TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
HEAD
Sec. 333. Penalties
STATUTE
(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) 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(g) 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 (5)(A) shall not apply to any investigation
under this paragraph.
(3)(A) Any person who violates section 331(jj) of this title
shall be subject to a civil monetary penalty of not more than
$10,000 for all violations adjudicated in a single proceeding.
(B) If a violation of section 331(jj) of this title is not
corrected within the 30-day period following notification under
section 282(j)(5)(C)(ii) (!2) of title 42, the person shall, in
addition to any penalty under subparagraph (A), be subject to a
civil monetary penalty of not more than $10,000 for each day of the
violation after such period until the violation is corrected.
(4)(A) Any responsible person (as such term is used in section
355-1 of this title) that violates a requirement of section 355(o),
355(p), or 355-1 of this title shall be subject to a civil monetary
penalty of -
(i) not more than $250,000 per violation, and not to exceed
$1,000,000 for all such violations adjudicated in a single
proceeding; or
(ii) in the case of a violation that continues after the
Secretary provides written notice to the responsible person, the
responsible person shall be subject to a civil monetary penalty
of $250,000 for the first 30-day period (or any portion thereof)
that the responsible person continues to be in violation, and
such amount shall double for every 30-day period thereafter that
the violation continues, not to exceed $1,000,000 for any 30-day
period, and not to exceed $10,000,000 for all such violations
adjudicated in a single proceeding.
(B) In determining the amount of a civil penalty under
subparagraph (A)(ii), the Secretary shall take into consideration
whether the responsible person is making efforts toward correcting
the violation of the requirement of section 355(o), 355(p), or 355-
1 of this title for which the responsible person is subject to
such civil penalty.
(5)(A) A civil penalty under paragraph (1), (2), (3), or (4)
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), (2), (3), or (4). 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.
(6) Any person who requested, in accordance with paragraph
(5)(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.
(7) 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 (6), or
(B) after a court in an action brought under paragraph (6) 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 (6) 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.
(g) Violations regarding direct-to-consumer advertising
(1) With respect to a person who is a holder of an approved
application under section 355 of this title for a drug subject to
section 353(b) of this title or under section 262 of title 42, any
such person who disseminates or causes another party to disseminate
a direct-to-consumer advertisement that is false or misleading
shall be liable to the United States for a civil penalty in an
amount not to exceed $250,000 for the first such violation in any 3-
year period, and not to exceed $500,000 for each subsequent
violation in any 3-year period. No other civil monetary penalties
in this chapter (including the civil penalty in subsection (f)(4))
shall apply to a violation regarding direct-to-consumer
advertising. For purposes of this paragraph: (A) Repeated
dissemination of the same or similar advertisement prior to the
receipt of the written notice referred to in paragraph (2) for such
advertisements shall be considered one violation. (B) On and after
the date of the receipt of such a notice, all violations under this
paragraph occurring in a single day shall be considered one
violation. With respect to advertisements that appear in magazines
or other publications that are published less frequently than
daily, each issue date (whether weekly or monthly) shall be treated
as a single day for the purpose of calculating the number of
violations under this paragraph.
(2) A civil penalty under paragraph (1) shall be assessed by the
Secretary by an order made on the record after providing written
notice to the person to be assessed a civil penalty and an
opportunity for a hearing in accordance with this paragraph and
section 554 of title 5. If upon receipt of the written notice, the
person to be assessed a civil penalty objects and requests a
hearing, then in the course of any investigation related to such
hearing, the Secretary may issue subpoenas requiring the attendance
and testimony of witnesses and the production of evidence that
relates to the matter under investigation, including information
pertaining to the factors described in paragraph (3).
(3) The Secretary, in determining the amount of the civil penalty
under paragraph (1), shall take into account the nature,
circumstances, extent, and gravity of the violation or violations,
including the following factors:
(A) Whether the person submitted the advertisement or a similar
advertisement for review under section 379h-1 of this title.
(B) Whether the person submitted the advertisement for review
if required under section 353b of this title.
(C) Whether, after submission of the advertisement as described
in subparagraph (A) or (B), the person disseminated or caused
another party to disseminate the advertisement before the end of
the 45-day comment period.
(D) Whether the person incorporated any comments made by the
Secretary with regard to the advertisement into the advertisement
prior to its dissemination.
(E) Whether the person ceased distribution of the advertisement
upon receipt of the written notice referred to in paragraph (2)
for such advertisement.
