement under section 360n-2(b)(2). (r) Moving a device, drug, or tobacco product in violation of a detention order under section 334(g), or removing or altering a mark or label required by that order to identify the item as detained. (s) Failing to give notices required by section 350a(c) or (e); failing to make reports required by section 350a(f)(1)(B); failing to keep records required by section 350a(b)(4); or failing to meet requirements under section 350a(f)(3). (t) Importing a drug in violation of section 381(d)(1); selling, buying, trading, or offering to sell, buy, or trade a drug or drug sample in violation of section 353(c); selling, buying, trading, offering, or counterfeiting a drug coupon in violation of section 353(c)(2); distributing a drug sample in violation of, or otherwise failing to comply with, section 353(d); distributing drugs in violation of section 353(e); or failing to comply with section 360eee-1 or 360eee-3, as applicable. (u) Failing to comply with requirements, regulations, or orders under section 360b(a)(4)(A), (a)(4)(D), or (a)(5). (v) Bringing an unsafe dietary supplement -- unsafe under section 350b -- into interstate commerce. (w) Making a knowingly false statement in a statement, certificate of analysis, record, or report required under section 381(d)(3); failing to submit that certificate; failing to keep or submit required records or reports; releasing an imported article, or a finished product made from it, into interstate commerce without proper export under sections 381(e), 382, or 262(h) of title 42; or failing to export or destroy that article or product as required. (x) Falsifying a declaration of conformity submitted under section 360d(c), or failing or refusing to give data the Secretary requests under that section's paragraph (3). (y) For a drug, device, or food: (1) an accredited person under section 360m submitting a false or misleading report or recommendation; (2) that person disclosing confidential business information or a trade secret without written consent from whoever provided it; or (3) that person taking a bribe or doing anything corrupt connected to their delegated duties. (z) Omitted; no content. (aa) Importing a prescription drug in violation of section 384; falsifying a record required under that section; or otherwise violating regulations under that section. (bb) Moving a food item in violation of a detention order under section 334(h), or removing or altering a required mark or label showing it is detained. (cc) Importing or offering to import a food or drug with the help of, or at the direction of, a person barred from that activity under section 335a(b)(3). (dd) Failing to register under section 350d. (ee) Importing or offering to import food that violates requirements under section 381(m). (ff) Importing or offering to import a drug or device when someone failed to submit a statement the Secretary requested under section 381(o). (gg) Knowingly failing to comply with section 374(g)(7)(E); an accredited person under section 374(g)(2) knowingly including false information in an inspection report under (g)(7)(A); or that person knowingly leaving out material facts from such a report. (hh) A shipper, carrier, receiver, or anyone else transporting food failing to follow the sanitary transportation rules set under section 350e. (ii) Falsifying a serious-adverse-event report submitted to a "responsible person" as defined under sections 364, 379aa, or 379aa-1; or falsifying such a report submitted to the Secretary as defined or required under sections 379aa, 379aa-1, or 364a(a). (jj) (1) Failing to submit the certification required by section 282(j)(5)(B) of title 42, or knowingly submitting a false one. (2) Failing to submit clinical trial information required under section 282(j) of title 42. (3) Submitting clinical trial information under that subsection that is false or misleading, as described in paragraph (5)(D). (kk) Airing a television advertisement without complying with section 353c of this title. (ll) Bringing into interstate commerce a food containing an approved drug or licensed biological product, or one with substantial ongoing and publicly known clinical trials, unless one of four