§ 301. — Short title.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 21USC301]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER I--SHORT TITLE
Sec. 301. Short title
This chapter may be cited as the Federal Food, Drug, and Cosmetic
Act.
(June 25, 1938, ch. 675, Sec. 1, 52 Stat. 1040.)
Effective Date; Postponement in Certain Cases
Act June 23, 1939, ch. 242, Secs. 1, 2, 53 Stat. 853, 854, provided
that:
``[Sec. 1] (a) The effective date of the following provisions of the
Federal Food, Drug, and Cosmetic Act is hereby postponed until January
1, 1940: Sections 402(c) [342(c) of this title]; 403(e)(1) [343(e)(1) of
this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k) of this
title]; 501(a), (4) [351(a)(4) of this title]; 502(b), (d), (e), (f),
(g), and (h) [352(b), (d) to (h) of this title]; 601(e) [361(e) of this
title]; and 602(b) [362(b) of this title].
``(b) The Secretary of Agriculture shall promulgate regulations
further postponing to July 1, 1940 the effective date of the provisions
of sections 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j),
and (k) [343(g) to (k)]; 502(b), (d), (e), (f), (g), and (h) [352(b),
(d) to (h) of this title]; and 602(b) [362(b) of this title] of such Act
with respect to lithographed labeling which was manufactured prior to
February 1, 1939, and to containers bearing labeling which, prior to
February 1, 1939, was lithographed, etched, stamped, pressed, printed,
fused or blown on or in such containers, where compliance with such
provisions would be unduly burdensome by reason of causing the loss of
valuable stocks of such labeling or containers, and where such
postponement would not prevent the public interest being adequately
served: Provided, That in no case shall such regulations apply to
labeling which would not have complied with the requirements of the Food
and Drugs Act of June 30, 1906, as amended.
``Sec. 2. (a) The provisions of section 8 [section 10 of this
title], paragraph fifth, under the heading `In the case of food:', of
the Food and Drugs Act of June 30, 1906, as amended, and regulations
promulgated thereunder, and all other provisions of such Act to the
extent that they may relate to the enforcement of such section 8
[section 10 of this title] and of such regulations, shall remain in
force until January 1, 1940.
``(b) The provisions of such Act of June 30, 1906, as amended,
[sections 1 to 5, 7 to 15, and 372a of this title] to the extent that
they impose, or authorize the imposition of, any requirement imposed by
section 403(k) of the Federal Food, Drug, and Cosmetic Act [section
343(k) of this title], shall remain in force until January 1, 1940.
``(c) Notwithstanding the provisions of section 1 of this Act, such
section shall not apply--
``(1) to the provisions of section 502(d) and (e) of the Federal
Food, Drug, and Cosmetic Act [352(d), (e) of this title], insofar as
such provisions relate to any substance named in section 8 [section
10 of this title], paragraph second, under the heading `In the case
of drugs:', of the Food and Drugs Act of June 30, 1906, as amended,
or a derivative of any such substance; or
``(2) to the provisions of section 502(b), (d), (e), (f), (g),
and (h) of the Federal Food, Drug, and Cosmetic Act [352(b), (d) to
(h) of this title], insofar as such provisions relate to drugs to
which section 505 [355 of this title] of such Act applies.''
