All Agencies, Latest Month All Agencies, Previous FY Geographic Distribution
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All Agencies, FY 2013
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55 Prosecutions
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3 Convictions
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54 Convictions
in Fiscal Year 2013

CITE

    21 USC Sec. 331                                             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. 331. Prohibited acts

STATUTE

      The following acts and the causing thereof are prohibited:
      (a) The introduction or delivery for introduction into interstate
    commerce of any food, drug, device, or cosmetic that is adulterated
    or misbranded.
      (b) The adulteration or misbranding of any food, drug, device, or
    cosmetic in interstate commerce.
      (c) The receipt in interstate commerce of any food, drug, device,
    or cosmetic that is adulterated or misbranded, and the delivery or
    proffered delivery thereof for pay or otherwise.
      (d) The introduction or delivery for introduction into interstate
    commerce of any article in violation of section 344, 355, or 360bbb-
    3 of this title.
      (e) The refusal to permit access to or copying of any record as
    required by section 350a, 350c, 350f(g), 350e, 354, 360bbb-3, 373,
    374(a), 379aa, or 379aa-1 of this title; or the failure to
    establish or maintain any record, or make any report, required
    under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k),
    360b(a)(4)(C), 360b(j), (l) or (m), 360ccc-1(i).,(!1) 360e(f),
    360i, 360bbb-3, 379aa, or 379aa-1 of this title, or the refusal to
    permit access to or verification or copying of any such required
    record.
      (f) The refusal to permit entry or inspection as authorized by
    section 374 of this title.
      (g) The manufacture within any Territory of any food, drug,
    device, or cosmetic that is adulterated or misbranded.
      (h) The giving of a guaranty or undertaking referred to in
    section 333(c)(2) of this title, which guaranty or undertaking is
    false, except by a person who relied upon a guaranty or undertaking
    to the same effect signed by, and containing the name and address
    of, the person residing in the United States from whom he received
    in good faith the food, drug, device, or cosmetic; or the giving of
    a guaranty or undertaking referred to in section 333(c)(3) of this
    title, which guaranty or undertaking is false.
      (i)(1) Forging, counterfeiting, simulating, or falsely
    representing, or without proper authority using any mark, stamp,
    tag, label, or other identification device authorized or required
    by regulations promulgated under the provisions of section 344 or
    379e of this title.
      (2) Making, selling, disposing of, or keeping in possession,
    control, or custody, or concealing any punch, die, plate, stone, or
    other thing designed to print, imprint, or reproduce the trademark,
    trade name, or other identifying mark, imprint, or device of
    another or any likeness of any of the foregoing upon any drug or
    container or labeling thereof so as to render such drug a
    counterfeit drug.
      (3) The doing of any act which causes a drug to be a counterfeit
    drug, or the sale or dispensing, or the holding for sale or
    dispensing, of a counterfeit drug.
      (j) The using by any person to his own advantage, or revealing,
    other than to the Secretary or officers or employees of the
    Department, or to the courts when relevant in any judicial
    proceeding under this chapter, any information acquired under
    authority of section 344, 348, 350a, 350c, 355, 360, 360b, 360c,
    360d, 360e, 360f, 360h, 360i, 360j, 360ccc, 360ccc-1, 360ccc-
    2.,(!1) 374, 379, or 379e of this title concerning any method or
    process which as a trade secret is entitled to protection; or the
    violating of section 346a(i)(2) of this title or any regulation
    issued under that section..(!1) This paragraph does not authorize
    the withholding of information from either House of Congress or
    from, to the extent of matter within its jurisdiction, any
    committee or subcommittee of such committee or any joint committee
    of Congress or any subcommittee of such joint committee.
      (k) The alteration, mutilation, destruction, obliteration, or
    removal of the whole or any part of the labeling of, or the doing
    of any other act with respect to, a food, drug, device, or
    cosmetic, if such act is done while such article is held for sale
    (whether or not the first sale) after shipment in interstate
    commerce and results in such article being adulterated or
    misbranded.
      (l) Repealed. Pub. L. 105-115, title IV, Sec. 421, Nov. 21, 1997,
    111 Stat. 2380.
      (m) The sale or offering for sale of colored oleomargarine or
    colored margarine, or the possession or serving of colored
    oleomargarine or colored margarine in violation of subsections (b)
    or (c) of section 347 of this title.
      (n) The using, in labeling, advertising or other sales promotion
    of any reference to any report or analysis furnished in compliance
    with section 374 of this title.
      (o) In the case of a prescription drug distributed or offered for
    sale in interstate commerce, the failure of the manufacturer,
    packer, or distributor thereof to maintain for transmittal, or to
    transmit, to any practitioner licensed by applicable State law to
    administer such drug who makes written request for information as
    to such drug, true and correct copies of all printed matter which
    is required to be included in any package in which that drug is
    distributed or sold, or such other printed matter as is approved by
    the Secretary. Nothing in this paragraph shall be construed to
    exempt any person from any labeling requirement imposed by or under
    other provisions of this chapter.