exceptions applies: (1) the drug or biological product was already used in food before it was approved, licensed, or before substantial trials began; (2) the Secretary issued a regulation, after notice and comment, approving that use in food; (3) the drug or biological product is used only to make the food safer, not for its own biological or medical effect on people, consistent with specific existing safety regulations, notifications, or food-contact-substance rules, or it was marketed for smoking cessation before September 27, 2007; or (4) the drug is a new animal drug whose use is not unsafe under section 360b. (mm) Failing to submit a report or notification required under section 350f(d). (nn) Falsifying a report or notification required under section 350f(d). (oo) Selling tobacco products in violation of a no-tobacco-sale order issued under section 333(f). (pp) Bringing a tobacco product into interstate commerce in violation of section 387k. (qq) (1) Forging, counterfeiting, simulating, or falsely using a mark, stamp (including a tax stamp), tag, label, or identification device on a tobacco product or its container or labeling, making it counterfeit. (2) Making, selling, disposing of, keeping, or concealing tools designed to reproduce someone else's trademark or identifying mark on a tobacco product, making it counterfeit. (3) Doing anything that causes a tobacco product to become counterfeit, or selling, dispensing, or holding one for sale. (rr) The charitable distribution of tobacco products. (ss) A manufacturer or distributor failing to notify the Attorney General and the Treasury Secretary of known illicit trade involving tobacco products. (tt) Making a statement to consumers, in labeling, media, or advertising, that says or misleadingly implies a tobacco product (1) is FDA-approved; (2) is deemed safe by the FDA; (3) is FDA-endorsed; or (4) is safe or less harmful because of (A) FDA regulation or inspection, or (B) compliance with FDA rules -- including anything that renders the product misbranded under section 387c. (uu) Operating a U.S. food facility whose owner, operator, or manager does not comply with section 350g. (vv) Failing to comply with section 350h. (ww) Failing to comply with section 350i. (xx) Refusing or failing to follow an order under section 350l. (yy) Knowingly and willfully failing to comply with the notification requirement under section 350f(h). (zz) Importing or offering to import food when the importer, as defined in section 384a, does not have a compliant foreign supplier verification program under that section. (aaa) Failing to register under section 381(s). (bbb) Failing to notify the Secretary as required by section 360bbb-7. (ccc) (1) Reselling a compounded drug labeled "not for resale," in violation of section 353b. (2) Intentionally falsifying a prescription for a drug compounded under section 353a or 353b. (3) A registered entity under section 353b(b) failing to report drugs or adverse events. (ddd) (1) Manufacturing, or bringing into interstate commerce, a rinse-off cosmetic containing intentionally added plastic microbeads. (2) Defines "plastic microbead" as any solid plastic particle under five millimeters used to exfoliate or cleanse the body, and "rinse-off cosmetic" as including toothpaste. (eee) Failing to comply with an order issued under section 360bbb-8d. (fff) (1) Forging, counterfeiting, simulating, or falsely using a mark, stamp, tag, label, or identification on a device or its container, packaging, or labeling, making it a counterfeit device. (2) Making, selling, disposing of, keeping, or concealing tools designed to reproduce someone else's trademark or mark on a device, making it counterfeit. (3) Doing anything that causes a device to become counterfeit, or selling, dispensing, or holding one for sale. (ggg) A sponsor of a product with accelerated approval under section 356(c) failing to (1) diligently conduct a required post-approval study, or (2) submit timely reports about it under section 356b(a)(2). (hhh) Failing to register or submit listing information under section 364c. (iii) Refusing or failing to follow an order under section 364g.
the actual law source: uscode.house.gov ↗public domain

