21 U.S.C. 331: Prohibited acts

2022

• Pub. L. 117–328, §3503(a)(1)(B), which directed the substitution of ", 360bbb–3, or 364c" for "or 360bbb–3" in par. (d), was executed by making the substitution in subsec. (d) to reflect the probable intent of Congress. (Consolidated Appropriations Act, 2023) Law text · (d)
• Pub. L. 117–328, §3503(a)(4)(A), substituted "360bbb–3, 364a, 373" for "360bbb–3, 373" and "360bbb–3, 364a, 364g, 379aa" for "360bbb–3, 379aa". (Consolidated Appropriations Act, 2023) Law text · (e)
• Pub. L. 117–328, §3305(b), added par. (3). (Consolidated Appropriations Act, 2023) Law text · (q)
• Pub. L. 117–328, §3503(a)(4)(B)(ii), inserted "or required under section 364a(a) of this title" after "report (as defined under section 379aa or 379aa–1 of this title". (Consolidated Appropriations Act, 2023) Law text · (ii)
• Pub. L. 117–328, §3503(a)(4)(B)(i), substituted "364, 379aa, or 379aa–1 of this title) or" for "379aa or 379aa–1 of this title) or". (Consolidated Appropriations Act, 2023) Law text · (ii)
• Pub. L. 117–328, §2513(a), added subsec. (fff). (Consolidated Appropriations Act, 2023) Law text · (fff)
• Pub. L. 117–328, §3210(c), added subsec. (ggg). (Consolidated Appropriations Act, 2023) Law text · (ggg)
• Pub. L. 117–328, §3503(a)(1)(A), added subsecs. (hhh) and (iii). (Consolidated Appropriations Act, 2023) Law text · (hhh), (iii)

2018

• Pub. L. 115–271, §3022(b)(1), inserted "or a drug" after "food" and "from such activity" after "person debarred". (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (cc)
• Pub. L. 115–271, §3012(a), added par. (eee). (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (eee)

2016

• Pub. L. 114–255 inserted ", drug," after "device" in two places. (21st Century Cures Act) Law text · (r)

2015

• Pub. L. 114–114 added par. (ddd). Law text · (ddd)

2013

• Pub. L. 113–54, §206(a), struck out "or" after "the requirements of section 353(d) of this title," and inserted ", failure to comply with the requirements under section 360eee–1 of this title, the failure to comply with the requirements under section 360eee–3 of this title, as applicable,… Law text · (t)
• Pub. L. 113–54, §103(a), added par. (ccc). Law text · (ccc)

2012

• Pub. L. 112–144, §714(a), added par. (aaa). (Food and Drug Administration Safety and Innovation Act) Law text · (aaa)
• Pub. L. 112–144, §715(a), added par. (bbb). (Food and Drug Administration Safety and Innovation Act) Law text · (bbb)

2011

• Pub. L. 111–353, §102(d)(1), inserted "350d," after "344,". (FDA Food Safety Modernization Act) Law text · (d)
• Pub. L. 111–353, §§204(j)(1), 211(c), substituted "350f(j)" for "350f(g)" and inserted before period at end "; or the violation of any recordkeeping requirement under section 2223 of this title (except when such violation is committed by a farm)". (FDA Food Safety Modernization Act) Law text · (e)
• Pub. L. 111–353, §103(e), added par. (uu). (FDA Food Safety Modernization Act) Law text · (uu)
• Pub. L. 111–353, §105(c), added par. (vv). (FDA Food Safety Modernization Act) Law text · (vv)
• Pub. L. 111–353, §106(d), added par. (ww). (FDA Food Safety Modernization Act) Law text · (ww)
• Pub. L. 111–353, §206(d), added par. (xx). (FDA Food Safety Modernization Act) Law text · (xx)
• Pub. L. 111–353, §211(b), added par. (yy). (FDA Food Safety Modernization Act) Law text · (yy)
• Pub. L. 111–353, §301(b), added par. (zz). (FDA Food Safety Modernization Act) Law text · (zz)

