21 U.S.C. § 331 : US Code - Section 331: Prohibited acts

Search 21 U.S.C. § 331 : US Code - Section 331: Prohibited acts

The following acts and the causing thereof are prohibited:
(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 344, 355, or 360bbb-
3 of this title.
(e) The refusal to permit access to or copying of any record as
required by section 350a, 350c, 350e, 354, 360bbb-3, 373, or 374(a)
of this title; or the failure to establish or maintain any record,
or make any report, required under section 350a, 350c(b), 350e,
354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc-
1(i).,(!1) 360e(f), 360i, or 360bbb-3 of this title, 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 374 of this title.
(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 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, 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.,(!1) 374, 379, or 379e 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..(!1) 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) Repealed. Pub. L. 105-115, title IV, Sec. 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 of
this title, the failure to provide any information required by
section 360(j) or 360(k) of this title, or the failure to provide a
notice required by section 360(j)(2) of this title.
(q)(1) The failure or refusal to (A) comply with any requirement
prescribed under section 360h or 360j(g) of this title, (B) furnish
any notification or other material or information required by or
under section 360i or 360j(g) of this title, or (C) comply with a
requirement under section 360l of this title.
(2) With respect to any device, the submission of any report that
is required by or under this chapter that is false or misleading in
any material respect.
(r) The movement of a device 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 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, or the distribution of drugs in violation of section
353(e) of this title 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) The dissemination of information in violation of section
360aaa of this title.
(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 by, with the assistance of, or at the
direction of, a person debarred 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.