21 U.S.C. § 333 : US Code - Section 333: Penalties

Search 21 U.S.C. § 333 : US Code - Section 333: Penalties

(a) Violation of section 331 of this title; second violation;
intent to defraud or mislead
(1) Any person who violates a provision of section 331 of this
title shall be imprisoned for not more than one year or fined not
more than $1,000, or both.
(2) Notwithstanding the provisions of paragraph (1) of this
section,(!1) if any person commits such a violation after a
conviction of him under this section has become final, or commits
such a violation with the intent to defraud or mislead, such person
shall be imprisoned for not more than three years or fined not more
than $10,000, or both.
(b) Prescription drug marketing violations
(1) Notwithstanding subsection (a) of this section, any person
who violates section 331(t) of this title by -
(A) knowingly importing a drug in violation of section
381(d)(1) of this title,
(B) knowingly selling, purchasing, or trading a drug or drug
sample or knowingly offering to sell, purchase, or trade a drug
or drug sample, in violation of section 353(c)(1) of this title,
(C) knowingly selling, purchasing, or trading a coupon,
knowingly offering to sell, purchase, or trade such a coupon, or
knowingly counterfeiting such a coupon, in violation of section
353(c)(2) of this title, or
(D) knowingly distributing drugs in violation of section
353(e)(2)(A) of this title,
shall be imprisoned for not more than 10 years or fined not more
than $250,000, or both.
(2) Any manufacturer or distributor who distributes drug samples
by means other than the mail or common carrier whose
representative, during the course of the representative's
employment or association with that manufacturer or distributor,
violated section 331(t) of this title because of a violation of
section 353(c)(1) of this title or violated any State law
prohibiting the sale, purchase, or trade of a drug sample subject
to section 353(b) of this title or the offer to sell, purchase, or
trade such a drug sample shall, upon conviction of the
representative for such violation, be subject to the following
civil penalties:
(A) A civil penalty of not more than $50,000 for each of the
first two such violations resulting in a conviction of any
representative of the manufacturer or distributor in any 10-year
period.
(B) A civil penalty of not more than $1,000,000 for each
violation resulting in a conviction of any representative after
the second conviction in any 10-year period.
For the purposes of this paragraph, multiple convictions of one or
more persons arising out of the same event or transaction, or a
related series of events or transactions, shall be considered as
one violation.
(3) Any manufacturer or distributor who violates section 331(t)
of this title because of a failure to make a report required by
section 353(d)(3)(E) of this title shall be subject to a civil
penalty of not more than $100,000.
(4)(A) If a manufacturer or distributor or any representative of
such manufacturer or distributor provides information leading to
the institution of a criminal proceeding against, and conviction
of, any representative of that manufacturer or distributor for a
violation of section 331(t) of this title because of a sale,
purchase, or trade or offer to purchase, sell, or trade a drug
sample in violation of section 353(c)(1) of this title or for a
violation of State law prohibiting the sale, purchase, or trade or
offer to sell, purchase, or trade a drug sample, the conviction of
such representative shall not be considered as a violation for
purposes of paragraph (2).
(B) If, in an action brought under paragraph (2) against a
manufacturer or distributor relating to the conviction of a
representative of such manufacturer or distributor for the sale,
purchase, or trade of a drug or the offer to sell, purchase, or
trade a drug, it is shown, by clear and convincing evidence -
(i) that the manufacturer or distributor conducted, before the
institution of a criminal proceeding against such representative
for the violation which resulted in such conviction, an
investigation of events or transactions which would have led to
the reporting of information leading to the institution of a
criminal proceeding against, and conviction of, such
representative for such purchase, sale, or trade or offer to
purchase, sell, or trade, or
(ii) that, except in the case of the conviction of a
representative employed in a supervisory function, despite
diligent implementation by the manufacturer or distributor of an
independent audit and security system designed to detect such a
violation, the manufacturer or distributor could not reasonably
have been expected to have detected such violation,
the conviction of such representative shall not be considered as a
conviction for purposes of paragraph (2).
(5) If a person provides information leading to the institution
of a criminal proceeding against, and conviction of, a person for a
violation of section 331(t) of this title because of the sale,
purchase, or trade of a drug sample or the offer to sell, purchase,
or trade a drug sample in violation of section 353(c)(1) of this
title, such person shall be entitled to one-half of the criminal
fine imposed and collected for such violation but not more than
$125,000.
