Notes on 21 U.S.C. § 333 : US Code - Notes

Search Notes on 21 U.S.C. § 333 : US Code - Notes

(June 25, 1938, ch. 675, Sec. 303, 52 Stat. 1043; Oct. 26, 1951,
ch. 578, Sec. 2, 65 Stat. 649; Pub. L. 86-618, title I, Sec.
105(b), July 12, 1960, 74 Stat. 403; Pub. L. 89-74, Secs. 7, 9(d),
July 15, 1965, 79 Stat. 233, 235; Pub. L. 90-639, Sec. 3, Oct. 24,
1968, 82 Stat. 1361; Pub. L. 91-513, title II, Sec. 701(b), Oct.
27, 1970, 84 Stat. 1281; Pub. L. 94-278, title V, Sec.
502(a)(2)(B), Apr. 22, 1976, 90 Stat. 411; Pub. L. 100-293, Sec.
7(b), Apr. 22, 1988, 102 Stat. 99; Pub. L. 100-690, title II, Sec.
2403, Nov. 18, 1988, 102 Stat. 4230; Pub. L. 101-629, Sec. 17(a),
Nov. 28, 1990, 104 Stat. 4526; Pub. L. 101-647, title XIX, Sec.
1904, Nov. 29, 1990, 104 Stat. 4853; Pub. L. 102-353, Sec. 3, Aug.
26, 1992, 106 Stat. 941; Pub. L. 103-80, Sec. 3(e), Aug. 13, 1993,
107 Stat. 775; Pub. L. 103-322, title XXXIII, Sec. 330015, Sept.
13, 1994, 108 Stat. 2146; Pub. L. 104-170, title IV, Sec. 407, Aug.
3, 1996, 110 Stat. 1535; Pub. L. 106-387, Sec. 1(a) [title VII,
Sec. 745(d)(2)], Oct. 28, 2000, 114 Stat. 1549, 1549A-40; Pub. L.
107-250, title II, Sec. 201(c), Oct. 26, 2002, 116 Stat. 1609; Pub.
L. 108-173, title XI, Sec. 1121(b)(2), Dec. 8, 2003, 117 Stat.
2469.)
REFERENCES IN TEXT
The Controlled Substances Act, referred to in subsec. (e)(3), is
title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as
amended, which is classified principally to subchapter I (Sec. 801
et seq.) of chapter 13 of this title. For complete classification
of this Act to the Code, see Short Title note set out under section
801 of this title and Tables.
AMENDMENTS
2003 - Subsec. (b)(6). Pub. L. 108-173, which directed amendment
of subsec. (a)(6) by substituting "prescription drug under section
384(b)" for "covered product pursuant to section 384(a)", was
executed by making the substitution in subsec. (b)(6), to reflect
the probable intent of Congress.
2002 - Subsec. (g)(1)(A). Pub. L. 107-250 inserted at end "For
purposes of the preceding sentence, a person accredited under
paragraph (2) of section 374(g) of this title who is substantially
not in compliance with the standards of accreditation under such
section, or who poses a threat to public health or fails to act in
a manner that is consistent with the purposes of such section,
shall be considered to have violated a requirement of this chapter
that relates to devices."
2000 - Subsec. (b)(6). Pub. L. 106-387 added par. (6).
1996 - Subsec. (g)(2). Pub. L. 104-170, Sec. 407(1), (2), added
par. (2). Former par. (2) redesignated (3).
Subsec. (g)(3). Pub. L. 104-170, Sec. 407(1), (3), redesignated
par. (2) as (3) and substituted "paragraph (1) or (2)" for
"paragraph (1)" in subpars. (A) and (C). Former par. (3)
redesignated (4).
Subsec. (g)(4). Pub. L. 104-170, Sec. 407(1), (4), redesignated
par. (3) as (4) and substituted "paragraph (3)(A)" for "paragraph
(2)(A)". Former par. (4) redesignated (5).
Subsec. (g)(5). Pub. L. 104-170, Sec. 407(1), (5), redesignated
par. (4) as (5) and substituted "paragraph (4)" for "paragraph (3)"
wherever appearing.