Effective Date
Section 902(a) of act June 25, 1938, provided that: ``This Act
[enacting this chapter and repealing sections 1 to 5 and 7 to 15 of this
title], shall take effect twelve months after the date of its enactment
[June 25, 1938]. The Federal Food and Drugs Act of June 30, 1906, as
amended (U.S.C., 1934 ed., title 21, secs. 1-15), shall remain in force
until such effective date, and, except as otherwise provided in this
subsection, is hereby repealed effective upon such date: Provided, That
the provisions of section 701 [section 371 of this title] shall become
effective on the enactment of this Act, and thereafter the Secretary is
authorized hereby to (1) conduct hearings and to promulgate regulations
which shall become effective on or after the effective date of this Act
as the Secretary shall direct, and (2) designate prior to the effective
date of this Act food having common or usual names and exempt such food
from the requirements of clause (2) of section 403(i) [section 343(i) of
this title] for a reasonable time to permit the formulation,
promulgation, and effective application of definitions and standards of
identity therefor as provided by section 401 [section 341 of this
title]: Provided further, That sections 502(j), 505, and 601(a)
[sections 352(j), 355, 361(a), respectively of this title], and all
other provisions of this Act to the extent that they may relate to the
enforcement of such sections, shall take effect on the date of the
enactment of this Act, except that in the case of a cosmetic to which
the proviso of section 601(a) [section 361(a) of this title], relates,
such cosmetic shall not, prior to the ninetieth day after such date of
enactment, be deemed adulterated by reason of the failure of its label
to bear the legend prescribed in such proviso: Provided further, That
the Act of March 4, 1923 (U.S.C., 1934 ed., title 21, sec. 6 [section
321a of this title]; 42 Stat. 1500, ch. 268), defining butter and
providing a standard therefor; the Act of July 24, 1919 (U.S.C., 1934
ed., title 21, sec. 10 [section 321b of this title]; 41 Stat. 271, ch.
26], defining wrapped meats as in package form; and the amendment to the
Food and Drugs Act, section 10A, approved August 27, 1935 (U.S.C. 1934
ed., Sup. III, title 21, sec. 14a [section 372a of this title]) shall
remain in force and effect and be applicable to the provisions of this
Act.''
Hazardous Substances
Federal Hazardous Substances Act as not modifying this chapter, see
Pub. L. 86-613, Sec. 18, July 12, 1960, 74 Stat. 380, set out as an
Effect Upon Federal and State Laws note under section 1261 of Title 15,
Commerce and Trade.
Short Title of 2002 Amendments
Pub. L. 107-281, Sec. 1, Nov. 6, 2002, 116 Stat. 1992, provided
that: ``This Act [amending sections 360cc and 360ee of this title and
enacting provisions set out as a note under section 360ee of this title]
may be cited as the `Rare Diseases Orphan Product Development Act of
2002'.''
Pub. L. 107-250, Sec. 1(a), Oct. 26, 2002, 116 Stat. 1588, provided
that: ``This Act [enacting sections 379i and 379j of this title and
section 289g-3 of Title 42, The Public Health and Welfare, amending
sections 321, 331, 333, 335a, 352, 353, 360, 360c, 360e, 360m, and 374
of this title, and enacting provisions set out as notes under sections
352, 360e, 360j, 360l, 379i, and 379j of this title and section 289g-3
of Title 42] may be cited as the `Medical Device User Fee and
Modernization Act of 2002'.''
Pub. L. 107-188, title V, Sec. 501, June 12, 2002, 116 Stat. 687,
provided that: ``This subtitle [subtitle A (Secs. 501-509) of title V of
Pub. L. 107-188, amending sections 356b, 379g, and 379h of this title
and enacting provisions set out as notes under sections 356b and 379g of
this title] may be cited as the `Prescription Drug User Fee Amendments
of 2002'.''
Pub. L. 107-109, Sec. 1, Jan. 4, 2002, 115 Stat. 1408, provided
that: ``This Act [enacting sections 355b and 393a of this title and
section 284m of Title 42, The Public Health and Welfare, amending
sections 321, 355, 355a, and 379h of this title and sections 282, 284k,
284l, 285a-2, and 290b of Title 42, and enacting provisions set out as
notes under sections 355 and 355a of this title and sections 284m and
289 of Title 42] may be cited as the `Best Pharmaceuticals for Children
Act'.''
Short Title of 2000 Amendment
Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 745(a)], Oct. 28, 2000,
114 Stat. 1549, 1549A-35, provided that: ``This section [enacting
section 384 of this title, amending sections 331, 333, and 381 of this
title, and enacting provisions set out as a note under section 384 of
this title] may be cited as the `Medicine Equity and Drug Safety Act of
2000'.''
Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 746(a)], Oct. 28, 2000,
114 Stat. 1549, 1549A-40, provided that: ``This section [amending
section 381 of this title and enacting provisions set out as a note
under section 381 of this title] may be cited as the `Prescription Drug
Import Fairness Act of 2000'.''
