Fresh-cut 21 USC 342 Attachment A

Attachment A

Section 301 of the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 331)

Sec. 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, 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), 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.

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\1\ So in original.

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(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.