1994 - Subsec. (e). Pub. L. 103-322 amended directory language of
Pub. L. 101-647. See 1990 Amendment note below.
1993 - Subsecs. (e) to (g). Pub. L. 103-80, which directed the
amendment of this section by redesignating the second subsec. (e)
and subsec. (f) as subsecs. (f) and (g), respectively, could only
be executed by designating subsec. (f) as (g) because this section
did not contain a second subsec. (e) subsequent to amendment of
Pub. L. 101-647 by Pub. L. 103-322. See 1990 and 1994 amendment
notes for subsec. (e) under this section.
1992 - Subsec. (b)(1). Pub. L. 102-353, Sec. 3(a), amended par.
(1) generally. Prior to amendment, par. (1) read as follows:
"Notwithstanding subsection (a) of this section, any person who
violates section 331(t) of this title because of an importation of
a drug in violation of section 381(d)(1) of this title, because of
a 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, because of 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, or the distribution of drugs in
violation of section 353(e)(2)(A) of this title shall be imprisoned
for not more than 10 years or fined not more than $250,000, or
both."
Subsec. (b)(4)(A). Pub. L. 102-353, Sec. 3(b)(1), substituted
"the institution of a criminal proceeding against, and conviction
of," for "the arrest and conviction of".
Subsec. (b)(4)(B)(i). Pub. L. 102-353, Sec. 3(b)(1), (2),
substituted "before the institution of a criminal proceeding
against" for "before the arrest of" and "the institution of a
criminal proceeding against, and conviction of," for "the arrest
and conviction of".
Subsec. (b)(5). Pub. L. 102-353, Sec. 3(b)(3), substituted "the
institution of a criminal proceeding against, and conviction of,"
for "the arrest and conviction of".
Subsec. (c). Pub. L. 102-353, Sec. 3(b)(4), substituted
"subsection (a)(1) of this section" for "subsection (a) of this
section".
Subsec. (d). Pub. L. 102-353, Sec. 3(b)(4), (5), substituted
"subsection (a)(1) of this section" for "subsection (a) of this
section" and struck out ", and no person shall be subject to the
penalties of subsection (b) of this section for such a violation
unless the violation is committed with the intent to defraud or
mislead" after "advertising".
1990 - Subsec. (e). Pub. L. 101-647, as amended by Pub. L. 103-
322, amended subsec. (e) generally. Prior to amendment, subsec.
(e) read as follows:
"(e)(1) Except as provided in paragraph (2), any person who
distributes or possesses with the intent to distribute any anabolic
steroid for any use in humans other than the treatment of disease
pursuant to the order of a physician shall be imprisoned for not
more than three years or fined under title 18, or both.
"(2) Any person who distributes or possesses with the intent to
distribute to an individual under 18 years of age, any anabolic
steroid for any use in humans other than the treatment of disease
pursuant to the order of a physician shall be imprisoned for not
more than six years or fined under title 18, or both."
Subsec. (f). Pub. L. 101-629 added subsec. (f).
1988 - Subsecs. (a), (b). Pub. L. 100-293 designated existing
subsecs. (a) and (b) as pars. (1) and (2) of subsec. (a),
substituted "paragraph (1)" for "subsection (a)" in par. (2), and
added subsec. (b).
Subsec. (e). Pub. L. 100-690 added subsec. (e).
1976 - Subsec. (d). Pub. L. 94-278 added subsec. (d).
1970 - Subsec. (a). Pub. L. 91-513 struck out reference to
subsec. (b) and transferred to subsec. (b) provisions covering
second offenses and offenses committed with intent to defraud or
mislead.
Subsec. (b). Pub. L. 91-513 inserted provisions covering second
offenses and offenses committed with intent to defraud or mislead
formerly set out in subsec. (a) and struck out provisions covering
violations involving depressant and stimulant drugs. See section
801 et seq. of this title.
