SEC. 301. [21 USC §331] Prohibited acts

Note: revisions were posted to this section in February 2008.

The following acts and the causing thereof are hereby prohibited:  1

(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.

 

(b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce.

 

(c) The receipt in interstate commerce of any food, drug, device, 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 404, 505 or 564.

 

(e) The refusal to permit access to or copying of any record as required by section 412, 414, 416, 417(g), 504, 564, 703, 704(a), 760, or 761; or the failure to establish or maintain any record, or make any report, required under section 412, 414(b), 416, 417, 504, 505(i) or (k), 512(a)(4)(C), 512 (j), (l) or (m), 572(i),  2 515(f), 519, 564, 760, or 761 or the refusal to permit access to or verification or copying of any such required record.

 

(f) The refusal to permit entry or inspection as authorized by section 704.

 

(g) The manufacture, within any Territory of any food, drug, device, or cosmetic that is adulterated or misbranded.

 

(h) The giving of a guaranty or undertaking referred to in section 303(c)(2), which guaranty or undertaking is false, except by a person who relied upon a guaranty or undertaking to the same effect signed by, containing the name and address of, the person residing in the United States from whom he received in good faith the food, drug, device, or cosmetic; or the giving of a guaranty or undertaking referred to in section 303(c)(3), 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 404 or 721.

(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 Act, any information acquired under authority of section 404, 409, 412, 414, 505, 510, 512, 513, 514, 515, 516, 518, 519, 520, 571, 572, 573 ,  3 704, 708, or 721 concerning any method or process which as a trade secret is entitled to protection; or the violating of section 408(i)(2) or any regulation issued under that section.  4 This 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, 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) [Deleted]  5

 

(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 sections 407(b) or 407(c).

 

(n) The using, in labeling, advertising or other sales promotion of any reference to any report or analysis furnished in compliance with section 704.

 

(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 Act .

(p) The failure to register in accordance with section 510, the failure to provide any information required by section 510(j) or 510(k), 21 USC § 360(j) or (k)] or the failure to provide a notice required by section 510(j)(2).

 

(q)(1) The failure or refusal to (A) comply with any requirement prescribed under section 518 or 520(g), (B) furnish any notification or other material or information required by or under section 519 or 520(g), or (C) comply with a requirement under section 522.

(2) With respect to any device, the submission of any report that is required by or under this Act that is false or misleading in any material respect.

 

(r) The movement of a device in violation of an order under section 304(g) or the removal or alteration of any mark or label required by the order to identify the device as detained.

 

(s) The failure to provide the notice required by section 412(c) or 412(e), the failure to make the reports required by section 412(f)(1)(B), the failure to retain the records required by section 412(b)(4), or the failure to meet the requirements prescribed under section 412(f)(3).

 

(t) The importation of a drug in violation of section 801(d)(1) , 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 503(c), 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 503(c)(2), the distribution of a drug sample in violation of section 503(d) or the failure to otherwise comply with the requirements of section 503(d), or the distribution of drugs in violation of section 503(e) or the failure to otherwise comply with the requirements of section 503(e).

 

(u) The failure to comply with any requirements of the provisions of, or any regulations or orders of the Secretary, under section 512(a)(4)(A), 512(a)(4)(D), or 512(a)(5).

 

(v) The introduction or delivery for introduction into interstate commerce of a dietary supplement that is unsafe under section 413.

 

(w) The making of a knowingly false statement in any statement, certificate of analysis, record, or report required or requested under section 801(d)(3); 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 801(e) or 802, or with section 351(h) of the Public Health Service Act [42 USC § 262(h)]; 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 514(c) 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 523 that is false or misleading in any material respect;

(2) the disclosure by a person accredited under section 523 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 523 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 Act.

 

(z) [Terminated] 6

 

( aa) The importation of a prescription drug in violation of section 804, the falsification of any record required to be maintained or provided to the Secretary under 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 304(h), 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 by, with the assistance of, or at the direction of, a person debarred under section 306(b)(3).

 

( dd) The failure to register in accordance with section 415.

 

( ee) The importing or offering for import into the United States of an article of food in violation of the requirements under section 801(m).

 

(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 801(o).

 

(gg) The knowing failure to comply with paragraph (7)(E) of section 704(g); 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 416.

 

 (ii) The falsification of a report of a serious adverse event submitted to a responsible person (as defined under section 760 or 761) or the falsification of a serious adverse event report (as defined under section 760 or 761) submitted to the Secretary.

 

(jj) (1) The failure to submit the certification required by section 402(j)(5)(B) of the Public Health Service Act [42 USC § 282(j)(5)(B)], or knowingly submitting a false certification under such section.

(2) The failure to submit clinical trial information required under subsection (j) of section 402 of the Public Health Service Act [42 USC § 282].

(3) The submission of clinical trial information under subsection (j) of section 402 of the Public Health Service Act [42 USC § 282] that is false or misleading in any particular under paragraph (5)(D) of such subsection (j).

 

(kk) [Note: This subsection takes effect 180 days after enactment of Act Sept. 27, 2007, P.L. 110-85, as provided by § 909(a) of such Act, which appears as a note to this section.] The dissemination of a television advertisement without complying with section 503B [21 USC § 353b].

 

(ll) The introduction or delivery for introduction into interstate commerce of any food to which has been added a drug approved under section 505 [21 USC § 355], a biological product licensed under section 351 of the Public Health Service Act [42 USC § 262], 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 505 [21 USC § 355], before licensure of the biological product under such section 351 [42 USC § 262], 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 409 [21 USC § 348] 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 409(h) [21 USC § 348(h)]; or

(E) such drug or biological product had been marketed for smoking cessation prior to the date of the enactment of the Food and Drug Administration Amendments Act of 2007 [enacted Sept. 27, 2007]; or

(4) the drug is a new animal drug whose use is not unsafe under section 512 [21 USC § 360b].

 

(mm) The failure to submit a report or provide a notification required under section 417(d) [21 USC § 350f(d)].

 

(nn) The falsification of a report or notification required under section 417(d) [21 USC § 350f(d)].

 

Footnotes

 1. See footnote for section 403(h)(3) regarding the stylistic use of a list consisting of "(a)", "(b)", etc.

 2. The period is so in law. See section 102(b)(5)(C) of Public Law 108-282

 3. The period is so in law. See section 102f(b)(5)(D) of Public Law 108-282.

 4. So in law. See the amendment made by section 403 of Public Law 104–170 (110 Stat. 1514).

 5. Paragraph (l) was struck by section 421 of Public Law 105–115 (111 Stat. 2380).

 6. Paragraph (z) was added by subsection (b) of section 401(b) of Public Law 105–115 (111 Stat. 2364). Subsection (e) of such section provides as follows:

(e) SUNSET.—The amendments made by this section cease to be effective September 30, 2006, or 7 years after the date on which the Secretary promulgates the regulations described in subsection (c), whichever is later.