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§ 333. —  Penalties.



[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
  January 24, 2002 and December 19, 2002]
[CITE: 21USC333]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
              SUBCHAPTER III--PROHIBITED ACTS AND PENALTIES
 
Sec. 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.
---------------------------------------------------------------------------
    \1\ So in original. Words ``of this section'' probably should not 
appear.
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(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 covered product pursuant to section 
384(a) 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.

(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.)

                       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.


                               Amendments

    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 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 note set out under section 
41 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].''

                  Section Referred to in Other Sections

    This section is referred to in sections 331, 360j, 859 of this 
title; title 15 section 1456.



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