Notes on 21 U.S.C. § 802 : US Code - Notes

Search Notes on 21 U.S.C. § 802 : US Code - Notes

(Pub. L. 91-513, title II, Sec. 102, Oct. 27, 1970, 84 Stat. 1242;
Pub. L. 93-281, Sec. 2, May 14, 1974, 88 Stat. 124; Pub. L. 95-633,
title I, Sec. 102(b), Nov. 10, 1978, 92 Stat. 3772; Pub. L. 96-88,
title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 96-132,
Sec. 16(a), Nov. 30, 1979, 93 Stat. 1049; Pub. L. 98-473, title II,
Sec. 507(a), (b), Oct. 12, 1984, 98 Stat. 2071; Pub. L. 98-509,
title III, Sec. 301(a), Oct. 19, 1984, 98 Stat. 2364; Pub. L. 99-
514, Sec. 2, Oct. 22, 1986, 100 Stat. 2095; Pub. L. 99-570, title
I, Secs. 1003(b), 1203, 1870, Oct. 27, 1986, 100 Stat. 3207-6, 3207-
13, 3207-56; Pub. L. 99-646, Sec. 83, Nov. 10, 1986, 100 Stat.
3619; Pub. L. 100-690, title VI, Sec. 6054, Nov. 18, 1988, 102
Stat. 4316; Pub. L. 101-647, title XIX, Sec. 1902(b), title XXIII,
Sec. 2301, title XXXV, Sec. 3599I, Nov. 29, 1990, 104 Stat. 4852,
4858, 4932; Pub. L. 103-200, Secs. 2(a), 7-9(a), Dec. 17, 1993, 107
Stat. 2333, 2340; Pub. L. 103-322, title IX, Sec. 90105(d), title
XXXIII, Sec. 330024(a), (b), (d)(1), Sept. 13, 1994, 108 Stat.
1988, 2150; Pub. L. 104-237, title II, Secs. 204(a), 209, title IV,
Sec. 401(a), (b), Oct. 3, 1996, 110 Stat. 3102, 3104, 3106, 3107;
Pub. L. 104-294, title VI, Secs. 604(b)(4), 607(j), Oct. 11, 1996,
110 Stat. 3506, 3512; Pub. L. 105-115, title I, Sec. 126(c)(3),
Nov. 21, 1997, 111 Stat. 2328; Pub. L. 106-172, Secs. 3(c), 5(a),
Feb. 18, 2000, 114 Stat. 9, 10; Pub. L. 106-310, div. B, title
XXXVI, Sec. 3622(a), Oct. 17, 2000, 114 Stat. 1231; Pub. L. 107-
273, div. B, title IV, Sec. 4002(c)(1), Nov. 2, 2002, 116 Stat.
1808; Pub. L. 108-358, Sec. 2(a), Oct. 22, 2004, 118 Stat. 1661;
Pub. L. 109-162, title XI, Sec. 1180, Jan. 5, 2006, 119 Stat.
3126.)
REFERENCES IN TEXT
This subchapter, referred to in introductory provisions and in
par. (39)(A)(iii), (v), was in the original "this title", meaning
title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as
amended, and is popularly known as the "Controlled Substances Act".
For complete classification of title II to the Code, see second
paragraph of Short Title note set out under section 801 of this
title and Tables.
Schedules I, II, III, IV, and V, referred to in pars. (6), (14),
and (32)(A), are set out in section 812(c) of this title.
Subchapter II of this chapter, referred to in par. (39)(A)(iii),
(v), was in the original "title III", meaning title III of Pub. L.
91-513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises
subchapter II of this chapter. For classification of Part B,
consisting of sections 1101 to 1105 of title III, see Tables.
The Federal Food, Drug, and Cosmetic Act, referred to in par.
(39)(A)(iv), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
amended, which is classified generally to chapter 9 (Sec. 301 et
seq.) of this title. For complete classification of this Act to the
Code, see section 301 of this title and Tables.
Section 401(d) of the Comprehensive Methamphetamine Control Act
of 1996, referred to in par. (39)(A)(iv)(I)(aa), is section 401(d)
of Pub. L. 104-237, which is set out below.