      (p) The failure to register in accordance with section 360 of
    this title, the failure to provide any information required by
    section 360(j) or 360(k) of this title, or the failure to provide a
    notice required by section 360(j)(2) of this title.
      (q)(1) The failure or refusal to (A) comply with any requirement
    prescribed under section 360h or 360j(g) of this title, (B) furnish
    any notification or other material or information required by or
    under section 360i or 360j(g) of this title, or (C) comply with a
    requirement under section 360l of this title.
      (2) With respect to any device, the submission of any report that
    is required by or under this chapter that is false or misleading in
    any material respect.
      (r) The movement of a device in violation of an order under
    section 334(g) of this title or the removal or alteration of any
    mark or label required by the order to identify the device as
    detained.
      (s) The failure to provide the notice required by section 350a(c)
    or 350a(e) of this title, the failure to make the reports required
    by section 350a(f)(1)(B) of this title, the failure to retain the
    records required by section 350a(b)(4) of this title, or the
    failure to meet the requirements prescribed under section
    350a(f)(3) of this title.
      (t) The importation of a drug in violation of section 381(d)(1)
    of this title, the sale, purchase, or trade of a drug or drug
    sample or the offer to sell, purchase, or trade a drug or drug
    sample in violation of section 353(c) of this title, the sale,
    purchase, or trade of a coupon, the offer to sell, purchase, or
    trade such a coupon, or the counterfeiting of such a coupon in
    violation of section 353(c)(2) of this title, the distribution of a
    drug sample in violation of section 353(d) of this title or the
    failure to otherwise comply with the requirements of section 353(d)
    of this title, or the distribution of drugs in violation of section
    353(e) of this title or the failure to otherwise comply with the
    requirements of section 353(e) of this title.
      (u) The failure to comply with any requirements of the provisions
    of, or any regulations or orders of the Secretary, under section
    360b(a)(4)(A), 360b(a)(4)(D), or 360b(a)(5) of this title.
      (v) The introduction or delivery for introduction into interstate
    commerce of a dietary supplement that is unsafe under section 350b
    of this title.
      (w) The making of a knowingly false statement in any statement,
    certificate of analysis, record, or report required or requested
    under section 381(d)(3) of this title; the failure to submit a
    certificate of analysis as required under such section; the failure
    to maintain records or to submit records or reports as required by
    such section; the release into interstate commerce of any article
    or portion thereof imported into the United States under such
    section or any finished product made from such article or portion,
    except for export in accordance with section 381(e) or 382 of this
    title, or with section 262(h) of title 42; or the failure to so
    export or to destroy such an article or portions thereof, or such a
    finished product.
      (x) The falsification of a declaration of conformity submitted
    under section 360d(c) of this title or the failure or refusal to
    provide data or information requested by the Secretary under
    paragraph (3) of such section.
      (y) In the case of a drug, device, or food -
        (1) the submission of a report or recommendation by a person
      accredited under section 360m of this title that is false or
      misleading in any material respect;
        (2) the disclosure by a person accredited under section 360m of
      this title of confidential commercial information or any trade
      secret without the express written consent of the person who
      submitted such information or secret to such person; or
        (3) the receipt by a person accredited under section 360m of
      this title of a bribe in any form or the doing of any corrupt act
      by such person associated with a responsibility delegated to such
      person under this chapter.
      (z) Omitted.
      (aa) The importation of a prescription drug in violation of
    section 384 of this title, the falsification of any record required
    to be maintained or provided to the Secretary under such section,
    or any other violation of regulations under such section.
      (bb) The transfer of an article of food in violation of an order
    under section 334(h) of this title, or the removal or alteration of
    any mark or label required by the order to identify the article as
    detained.
      (cc) The importing or offering for import into the United States
    of an article of food by, with the assistance of, or at the
    direction of, a person debarred under section 335a(b)(3) of this
    title.
      (dd) The failure to register in accordance with section 350d of
    this title.
      (ee) The importing or offering for import into the United States
    of an article of food in violation of the requirements under
    section 381(m) of this title.
      (ff) The importing or offering for import into the United States
    of a drug or device with respect to which there is a failure to
    comply with a request of the Secretary to submit to the Secretary a
    statement under section 381(o) of this title.
      (gg) The knowing failure to comply with paragraph (7)(E) of
    section 374(g) of this title; the knowing inclusion by a person
    accredited under paragraph (2) of such section of false information
    in an inspection report under paragraph (7)(A) of such section; or
    the knowing failure of such a person to include material facts in
    such a report.