(F) Whether the person had the advertisement reviewed by
qualified medical, regulatory, and legal reviewers prior to its
dissemination.
(G) Whether the violations were material.
(H) Whether the person who created the advertisement or caused
the advertisement to be created acted in good faith.
(I) Whether the person who created the advertisement or caused
the advertisement to be created has been assessed a civil penalty
under this provision within the previous 1-year period.
(J) The scope and extent of any voluntary, subsequent remedial
action by the person.
(K) Such other matters, as justice may require.
(4)(A) Subject to subparagraph (B), no person shall be required
to pay a civil penalty under paragraph (1) if the person submitted
the advertisement to the Secretary and disseminated or caused
another party to disseminate such advertisement after incorporating
each comment received from the Secretary.
(B) The Secretary may retract or modify any prior comments the
Secretary has provided to an advertisement submitted to the
Secretary based on new information or changed circumstances, so
long as the Secretary provides written notice to the person of the
new views of the Secretary on the advertisement and provides a
reasonable time for modification or correction of the advertisement
prior to seeking any civil penalty under paragraph (1).
(5) The Secretary may compromise, modify, or remit, with or
without conditions, any civil penalty which may be assessed under
paragraph (1). The amount of such penalty, when finally determined,
or the amount charged upon in compromise, may be deducted from any
sums owed by the United States to the person charged.
(6) Any person who requested, in accordance with paragraph (2), a
hearing with respect to the assessment of a civil penalty and who
is aggrieved by an order assessing a civil penalty, may file a
petition for de novo 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 assessments was
issued.
(7) If any person fails to pay an assessment of a civil penalty
under paragraph (1) -
(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 (6), or
(B) after a court in an action brought under paragraph (6) has
entered a final judgment in favor of the Secretary,
the Attorney General of the United States 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 (6)
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.
SOURCE
(June 25, 1938, ch. 675, Sec. 303, 52 Stat. 1043; Oct. 26, 1951,
ch. 578, Sec. 2, 65 Stat. 649; Pub. L. 86-618, title I, Sec.
105(b), July 12, 1960, 74 Stat. 403; Pub. L. 89-74, Secs. 7, 9(d),
July 15, 1965, 79 Stat. 233, 235; Pub. L. 90-639, Sec. 3, Oct. 24,
1968, 82 Stat. 1361; Pub. L. 91-513, title II, Sec. 701(b), Oct.
27, 1970, 84 Stat. 1281; Pub. L. 94-278, title V, Sec.
502(a)(2)(B), Apr. 22, 1976, 90 Stat. 411; Pub. L. 100-293, Sec.
7(b), Apr. 22, 1988, 102 Stat. 99; Pub. L. 100-690, title II, Sec.
2403, Nov. 18, 1988, 102 Stat. 4230; Pub. L. 101-629, Sec. 17(a),
Nov. 28, 1990, 104 Stat. 4526; Pub. L. 101-647, title XIX, Sec.
1904, Nov. 29, 1990, 104 Stat. 4853; Pub. L. 102-353, Sec. 3, Aug.
26, 1992, 106 Stat. 941; Pub. L. 103-80, Sec. 3(e), Aug. 13, 1993,
107 Stat. 775; Pub. L. 103-322, title XXXIII, Sec. 330015, Sept.
13, 1994, 108 Stat. 2146; Pub. L. 104-170, title IV, Sec. 407, Aug.
3, 1996, 110 Stat. 1535; Pub. L. 106-387, Sec. 1(a) [title VII,
Sec. 745(d)(2)], Oct. 28, 2000, 114 Stat. 1549, 1549A-40; Pub. L.
107-250, title II, Sec. 201(c), Oct. 26, 2002, 116 Stat. 1609; Pub.
L. 108-173, title XI, Sec. 1121(b)(2), Dec. 8, 2003, 117 Stat.
2469; Pub. L. 110-85, title II, Sec. 226(b), title VIII, Sec.
801(b)(2), title IX, Secs. 901(d)(4), 902(b), Sept. 27, 2007, 121
Stat. 854, 920, 940, 943.)
REFERENCES IN TEXT
The Controlled Substances Act, referred to in subsec. (e)(3), is
title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as
amended, which is classified principally to subchapter I (Sec. 801
et seq.) of chapter 13 of this title. For complete classification
of this Act to the Code, see Short Title note set out under section
801 of this title and Tables.
