All Agencies, Latest Month All Agencies, Current FY Geographic Distribution
of Convictions for
All Agencies, FY 2024
5 Prosecutions
in September 2024
33 Prosecutions
in Fiscal Year 2024
4 Convictions
in September 2024
34 Convictions
in Fiscal Year 2024CITE
21 USC Sec. 331 01/05/2009EXPCITE
TITLE 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER III - PROHIBITED ACTS AND PENALTIESHEAD
Sec. 331. Prohibited actsSTATUTE
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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