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,,1 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 2 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.

(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, 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, 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 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.

(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.

(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 (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 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, the failure to retain the records required by section 350a(b)(4) of this title, or the failure to meet the requirements prescribed under section 350a(f)(3) of this title.

(t)

The importation of a drug in violation of section 381(d)(1) of this title, 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, 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, the distribution of a drug sample in violation of section 353(d) of this title or the failure to otherwise comply with the requirements of section 353(d) of this title, the distribution of drugs in violation of section 353(e) of this title, failure to comply with the requirements under section 360eee–1 of this title, the failure to comply with the requirements under section 360eee–3 of this title, as applicable, or the failure to otherwise comply with the requirements of section 353(e) of this title.

(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.

(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; 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; 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 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 that is false or misleading in any material respect;

(2)

the disclosure by a person accredited under section 360m of this title 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 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, 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, 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.

(dd)

The failure to register in accordance with section 350d of this title.

(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.

(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; 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.

(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) submitted to the Secretary.

(jj)
(1)

The failure to submit the certification required by section 282(j)(5)(B) of title 42, 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.

(3)

The submission of clinical trial information under subsection (j) of section 282 of title 42 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 353c2 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, a biological product licensed under section 262 of title 42, 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, before licensure of the biological product under such section 262 of title 42, 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 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; 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.

(mm)

The failure to submit a report or provide a notification required under section 350f(d) of this title.

(nn)

The falsification of a report or notification required under section 350f(d) of this title.

(oo)

The sale of tobacco products in violation of a no-tobacco-sale order issued under section 333(f) of this title.

(pp)

The introduction or delivery for introduction into interstate commerce of a tobacco product in violation of section 387k of this title.

(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.

(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.

(vv)

The failure to comply with the requirements under section 350h of this title.

(ww)

The failure to comply with section 350i of this title.

(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.

(zz)

The importation or offering for importation of a food if the importer (as defined in section 384a of this title) does not have in place a foreign supplier verification program in compliance with such section 384a of this title.

(aaa)

The failure to register in accordance with section 381(s) of this title.

(bbb)

The failure to notify the Secretary in violation of section 360bbb–7 of this title.

(ccc)
(1)

The resale of a compounded drug that is labeled “not for resale” in accordance with section 353b of this title.

(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.

(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.

(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—

(1)

to conduct with due diligence any postapproval study required under section 356(c) of this title 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.

(hhh)

The failure to register or submit listing information in accordance with section 364c of this title.

(iii)

The refusal or failure to follow an order under section 364g of this title.