Section 282(j)(5)(C)(ii) of title 42, referred to in subsec.
(f)(3)(B), was in the original "section 402(j)(5)(C)(ii)", and was
translated as meaning section 402(j)(5)(C)(ii) of the Public Health
Service Act to reflect the probable intent of Congress because
there is no subsec. (j) of section 402 of The Federal Food, Drug,
and Cosmetic Act and section 402(j)(5)(C)(ii) of the Public Health
Service Act relates to notification of noncompliance with clinical
trial information requirements.
AMENDMENTS
2007 - Subsec. (f). Pub. L. 110-85, Sec. 226(b)(1), redesignated
subsec. (g) as (f).
Subsec. (f)(1)(B)(ii). Pub. L. 110-85, Sec. 226(b)(2),
substituted "360i(g)" for "360i(f)".
Subsec. (f)(2)(C). Pub. L. 110-85, Sec. 801(b)(2)(C), substituted
"paragraph (5)(A)" for "paragraph (3)(A)".
Subsec. (f)(3). Pub. L. 110-85, Sec. 801(b)(2)(B), added par.
(3). Former par. (3) redesignated (5).
Subsec. (f)(4). Pub. L. 110-85, Sec. 902(b)(1), added par. (4).
Pub. L. 110-85, Sec. 801(b)(2)(A), redesignated par. (4) as (6).
Subsec. (f)(5). Pub. L. 110-85, Sec. 801(b)(2)(A), redesignated
par. (3) as (5). Former par. (5) redesignated (7).
Subsec. (f)(5)(A), (C). Pub. L. 110-85, Sec. 902(b)(2),
substituted "paragraph (1), (2), (3), or (4)" for "paragraph (1),
(2), or (3)".
Pub. L. 110-85, Sec. 801(b)(2)(D), substituted "paragraph (1),
(2), or (3)" for "paragraph (1) or (2)".
Subsec. (f)(6). Pub. L. 110-85, Sec. 801(b)(2)(A), (E),
redesignated par. (4) as (6) and substituted "paragraph (5)(A)" for
"paragraph (3)(A)".
Subsec. (f)(7). Pub. L. 110-85, Sec. 801(b)(2)(A), (F),
redesignated par. (5) as (7) and substituted "paragraph (6)" for
"paragraph (4)" wherever appearing.
Subsec. (g). Pub. L. 110-85, Sec. 901(d)(4), added subsec. (g).
Pub. L. 110-85, Sec. 226(b)(1), redesignated subsec. (g) as (f).
2003 - Subsec. (b)(6). Pub. L. 108-173, which directed amendment
of subsec. (a)(6) by substituting "prescription drug under section
384(b)" for "covered product pursuant to section 384(a)", was
executed by making the substitution in subsec. (b)(6), to reflect
the probable intent of Congress.
2002 - Subsec. (g)(1)(A). Pub. L. 107-250 inserted at end "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."
2000 - Subsec. (b)(6). Pub. L. 106-387 added par. (6).
1996 - Subsec. (g)(2). Pub. L. 104-170, Sec. 407(1), (2), added
par. (2). Former par. (2) redesignated (3).
Subsec. (g)(3). Pub. L. 104-170, Sec. 407(1), (3), redesignated
par. (2) as (3) and substituted "paragraph (1) or (2)" for
"paragraph (1)" in subpars. (A) and (C). Former par. (3)
redesignated (4).
Subsec. (g)(4). Pub. L. 104-170, Sec. 407(1), (4), redesignated
par. (3) as (4) and substituted "paragraph (3)(A)" for "paragraph
(2)(A)". Former par. (4) redesignated (5).
Subsec. (g)(5). Pub. L. 104-170, Sec. 407(1), (5), redesignated
par. (4) as (5) and substituted "paragraph (4)" for "paragraph (3)"
wherever appearing.
1994 - Subsec. (e). Pub. L. 103-322 amended directory language of
Pub. L. 101-647. See 1990 Amendment note below.
1993 - Subsecs. (e) to (g). Pub. L. 103-80, which directed the
amendment of this section by redesignating the second subsec. (e)
and subsec. (f) as subsecs. (f) and (g), respectively, could only
be executed by designating subsec. (f) as (g) because this section
did not contain a second subsec. (e) subsequent to amendment of
Pub. L. 101-647 by Pub. L. 103-322. See 1990 and 1994 amendment
notes for subsec. (e) under this section.
