21 U.S.C. 321: Definitions; generally

2022

• Pub. L. 117–103, §111(a)(1), inserted ", or containing nicotine from any source," after "from tobacco". Law text · (rr)
• Pub. L. 117–103, §111(a)(2), added subpar. (5). Law text · (rr)
• Pub. L. 117–328 added par. (ss). Law text · (ss)

2021

• Pub. L. 116–304 redesignated introductory provisions as subpar. (1) and former subpars. (1) to (3) as cls. (A) to (C), respectively, of subpar. (1) and added subpar. (2). Law text · (h)
• Pub. L. 117–11 substituted "soybeans, and sesame" for "and soybeans". Law text · (qq)

2016

• Pub. L. 114–255 inserted at end of concluding provisions "The term 'device' does not include software functions excluded pursuant to section 360j(o) of this title." Law text · (h)

2009

• Pub. L. 111–31 added par. (rr). Law text · (rr)

2007

• Pub. L. 110–85 substituted "paragraph (g) and section 350f of this title" for "paragraph (g)" in concluding provisions. Law text · (ff)
• 2004–Par. (u). Pub. L. 108–282, §102(b)(5)(A), substituted "360b, 360ccc" for "360b". Law text · (ff)
• Pub. L. 108–282, §102(b)(5)(B), inserted concluding provisions. Law text · (v)
• Pub. L. 108–282, §102(b)(1), added pars. (nn) to (pp). Law text · (nn)
• Pub. L. 108–282, §203(c)(1), added par. (qq). Law text · (qq)

2002

• Pub. L. 107–109 added par. (kk). Law text · (kk)
• Pub. L. 107–250 added pars. (ll) and (mm). Law text · (ll), (mm)

1998

• Pub. L. 105–324, §2(a), added subpar. (1) and struck out former subpar. (1) which read as follows: "The term 'pesticide chemical' means any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act, including all active and inert ingred… Law text · (q)
• Pub. L. 105–324, §2(c), substituted "subparagraphs (1) and (2)" for "paragraphs (1) and (2)" in introductory provisions. Law text · (q)

1997

• Pub. L. 105–115, §125(b)(2)(A), struck out "or 357" after "section 355(j)". Law text · (aa)
• Pub. L. 105–115, §125(b)(2)(A), struck out "357," after "section 355,". Law text · (dd)
• Pub. L. 105–115, §125(b)(2)(A), struck out ", certified as an antibiotic under section 357 of this title," before "or licensed as a biologic". Law text · (ff)
• Pub. L. 105–115, §121(a), added par. (ii). Law text · (ii)
• Pub. L. 105–115, §125(e), added par. (jj). Law text · (jj)

1996

• Pub. L. 104–170, §402(a), amended par. (q) generally. Prior to amendment, par. (q) read as follows: "The term 'pesticide chemical' means any substance which, alone, in chemical combination or in formulation with one or more other substances, is 'a pesticide' within the meaning of the Fede… Law text · (q)
• Pub. L. 104–170, §402(b), amended subpars. (1) and (2) generally. Prior to amendment, subpars. (1) and (2) read as follows: Law text · (s), (2)
• Pub. L. 104–170, §402(c), added pars. (gg) and (hh). Law text · (gg), (hh)

1994

• Pub. L. 103–417, §10(a), amended last sentence generally. Prior to amendment, last sentence read as follows: "A food for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the r… · (g)
• Pub. L. 103–417, §3(b), added subpar. (6). · (s)
• Pub. L. 103–417, §3(a), added par. (ff). · (ff)

1993

• Pub. L. 103–80, §3(dd)(1), substituted "Health and Human Services" for "Agriculture". · (c), (d)
• Pub. L. 103–80, §4(b), amended directory language of Pub. L. 102–300, §6(a)(1). See 1992 amendment note below. · (h)
• Pub. L. 103–80, §3(b), redesignated pars. (w) to (ff) as (v) to (ee), respectively. · (v)