Source credit: (June 25, 1938, ch. 675, § 301, 52 Stat. 1042; Dec. 22, 1941, ch. 613, § 1, 55 Stat. 851; July 6, 1945, ch. 281, § 1, 59 Stat. 463; Mar. 10, 1947, ch. 16, § 1, 61 Stat. 11; June 24, 1948, ch. 613, § 1, 62 Stat. 582; Mar. 16, 1950, ch. 61, § 3(b), 64 Stat. 20; Aug. 7, 1953, ch. 350, § 2, 67 Stat. 477; Pub. L. 85–929, § 5, Sept. 6, 1958, 72 Stat. 1788; Pub. L. 86–618, title I, §§ 104, 105(a), July 12, 1960, 74 Stat. 403; Pub. L. 87–781, title I, §§ 103(c), 104(e)(1), 106(c), 114(a), title III, § 304, Oct. 10, 1962, 76 Stat. 784, 785, 788, 791, 795; Pub. L. 89–74, §§ 5, 9(c), July 15, 1965, 79 Stat. 232, 235; Pub. L. 90–399, § 103, July 13, 1968, 82 Stat. 352; Pub. L. 90–639, § 2(b), Oct. 24, 1968, 82 Stat. 1361; Pub. L. 91–513, title II, § 701(a), Oct. 27, 1970, 84 Stat. 1281; Pub. L. 92–387, § 4(e), Aug. 16, 1972, 86 Stat. 562; Pub. L. 94–295, §§ 3(b), 4(b)(1), 7(b), May 28, 1976, 90 Stat. 576, 580, 582; Pub. L. 96–359, § 5, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 99–570, title IV, § 4014(b)(2), Oct. 27, 1986, 100 Stat. 3207–120; Pub. L. 100–293, § 7(a), Apr. 22, 1988, 102 Stat. 99; Pub. L. 101–502, § 5(j), Nov. 3, 1990, 104 Stat. 1289; Pub. L. 101–508, title IV, § 4755(c)(2), Nov. 5, 1990, 104 Stat. 1388–210; Pub. L. 102–300, § 3(a)(1), June 16, 1992, 106 Stat. 238; Pub. L. 102–571, title I, § 107(2), (3), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, § 3(c), Aug. 13, 1993, 107 Stat. 775; Pub. L. 103–396, § 2(b)(1), Oct. 22, 1994, 108 Stat. 4154; Pub. L. 103–417, § 10(b), Oct. 25, 1994, 108 Stat. 4332; Pub. L. 104–134, title II, § 2103, Apr. 26, 1996, 110 Stat. 1321–319; Pub. L. 104–170, title IV, § 403, Aug. 3, 1996, 110 Stat. 1514; Pub. L. 104–250, § 5(d), Oct. 9, 1996, 110 Stat. 3156; Pub. L. 105–115, title I, § 125(a)(2)(A), (C), (b)(2)(B), title II, §§ 204(b), 210(c), title IV, §§ 401(b), 421, Nov. 21, 1997, 111 Stat. 2325, 2336, 2345, 2364, 2380; Pub. L. 106–387, § 1(a) [title VII, § 745(d)(1)], Oct. 28, 2000, 114 Stat. 1549, 1549A–39; Pub. L. 107–188, title III, §§ 303(b), 304(d), 305(b), 306(c), 307(b), 321(b)(2), 322(b), June 12, 2002, 116 Stat. 664, 666, 668, 670, 672, 676, 677; Pub. L. 107–250, title II, § 201(d), Oct. 26, 2002, 116 Stat. 1609; Pub. L. 108–136, div. A, title XVI, § 1603(c), Nov. 24, 2003, 117 Stat. 1690; Pub. L. 108–173, title XI, § 1121(b)(1), Dec. 8, 2003, 117 Stat. 2469; Pub. L. 108–214, § 2(b)(2)(A), Apr. 1, 2004, 118 Stat. 575; Pub. L. 108–282, title I, § 102(b)(5)(C), (D), Aug. 2, 2004, 118 Stat. 902; Pub. L. 109–59, title VII, § 7202(d), (e), Aug. 10, 2005, 119 Stat. 1913; Pub. L. 109–462, §§ 2(c), 3(b), 4(a), Dec. 22, 2006, 120 Stat. 3472, 3475; Pub. L. 110–85, title VIII, § 801(b)(1), title IX, §§ 901(d)(1), 912(a), title X, § 1005(d), Sept. 27, 2007, 121 Stat. 920, 939, 951, 968; Pub. L. 111–31, div. A, title I, § 103(b), June 22, 2009, 123 Stat. 1833; Pub. L. 111–353, title I, §§ 102(d)(1), 103(e), 105(c), 106(d), title II, §§ 204(j)(1), 206(d), 211(b), (c), title III, § 301(b), Jan. 4, 2011, 124 Stat. 3889, 3898, 3904, 3906, 3937, 3943, 3953, 3954; Pub. L. 112–144, title VII, §§ 714(a), 715(a), July 9, 2012, 126 Stat. 1073, 1075; Pub. L. 113–54, title I, § 103(a), title II, § 206(a), Nov. 27, 2013, 127 Stat. 597, 639; Pub. L. 114–114, § 2(a), Dec. 28, 2015, 129 Stat. 3129; Pub. L. 114–255, div. A, title III, § 3101(a)(2)(A), Dec. 13, 2016, 130 Stat. 1152; Pub. L. 115–271, title III, §§ 3012(a), 3022(b)(1), Oct. 24, 2018, 132 Stat. 3935, 3938; Pub. L. 117–328, div. FF, title II, § 2513(a), title III, §§ 3210(c), 3305(b), 3503(a)(1), (4)(A), (B), Dec. 29, 2022, 136 Stat. 5805, 5824, 5833, 5858.)