1992 - Subsec. (b)(1). Pub. L. 102-353, Sec. 3(a), amended par.
(1) generally. Prior to amendment, par. (1) read as follows:
"Notwithstanding subsection (a) of this section, any person who
violates section 331(t) of this title because of an importation of
a drug in violation of section 381(d)(1) of this title, because of
a 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, because of 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, or the distribution of 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."
Subsec. (b)(4)(A). Pub. L. 102-353, Sec. 3(b)(1), substituted
"the institution of a criminal proceeding against, and conviction
of," for "the arrest and conviction of".
Subsec. (b)(4)(B)(i). Pub. L. 102-353, Sec. 3(b)(1), (2),
substituted "before the institution of a criminal proceeding
against" for "before the arrest of" and "the institution of a
criminal proceeding against, and conviction of," for "the arrest
and conviction of".
Subsec. (b)(5). Pub. L. 102-353, Sec. 3(b)(3), substituted "the
institution of a criminal proceeding against, and conviction of,"
for "the arrest and conviction of".
Subsec. (c). Pub. L. 102-353, Sec. 3(b)(4), substituted
"subsection (a)(1) of this section" for "subsection (a) of this
section".
Subsec. (d). Pub. L. 102-353, Sec. 3(b)(4), (5), substituted
"subsection (a)(1) of this section" for "subsection (a) of this
section" and struck out ", and no person shall be subject to the
penalties of subsection (b) of this section for such a violation
unless the violation is committed with the intent to defraud or
mislead" after "advertising".
1990 - Subsec. (e). Pub. L. 101-647, as amended by Pub. L. 103-
322, amended subsec. (e) generally. Prior to amendment, subsec.
(e) read as follows:
"(e)(1) Except as provided in paragraph (2), any person who
distributes or possesses with the intent to distribute any anabolic
steroid for any use in humans other than the treatment of disease
pursuant to the order of a physician shall be imprisoned for not
more than three years or fined under title 18, or both.
"(2) Any person who distributes or possesses with the intent to
distribute to an individual under 18 years of age, any anabolic
steroid for any use in humans other than the treatment of disease
pursuant to the order of a physician shall be imprisoned for not
more than six years or fined under title 18, or both."
Subsec. (f). Pub. L. 101-629 added subsec. (f).
1988 - Subsecs. (a), (b). Pub. L. 100-293 designated existing
subsecs. (a) and (b) as pars. (1) and (2) of subsec. (a),
substituted "paragraph (1)" for "subsection (a)" in par. (2), and
added subsec. (b).
Subsec. (e). Pub. L. 100-690 added subsec. (e).
1976 - Subsec. (d). Pub. L. 94-278 added subsec. (d).
1970 - Subsec. (a). Pub. L. 91-513 struck out reference to
subsec. (b) and transferred to subsec. (b) provisions covering
second offenses and offenses committed with intent to defraud or
mislead.
Subsec. (b). Pub. L. 91-513 inserted provisions covering second
offenses and offenses committed with intent to defraud or mislead
formerly set out in subsec. (a) and struck out provisions covering
violations involving depressant and stimulant drugs. See section
801 et seq. of this title.
1968 - Subsecs. (a), (b). Pub. L. 90-639 made a general revision
in the penalties prescribed for offenses involving depressant or
stimulant drugs, set a fine of not to exceed $10,000 or
imprisonment of not more than 5 years for offenses involving the
unlawful manufacturing of, sale, or disposal of, or possession with
intent to sell, a depressant or stimulant drug or involving
counterfeit depressant or stimulant drugs, stiffened the penalties
for unlawful sales or other disposals by persons over 18 to persons
under 21, and set new penalties for possession of a depressant or
stimulant drug for purposes other than sale or other disposal.
1965 - Subsec. (a). Pub. L. 89-74, Sec. 7(a), inserted proviso
limiting the penalties for depressant or stimulant drug violations
to two years imprisonment or $5,000 fine or both for first offense
and to two years imprisonment or $15,000 fine or both for
subsequent offenses.
Subsec. (b). Pub. L. 89-74, Sec. 7(b), inserted parenthetical
exception provision.
Subsec. (c)(5). Pub. L. 89-74, Sec. 9(d), added cl. (5).