(6) Notwithstanding subsection (a) of this section, any person
who is a manufacturer or importer of a prescription drug under
section 384(b) of this title and knowingly fails to comply with a
requirement of section 384(e) of this title that is applicable to
such manufacturer or importer, respectively, shall be imprisoned
for not more than 10 years or fined not more than $250,000, or
both.
(c) Exceptions in certain cases of good faith, etc.
No person shall be subject to the penalties of subsection (a)(1)
of this section, (1) for having received in interstate commerce any
article and delivered it or proffered delivery of it, if such
delivery or proffer was made in good faith, unless he refuses to
furnish on request of an officer or employee duly designated by the
Secretary the name and address of the person from whom he purchased
or received such article and copies of all documents, if any there
be, pertaining to the delivery of the article to him; or (2) for
having violated section 331(a) or (d) of this title, if he
establishes a guaranty or undertaking signed by, and containing the
name and address of, the person residing in the United States from
whom he received in good faith the article, to the effect, in case
of an alleged violation of section 331(a) of this title, that such
article is not adulterated or misbranded, within the meaning of
this chapter designating this chapter or to the effect, in case of
an alleged violation of section 331(d) of this title, that such
article is not an article which may not, under the provisions of
section 344 or 355 of this title, be introduced into interstate
commerce; or (3) for having violated section 331(a) of this title,
where the violation exists because the article is adulterated by
reason of containing a color additive not from a batch certified in
accordance with regulations promulgated by the Secretary under this
chapter, if such person establishes a guaranty or undertaking
signed by, and containing the name and address of, the manufacturer
of the color additive, to the effect that such color additive was
from a batch certified in accordance with the applicable
regulations promulgated by the Secretary under this chapter; or (4)
for having violated section 331(b), (c) or (k) of this title by
failure to comply with section 352(f) of this title in respect to
an article received in interstate commerce to which neither section
353(a) nor 353(b)(1) of this title is applicable, if the delivery
or proffered delivery was made in good faith and the labeling at
the time thereof contained the same directions for use and warning
statements as were contained in the labeling at the time of such
receipt of such article; or (5) for having violated section
331(i)(2) of this title if such person acted in good faith and had
no reason to believe that use of the punch, die, plate, stone, or
other thing involved would result in a drug being a counterfeit
drug, or for having violated section 331(i)(3) of this title if the
person doing the act or causing it to be done acted in good faith
and had no reason to believe that the drug was a counterfeit drug.
(d) Exceptions involving misbranded food
No person shall be subject to the penalties of subsection (a)(1)
of this section for a violation of section 331 of this title
involving misbranded food if the violation exists solely because
the food is misbranded under section 343(a)(2) of this title
because of its advertising.
(e) Prohibited distribution of human growth hormone
(1) Except as provided in paragraph (2), whoever knowingly
distributes, or possesses with intent to distribute, human growth
hormone for any use in humans other than the treatment of a disease
or other recognized medical condition, where such use has been
authorized by the Secretary of Health and Human Services under
section 355 of this title and pursuant to the order of a physician,
is guilty of an offense punishable by not more than 5 years in
prison, such fines as are authorized by title 18, or both.
(2) Whoever commits any offense set forth in paragraph (1) and
such offense involves an individual under 18 years of age is
punishable by not more than 10 years imprisonment, such fines as
are authorized by title 18, or both.
(3) Any conviction for a violation of paragraphs (1) and (2) of
this subsection shall be considered a felony violation of the
Controlled Substances Act [21 U.S.C. 801 et seq.] for the purposes
of forfeiture under section 413 of such Act [21 U.S.C. 853].
(4) As used in this subsection the term "human growth hormone"
means somatrem, somatropin, or an analogue of either of them.
(5) The Drug Enforcement Administration is authorized to
investigate offenses punishable by this subsection.