Short Title of 1998 Amendment
Pub. L. 105-324, Sec. 1, Oct. 30, 1998, 112 Stat. 3035, provided
that: ``This Act [amending sections 321 and 346a of this title] may be
cited as the `Antimicrobial Regulation Technical Corrections Act of
1998'.''
Short Title of 1997 Amendment
Pub. L. 105-115, Sec. 1(a), Nov. 21, 1997, 111 Stat. 2296, provided
that: ``This Act [enacting sections 343-3, 353a, 355a, 356 to 356c,
360m, 360aaa to 360aaa-6, 360bbb to 360bbb-2, 379k, 379l, 379o, 379r,
379s, 379v, 396, and 397 of this title and sections 247b-8 and 299a-3 of
Title 42, The Public Health and Welfare, amending sections 321, 331,
334, 335a, 343, 348, 351 to 353, 355, 360, 360b to 360e, 360g, 360i,
360j, 360l, 360aa to 360cc, 360ee, 371, 374, 379a, 379g, 379h, 381 to
383, 393, and 802 of this title, section 45C of Title 26, Internal
Revenue Code, section 156 of Title 35, Patents, section 8126 of Title
38, Veterans' Benefits, and sections 262, 263a, and 282 of Title 42,
repealing sections 356 and 357 of this title, and enacting provisions
set out as notes under sections 321, 348, 351, 352, 353a, 355 to 356b,
360i, 360l, 360m, 360aaa, 371, 379g, 379h, 379k, and 393 of this title
and sections 247b-8 and 282 of Title 42] may be cited as the `Food and
Drug Administration Modernization Act of 1997'.''
Short Title of 1996 Amendments
Pub. L. 104-250, Sec. 1(a), Oct. 9, 1996, 110 Stat. 3151, provided
that: ``This Act [enacting section 354 of this title, amending sections
331, 353, and 360b of this title, and enacting provisions set out as
notes under section 360b of this title] may be cited as the `Animal Drug
Availability Act of 1996'.''
Pub. L. 104-170, title IV, Sec. 401(a), Aug. 3, 1996, 110 Stat.
1513, provided that: ``This title [amending sections 321, 331, 333, 342,
and 346a of this title] may be cited as the `Food Quality Protection Act
of 1996'.''
[Another ``Food Quality Protection Act of 1996'', was enacted by
Pub. L. 104-170, Sec. 1, 110 Stat. 1489, which is set out as a note
under section 136 of Title 7, Agriculture.]
Pub. L. 104-134, title II, Sec. 2101(a), Apr. 26, 1996, 110 Stat.
1321-313, provided that: ``This chapter [chapter 1A (Secs. 2101-2105) of
title II of Pub. L. 104-134, enacting section 382 of this title and
amending sections 331 and 381 of this title and section 262 of Title 42,
The Public Health and Welfare] may be cited as the `FDA Export Reform
and Enhancement Act of 1996'.''
Short Title of 1994 Amendments
Pub. L. 103-417, Sec. 1(a), Oct. 25, 1994, 108 Stat. 4325, provided
that: ``This Act [enacting sections 343-2 and 350b of this title and
section 287c-11 of Title 42, The Public Health and Welfare, amending
sections 321, 331, 342, 343, and 350 of this title and section 281 of
Title 42, and enacting provisions set out as notes under sections 321
and 343 of this title] may be cited as the `Dietary Supplement Health
and Education Act of 1994'.''
Pub. L. 103-396, Sec. 1, Oct. 22, 1994, 108 Stat. 4153, provided
that: ``This Act [amending sections 331, 343-1, 360b, and 371 of this
title and enacting provisions set out as notes under section 360b of
this title] may be cited as the `Animal Medicinal Drug Use Clarification
Act of 1994'.''
Short Title of 1993 Amendment
Pub. L. 103-80, Sec. 1, Aug. 13, 1993, 107 Stat. 773, provided that:
``This Act [amending sections 321, 331 to 333, 334, 335b, 341 to 343,
346a, 350a, 352, 355 to 358, 360b to 360e, 360i, 360cc, 360hh to 360ss,
361, 371, 372, 373, 374, 376, 379e, and 381 of this title and section
263b of Title 42, The Public Health and Welfare, and enacting provisions
set out as a note under section 343 of this title] may be cited as the
`Nutrition Labeling and Education Act Amendments of 1993'.''
