Laws: Cases and Codes : U.S. Code : Title 21 : Section 321
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U.S. Code as of:
01/19/04
Section 321 - Notes
SOURCE
(June 25, 1938, ch. 675, Sec. 201, 52 Stat. 1040; July 22, 1954,
ch. 559, Sec. 1, 68 Stat. 511; Pub. L. 85-929, Sec. 2, Sept. 6,
1958, 72 Stat. 1784; Pub. L. 86-618, title I, Sec. 101, July 12,
1960, 74 Stat. 397; Pub. L. 87-781, title I, Sec. 102(a), title
III, Sec. 307(a), Oct. 10, 1962, 76 Stat. 781, 796; Pub. L. 89-74,
Secs. 3(a), 9(b), July 15, 1965, 79 Stat. 227, 234; Pub. L. 90-399,
Sec. 102, July 13, 1968, 82 Stat. 351; Pub. L. 90-639, Secs. 1,
4(a), Oct. 24, 1968, 82 Stat. 1361, 1362; Pub. L. 91-513, title II,
Sec. 701(a), (g), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L.
92-516, Sec. 3(3), Oct. 21, 1972, 86 Stat. 998; Pub. L. 94-278,
title V, Sec. 502(a)(2)(A), Apr. 22, 1976, 90 Stat. 411; Pub. L.
94-295, Sec. 3(a)(1)(A), (2), May 28, 1976, 90 Stat. 575; Pub. L.
95-203, Sec. 4(b)(3), Nov. 23, 1977, 91 Stat. 1453; Pub. L. 96-359,
Sec. 3, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 100-670, title I,
Sec. 107(a)(1), Nov. 16, 1988, 102 Stat. 3984; Pub. L. 101-535,
Sec. 5(b), Nov. 8, 1990, 104 Stat. 2362; Pub. L. 101-629, Sec.
16(b), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102-282, Sec. 6, May
13, 1992, 106 Stat. 161; Pub. L. 102-300, Sec. 6(a), (b), June 16,
1992, 106 Stat. 240; Pub. L. 102-571, title I, Sec. 107(1), Oct.
29, 1992, 106 Stat. 4499; Pub. L. 103-80, Secs. 3(b), (dd)(1),
4(b), Aug. 13, 1993, 107 Stat. 775, 779; Pub. L. 103-417, Secs.
3(a), (b), 10(a), Oct. 25, 1994, 108 Stat. 4327, 4332; Pub. L.
104-170, title IV, Sec. 402, Aug. 3, 1996, 110 Stat. 1513; Pub. L.
105-115, title I, Secs. 121(a), 125(b)(2)(A), (e), Nov. 21, 1997,
111 Stat. 2320, 2325, 2327; Pub. L. 105-324, Sec. 2(a), (c), Oct.
30, 1998, 112 Stat. 3035, 3037; Pub. L. 107-109, Sec. 5(b)(1), Jan.
4, 2002, 115 Stat. 1413; Pub. L. 107-250, title III, Sec. 302(d),
Oct. 26, 2002, 116 Stat. 1619.)
REFERENCES IN TEXT
The Food and Drugs Act of June 30, 1906, as amended, referred to
in par. (p)(1), and the Food and Drug Act of June 30, 1906, as
amended, referred to in par. (v)(1), is act June 30, 1906, ch.
3915, 34 Stat. 768, as amended, which was classified to subchapter
I (Sec. 1 et seq.) of chapter 1 of this title, was repealed (except
for section 14a which was transferred to section 372a of this
title) by act June 25, 1938, ch. 675, Sec. 902(a), 52 Stat. 1059,
and is covered by this chapter.
The Federal Insecticide, Fungicide, and Rodenticide Act, referred
to in par. (q)(1), is act June 25, 1947, ch. 125, as amended
generally by Pub. L. 92-516, Oct. 21, 1972, 86 Stat. 973, which is
classified generally to subchapter II (Sec. 136 et seq.) of chapter
6 of Title 7, Agriculture. For complete classification of this Act
to the Code, see Short Title note set out under section 136 of
Title 7 and Tables.
The Poultry Products Inspection Act, referred to in par. (s)(4),
is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as amended, which
is classified generally to chapter 10 (Sec. 451 et seq.) of this
title. For complete classification of this Act to the Code, see
Short Title note set out under section 451 of this title and
Tables.
The Meat Inspection Act of March 4, 1907, as amended and
extended, referred to in par. (s)(4), is act Mar. 4, 1907, ch.
2907, titles I to IV, as added Dec. 15, 1967, Pub. L. 90-201, 81
Stat. 584, which are classified generally to subchapters I to IV
(Sec. 601 et seq.) of chapter 12 of this title. For complete
classification of this Act to the Code, see Short Title note set
out under section 601 of this title and Tables.