AMENDMENTS
2006 - Par. (41)(A)(xvii). Pub. L. 109-162, Sec. 1180(1),
substituted "13β-ethyl-17β-hydroxygon-4-en-3-one;" for
"13β-ethyl-17α-hydroxygon-4-en-3-one;".
Par. (41)(A)(xliv). Pub. L. 109-162, Sec. 1180(2), substituted
"(17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-
pyrazole);" for "(17α-methyl-17α-hydroxy-[5α]-
androst-2-eno[3,2-c]-pyrazole);".
2004 - Par. (41). Pub. L. 108-358, Sec. 2(a)(1), realigned
margins, added subpar. (A), and struck out former subpar. (A) which
defined "anabolic steroid".
Par. (44). Pub. L. 108-358, Sec. 2(a)(2), inserted "anabolic
steroids," after "marihuana,".
2002 - Pars. (43), (44). Pub. L. 107-273 repealed Pub. L. 104-
294, Secs. 604(b)(4), 607(j)(2). See 1996 Amendment note below.
2000 - Par. (32)(A). Pub. L. 106-172, Sec. 5(a)(1), substituted
"subparagraph (C)" for "subparagraph (B)" in introductory
provisions.
Par. (32)(B), (C). Pub. L. 106-172, Sec. 5(a)(2), (3), added
subpar. (B) and redesignated former subpar. (B) as (C).
Par. (34)(X), (Y). Pub. L. 106-172, Sec. 3(c), added subpar. (X)
and redesignated former subpar. (X) as (Y).
Par. (39)(A)(iv)(II). Pub. L. 106-310 substituted "9 grams" for
"24 grams" in two places and inserted before semicolon at end "and
sold in package sizes of not more than 3 grams of pseudoephedrine
base or 3 grams of phenylpropanolamine base".
1997 - Par. (9)(A). Pub. L. 105-115 redesignated cl. (i) as
subpar. (A) and struck out cl. (ii) which read as follows: "any
derivative of barbituric acid which has been designated by the
Secretary as habit forming under section 352(d) of this title; or".
1996 - Par. (26). Pub. L. 104-294, Sec. 607(j)(1), amended par.
(26) generally. Prior to amendment, par. (26) read as follows: "The
term 'State' means any State, territory, or possession of the
United States, the District of Columbia, the Commonwealth of Puerto
Rico, the Trust Territory of the Pacific Islands, and the Canal
Zone."
Par. (34)(P), (S), (U). Pub. L. 104-237, Sec. 209(1), substituted
"Isosafrole" for "Insosafrole" in subpar. (P), "N-Methylephedrine"
for "N-Methylepherdrine" in subpar. (S), and "Hydriodic acid" for
"Hydriotic acid" in subpar. (U).
Par. (35)(G). Pub. L. 104-237, Sec. 209(2), amended subpar. (G)
generally, inserting "(or Methyl Ethyl Ketone)" before period at
end.
Par. (35)(I), (J). Pub. L. 104-237, Sec. 204(a), added subpars.
(I) and (J).
Par. (39)(A)(iv)(I)(aa). Pub. L. 104-237, Sec. 401(a)(1), (b)(1),
substituted ", pseudoephedrine or its salts, optical isomers, or
salts of optical isomers, or phenylpropanolamine or its salts,
optical isomers, or salts of optical isomers unless otherwise
provided by regulation of the Attorney General issued pursuant to
section 814(e) of this title, except that any sale of ordinary over-
the-counter pseudoephedrine or phenylpropanolamine products by
retail distributors shall not be a regulated transaction (except as
provided in section 401(d) of the Comprehensive Methamphetamine
Control Act of 1996);" for "as the only active medicinal ingredient
or contains ephedrine or its salts, optical isomers, or salts of
optical isomers and therapeutically insignificant quantities of
another active medicinal ingredient;".