Short Title of 1992 Amendments
Pub. L. 102-571, title I, Sec. 101(a), Oct. 29, 1992, 106 Stat.
4491, provided that: ``This title [enacting sections 379g and 379h of
this title, transferring sections 372a, 376, and 379c of this title to
sections 376, 379e and 379f, respectively, of this title, amending
sections 321, 331, 342, 343, 346a, 351, 352, 360j, 361, 362, 453, 601,
and 1033 of this title, enacting provisions set out as notes under
section 379g of this title, and amending provisions set out as notes
under sections 343 and 343-1 of this title] may be cited as the
`Prescription Drug User Fee Act of 1992'.''
Pub. L. 102-571, title II, Sec. 201, Oct. 29, 1992, 106 Stat. 4500,
provided that: ``This title [enacting provisions set out as notes under
sections 343 and 393 of this title and amending provisions set out as
notes under sections 343 and 343-1 of this title] may be cited as the
`Dietary Supplement Act of 1992'.''
Pub. L. 102-353, Sec. 1(a), Aug. 26, 1992, 106 Stat. 941, provided
that: ``This Act [amending sections 333, 353, and 381 of this title and
enacting provisions set out as a note under section 353 of this title]
may be cited as the `Prescription Drug Amendments of 1992'.''
Pub. L. 102-300, Sec. 1(a), June 16, 1992, 106 Stat. 238, provided
that: ``This Act [amending sections 321, 331, 334, 346a, 352, 353, 356,
357, 360c, 360d, 360g to 360i, 360l, 360mm, 371 to 372a, 376, and 381 of
this title and section 262 of Title 42, The Public Health and Welfare
and enacting and amending provisions set out as notes under section 360i
of this title] may be cited as the `Medical Device Amendments of
1992'.''
Pub. L. 102-282, Sec. 1(a), May 13, 1992, 106 Stat. 149, provided
that: ``This Act [enacting sections 335a to 335c of this title, amending
sections 321, 336, 337, and 355 of this title, and enacting provisions
set out as notes under section 335a of this title] may be cited as the
`Generic Drug Enforcement Act of 1992'.''
Short Title of 1990 Amendments
Pub. L. 101-635, Sec. 1(a), Nov. 28, 1990, 104 Stat. 4583, provided
that: ``This Act [enacting sections 379b to 379d and 394 of this title]
may be cited as the `Food and Drug Administration Revitalization Act'.''
Pub. L. 101-629, Sec. 1(a), Nov. 28, 1990, 104 Stat. 4511, provided
that: ``This Act [enacting sections 360l and 383 of this title, amending
sections 321, 333, 351, 353, and 360c to 360j of this title and sections
263b to 263n of Title 42, The Public Health and Welfare, redesignating
sections 263b to 263n of Title 42 as sections 360gg to 360ss of this
title, repealing section 263b of Title 42, and enacting provisions set
out as notes under sections 333, 360c, 360i, 360j, 360hh and 383 of this
title] may be cited as the `Safe Medical Devices Act of 1990'.''
Pub. L. 101-535, Sec. 1(a), Nov. 8, 1990, 104 Stat. 2353, provided
that: ``This Act [enacting section 343-1 of this title, amending
sections 321, 337, 343, 345, and 371 of this title, and enacting
provisions set out as notes under sections 343 and 343-1 of this title]
may be cited as the `Nutrition Labeling and Education Act of 1990'.''
Short Title of 1988 Amendments
Pub. L. 100-670, Sec. 1(a), Nov. 16, 1988, 102 Stat. 3971, provided
that: ``This Act [amending sections 321, 353, and 360b of this title,
section 2201 of Title 28, Judiciary and Judicial Procedure, and sections
156 and 271 of Title 35, Patents, and enacting provisions set out as
notes under section 360b of this title] may be cited as the `Generic
Animal Drug and Patent Term Restoration Act'.''