2009

• Pub. L. 111–31, §103(b)(1)–(3), inserted "tobacco product," after "device,". Law text · (a), (b), (c)
• Pub. L. 111–31, §103(b)(4)(B), which directed substitution of "379aa–1, 387i, or 387t of this title or the refusal to permit access to" for "or 379aa–1 of this title or the refusal to permit access to", was executed by making the substitution for "or 379aa–1 of this title, or the refusal … Law text · (e)
• Pub. L. 111–31, §103(b)(4)(A), struck out period after "360ccc–1(i)". Law text · (e)
• Pub. L. 111–31, §103(b)(5), (6), inserted "tobacco product," after "device,". Law text · (g), (h)
• Pub. L. 111–31, §103(b)(7), struck out period after "360ccc–2" and substituted "379, 379e, 387d, 387e, 387f, 387g, 387h, 387i, or 387t(b)" for "379, or 379e". Law text · (j)
• Pub. L. 111–31, §103(b)(8), inserted "tobacco product," after "device,". Law text · (k)
• Pub. L. 111–31, §103(b)(9), added par. (p) and struck out former par. (p) which read as follows: "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 no… Law text · (p)
• Pub. L. 111–31, §103(b)(10), added subpar. (1) and struck out former subpar. (1) which read as follows: "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 requi… Law text · (q)
• Pub. L. 111–31, §103(b)(11), substituted "device or tobacco product," for "device,". Law text · (q)
• Pub. L. 111–31, §103(b)(12), inserted "or tobacco product" after "device" in two places. Law text · (r)
• Pub. L. 111–31, §103(b)(13), added pars. (oo) to (tt). Law text · (oo)

2007

• Pub. L. 110–85, §1005(d)(1), substituted "350c, 350f(g)," for "350c," and "350c(b), 350f" for "350c(b)". (Food and Drug Administration Amendments Act of 2007) Law text · (e)
• Pub. L. 110–85, §801(b)(1), added par. (jj). (Food and Drug Administration Amendments Act of 2007) Law text · (jj)
• Pub. L. 110–85, §901(d)(1), added par. (kk). (Food and Drug Administration Amendments Act of 2007) Law text · (kk)
• Pub. L. 110–85, §912(a), added par. (ll). (Food and Drug Administration Amendments Act of 2007) Law text · (ll)
• Pub. L. 110–85, §1005(d)(2), added pars. (mm) and (nn). (Food and Drug Administration Amendments Act of 2007) Law text · (mm), (nn)

2006

• Pub. L. 109–462, §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". (Dietary Supplement and Nonprescription Drug Consumer Protection Act) Law text · (e)
• Pub. L. 109–462, §2(c), substituted ", 374(a), or 379aa" for ", or 374(a)" and ", 360bbb–3, or 379aa" for ", or 360bbb–3". (Dietary Supplement and Nonprescription Drug Consumer Protection Act) Law text · (e)
• Pub. L. 109–462, §4(a), added par. (ii). (Dietary Supplement and Nonprescription Drug Consumer Protection Act) Law text · (ii)

2005

• Pub. L. 109–59, §7202(d), inserted "350e," before "354," in two places. (Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users) Law text · (e)
• Pub. L. 109–59, §7202(e), added par. (hh). (Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users) Law text · (hh)

2004

• Pub. L. 108–282, §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. Law text · (e)
• Pub. L. 108–282, §102(b)(5)(D), substituted "360j, 360ccc, 360ccc–1, 360ccc–2." for "360j". Law text · (j)
• 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 informat… Law text · (gg)

2003

• Pub. L. 108–136 substituted "section 344, 355, or 360bbb–3" for "section 344 or 355". (National Defense Authorization Act for Fiscal Year 2004) Law text · (d)
• Pub. L. 108–136 inserted "360bbb–3," after "350c, 354," and substituted "360i, or 360bbb–3" for "or 360i". (National Defense Authorization Act for Fiscal Year 2004) Law text · (e)
• Pub. L. 108–173 substituted "prescription drug in violation of section 384" for "covered product in violation of section 384". (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (aa)

2002

• Pub. L. 107–188, §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". (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (e)
• Pub. L. 107–188, §306(c)(2), inserted "350c," after "350a,". (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (j)
• Pub. L. 107–188, §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 … (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (w)
• Pub. L. 107–188, §303(b), added par. (bb). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (bb)
• Pub. L. 107–188, §304(d), added par. (cc). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (cc)
• Pub. L. 107–188, §305(b), added par. (dd). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (dd)
• Pub. L. 107–188, §307(b), added par. (ee). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (ee)
• Pub. L. 107–188, §321(b)(2), added par. (ff). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (ff)
• Pub. L. 107–250 added par. (gg). (Medical Device User Fee and Modernization Act of 2002) Law text · (gg)

2000

• Pub. L. 106–387 added par. (aa). (Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2001) Law text · (aa)