Par. (39)(A)(iv)(II). Pub. L. 104-237, Sec. 401(a)(2), (b)(2),
inserted ", pseudoephedrine, phenylpropanolamine," after
"ephedrine" and inserted before semicolon ", except that the
threshold for any sale of products containing pseudoephedrine or
phenylpropanolamine products by retail distributors or by
distributors required to submit reports by section 830(b)(3) of
this title shall be 24 grams of pseudoephedrine or 24 grams of
phenylpropanolamine in a single transaction".
Pars. (43), (44). Pub. L. 104-294, Secs. 604(b)(4), 607(j)(2),
which provided for amendment to section identical to Pub. L. 104-
237, Sec. 401(b)(3), below, were repealed by Pub. L. 107-273, Sec.
4002(c)(1).
Pub. L. 104-237, Sec. 401(b)(3), redesignated par. (43), relating
to felony drug offense, as (44).
Pars. (45), (46). Pub. L. 104-237, Sec. 401(b)(4), added pars.
(45) and (46).
1994 - Par. (34)(V), (W). Pub. L. 103-322, Sec. 330024(b),
realigned margins and capitalized first letter.
Par. (35). Pub. L. 103-322, Sec. 330024(d)(1), made technical
correction to directory language of Pub. L. 103-200, Sec.
2(a)(4)(B). See 1993 Amendment note below.
Par. (39)(A)(iv)(II). Pub. L. 103-322, Sec. 330024(a),
substituted "; or" for period at end.
Par. (43). Pub. L. 103-322, Sec. 90105(d), added par. (43)
defining "felony drug offense".
1993 - Par. (33). Pub. L. 103-200, Sec. 2(a)(1), substituted "any
list I chemical or any list II chemical" for "any listed precursor
chemical or listed essential chemical".
Par. (34). Pub. L. 103-200, Sec. 2(a)(2), substituted "list I
chemical" for "listed precursor chemical" and "important to the
manufacture" for "critical to the creation" in introductory
provisions.
Par. (34)(A), (F), (H). Pub. L. 103-200, Sec. 2(a)(3), inserted
", its esters," before "and".
Par. (34)(O). Pub. L. 103-200, Sec. 8(1), (2), redesignated
subpar. (P) as (O) and struck out former subpar. (O) which read as
follows: "D-lysergic acid."
Par. (34)(P) to (S). Pub. L. 103-200, Sec. 8(2), redesignated
subpars. (Q) to (T) as (P) to (S), respectively. Former subpar. (P)
redesignated (O).
Par. (34)(T). Pub. L. 103-200, Sec. 8(2), redesignated subpar.
(V) as (T). Former subpar. (T) redesignated (S).
Par. (34)(U). Pub. L. 103-200, Sec. 8(1), (2), redesignated
subpar. (X) as (U) and struck out former subpar. (U) which read as
follows: "N-ethylephedrine."
Par. (34)(V). Pub. L. 103-200, Sec. 8(2), (4), added subpar. (V)
and redesignated former subpar. (V) as (T).
Par. (34)(W). Pub. L. 103-200, Sec. 8(1), (4), added subpar. (W)
and struck out former subpar. (W) which read as follows: "N-
ethylpseudoephedrine."
Par. (34)(X). Pub. L. 103-200, Sec. 8(2), (3), redesignated
subpar. (Y) as (X) and substituted "through (U)" for "through (X)".
Par. (34)(Y). Pub. L. 103-200, Sec. 8(2), redesignated subpar.
(Y) as (X).
Par. (35). Pub. L. 103-200, Sec. 2(a)(4)(A), (C), substituted
"list II chemical" for "listed essential chemical" and struck out
"as a solvent, reagent, or catalyst" before "in manufacturing".
Pub. L. 103-200, Sec. 2(a)(4)(B), as amended by Pub. L. 103-322,
Sec. 330024(d)(1), inserted "(other than a list I chemical)" before
"specified" the first time appearing.
Par. (37). Pub. L. 103-200, Sec. 9(a), amended par. (37)
generally. Prior to amendment, par. (37) read as follows: "The term
'regular supplier' means, with respect to a regulated person, a
supplier with whom the regulated person has an established business
relationship that is reported to the Attorney General."