Pub. L. 100-607, title V, Sec. 501, Nov. 4, 1988, 102 Stat. 3120,
provided that: ``This title [enacting section 393 of this title,
amending sections 5315 and 5316 of Title 5, Government Organization and
Employees, and enacting provisions set out as notes under section 393 of
this title] may be cited as the `Food and Drug Administration Act of
1988'.''
Pub. L. 100-293, Sec. 1(a), Apr. 22, 1988, 102 Stat. 95, provided
that: ``This Act [amending sections 331, 333, 353, and 381 of this title
and enacting provisions set out as notes under section 353 of this
title] may be cited as the `Prescription Drug Marketing Act of 1987'.''
Pub. L. 100-290, Sec. 1, Apr. 18, 1988, 102 Stat. 90, provided that:
``This Act [amending sections 360bb and 360ee of this title, enacting
provisions set out as a note under section 360aa of this title, and
amending provisions set out as a note under section 236 of Title 42, The
Public Health and Welfare] may be cited as the `Orphan Drug Amendments
of 1988'.''
Short Title of 1986 Amendment
Pub. L. 99-660, title I, Sec. 101(a), Nov. 14, 1986, 100 Stat. 3743,
provided that: ``This title [enacting section 382 of this title,
amending sections 241 and 262 of Title 42, The Public Health and
Welfare, and enacting provisions set out as notes under section 333 of
this title and section 262 of Title 42] may be cited as the `Drug Export
Amendments Act of 1986'.''
Short Title of 1985 Amendment
Pub. L. 99-91, Sec. 1, Aug. 15, 1985, 99 Stat. 387, provided that:
``This Act [amending sections 360aa to 360cc, and 360ee of this title,
and sections 295g-1 and 6022 of Title 42, The Public Health and Welfare,
and enacting provisions set out as notes under section 360aa of this
title and section 236 of Title 42] may be cited as the `Orphan Drug
Amendments of 1985'.''
Short Title of 1984 Amendment
Pub. L. 98-417, Sec. 1, Sept. 24, 1984, 98 Stat. 1585, provided:
``That this Act [enacting section 156 of Title 35, Patents, amending
sections 355 and 360cc of this title, sections 68b, 68c, and 70b of
Title 15, Commerce and Trade, section 2201 of Title 28, Judiciary and
Judicial Procedure, and sections 271 and 282 of Title 35, and enacting
provisions set out as notes under section 355 of this title and section
68b of Title 15] may be cited as the `Drug Price Competition and Patent
Term Restoration Act of 1984'.''
Short Title of 1983 Amendments
Pub. L. 98-22, Sec. 1, Apr. 22, 1983, 97 Stat. 173, provided: ``That
this Act [amending provisions set out as a note under section 348 of
this title] may be cited as the `Saccharin Study and Labeling Act
Amendment of 1983'.''
Pub. L. 97-414, Sec. 1(a), Jan. 4, 1983, 96 Stat. 2049, provided
that: ``This Act [enacting part B of subchapter V of chapter 9 of this
title, section 44H of Title 26, Internal Revenue Code, section 155 of
Title 35, Patents, and sections 236, 255, and 298b-4 of Title 42, The
Public Health and Welfare, amending sections 1274, 1472, 2055, 2060,
2064, 2068, and 2080 of Title 15, Commerce and Trade, section 904 of
this title, sections 280C and 6096 of Title 26, and sections 209, 231,
242k, 242m, 243, 254c, 254j, 254m, 254o, 254p, 256, 294j, 295g-1, 295g-
4, 295h, 295h-1a, 297-1, 300, 300a-1, 300a-3, 300b, 300e-1, 300m, 300n-
5, 300q-2, 300u-5, 300w-3, 300x-1, 300x-4, 300y-11, 4577, and 4588 of
Title 42, enacting provisions set out as notes under section 360aa of
this title, section 44H of Title 26, and sections 241, 255, 287i, and
300x-1 of Title 42, and repealing provisions set out as a note under
section 300t-11 of Title 42] may be cited as the `Orphan Drug Act'.''
Short Title of 1981 Amendment
Pub. L. 97-42, Sec. 1, Aug. 14, 1981, 95 Stat. 946, provided: ``That
this Act [amending provisions set out as a note under section 348 of
this title] may be cited as the `Saccharin Study and Labeling Act
Amendment of 1981'.''