history & why it existsrecord from the source credit
  • 1938Enacted · Act of June 25, 1938, ch. 675 · 52 Stat. 1042
  • 1941Amended · Act of Dec. 22, 1941, ch. 613 · 55 Stat. 851
  • 1945Amended · Act of July 6, 1945, ch. 281 · 59 Stat. 463
  • 1947Amended · Act of Mar. 10, 1947, ch. 16 · 61 Stat. 11
  • 1948Amended · Act of June 24, 1948, ch. 613 · 62 Stat. 582
  • 1950Amended · Act of Mar. 16, 1950, ch. 61 · 64 Stat. 20
  • 1953Amended · Act of Aug. 7, 1953, ch. 350 · 67 Stat. 477
  • 1958Amended · Pub. L. 85-929 · 72 Stat. 1788
  • 1960Amended · Pub. L. 86-618 · 74 Stat. 403
  • 1962Amended · Pub. L. 87-781 · 76 Stat. 784, 785, 788, 791, 795
  • 1965Amended · Pub. L. 89-74 · 79 Stat. 232, 235
  • 1968Amended · Pub. L. 90-399 · 82 Stat. 352
  • 1968Amended · Pub. L. 90-639 · 82 Stat. 1361
  • 1970Amended · Pub. L. 91-513 · 84 Stat. 1281
  • 1972Amended · Pub. L. 92-387 · 86 Stat. 562
  • 1976Amended · Pub. L. 94-295 · 90 Stat. 576, 580, 582
  • 1980Amended · Pub. L. 96-359 · 94 Stat. 1193
  • 1986Amended · Pub. L. 99-570 · 100 Stat. 3207
  • 1988Amended · Pub. L. 100-293 · 102 Stat. 99
  • 1990Amended · Pub. L. 101-502 · 104 Stat. 1289
  • 1990Amended · Pub. L. 101-508 · 104 Stat. 1388
  • 1992Amended · Pub. L. 102-300 · 106 Stat. 238
  • 1992Amended · Pub. L. 102-571 · 106 Stat. 4499
  • 1993Amended · Pub. L. 103-80 · 107 Stat. 775
  • 1994Amended · Pub. L. 103-396 · 108 Stat. 4154
  • 1994Amended · Pub. L. 103-417 · 108 Stat. 4332
  • 1996Amended · Pub. L. 104-134 · 110 Stat. 1321
  • 1996Amended · Pub. L. 104-170 · 110 Stat. 1514
  • 1996Amended · Pub. L. 104-250 · 110 Stat. 3156
  • 1997Amended · Pub. L. 105-115 · 111 Stat. 2325, 2336, 2345, 2364, 2380
  • 2000Amended · Pub. L. 106-387 · 114 Stat. 1549, 1549
  • 2002Amended · Pub. L. 107-188 · 116 Stat. 664, 666, 668, 670, 672, 676, 677
  • 2002Amended · Pub. L. 107-250 · 116 Stat. 1609
  • 2003Amended · Pub. L. 108-136 · 117 Stat. 1690
  • 2003Amended · Pub. L. 108-173 · 117 Stat. 2469
  • 2004Amended · Pub. L. 108-214 · 118 Stat. 575
  • 2004Amended · Pub. L. 108-282 · 118 Stat. 902
  • 2005Amended · Pub. L. 109-59 · 119 Stat. 1913
  • 2006Amended · Pub. L. 109-462 · 120 Stat. 3472, 3475
  • 2007Amended · Pub. L. 110-85 · 121 Stat. 920, 939, 951, 968
  • 2009Amended · Pub. L. 111-31 · 123 Stat. 1833
  • 2011Amended · Pub. L. 111-353 · 124 Stat. 3889, 3898, 3904, 3906, 3937, 3943, 3953, 3954
  • 2012Amended · Pub. L. 112-144 · 126 Stat. 1073, 1075
  • 2013Amended · Pub. L. 113-54 · 127 Stat. 597, 639
  • 2015Amended · Pub. L. 114-114 · 129 Stat. 3129
  • 2016Amended · Pub. L. 114-255 · 130 Stat. 1152
  • 2018Amended · Pub. L. 115-271 · 132 Stat. 3935, 3938
  • 2022Amended · Pub. L. 117-328 · 136 Stat. 5805, 5824, 5833, 5858

A history note hasn’t been published yet. The record shows enactment by ch. 675 on 1938-06-25.

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