      (hh) The failure by a shipper, carrier by motor vehicle or rail
    vehicle, receiver, or any other person engaged in the
    transportation of food to comply with the sanitary transportation
    practices prescribed by the Secretary under section 350e of this
    title.
      (ii) The falsification of a report of a serious adverse event
    submitted to a responsible person (as defined under section 379aa
    or 379aa-1 of this title) or the falsification of a serious adverse
    event report (as defined under section 379aa or 379aa-1 of this
    title) submitted to the Secretary.
      (jj)(1) The failure to submit the certification required by
    section 282(j)(5)(B) of title 42, or knowingly submitting a false
    certification under such section.
      (2) The failure to submit clinical trial information required
    under subsection (j) of section 282 of title 42.
      (3) The submission of clinical trial information under subsection
    (j) of section 282 of title 42 that is false or misleading in any
    particular under paragraph (5)(D) of such subsection (j).
      (kk) The dissemination of a television advertisement without
    complying with section 353b of this title.
      (ll) The introduction or delivery for introduction into
    interstate commerce of any food to which has been added a drug
    approved under section 355 of this title, a biological product
    licensed under section 262 of title 42, or a drug or a biological
    product for which substantial clinical investigations have been
    instituted and for which the existence of such investigations has
    been made public, unless -
        (1) such drug or such biological product was marketed in food
      before any approval of the drug under section 355 of this title,
      before licensure of the biological product under such section 262
      of title 42, and before any substantial clinical investigations
      involving the drug or the biological product have been
      instituted;
        (2) the Secretary, in the Secretary's discretion, has issued a
      regulation, after notice and comment, approving the use of such
      drug or such biological product in the food;
        (3) the use of the drug or the biological product in the food
      is to enhance the safety of the food to which the drug or the
      biological product is added or applied and not to have
      independent biological or therapeutic effects on humans, and the
      use is in conformity with -
          (A) a regulation issued under section 348 of this title
        prescribing conditions of safe use in food;
          (B) a regulation listing or affirming conditions under which
        the use of the drug or the biological product in food is
        generally recognized as safe;
          (C) the conditions of use identified in a notification to the
        Secretary of a claim of exemption from the premarket approval
        requirements for food additives based on the notifier's
        determination that the use of the drug or the biological
        product in food is generally recognized as safe, provided that
        the Secretary has not questioned the general recognition of
        safety determination in a letter to the notifier;
          (D) a food contact substance notification that is effective
        under section 348(h) of this title; or
          (E) such drug or biological product had been marketed for
        smoking cessation prior to September 27, 2007; or
        (4) the drug is a new animal drug whose use is not unsafe under
      section 360b of this title.
      (mm) The failure to submit a report or provide a notification
    required under section 350f(d) of this title.
      (nn) The falsification of a report or notification required under
    section 350f(d) of this title.

SOURCE

    (June 25, 1938, ch. 675, Sec. 301, 52 Stat. 1042; Dec. 22, 1941,
    ch. 613, Sec. 1, 55 Stat. 851; July 6, 1945, ch. 281, Sec. 1, 59
    Stat. 463; Mar. 10, 1947, ch. 16, Sec. 1, 61 Stat. 11; June 24,
    1948, ch. 613, Sec. 1, 62 Stat. 582; Mar. 16, 1950, ch. 61, Sec.
    3(b), 64 Stat. 20; Aug. 7, 1953, ch. 350, Sec. 2, 67 Stat. 477;
    Pub. L. 85-929, Sec. 5, Sept. 6, 1958, 72 Stat. 1788; Pub. L. 86-
    618, title I, Secs. 104, 105(a), July 12, 1960, 74 Stat. 403; Pub.
    L. 87-781, title I, Secs. 103(c), 104(e)(1), 106(c), 114(a), title
    III, Sec. 304, Oct. 10, 1962, 76 Stat. 784, 785, 788, 791, 795;
    Pub. L. 89-74, Secs. 5, 9(c), July 15, 1965, 79 Stat. 232, 235;
    Pub. L. 90-399, Sec. 103, July 13, 1968, 82 Stat. 352; Pub. L. 90-
    639, Sec. 2(b), Oct. 24, 1968, 82 Stat. 1361; Pub. L. 91-513,
    title II, Sec. 701(a), Oct. 27, 1970, 84 Stat. 1281; Pub. L. 92-
    387, Sec. 4(e), Aug. 16, 1972, 86 Stat. 562; Pub. L. 94-295, Secs.
    3(b), 4(b)(1), 7(b), May 28, 1976, 90 Stat. 576, 580, 582; Pub. L.
    96-359, Sec. 5, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 99-570,
    title IV, Sec. 4014(b)(2), Oct. 27, 1986, 100 Stat. 3207-120; Pub.