Par. (38). Pub. L. 103-200, Sec. 2(a)(5), inserted before period
at end "or who acts as a broker or trader for an international
transaction involving a listed chemical, a tableting machine, or an
encapsulating machine".
Par. (39)(A). Pub. L. 103-200, Secs. 2(a)(6)(A), 7, in
introductory provisions, substituted "importation, or exportation
of, or an international transaction involving shipment of," for
"importation or exportation of" and inserted "a listed chemical, or
if the Attorney General establishes a threshold amount for a
specific listed chemical," before "a threshold amount,".
Par. (39)(A)(iii). Pub. L. 103-200, Sec. 2(a)(6)(B), inserted "or
any category of transaction for a specific listed chemical or
chemicals" after "transaction".
Par. (39)(A)(iv). Pub. L. 103-200, Sec. 2(a)(6)(C), amended cl.
(iv) generally. Prior to amendment, cl. (iv) read as follows: "any
transaction in a listed chemical that is contained in a drug that
may be marketed or distributed lawfully in the United States under
the Federal Food, Drug, and Cosmetic Act; or".
Par. (39)(A)(v). Pub. L. 103-200, Sec. 2(a)(6)(D), inserted
before semicolon at end "which the Attorney General has by
regulation designated as exempt from the application of this
subchapter and subchapter II of this chapter based on a finding
that the mixture is formulated in such a way that it cannot be
easily used in the illicit production of a controlled substance and
that the listed chemical or chemicals contained in the mixture
cannot be readily recovered".
Par. (40). Pub. L. 103-200, Sec. 2(a)(7), substituted "list I
chemical or a list II chemical" for "listed precursor chemical or a
listed essential chemical" in two places.
Pars. (42), (43). Pub. L. 103-200, Sec. 2(a)(8), added pars. (42)
and (43).
1990 - Par. (32)(A). Pub. L. 101-647, Sec. 3599I, substituted
"the stimulant" for "the stimulent" in cl. (ii) and "a stimulant"
for "a stimulent" in cl. (iii).
Par. (34)(M) to (Y). Pub. L. 101-647, Sec. 2301(a), added
subpars. (M) to (Y).
Par. (35)(E). Pub. L. 101-647, Sec. 2301(b), struck out subpar.
(E) "Hydriodic acid."
Par. (41). Pub. L. 101-647, Sec. 1902(b), added par. (41).
1988 - Par. (8). Pub. L. 100-690, Sec. 6054(1), inserted "or a
listed chemical" after "a controlled substance".
Par. (11). Pub. L. 100-690, Sec. 6054(2), inserted "or a listed
chemical" after "a controlled substance" in two places.
Pars. (33) to (40). Pub. L. 100-690, Sec. 6054(3), added pars.
(33) to (40).
1986 - Par. (6). Pub. L. 99-514 substituted "Internal Revenue
Code of 1986" for "Internal Revenue Code of 1954".
Par. (14). Pub. L. 99-570, Sec. 1870, and Pub. L. 99-646 amended
par. (14) identically, substituting "any optical" for "the optical"
in second and third sentences.
Par. (25). Pub. L. 99-570, Sec. 1003(b)(1), added par. (25).
Former par. (25) redesignated (26).
Pars. (26) to (31). Pub. L. 99-570, Sec. 1003(b)(2), redesignated
pars. (25) to (30) as (26) to (31), respectively.
Par. (32). Pub. L. 99-570, Sec. 1203, added par. (32).
1984 - Pars. (14) to (16). Pub. L. 98-473, Sec. 507(a), added
par. (14) and redesignated former pars. (14) to (16) as (15) to
(17), respectively.
Par. (17). Pub. L. 98-473, Sec. 507, redesignated former par.
(16) as (17), and expanded and revised definition of "narcotic
drug", including within term poppy straw, cocaine, and ecgonine.
Former par. (17) redesignated (18).
Pars. (18) to (28). Pub. L. 98-473, Sec. 507(a), redesignated
former pars. (17) to (27) as (18) to (28), respectively.
Par. (29). Pub. L. 98-509 which directed the substitution of "one
hundred and eighty" for "twenty-one" in par. (28), was executed to
par. (29) in view of the redesignation of par. (28) as par. (29) by
Pub. L. 98-473.