(f) Redesignated (g)
(g) Violations related to devices
(1)(A) Except as provided in subparagraph (B), any person who
violates a requirement of this chapter which relates to devices
shall be liable to the United States for a civil penalty in an
amount not to exceed $15,000 for each such violation, and not to
exceed $1,000,000 for all such violations adjudicated in a single
proceeding. For purposes of the preceding sentence, a person
accredited under paragraph (2) of section 374(g) of this title who
is substantially not in compliance with the standards of
accreditation under such section, or who poses a threat to public
health or fails to act in a manner that is consistent with the
purposes of such section, shall be considered to have violated a
requirement of this chapter that relates to devices.
(B) Subparagraph (A) shall not apply -
(i) to any person who violates the requirements of section
360i(a) or 360j(f) of this title unless such violation
constitutes (I) a significant or knowing departure from such
requirements, or (II) a risk to public health,
(ii) to any person who commits minor violations of section
360i(e) or 360i(f) of this title (only with respect to correction
reports) if such person demonstrates substantial compliance with
such section, or
(iii) to violations of section 351(a)(2)(A) of this title which
involve one or more devices which are not defective.
(2)(A) Any person who introduces into interstate commerce or
delivers for introduction into interstate commerce an article of
food that is adulterated within the meaning of section 342(a)(2)(B)
of this title shall be subject to a civil money penalty of not more
than $50,000 in the case of an individual and $250,000 in the case
of any other person for such introduction or delivery, not to
exceed $500,000 for all such violations adjudicated in a single
proceeding.
(B) This paragraph shall not apply to any person who grew the
article of food that is adulterated. If the Secretary assesses a
civil penalty against any person under this paragraph, the
Secretary may not use the criminal authorities under this section
to sanction such person for the introduction or delivery for
introduction into interstate commerce of the article of food that
is adulterated. If the Secretary assesses a civil penalty against
any person under this paragraph, the Secretary may not use the
seizure authorities of section 334 of this title or the injunction
authorities of section 332 of this title with respect to the
article of food that is adulterated.
(C) In a hearing to assess a civil penalty under this paragraph,
the presiding officer shall have the same authority with regard to
compelling testimony or production of documents as a presiding
officer has under section 346a(g)(2)(B) of this title. The third
sentence of paragraph (3)(A) shall not apply to any investigation
under this paragraph.
(3)(A) A civil penalty under paragraph (1) or (2) shall be
assessed by the Secretary by an order made on the record after
opportunity for a hearing provided in accordance with this
subparagraph and section 554 of title 5. Before issuing such an
order, the Secretary shall give written notice to the person to be
assessed a civil penalty under such order of the Secretary's
proposal to issue such order and provide such person an opportunity
for a hearing on the order. In the course of any investigation, the
Secretary may issue subpoenas requiring the attendance and
testimony of witnesses and the production of evidence that relates
to the matter under investigation.
(B) In determining the amount of a civil penalty, the Secretary
shall take into account the nature, circumstances, extent, and
gravity of the violation or violations and, with respect to the
violator, ability to pay, effect on ability to continue to do
business, any history of prior such violations, the degree of
culpability, and such other matters as justice may require.
(C) The Secretary may compromise, modify, or remit, with or
without conditions, any civil penalty which may be assessed under
paragraph (1) or (2). The amount of such penalty, when finally
determined, or the amount agreed upon in compromise, may be
deducted from any sums owing by the United States to the person
charged.
(4) Any person who requested, in accordance with paragraph
(3)(A), a hearing respecting the assessment of a civil penalty and
who is aggrieved by an order assessing a civil penalty may file a
petition for judicial review of such order with the United States
Court of Appeals for the District of Columbia Circuit or for any
other circuit in which such person resides or transacts business.
Such a petition may only be filed within the 60-day period
beginning on the date the order making such assessment was issued.
(5) If any person fails to pay an assessment of a civil penalty -

(A) after the order making the assessment becomes final, and if
such person does not file a petition for judicial review of the
order in accordance with paragraph (4), or
(B) after a court in an action brought under paragraph (4) has
entered a final judgment in favor of the Secretary,
the Attorney General shall recover the amount assessed (plus
interest at currently prevailing rates from the date of the
expiration of the 60-day period referred to in paragraph (4) or the
date of such final judgment, as the case may be) in an action
brought in any appropriate district court of the United States. In
such an action, the validity, amount, and appropriateness of such
penalty shall not be subject to review.