    L. 100-293, Sec. 7(a), Apr. 22, 1988, 102 Stat. 99; Pub. L. 101-
    502, Sec. 5(j), Nov. 3, 1990, 104 Stat. 1289; Pub. L. 101-508,
    title IV, Sec. 4755(c)(2), Nov. 5, 1990, 104 Stat. 1388-210; Pub.
    L. 102-300, Sec. 3(a)(1), June 16, 1992, 106 Stat. 238; Pub. L. 102-
    571, title I, Sec. 107(2), (3), Oct. 29, 1992, 106 Stat. 4499;
    Pub. L. 103-80, Sec. 3(c), Aug. 13, 1993, 107 Stat. 775; Pub. L.
    103-396, Sec. 2(b)(1), Oct. 22, 1994, 108 Stat. 4154; Pub. L. 103-
    417, Sec. 10(b), Oct. 25, 1994, 108 Stat. 4332; Pub. L. 104-134,
    title II, Sec. 2103, Apr. 26, 1996, 110 Stat. 1321-319; Pub. L. 104-
    170, title IV, Sec. 403, Aug. 3, 1996, 110 Stat. 1514; Pub. L. 104-
    250, Sec. 5(d), Oct. 9, 1996, 110 Stat. 3156; Pub. L. 105-115,
    title I, Sec. 125(a)(2)(A), (C), (b)(2)(B), title II, Secs. 204(b),
    210(c), title IV, Secs. 401(b), 421, Nov. 21, 1997, 111 Stat. 2325,
    2336, 2345, 2364, 2380; Pub. L. 106-387, Sec. 1(a) [title VII, Sec.
    745(d)(1)], Oct. 28, 2000, 114 Stat. 1549, 1549A-39; Pub. L. 107-
    188, title III, Secs. 303(b), 304(d), 305(b), 306(c), 307(b),
    321(b)(2), 322(b), June 12, 2002, 116 Stat. 664, 666, 668, 670,
    672, 676, 677; Pub. L. 107-250, title II, Sec. 201(d), Oct. 26,
    2002, 116 Stat. 1609; Pub. L. 108-136, div. A, title XVI, Sec.
    1603(c), Nov. 24, 2003, 117 Stat. 1690; Pub. L. 108-173, title XI,
    Sec. 1121(b)(1), Dec. 8, 2003, 117 Stat. 2469; Pub. L. 108-214,
    Sec. 2(b)(2)(A), Apr. 1, 2004, 118 Stat. 575; Pub. L. 108-282,
    title I, Sec. 102(b)(5)(C), (D), Aug. 2, 2004, 118 Stat. 902; Pub.
    L. 109-59, title VII, Sec. 7202(d), (e), Aug. 10, 2005, 119 Stat.
    1913; Pub. L. 109-462, Secs. 2(c), 3(b), 4(a), Dec. 22, 2006, 120
    Stat. 3472, 3475; Pub. L. 110-85, title VIII, Sec. 801(b)(1), title
    IX, Secs. 901(d)(1), 912(a), title X, Sec. 1005(d), Sept. 27, 2007,
    121 Stat. 920, 939, 951, 968.)

AMENDMENTS

      2007 - Par. (e). Pub. L. 110-85, Sec. 1005(d)(1), substituted
    "350c, 350f(g)," for "350c," and "350c(b), 350f" for "350c(b)".
      Par. (jj). Pub. L. 110-85, Sec. 801(b)(1), added par. (jj).
      Par. (kk). Pub. L. 110-85, Sec. 901(d)(1), added par. (kk).
      Par. (ll). Pub. L. 110-85, Sec. 912(a), added par. (ll).
      Pars. (mm), (nn). Pub. L. 110-85, Sec. 1005(d)(2), added pars.
    (mm) and (nn).
      2006 - Par. (e). Pub. L. 109-462, Sec. 3(b), substituted "374(a),
    379aa, or 379aa-1" for "374(a), or 379aa" and "360bbb-3, 379aa, or
    379aa-1" for "360bbb-3, or 379aa".
      Pub. L. 109-462, Sec. 2(c), substituted ", 374(a), or 379aa" for
    ", or 374(a)" and ", 360bbb-3, or 379aa" for ", or 360bbb-3".
      Par. (ii). Pub. L. 109-462, Sec. 4(a), added par. (ii).
      2005 - Par. (e). Pub. L. 109-59, Sec. 7202(d), inserted "350e,"
    before "354," in two places.
      Par. (hh). Pub. L. 109-59, Sec. 7202(e), added par. (hh).
      2004 - Par. (e). Pub. L. 108-282, Sec. 102(b)(5)(C), which
    directed the substitution of "360b(a)(4)(C), 360b (j), (l) or (m),
    360ccc-1(i)." for "360b(a)(4)(C), 360b(j), (l) or (m)" was executed
    by making the substitution for "360b(a)(4)(C), 360b(j), (l), or
    (m)", to reflect the probable intent of Congress.