1997

• Pub. L. 105–115, §125(b)(2)(B), struck out "357(d) or (g)," after "355(i) or (k),". (Food and Drug Administration Modernization Act of 1997) Law text · (e)
• Pub. L. 105–115, §125(a)(2)(C), struck out ", 356, 357," before "or 379e of this title". (Food and Drug Administration Modernization Act of 1997) Law text · (i)
• Pub. L. 105–115, §125(a)(2)(A), struck out "356, 357," before "360,". (Food and Drug Administration Modernization Act of 1997) Law text · (j)
• Pub. L. 105–115, §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 u… (Food and Drug Administration Modernization Act of 1997) Law text · (l)
• Pub. L. 105–115, §204(b), added par. (x). (Food and Drug Administration Modernization Act of 1997) Law text · (x)
• Pub. L. 105–115, §210(c), added par. (y). (Food and Drug Administration Modernization Act of 1997) Law text · (y)
• Pub. L. 105–115, §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. (Food and Drug Administration Modernization Act of 1997) Law text · (z)

1996

• Pub. L. 104–250 inserted ", 354," before "or 373 of this title" and "354," before "355(i) or (k)". Law text · (e)
• 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." (Food Quality Protection Act of 1996) Law text · (j)
• Pub. L. 104–134 redesignated par. (u) relating to introduction into interstate commerce of unsafe dietary supplement as (v) and added par. (w). (Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 1996.) Law text · (u), (v), (w)

1994

• Pub. L. 103–396, §2(b)(1)(A), substituted "357(d) or (g), 360b(a)(4)(C)," for "357(d) or (g),". · (e)
• Pub. L. 103–417 added par. (u) relating to introduction into interstate commerce of unsafe dietary supplement. · (u)
• Pub. L. 103–396, §2(b)(1)(B), added par. (u) relating to failure to comply with regulations or orders of Secretary. · (u)

1993

• Pub. L. 103–80, §3(c)(1), substituted "379, or 379e" for "379e, or 379". · (j)
• Pub. L. 103–80, §3(c)(2), substituted "350a(e)" for "350a(d)". · (s)

1992

• Pub. L. 102–571 substituted "379e" for "376". · (i), (j)
• Pub. L. 102–300 added cl. (C). · (q)

1990

• Pub. L. 101–502 substituted "or (k)" for "or (j)". · (e)
• 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 … · (j)

1988

• Pub. L. 100–293 added par. (t). · (t)

1986

• 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 s… · (s)

1980

• Pub. L. 96–359, §5(b), inserted reference to section 350a of this title in two places. · (e)
• Pub. L. 96–359, §5(c), inserted reference to section 350a of this title. · (j)
• Pub. L. 96–359, §5(a), added par. (s). · (s)

1976

• Pub. L. 94–295, §3(b)(2), inserted references to sections 360e(f) and 360i of this title. · (e)
• Pub. L. 94–295, §3(b)(3), inserted references to sections 360, 360c, 360d, 360e, 360f, 360h, 360i, 360j, and 379 of this title. · (j)
• Pub. L. 94–295, §3(b)(4), substituted "drug or device" for "drug" wherever appearing, and inserted references to sections 360e and 360j(g) of this title. · (l)
• Pub. L. 94–295, §4(b)(1), substituted "section 360(j) or 360(k) of this title," for "section 360(j) of this title,". · (p)
• Pub. L. 94–295, §3(b)(1), added par. (q). · (q)
• Pub. L. 94–295, §7(b), added par. (r). · (r)

1972

• 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. · (p)

1970

• 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. · (q)

1968

• Pub. L. 90–399, §103(1), struck out "or" before "357(d) or (g)" and inserted ", or 360b(j), (l), or (m)" after "357(d) or (g)". Amendment striking out "or" was executed as described, notwithstanding directory language that "or" before "357," be stricken out, to reflect the probable intent… · (e)
• Pub. L. 90–399, §103(2), inserted reference to section 360b of this title. · (j)
• 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 t… · (q)

1965

• Pub. L. 89–74, §9(c), designated existing provisions as subpar. (1) and added subpars. (2) and (3). · (i)
• Pub. L. 89–74, §5, added par. (q). · (q)

1962

• Pub. L. 87–781, §§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. · (e)
• Pub. L. 87–781, §104(e)(1), inserted "approval of" before "an application", and substituted "in effect" for "effective". · (l)
• Pub. L. 87–781, §114(a), added par. (o). · (o)
• Pub. L. 87–781, §304, added par. (p). · (p)

1960

• Pub. L. 86–618, §105(a), struck out references to sections 346(b), 354, and 364 of this title and inserted reference to section 376 of this title. · (i)
• Pub. L. 86–618, §104, inserted reference to section 376 of this title. · (j)

1958

• Pub. L. 85–929, inserted reference to section 348 of this title. · (j)