All Agencies, Latest Month All Agencies, Current FY Geographic Distribution
of Convictions for
All Agencies, FY 2014
Prosecution Report
Not Available
13 Prosecutions
in Fiscal Year 2014
Conviction Report
Not Available
22 Convictions
in Fiscal Year 2014

CITE

    21 USC Sec. 333                                             01/05/2009

EXPCITE

    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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