      Par. (j). Pub. L. 108-282, Sec. 102(b)(5)(D), substituted "360j,
    360ccc, 360ccc-1, 360ccc-2." for "360j".
      Par. (gg). Pub. L. 108-214 amended par. (gg) generally. Prior to
    amendment, text read as follows: "The knowing failure of a person
    accredited under paragraph (2) of section 374(g) of this title to
    comply with paragraph (7)(E) of such section; the knowing inclusion
    by such a person of false information in an inspection report under
    paragraph (7)(A) of such section; or the knowing failure of such a
    person to include material facts in such a report."
      2003 - Par. (d). Pub. L. 108-136 substituted "section 344, 355,
    or 360bbb-3" for "section 344 or 355".
      Par. (e). Pub. L. 108-136 inserted "360bbb-3," after "350c, 354,"
    and substituted "360i, or 360bbb-3" for "or 360i".
      Par. (aa). Pub. L. 108-173 substituted "prescription drug in
    violation of section 384" for "covered product in violation of
    section 384".
      2002 - Par. (e). Pub. L. 107-188, Sec. 306(c)(1), substituted "by
    section 350a, 350c, 354, 373, or 374(a) of this title" for "by
    section 350a, 354, or 373 of this title" and "under section 350a,
    350c(b)" for "under section 350a".
      Par. (j). Pub. L. 107-188, Sec. 306(c)(2), inserted "350c," after
    "350a,".
      Par. (w). Pub. L. 107-188, Sec. 322(b), amended par. (w)
    generally. Prior to amendment, par. (w) read as follows: "The
    making of a knowingly false statement in any record or report
    required or requested under subparagraph (A) or (B) of section
    381(d)(3) of this title, the failure to submit or maintain records
    as required by sections 381(d)(3)(A) and 381(d)(3)(B) of this
    title, the release into interstate commerce of any article imported
    into the United States under section 381(d)(3) of this title or any
    finished product made from such article (except for export in
    accordance with section 381(e) or 382 of this title or section
    262(h) of title 42), or the failure to export or destroy any
    component, part or accessory not incorporated into a drug,
    biological product or device that will be exported in accordance
    with section 381(e) or 382 of this title or section 262(h) of title
    42."
      Par. (bb). Pub. L. 107-188, Sec. 303(b), added par. (bb).
      Par. (cc). Pub. L. 107-188, Sec. 304(d), added par. (cc).
      Par. (dd). Pub. L. 107-188, Sec. 305(b), added par. (dd).
      Par. (ee). Pub. L. 107-188, Sec. 307(b), added par. (ee).
      Par. (ff). Pub. L. 107-188, Sec. 321(b)(2), added par. (ff).
      Par. (gg). Pub. L. 107-250 added par. (gg).
      2000 - Par. (aa). Pub. L. 106-387 added par. (aa).
      1997 - Par. (e). Pub. L. 105-115, Sec. 125(b)(2)(B), struck out
    "357(d) or (g)," after "355(i) or (k),".
      Par. (i)(1). Pub. L. 105-115, Sec. 125(a)(2)(C), struck out ",
    356, 357," before "or 379e of this title".
      Par. (j). Pub. L. 105-115, Sec. 125(a)(2)(A), struck out "356,
    357," before "360,".
      Par. (l). Pub. L. 105-115, Sec. 421, struck out par. (l) which
    read as follows: "The using, on the labeling of any drug or device
    or in any advertising relating to such drug or device, of any
    representation or suggestion that approval of an application with
    respect to such drug or device is in effect under section 355,
    360e, or 360j(g) of this title, as the case may be, or that such
    drug or device complies with the provisions of such section."
      Par. (x). Pub. L. 105-115, Sec. 204(b), added par. (x).
      Par. (y). Pub. L. 105-115, Sec. 210(c), added par. (y).
      Par. (z). Pub. L. 105-115, Sec. 401(b), temporarily added par.
    (z) which related to dissemination of information in violation of
    section 360aaa of this title. See Effective and Termination Dates
    of 1997 Amendment note below.
      1996 - Par. (e). Pub. L. 104-250 inserted ", 354," before "or 373
    of this title" and "354," before "355(i) or (k)".
      Par. (j). Pub. L. 104-170 inserted before period at end of first
    sentence "; or the violating of section 346a(i)(2) of this title or
    any regulation issued under that section."
      Pars. (u) to (w). Pub. L. 104-134 redesignated par. (u) relating
    to introduction into interstate commerce of unsafe dietary
    supplement as (v) and added par. (w).
      1994 - Par. (e). Pub. L. 103-396, Sec. 2(b)(1)(A), substituted
    "357(d) or (g), 360b(a)(4)(C)," for "357(d) or (g),".
      Par. (u). Pub. L. 103-417 added par. (u) relating to introduction
    into interstate commerce of unsafe dietary supplement.