Pub. L. 98-473, Sec. 507(a), redesignated former par. (28) as
(29). Former par. (29) redesignated (30).
Par. (30). Pub. L. 98-473, Sec. 507(a), redesignated former par.
(29) as (30).
1979 - Par. (4). Pub. L. 96-132 substituted provisions defining
"Drug Enforcement Administration" for provisions defining "Bureau
of Narcotics and Dangerous Drugs".
1978 - Par. (29). Pub. L. 95-633 added par. (29).
1974 - Pars. (27), (28). Pub. L. 93-281 added pars. (27) and
(28).
CHANGE OF NAME
"Secretary of Health and Human Services" substituted for
"Secretary of Health, Education, and Welfare" in par. (24) pursuant
to section 509(b) of Pub. L. 96-88, which is classified to section
3508(b) of Title 20, Education.
EFFECTIVE DATE OF 2004 AMENDMENT
Pub. L. 108-358, Sec. 2(d), Oct. 22, 2004, 118 Stat. 1664,
provided that: "The amendments made by this section [amending this
section, section 811 of this title, and provisions set out as a
note under this section] shall take effect 90 days after the date
of enactment of this Act [Oct. 22, 2004]."
EFFECTIVE DATE OF 2002 AMENDMENT
Pub. L. 107-273, div. B, title IV, Sec. 4002(c)(1), Nov. 2, 2002,
116 Stat. 1808, provided that the amendment made by section
4002(c)(1) is effective Oct. 11, 1996.
EFFECTIVE DATE OF 2000 AMENDMENT
Pub. L. 106-310, div. B, title XXXVI, Sec. 3622(b), Oct. 17,
2000, 114 Stat. 1231, provided that: "The amendments made by
subsection (a) [amending this section] shall take effect 1 year
after the date of the enactment of this Act [Oct. 17, 2000]."
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
EFFECTIVE DATE OF 1996 AMENDMENTS
Amendment by section 604(b)(4) of Pub. L. 104-294 effective Sept.
13, 1994, see section 604(d) of Pub. L. 104-294, set out as a note
under section 13 of Title 18, Crimes and Criminal Procedure.
Section 401(g) of Pub. L. 104-237 provided that: "Notwithstanding
any other provision of this Act [see section 1(a) of Pub. L. 104-
237, set out as a Short Title of 1996 Amendments note under
section 801 of this title], this section [amending this section and
section 814 of this title and enacting provisions set out as a note
below] shall not apply to the sale of any pseudoephedrine or
phenylpropanolamine product prior to 12 months after the date of
enactment of this Act [Oct. 3, 1996], except that, on application
of a manufacturer of a particular pseudoephedrine or
phenylpropanolamine drug product, the Attorney General may, in her
sole discretion, extend such effective date up to an additional six
months. Notwithstanding any other provision of law, the decision of
the Attorney General on such an application shall not be subject to
judicial review."
EFFECTIVE DATE OF 1994 AMENDMENT
Section 330024(f) of Pub. L. 103-322 provided that: "The
amendments made by this section [amending this section and sections
824, 960, and 971 of this title] shall take effect as of the date
that is 120 days after the date of enactment of the Domestic
Chemical Diversion Control Act of 1993 [Dec. 17, 1993]."
EFFECTIVE DATE OF 1993 AMENDMENT
Section 11 of Pub. L. 103-200 provided that: "This Act [enacting
section 814 of this title, amending this section and sections 821
to 824, 830, 843, 880, 957, 958, 960, and 971 of this title, and
enacting provisions set out as a note under section 801 of this
title] and the amendments made by this Act shall take effect on the
date that is 120 days after the date of enactment of this Act [Dec.
17, 1993]."
EFFECTIVE DATE OF 1990 AMENDMENT
Section 1902(d) of Pub. L. 101-647 provided that: "This section
[amending this section and section 812 of this title and enacting
provisions set out as a note under section 829 of this title] and
the amendment made by this section shall take effect 90 days after
the date of enactment of this Act [Nov. 29, 1990]."