Section 101(4) of the Food and Drug Administration Modernization
Act of 1997, referred to in par. (kk), is section 101(4) of Pub. L.
105-115, which is set out as a note under section 379g of this
title.
AMENDMENTS
2002 - Pars. (ll), (mm). Pub. L. 107-250 added pars. (ll) and
(mm).
Par. (kk). Pub. L. 107-109 added par. (kk).
1998 - Par. (q)(1). Pub. L. 105-324, Sec. 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 ingredients of such pesticide."
Par. (q)(3). Pub. L. 105-324, Sec. 2(c), substituted
"subparagraphs (1) and (2)" for "paragraphs (1) and (2)" in
introductory provisions.
1997 - Par. (aa). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out
"or 357" after "section 355(j)".
Par. (dd). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out "357,"
after "section 355,".
Par. (ff)(3)(A). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out
", certified as an antibiotic under section 357 of this title,"
before "or licensed as a biologic".
Par. (ii). Pub. L. 105-115, Sec. 121(a), added par. (ii).
Par. (jj). Pub. L. 105-115, Sec. 125(e), added par. (jj).
1996 - Par. (q). Pub. L. 104-170, Sec. 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 Federal Insecticide,
Fungicide, and Rodenticide Act as now in force or as hereafter
amended, and which is used in the production, storage, or
transportation of raw agricultural commodities."
Par. (s)(1), (2). Pub. L. 104-170, Sec. 402(b), amended subpars.
(1) and (2) generally. Prior to amendment, subpars. (1) and (2)
read as follows:
"(1) a pesticide chemical in or on a raw agricultural commodity;
or
"(2) a pesticide chemical to the extent that it is intended for
use or is used in the production, storage, or transportation of any
raw agricultural commodity; or".
Pars. (gg), (hh). Pub. L. 104-170, Sec. 402(c), added pars. (gg)
and (hh).
1994 - Par. (g)(1). Pub. L. 103-417, Sec. 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
requirements of section 343(r) of this title is not a drug under
clause (B) solely because the label or labeling contains such a
claim."
Par. (s)(6). Pub. L. 103-417, Sec. 3(b), added subpar. (6).
Par. (ff). Pub. L. 103-417, Sec. 3(a), added par. (ff).
1993 - Pars. (c), (d). Pub. L. 103-80, Sec. 3(dd)(1), substituted
"Health and Human Services" for "Agriculture".
Par. (h). Pub. L. 103-80, Sec. 4(b), amended directory language
of Pub. L. 102-300, Sec. 6(a)(1). See 1992 amendment note below.
Pars. (v) to (ff). Pub. L. 103-80, Sec. 3(b), redesignated pars.
(w) to (ff) as (v) to (ee), respectively.
1992 - Pars. (c), (d). Pub. L. 102-300, Sec. 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.
Par. (h). Pub. L. 102-300, Sec. 6(a)(1), as amended by Pub. L.
103-80, Sec. 4(b), substituted "its primary" for "any of its
principal" in two places in concluding provisions.
Par. (u). Pub. L. 102-571 substituted "379e" for "376".
Par. (y)(1). Pub. L. 102-300, Sec. 6(b)(2), struck out "of
Health, Education, and Welfare" after "employees of the
Department".
Pars. (bb) to (ee). Pub. L. 102-282 added pars. (bb) to (ee).
Par. (ff). Pub. L. 102-300, Sec. 6(a)(2), added par. (ff).
1990 - Par. (g)(1). Pub. L. 101-629, Sec. 16(b)(1), struck out ";
but does not include devices or their components, parts, or
accessories" after "clause (A), (B), or (C)".
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 the label or labeling
contains such a claim."
Par. (h)(3). Pub. L. 101-629, Sec. 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).
1988 - Par. (w)(3). 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 Secretary
declaring such drug not to be a new animal drug on the grounds that
(A) the requirement of certification of batches of such drug, as
provided for in section 360b(n) of this title, is not necessary to
insure that the objectives specified in paragraph (3) thereof are
achieved and (B) that neither subparagraph (1) nor (2) of this
paragraph (w) applies to such drug."
1980 - Par. (aa). Pub. L. 96-359 added par. (aa).
1977 - Par. (z). Pub. L. 95-203 added par. (z).
1976 - Par. (h). Pub. L. 94-295, Sec. 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 Pharmacopeia,
to the enumeration of conditions under which a device may qualify
for inclusion under this chapter, and inserted requirements that a
device be one which does not achieve any of its principal intended
purposes through chemical action within or on the body of man or
other animals and which is not dependent upon being metabolized for
the achievement of any of its principal intended purposes.