      Pub. L. 103-396, Sec. 2(b)(1)(B), added par. (u) relating to
    failure to comply with regulations or orders of Secretary.
      1993 - Par. (j). Pub. L. 103-80, Sec. 3(c)(1), substituted "379,
    or 379e" for "379e, or 379".
      Par. (s). Pub. L. 103-80, Sec. 3(c)(2), substituted "350a(e)" for
    "350a(d)".
      1992 - Pars. (i)(1), (j). Pub. L. 102-571 substituted "379e" for
    "376".
      Par. (q)(1)(C). Pub. L. 102-300 added cl. (C).
      1990 - Par. (e). Pub. L. 101-502 substituted "or (k)" for "or
    (j)".
      Par. (j). Pub. L. 101-508 inserted at end "This paragraph does
    not authorize the withholding of information from either House of
    Congress or from, to the extent of matter within its jurisdiction,
    any committee or subcommittee of such committee or any joint
    committee of Congress or any subcommittee of such joint committee."
      1988 - Par. (t). Pub. L. 100-293 added par. (t).
      1986 - Par. (s). Pub. L. 99-570 amended par. (s) generally. Prior
    to amendment, par. (s) read as follows: "The failure to provide the
    notice required by section 350a(b) or 350a(c), the failure to make
    the reports required by section 350a(d)(1)(B), or the failure to
    meet the requirements prescribed under section 350a(d)(2)."
      1980 - Par. (e). Pub. L. 96-359, Sec. 5(b), inserted reference to
    section 350a of this title in two places.
      Par. (j). Pub. L. 96-359, Sec. 5(c), inserted reference to
    section 350a of this title.
      Par. (s). Pub. L. 96-359, Sec. 5(a), added par. (s).
      1976 - Par. (e). Pub. L. 94-295, Sec. 3(b)(2), inserted
    references to sections 360e(f) and 360i of this title.
      Par. (j). Pub. L. 94-295, Sec. 3(b)(3), inserted references to
    sections 360, 360c, 360d, 360e, 360f, 360h, 360i, 360j, and 379 of
    this title.
      Par. (l). Pub. L. 94-295, Sec. 3(b)(4), substituted "drug or
    device" for "drug" wherever appearing, and inserted references to
    sections 360e and 360j(g) of this title.
      Par. (p). Pub. L. 94-295, Sec. 4(b)(1), substituted "section
    360(j) or 360(k) of this title," for "section 360(j) of this
    title,".
      Par. (q). Pub. L. 94-295, Sec. 3(b)(1), added par. (q).
      Par. (r). Pub. L. 94-295, Sec. 7(b), added par. (r).
      1972 - Par. (p). Pub. L. 92-387 added failure to provide
    information required by section 360(j) of this title, and failure
    to provide notice required by section 360(j)(2) of this title as
    prohibited acts.
      1970 - Par. (q). Pub. L. 91-513 struck out par. (q) which set out
    penalties for illegal manufacture, sale, disposition, possession
    and other traffic in stimulant and depressant drugs. See section
    801 et seq. of this title.
      1968 - Par. (e). Pub. L. 90-399, Sec. 103(1), inserted reference
    to section 360b(j), (l), and (m) of this title.
      Par. (j). Pub. L. 90-399, Sec. 103(2), inserted reference to
    section 360b of this title.
      Par. (q). Pub. L. 90-639 divided cl. (3), which referred simply
    to possession in violation of section 360a(c) of this title, into
    subcls. (A) and (B) which refer, respectively, to possession in
    violation of section 360a(c)(1) of this title and possession in
    violation of section 360a(c)(2) of this title.
      1965 - Par. (i). Pub. L. 89-74, Sec. 9(c), designated existing
    provisions as subpar. (1) and added subpars. (2) and (3).
      Par. (q). Pub. L. 89-74, Sec. 5, added par. (q).
      1962 - Par. (e). Pub. L. 87-781, Secs. 103(c), 106(c), prohibited
    the failure to establish or maintain any record, or make any
    report, required under sections 355(i) or (j) and 507(d) or (g) of
    this title, or the refusal to permit access to, or verification or
    copying of, any such required record.
      Par. (l). Pub. L. 87-781, Sec. 104(e)(1), inserted "approval of"
    before "an application", and substituted "in effect" for
    "effective".
      Par. (o). Pub. L. 87-781, Sec. 114(a), added par. (o).
      Par. (p). Pub. L. 87-781, Sec. 304, added par. (p).
      1960 - Par. (i). Pub. L. 86-618, Sec. 105(a), struck out
    references to sections 346(b), 354, and 364 of this title and
    inserted reference to section 376 of this title.
      Par. (j). Pub. L. 86-618, Sec. 104, inserted reference to section
    376 of this title.