EFFECTIVE DATE OF 1988 AMENDMENT
Section 6061 of title VI of Pub. L. 100-690 provided that:
"Except as otherwise provided in this subtitle, this subtitle
[subtitle A (Secs. 6051-6061) of title VI of Pub. L. 100-690,
enacting section 971 of this title, amending this section and
sections 830, 841 to 843, 872, 876, 881, 960, and 961 of this
title, and enacting provisions set out as notes under this section
and section 971 of this title] shall take effect 120 days after the
enactment of this Act [Nov. 18, 1988]."
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States
[July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
Effective Date note under section 801a of this title.
REGULATIONS
Section 301(b) of Pub. L. 98-509 provided that: "The Secretary of
Health and Human Services shall, within ninety days of the date of
the enactment of this Act [Oct. 19, 1984], promulgate regulations
for the administration of section 102(28) of the Controlled
Substances Act [21 U.S.C. 802(29)] as amended by subsection (a) and
shall include in the first report submitted under section 505(b)
[503(b)] of the Public Health Service Act [former 42 U.S.C. 290aa-
2(b)] after the expiration of such ninety days the findings of the
Secretary with respect to the effect of the amendment made by
subsection (a)."
REPORT ON DIVERSION OF ORDINARY, OVER-THE-COUNTER PSEUDOEPHEDRINE
AND PHENYLPROPANOLAMINE PRODUCTS
Pub. L. 106-310, div. B, title XXXVI, Sec. 3642, Oct. 17, 2000,
114 Stat. 1237, provided that:
"(a) Study. - The Attorney General shall conduct a study of the
use of ordinary, over-the-counter pseudoephedrine and
phenylpropanolamine products in the clandestine production of
illicit drugs. Sources of data for the study shall include the
following:
"(1) Information from Federal, State, and local clandestine
laboratory seizures and related investigations identifying the
source, type, or brand of drug products being utilized and how
they were obtained for the illicit production of methamphetamine
and amphetamine.
"(2) Information submitted voluntarily from the pharmaceutical
and retail industries involved in the manufacture, distribution,
and sale of drug products containing ephedrine, pseudoephedrine,
and phenylpropanolamine, including information on changes in the
pattern, volume, or both, of sales of ordinary, over-the-counter
pseudoephedrine and phenylpropanolamine products.
"(b) Report. -
"(1) Requirement. - Not later than 1 year after the date of the
enactment of this Act [Oct. 17, 2000], the Attorney General shall
submit to Congress a report on the study conducted under
subsection (a).
"(2) Elements. - The report shall include -
"(A) the findings of the Attorney General as a result of the
study; and
"(B) such recommendations on the need to establish additional
measures to prevent diversion of ordinary, over-the-counter
pseudoephedrine and phenylpropanolamine (such as a threshold on
ordinary, over-the-counter pseudoephedrine and
phenylpropanolamine products) as the Attorney General considers
appropriate.
"(3) Matters considered. - In preparing the report, the
Attorney General shall consider the comments and recommendations
including the comments on the Attorney General's proposed
findings and recommendations, of State and local law enforcement
and regulatory officials and of representatives of the industry
described in subsection (a)(2).
"(c) Regulation of Retail Sales. -
"(1) In general. - Notwithstanding section 401(d) of the
Comprehensive Methamphetamine Control Act of 1996 [Pub. L. 104-
237] (21 U.S.C. 802 note) and subject to paragraph (2), the
Attorney General shall establish by regulation a single-
transaction limit of not less than 24 grams of ordinary, over-
the-counter pseudoephedrine or phenylpropanolamine (as the case
may be) for retail distributors, if the Attorney General finds,
in the report under subsection (b), that -
"(A) there is a significant number of instances (as set forth
in paragraph (3)(A) of such section 401(d) for purposes of such
section) where ordinary, over-the-counter pseudoephedrine
products, phenylpropanolamine products, or both such products
that were purchased from retail distributors were widely used
in the clandestine production of illicit drugs; and
"(B) the best practical method of preventing such use is the
establishment of single-transaction limits for retail
distributors of either or both of such products.