Par. (n). Pub. L. 94-278 inserted "or advertising" after
"labeling" wherever appearing.
Par. (y). Pub. L. 94-295, Sec. 3(a)(2), added par. (y).
1972 - Par. (q). Pub. L. 92-516 substituted reference to
pesticide for reference to economic poison.
1970 - Par. (a)(2). Pub. L. 91-513, Sec. 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.
Par. (v). Pub. L. 91-513, Sec. 701(a), struck out par. (v) which
defined "depressant or stimulant drug".
1968 - Par. (a)(2). Pub. L. 90-639, Sec. 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.
Par. (p). Pub. L. 90-399, Sec. 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.
Par. (s)(5). Pub. L. 90-399, Sec. 102(c), added subpar. (5).
Par. (u). Pub. L. 90-399, Sec. 102(d), inserted reference to
section 360b of this title.
Par. (v)(3). Pub. L. 90-639, Sec. 1, inserted reference to
lysergic acid diethylamide.
Pars. (w), (x). Pub. L. 90-399, Sec. 102(e), added pars. (w) and
(x).
1965 - Par. (g). Pub. L. 89-74, Sec. 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).
Par. (v). Pub. L. 89-74, Sec. 3(a), added par. (v).
1962 - Par. (a). Pub. L. 87-781, Sec. 307(a), designated existing
provisions as subpar. (2), inserted "Commonwealth of Puerto Rico
and the", and added subpar. (1).
Par. (p)(1). Pub. L. 87-781, Sec. 102(a)(1), inserted "and
effectiveness" after "to evaluate the safety", and "and effective"
after "as safe".
Par. (p)(2). Pub. L. 87-781, Sec. 102(a)(2), inserted "and
effectiveness" after "safety".
1960 - Par. (s). Pub. L. 86-618, Sec. 101(a), excluded color
additives from definition of "food additive".
Par. (t). Pub. L. 86-618, Sec. 101(c), added par. (t). Former
par. (t) redesignated (u).
Par. (u). Pub. L. 86-618, Sec. 101(b), redesignated par. (t) as
(u) and inserted reference to section 376 of this title.
1958 - Pars. (s), (t). Pub. L. 85-929 added pars. (s) and (t).
1954 - Pars. (q), (r). Act July 22, 1954, added pars. (q) and
(r).
TRANSFER OF FUNCTIONS
Secretary and Department of Health, Education, and Welfare
redesignated Secretary and Department of Health and Human Services
by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
695, which is classified to section 3508(b) of Title 20, Education.
Functions of Secretary of Health, Education, and Welfare [now
Health and Human Services] under Federal Food, Drug, and Cosmetic
Act, to the extent such functions related to administration and
enforcement of the Poison Prevention Packaging Act of 1970 (15
U.S.C. 1471 et seq.), transferred to Consumer Product Safety
Commission by section 2079 of Title 15, Commerce and Trade.
Functions of Secretary of Health, Education, and Welfare [now
Health and Human Services] under Drug Abuse Control Amendments of
1965 [see Short Title of 1965 Amendment note set out under section
301 of this title] transferred to Attorney General except function
of regulating counterfeiting of those drugs which are not
"depressant or stimulant" drugs, see section 2 of Reorg. Plan No. 1
of 1968, set out in the Appendix to Title 5, Government
Organization and Employees.
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 note set out under
section 41 of this title.
REGULATION OF TOBACCO
Section 422 of Pub. L. 105-115 provided that: "Nothing in this
Act [see Short Title of 1997 Amendment note set out under section
301 of this title] or the amendments made by this Act shall be
construed to affect the question of whether the Secretary of Health
and Human Services has any authority to regulate any tobacco
product, tobacco ingredient, or tobacco additive. Such authority,
if any, shall be exercised under the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 301 et seq.] as in effect on the day before
the date of the enactment of this Act [Nov. 21, 1997]."
DEFINITIONS
Section 2 of Pub. L. 105-115 provided that: "In this Act [see
Short Title of 1997 Amendment note set out under section 301 of
this title], the terms 'drug', 'device', 'food', and 'dietary
supplement' have the meaning given such terms in section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)."
SECTION REFERRED TO IN OTHER SECTIONS
This section is referred to in sections 343, 343-3, 346a, 346b,
350, 352, 353a, 355, 360b, 379e, 383, 802, 825, 1602 of this title;
title 7 section 136; title 15 sections 1454, 1456, 1471, 2052,
2602; title 18 section 1365; title 22 section 7201; title 35
section 156; title 42 sections 274e, 287c-11, 289g-2, 300cc-12,
1396r-8; title 49 section 5702.
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