1992

• Pub. L. 102–300, §6(b)(1), which directed the substitution of "Health and Human Services" for "Health, Education, and Welfare", could not be executed because such words did not appear in the original statutory text. See 1993 Amendment note above and Transfer of Functions notes below. · (c), (d)
• Pub. L. 102–300, §6(a)(1), as amended by Pub. L. 103–80, §4(b), substituted "its primary" for "any of its principal" in two places in concluding provisions. · (h)
• Pub. L. 102–571 substituted "379e" for "376". · (u)
• Pub. L. 102–300, §6(b)(2), struck out "of Health, Education, and Welfare" after "employees of the Department". · (y)
• Pub. L. 102–282 added pars. (bb) to (ee). · (bb)
• Pub. L. 102–300, §6(a)(2), added par. (ff). · (ff)

1990

• Pub. L. 101–629, §16(b)(1), struck out "; but does not include devices or their components, parts, or accessories" after "clause (A), (B), or (C)". · (g)
• Pub. L. 101–535 inserted at end "A food for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug under clause (B) solely because … · (g)
• Pub. L. 101–629, §16(b)(2), which directed the amendment of subpar. (3) by substituting "its primary" for "any of its principal", could not be executed because "any of its principal" did not appear in subpar. (3). · (h)

1988

• Pub. L. 100–670 struck out subpar. (3) which read as follows: "which drug is composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, or any derivative thereof, except when there is in effect a published order of the Secretar… · (w)

1980

• Pub. L. 96–359 added par. (aa). · (aa)

1977

• Pub. L. 95–203 added par. (z). · (z)

1976

• Pub. L. 94–295, §3(a)(1)(A), expanded definition of "device" to include implements, machines, implants, in vitro reagents, and other similar or related articles, added recognition in the National Formulary or the United States Pharmacopeia, or any supplement to the Formulary or Pharmacope… · (h)
• Pub. L. 94–278 inserted "or advertising" after "labeling" wherever appearing. · (n)
• Pub. L. 94–295, §3(a)(2), added par. (y). · (y)

1972

• Pub. L. 92–516 substituted reference to pesticide for reference to economic poison. · (q)

1970

• Pub. L. 91–513, §701(g), struck out reference to sections 321, 331(i), 331(p), 331(q), 332, 333, 334, 337, 360, 360a, 372, 373, 374, and 375 of this title as they apply to depressant or stimulant drugs. · (a)
• Pub. L. 91–513, §701(a), struck out par. (v) which defined "depressant or stimulant drug". · (v)

1968

• Pub. L. 90–639, §4(a), extended provisions to cover depressant and stimulant drugs, the containers thereof, and equipment used in manufacturing, compounding, or processing such drugs, to the Canal Zone. · (a)
• Pub. L. 90–399, §102(a), (b), inserted "(except a new animal drug or an animal feed bearing or containing a new animal drug)" after "Any drug" in subpars. (1) and (2), respectively. · (p)
• Pub. L. 90–399, §102(c), added subpar. (5). · (s)
• Pub. L. 90–399, §102(d), inserted reference to section 360b of this title. · (u)
• Pub. L. 90–639, §1, inserted reference to lysergic acid diethylamide. · (v)
• Pub. L. 90–399, §102(e), added pars. (w) and (x). · (w), (x)

1965

• Pub. L. 89–74, §9(b), designated existing provisions as subpar. (1), redesignated cls. (1) to (4) thereof as (A) to (D), substituted "(A), (B), or (C)" for "(1), (2), or (3)" and added subpar. (2). · (g)
• Pub. L. 89–74, §3(a), added par. (v). · (v)

1962

• Pub. L. 87–781, §307(a), designated existing provisions as subpar. (2), inserted "Commonwealth of Puerto Rico and the", and added subpar. (1). · (a)
• Pub. L. 87–781, §102(a)(1), inserted "and effectiveness" after "to evaluate the safety", and "and effective" after "as safe". · (p)
• Pub. L. 87–781, §102(a)(2), inserted "and effectiveness" after "safety". · (p)

1960

• Pub. L. 86–618, §101(a), excluded color additives from definition of "food additive". · (s)
• Pub. L. 86–618, §101(c), added par. (t). Former par. (t) redesignated (u). · (t)
• Pub. L. 86–618, §101(b), redesignated par. (t) as (u) and inserted reference to section 376 of this title. · (u)

1958

• Pub. L. 85–929 added pars. (s) and (t). · (s), (t)