1968 - Subsecs. (a), (b). Pub. L. 90-639 made a general revision
in the penalties prescribed for offenses involving depressant or
stimulant drugs, set a fine of not to exceed $10,000 or
imprisonment of not more than 5 years for offenses involving the
unlawful manufacturing of, sale, or disposal of, or possession with
intent to sell, a depressant or stimulant drug or involving
counterfeit depressant or stimulant drugs, stiffened the penalties
for unlawful sales or other disposals by persons over 18 to persons
under 21, and set new penalties for possession of a depressant or
stimulant drug for purposes other than sale or other disposal.
1965 - Subsec. (a). Pub. L. 89-74, Sec. 7(a), inserted proviso
limiting the penalties for depressant or stimulant drug violations
to two years imprisonment or $5,000 fine or both for first offense
and to two years imprisonment or $15,000 fine or both for
subsequent offenses.
Subsec. (b). Pub. L. 89-74, Sec. 7(b), inserted parenthetical
exception provision.
Subsec. (c)(5). Pub. L. 89-74, Sec. 9(d), added cl. (5).
1960 - Subsec. (c)(3). Pub. L. 86-618 substituted "a color
additive" for "a coal-tar color", "the color additive" for "the
coal-tar color" and "such color additive was" for "such color was".
1951 - Subsec. (c)(4). Act Oct. 26, 1951, added cl. (4).
EFFECTIVE DATE OF 1994 AMENDMENT
Section 330015 of Pub. L. 103-322 provided that the amendment
made by that section is effective as of the date on which section
1904 of Pub. L. 101-647, which amended this section, took effect.
EFFECTIVE DATE OF 1990 AMENDMENT
Section 17(b) of Pub. L. 101-629 provided that:
"(b) Effective Date of Application to Device User Facilities. -
"(1) The Secretary of Health and Human Services shall conduct a
study to determine whether there has been substantial compliance
with the requirements of section 519(b) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 360i(b)] by device user
facilities (as defined in section 519(b)(5)(A) of such Act). The
Secretary shall report the results of the study to the Congress
after the expiration of 45 months after the date of the enactment
of this Act [Nov. 28, 1990].
"(2)(A) If upon the expiration of 48 months after the date of
the enactment of this Act [Nov. 28, 1990] the Secretary has not
made the report required by paragraph (1), section 303(f) of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 333(f)], as added
by the amendment made by subsection (a), shall take effect with
respect to device user facilities (as defined in section
519(b)(5)(A) of such Act). [Secretary of Health and Human
Services had not made the report required by par. (1) on the
expiration of 48 months after Nov. 28, 1990.]
"(B) If in the report under paragraph (1) the Secretary reports
that there has been substantial compliance with the requirements
of such section 519(b) by a type of device user facility and if
the Secretary does not make a determination under subparagraph
(C) with respect to such type of facility, such section 303(f)
shall not take effect with respect to such type of facility.
"(C) If the Secretary determines in the report under paragraph
(1) that there is not substantial compliance with the
requirements of such section 519(b) by a type of device user
facility or if the Secretary makes such a determination after
making the report under paragraph (1), such section 303(f) shall
take effect with respect to such type of facility upon the
effective date of the report."
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 1976 AMENDMENT
Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,
1976, see section 502(c) of Pub. L. 94-278, set out as a note under
section 334 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 AMENDMENT
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 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
the 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 1951 AMENDMENT
Section 3 of act Oct. 26, 1951, provided that: "The provisions of
this Act [amending this section and section 353 of this title]
shall take effect six months after the date of its enactment [Oct.
26, 1951]."
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.
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.
ENFORCEMENT
Pub. L. 99-660, title I, Sec. 103, Nov. 14, 1986, 100 Stat. 3751,
provided that: "For the fines authorized to be imposed under
section 303 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
333], see section 3623 of title 18, United States Code, for the
period ending October 31, 1986 [probably should be October 31,
1987], and sections 3559 and 3571 of such title for the period
beginning November 1, 1986 [probably should be November 1, 1987]."
(!1) So in original. Words "of this section" probably should not
appear.