"(2) Due process. - The Attorney General shall establish the
single-transaction limit under paragraph (1) only after notice,
comment, and an informal hearing."
REGULATION OF RETAIL SALES OF CERTAIN PRECURSOR CHEMICALS; EFFECT
ON THRESHOLDS; COMBINATION EPHEDRINE PRODUCTS
Section 401(d)-(f) of Pub. L. 104-237 provided that:
"(d) Regulation of Retail Sales. -
"(1) Pseudoephedrine. -
"(A) Limit. -
"(i) In general. - Not sooner than the effective date of
this section [see Effective Date of 1996 Amendments note
above] and subject to the requirements of clause (ii), the
Attorney General may establish by regulation a single-
transaction limit of 24 grams of pseudoephedrine base for
retail distributors. Notwithstanding any other provision of
law, the single-transaction threshold quantity for
pseudoephedrine-containing compounds may not be lowered
beyond that established in this paragraph.
"(ii) Conditions. - In order to establish a single-
transaction limit of 24 grams of pseudoephedrine base, the
Attorney General shall establish, following notice, comment,
and an informal hearing that since the date of enactment of
this Act [Oct. 3, 1996] there are a significant number of
instances where ordinary over-the-counter pseudoephedrine
products as established in paragraph (45) of section 102 of
the Controlled Substances Act (21 U.S.C. 802(45)), as added
by this Act, sold by retail distributors as established in
paragraph (46) in section 102 of the Controlled Substances
Act (21 U.S.C. 802(46)), are being widely used as a
significant source of precursor chemicals for illegal
manufacture of a controlled substance for distribution or
sale.
"(B) Violation. - Any individual or business that violates
the thresholds established in this paragraph shall, with
respect to the first such violation, receive a warning letter
from the Attorney General and, if a business, the business
shall be required to conduct mandatory education of the sales
employees of the firm with regard to the legal sales of
pseudoephedrine. For a second violation occurring within 2
years of the first violation, the business or individual shall
be subject to a civil penalty of not more than $5,000. For any
subsequent violation occurring within 2 years of the previous
violation, the business or individual shall be subject to a
civil penalty not to exceed the amount of the previous civil
penalty plus $5,000.
"(2) Phenylpropanolamine. -
"(A) Limit. -
"(i) In general. - Not sooner than the effective date of
this section and subject to the requirements of clause (ii),
the Attorney General may establish by regulation a single-
transaction limit of 24 grams of phenylpropanolamine base
for retail distributors. Notwithstanding any other provision
of law, the single-transaction threshold quantity for
phenylpropanolamine-containing compounds may not be lowered
beyond that established in this paragraph.
"(ii) Conditions. - In order to establish a single-
transaction limit of 24 grams of phenylpropanolamine base,
the Attorney General shall establish, following notice,
comment, and an informal hearing, that since the date of
enactment of this Act there are a significant number of
instances where ordinary over-the-counter phenylpropanolamine
products as established in paragraph (45) of section 102 of
the Controlled Substances Act (21 U.S.C. 802(45)), as added
by this Act, sold by retail distributors as established in
paragraph (46) in section 102 of the Controlled Substances
Act (21 U.S.C. 802(46)), are being used as a significant
source of precursor chemicals for illegal manufacture of a
controlled substance in bulk.
"(B) Violation. - Any individual or business that violates
the thresholds established in this paragraph shall, with
respect to the first such violation, receive a warning letter
from the Attorney General and, if a business, the business
shall be required to conduct mandatory education of the sales
employees of the firm with regard to the legal sales of
pseudoephedrine. For a second violation occurring within 2
years of the first violation, the business or individual shall
be subject to a civil penalty of not more than $5,000. For any
subsequent violation occurring within 2 years of the previous
violation, the business or individual shall be subject to a
civil penalty not to exceed the amount of the previous civil
penalty plus $5,000.