Short Title of 1980 Amendment
Pub. L. 96-359, Sec. 1, Sept. 26, 1980, 94 Stat. 1190, provided:
``That this Act [enacting section 350a of this title, amending sections
321, 331, 374, 830, 841 to 843, and 873 of this title, and enacting a
provision set out as a note under section 350a of this title] may be
cited as the `Infant Formula Act of 1980'.''
Short Title of 1977 Amendment
Pub. L. 95-203, Sec. 1, Nov. 23, 1977, 91 Stat. 1451, provided that:
``This Act [enacting section 343a of this title, amending sections 321
and 343 of this title, enacting provisions set out as notes under
sections 343 and 348 of this title, and amending provisions set out as
notes under sections 218 and 289l-1 of Title 42, The Public Health and
Welfare] may be cited as the `Saccharin Study and Labeling Act'.''
Short Title of 1976 Amendment
Pub. L. 94-295, Sec. 1(a), May 28, 1976, 90 Stat. 539, provided
that: ``This Act [enacting sections 360c to 360k, 379, and 379a of this
title and section 3512 of Title 42, The Public Health and Welfare, and
amending sections 321, 331, 334, 351, 352, 358, 360, 374, 379e, and 381
of this title and section 55 of Title 15, Commerce and Trade] may be
cited as the `Medical Device Amendments of 1976'.''
Short Title of 1972 Amendment
Pub. L. 92-387, Sec. 1, Aug. 16, 1972, 86 Stat. 559, provided that:
``This Act [amending sections 331, 335, and 360 of this title and
enacting provisions set out as notes under section 360 of this title]
may be cited as the `Drug Listing Act of 1972'.''
Short Title of 1968 Amendments
Pub. L. 90-602, Sec. 1, Oct. 18, 1968, 82 Stat. 1173, provided that:
``This Act [enacting provisions now comprising part C (Secs. 360hh-
360ss) of subchapter III of this chapter and provisions set out as notes
under section 360hh of this title] may be cited as the `Radiation
Control for Health and Safety Act of 1968'.''
Pub. L. 90-399, Sec. 1, July 13, 1968, 82 Stat. 342, provided:
``That this Act [enacting section 360b of this title, amending sections
321, 331, 342, 351, 352, 357, 381, and 392 of this title, and enacting
provisions set out as a note under section 360b of this title] may be
cited as the `Animal Drug Amendments of 1968'.''
Short Title of 1965 Amendment
Pub. L. 89-74, Sec. 1, July 15, 1965, 79 Stat. 226, provided: ``That
this Act [amending sections 321, 331, 333, 334, 360, and 372 of this
title and section 1114 of Title 18, Crimes and Criminal Procedure, and
enacting provisions set out as notes under sections 321 and 352 of this
title] may be cited as the `Drug Abuse Control Amendments of 1965'.''
Short Title of 1962 Amendment
Pub. L. 87-781, Sec. 1, Oct. 10, 1962, 76 Stat. 780, provided in
part that such Act [enacting sections 358 to 360 of this title, amending
sections 321, 331, 332, 348, 351 to 353, 355, 357, 372, 374, 379e, and
381 of this title, and enacting provisions set out as notes under
sections 321, 331, 332, 352, 355, 358, 360, and 374 of this title] may
be cited as the `Drug Amendments of 1962'.''
Short Title of 1960 Amendment
Pub. L. 86-618, Sec. 1, July 12, 1960, 74 Stat. 397, provided:
``That this Act [amending sections 321, 331, 333, 342, 346, 351, 352,
361, 362, 371, and 379e of this title, repealing sections 354 and 364 of
this title, and enacting notes set out under this section] may be cited
as the `Color Additive Amendments of 1960'.''
Short Title of 1958 Amendment
Pub. L. 85-929, Sec. 1, Sept. 6, 1958, 72 Stat. 1784, provided:
``That this Act [amending sections 321, 331, 342, 346, 348 of this title
and section 210 of Title 42, The Public Health and Welfare, and enacting
provisions set out as notes under sections 321, 342, and 451 of this
title] may be cited as the `Food Additives Amendment of 1958'.''