      1958 - Par. (j). Pub. L. 85-929, inserted reference to section
    348 of this title.
      1953 - Par. (n). Act Aug. 7, 1953, added par. (n).
      1950 - Par. (m). Act Mar. 16, 1950, added par. (m).
      1948 - Par. (k). Act June 24, 1948, inserted "(whether or not the
    first sale)" so as to make it clear that this subsection is not
    limited to the case where the act occurs while the article is held
    for the first sale after interstate shipment, and extended coverage
    of subsection to acts which result in adulteration.
      1947 - Par. (j). Act Mar. 10, 1947, inserted reference to
    sections 356 and 357 of this title.
      1945 - Par. (i). Act July 6, 1945, inserted reference to section
    357 of this title.
      1941 - Par. (i). Act Dec. 22, 1941, inserted reference to section
    356 of this title.
                     EFFECTIVE DATE OF 2007 AMENDMENT
      Pub. L. 110-85, title IX, Sec. 909, Sept. 27, 2007, 121 Stat.
    950, provided that:
      "(a) Effective Date. - This subtitle [subtitle A (Secs. 901-909)
    of title IX of Pub. L. 110-85, enacting sections 353b and 355-1 of
    this title, amending this section, sections 333, 352, and 355 of
    this title, and section 262 of Title 42, The Public Health and
    Welfare, and enacting provisions set out as notes under sections
    352, 355, and 355a of this title] takes effect 180 days after the
    date of the enactment of this Act [Sept. 27, 2007].
      "(b) Drugs Deemed to Have Risk Evaluation and Mitigation
    Strategies. -
        "(1) In general. - A drug that was approved before the
      effective date of this Act [probably means "this subtitle", see
      above] is, in accordance with paragraph (2), deemed to have in
      effect an approved risk evaluation and mitigation strategy under
      section 505-1 of the Federal Food, Drug, and Cosmetic Act [21
      U.S.C. 355-1] (as added by section 901) (referred to in this
      section as the 'Act') if there are in effect on the effective
      date of this Act elements to assure safe use -
          "(A) required under section 314.520 or section 601.42 of
        title 21, Code of Federal Regulations; or
          "(B) otherwise agreed to by the applicant and the Secretary
        for such drug.
        "(2) Elements of strategy; enforcement. - The approved risk
      evaluation and mitigation strategy in effect for a drug under
      paragraph (1) -
          "(A) is deemed to consist of the timetable required under
        section 505-1(d) and any additional elements under subsections
        (e) and (f) of such section in effect for such drug on the
        effective date of this Act; and
          "(B) is subject to enforcement by the Secretary to the same
        extent as any other risk evaluation and mitigation strategy
        under section 505-1 of the Act, except that sections 303(f)(4)
        and 502(y) and (z) of the Act [21 U.S.C. 333(f)(4), 352(y),
        (z)] (as added by section 902) shall not apply to such strategy
        before the Secretary has completed review of, and acted on, the
        first assessment of such strategy under such section 505-1.
        "(3) Submission. - Not later than 180 days after the effective
      date of this Act, the holder of an approved application for which
      a risk evaluation and mitigation strategy is deemed to be in
      effect under paragraph (1) shall submit to the Secretary a
      proposed risk evaluation and mitigation strategy. Such proposed
      strategy is subject to section 505-1 of the Act as if included in
      such application at the time of submission of the application to
      the Secretary."
                     EFFECTIVE DATE OF 2006 AMENDMENT
      Amendment by section 2(c) of Pub. L. 109-462 effective 1 year
    after Dec. 22, 2006, see section 2(e)(1) of Pub. L. 109-462, set
    out as a note under section 352 of this title.
      Amendment by section 3(b) of Pub. L. 109-462 effective 1 year
    after Dec. 22, 2006, see section 3(d)(1) of Pub. L. 109-462, set
    out as a note under section 343 of this title.
      Pub. L. 109-462, Sec. 4(b), Dec. 22, 2006, 120 Stat. 3475,
    provided that: "The amendment made by this section [amending this
    section] shall take effect 1 year after the date of enactment of
    this Act [Dec. 22, 2006]."
                     EFFECTIVE DATE OF 2005 AMENDMENT
      Pub. L. 109-59, title VII, Sec. 7204, Aug. 10, 2005, 119 Stat.
    1914, provided that: "This subtitle [subtitle B (Secs. 7201-7204)
    of title VII of Pub. L. 109-59, enacting section 350e of this
    title, amending this section, sections 342 and 373 of this title,
    and section 5701 of Title 49, Transportation, omitting sections
    5702 to 5714 of Title 49, and enacting provisions set out as a note
    under section 301 of this title] takes effect on October 1, 2005."
                     EFFECTIVE DATE OF 2002 AMENDMENT
      Pub. L. 107-188, title III, Sec. 321(c), June 12, 2002, 116 Stat.