1960 - Subsec. (c)(3). Pub. L. 86-618 substituted "a color
additive" for "a coal-tar color", "the color additive" for "the
coal-tar color" and "such color additive was" for "such color was".
1951 - Subsec. (c)(4). Act Oct. 26, 1951, added cl. (4).
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by sections 901(d)(4) and 902(b) of Pub. L. 110-85
effective 180 days after Sept. 27, 2007, see section 909 of Pub. L.
110-85, set out as a note under section 331 of this title.
EFFECTIVE DATE OF 1994 AMENDMENT
Section 330015 of Pub. L. 103-322 provided that the amendment
made by that section is effective as of the date on which section
1904 of Pub. L. 101-647, which amended this section, took effect.
EFFECTIVE DATE OF 1990 AMENDMENT
Section 17(b) of Pub. L. 101-629 provided that:
"(b) Effective Date of Application to Device User Facilities. -
"(1) The Secretary of Health and Human Services shall conduct a
study to determine whether there has been substantial compliance
with the requirements of section 519(b) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 360i(b)] by device user
facilities (as defined in section 519(b)(5)(A) of such Act). The
Secretary shall report the results of the study to the Congress
after the expiration of 45 months after the date of the enactment
of this Act [Nov. 28, 1990].
"(2)(A) If upon the expiration of 48 months after the date of
the enactment of this Act [Nov. 28, 1990] the Secretary has not
made the report required by paragraph (1), section 303(f) of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 333(f)], as added
by the amendment made by subsection (a), shall take effect with
respect to device user facilities (as defined in section
519(b)(5)(A) of such Act). [Secretary of Health and Human
Services had not made the report required by par. (1) on the
expiration of 48 months after Nov. 28, 1990.]
"(B) If in the report under paragraph (1) the Secretary reports
that there has been substantial compliance with the requirements
of such section 519(b) by a type of device user facility and if
the Secretary does not make a determination under subparagraph
(C) with respect to such type of facility, such section 303(f)
shall not take effect with respect to such type of facility.
"(C) If the Secretary determines in the report under paragraph
(1) that there is not substantial compliance with the
requirements of such section 519(b) by a type of device user
facility or if the Secretary makes such a determination after
making the report under paragraph (1), such section 303(f) shall
take effect with respect to such type of facility upon the
effective date of the report."
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100-293 effective upon expiration of 90 days
after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out
as a note under section 353 of this title.
EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,
1976, see section 502(c) of Pub. L. 94-278, set out as a note under
section 334 of this title.
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see section 704 of
Pub. L. 91-513, set out as an Effective Date note under section 801
of this title.
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-639 applicable only with respect to
violations of this chapter committed after Oct. 24, 1968, see
section 6 of Pub. L. 90-639, set out as an Effective Date of 1968
Amendments; Transitional Provisions note under section 321 of this
title.
EFFECTIVE DATE OF 1965 AMENDMENT
Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11
of Pub. L. 89-74, set out as a note under section 321 of this
title.
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
the provisions of section 203 of Pub. L. 86-618, see section 202 of
Pub. L. 86-618, set out as a note under section 379e of this title.
EFFECTIVE DATE OF 1951 AMENDMENT
Section 3 of act Oct. 26, 1951, provided that: "The provisions of
this Act [amending this section and section 353 of this title]
shall take effect six months after the date of its enactment [Oct.
26, 1951]."
SAVINGS PROVISION
Amendment by Pub. L. 91-513 not to affect or abate any
prosecutions for violation of law or any civil seizures or
forfeitures and injunctive proceedings commenced prior to the
effective date of such amendment, and all administrative
proceedings pending before the Bureau of Narcotics and Dangerous
Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970,
to be continued and brought to final determination in accord with
laws and regulations in effect prior to Oct. 27, 1970, see section
702 of Pub. L. 91-513, set out as a note under section 321 of this
title.
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
ENFORCEMENT
Pub. L. 99-660, title I, Sec. 103, Nov. 14, 1986, 100 Stat. 3751,
provided that: "For the fines authorized to be imposed under
section 303 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
333], see section 3623 of title 18, United States Code, for the
period ending October 31, 1986 [probably should be October 31,
1987], and sections 3559 and 3571 of such title for the period
beginning November 1, 1986 [probably should be November 1, 1987]."
FOOTNOTE
(!1) So in original. Words "of this section" probably should not
appear.
(!2) See References in Text note below.
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