    676, provided that: "The amendments made by this section [amending
    this section and sections 360 and 381 of this title] take effect
    upon the expiration of the 180-day period beginning on the date of
    the enactment of this Act [June 12, 2002]."
      Pub. L. 107-188, title III, Sec. 322(c), June 12, 2002, 116 Stat.
    678, provided that: "The amendments made by this section [amending
    this section and section 381 of this title] take effect upon the
    expiration of the 90-day period beginning on the date of the
    enactment of this Act [June 12, 2002]."
             EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT
      Amendment by sections 204, 210, and 421 of Pub. L. 105-115
    effective 90 days after Nov. 21, 1997, except as otherwise
    provided, see section 501 of Pub. L. 105-115, set out as a note
    under section 321 of this title.
      Amendment by section 401(b) of Pub. L. 105-115 effective 1 year
    after Nov. 21, 1997, or upon Secretary's issuance of final
    regulations pursuant to section 401(c) of Pub. L. 105-115,
    whichever is sooner, and ceases to be effective Sept. 30, 2006, see
    section 401(d), (e) of Pub. L. 105-115, set out as an Effective and
    Termination Dates note under former section 360aaa of this title.
                     EFFECTIVE DATE OF 1994 AMENDMENT
      Amendment by Pub. L. 103-396 effective upon adoption of final
    regulations under section 2(c) of Pub. L. 103-396, set out as a
    Regulations note under section 360b of this title, see section 2(d)
    of Pub. L. 103-396, set out as a note under section 360b of this
    title.
                     EFFECTIVE DATE OF 1990 AMENDMENT
      Section 4755(c)(2) of Pub. L. 101-508 provided that the amendment
    made by that section is effective as if included in subtitle D of
    title VI of the Omnibus Budget Reconciliation Act of 1989, Pub. L.
    101-239, title VI, Secs. 6601, 6602, Dec. 19, 1989, 103 Stat. 2285,
    see 42 U.S.C. 300aa-1 note, 300aa-10 note.
                     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 1972 AMENDMENT
      Amendment by Pub. L. 92-387 effective on first day of sixth month
    beginning after Aug. 16, 1972, see section 5 of Pub. L. 92-387, set
    out as a note under section 360 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 AMENDMENTS
      Amendment by Pub. L. 90-399 effective on first day of thirteenth
    calendar month after July 13, 1968, see section 108(a) of Pub. L.
    90-399, set out as an Effective Date and Transitional Provisions
    note under section 360b of this title.
      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 1962 AMENDMENT
      Amendment by sections 103(c) and 106(c) of Pub. L. 87-781
    effective on first day of seventh calendar month following Oct.
    1962, and amendment by section 104(e)(1) of Pub. L. 87-781
    effective Oct. 10, 1962, see section 107 of Pub. L. 87-781, set out
    as a note under section 321 of this title.
      Section 114(b) of Pub. L. 87-781 provided that: "This section
    [amending this section] shall take effect on the first day of the
    seventh calendar month following the month in which this Act is
    enacted [October 1962]."
                     EFFECTIVE DATE OF 1960 AMENDMENT
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    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 1958 AMENDMENT
      Amendment by Pub. L. 85-929 effective Sept. 6, 1958, see section
    6(a) of Pub. L. 85-929, set out as a note under section 342 of this
    title.
                     EFFECTIVE DATE OF 1950 AMENDMENT
      Amendment by act Mar. 16, 1950, effective July 1, 1950, see
    section 7 of that act, set out as an Effective Date note under
    section 347 of this title.
                                REGULATIONS
      Secretary of Health and Human Services to promulgate regulations
    to implement amendments made by section 401 of Pub. L. 105-115 not
    later than 1 year after Nov. 21, 1997, see section 401(c) of Pub.
    L. 105-115, set out as a note under section 360aaa of this title.
                             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.
               CONSTRUCTION OF AMENDMENTS BY PUB. L. 107-188
      Pub. L. 107-188, title III, Sec. 315, June 12, 2002, 116 Stat.
    675, provided that: "Nothing in this title [enacting sections 350c,
    350d, 398, 399, and 679c of this title, sections 3353, 3354, 8319,
    and 8320 of Title 7, Agriculture, and section 247b-20 of Title 42,
    The Public Health and Welfare, amending this section, sections 334,
    335a, 342, 343, 360, 372, 374, and 381 of this title, and section
    43 of Title 18, Crimes and Criminal Procedure, and enacting
    provisions set out as notes under this section and sections 341,
    350c, 350d, and 381 of this title], or an amendment made by this
    title, shall be construed to alter the jurisdiction between the
    Secretaries of Agriculture and of Health and Human Services, under
    applicable statutes and regulations."

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.

FOOTNOTE

    (!1) So in original.
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