"(3) Significant number of instances. -
"(A) In general. - For purposes of this subsection, isolated
or infrequent use, or use in insubstantial quantities, of
ordinary over-the-counter pseudoephedrine or
phenylpropanolamine, as defined in section 102(45) of the
Controlled Substances Act, as added by section 401(b) of this
Act, and sold at the retail level for the illicit manufacture
of methamphetamine or amphetamine may not be used by the
Attorney General as the basis for establishing the conditions
under paragraph (1)(A)(ii) of this subsection, with respect to
pseudoephedrine, and paragraph (2)(A)(ii) of this subsection,
with respect to phenylpropanolamine.
"(B) Considerations and report. - The Attorney General shall -

"(i) in establishing a finding under paragraph (1)(A)(ii)
or (2)(A)(ii) of this subsection, consult with the Secretary
of Health and Human Services in order to consider the effects
on public health that would occur from the establishment of
new single transaction limits as provided in such paragraph;
and
"(ii) upon establishing a finding, transmit a report to the
Committees on the Judiciary in both, respectively, the House
of Representatives and the Senate in which the Attorney
General will provide the factual basis for establishing the
new single transaction limits.
"(4) Definition of business. - For purposes of this subsection,
the term 'business' means the entity that makes the direct sale
and does not include the parent company of a business not
involved in a direct sale regulated by this subsection.
"(5) Judicial review. - Any regulation promulgated by the
Attorney General under this section shall be subject to judicial
review pursuant to section 507 of the Controlled Substances Act
(21 U.S.C. 877).
"(e) Effect on Thresholds. - Nothing in the amendments made by
subsection (b) [amending this section] or the provisions of
subsection (d) shall affect the authority of the Attorney General
to modify thresholds (including cumulative thresholds) for retail
distributors for products other than ordinary over-the-counter
pseudoephedrine or phenylpropanolamine products (as defined in
section 102(45) of the Controlled Substances Act [21 U.S.C.
802(45)], as added by this section) or for non-retail distributors,
importers, or exporters.
"(f) Combination Ephedrine Products. -
"(1) In general. - For the purposes of this section,
combination ephedrine products shall be treated the same as
pseudoephedrine products, except that -
"(A) a single transaction limit of 24 grams shall be
effective as of the date of enactment of this Act [Oct. 3,
1996] and shall apply to sales of all combination ephedrine
products, notwithstanding the form in which those products are
packaged, made by retail distributors or distributors required
to submit a report under section 310(b)(3) of the Controlled
Substances Act [21 U.S.C. 830(b)(3)] (as added by section 402
of this Act);
"(B) for regulated transactions for combination ephedrine
products other than sales described in subparagraph (A), the
transaction limit shall be -
"(i) 1 kilogram of ephedrine base, effective on the date of
enactment of this Act; or
"(ii) a threshold other than the threshold described in
clause (i), if established by the Attorney General not
earlier than 1 year after the date of enactment of this Act;
and
"(C) the penalties provided in subsection (d)(1)(B) of this
section shall take effect on the date of enactment of this Act
for any individual or business that violates the single
transaction limit of 24 grams for combination ephedrine
products.
"(2) Definition. - For the purposes of this section, the term
'combination ephedrine product' means a drug product containing
ephedrine or its salts, optical isomers, or salts of optical
isomers and therapeutically significant quantities of another
active medicinal ingredient."
EXEMPTION FOR SUBSTANCES IN PARAGRAPH (41)
Pub. L. 101-647, title XIX, Sec. 1903, Nov. 29, 1990, 104 Stat.
4853, as amended by Pub. L. 108-358, Sec. 2(c), Oct. 22, 2004, 118
Stat. 1663, provided that:
"(a) Drugs for Treatment of Rare Diseases. - If the Attorney
General finds that a drug listed in paragraph (41) of section 102
of the Controlled Substances Act (as added by section 2 [1902] of
this Act) is -
"(1) approved by the Food and Drug Administration as an
accepted treatment for a rare disease or condition, as defined in
section 526 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bb); and
"(2) does not have a significant potential for abuse, the
Attorney General may exempt such drug from any production
regulations otherwise issued under the Controlled Substances Act
as may be necessary to ensure adequate supplies of such drug for
medical purposes.
"(b) Date of Issuance of Regulations. - The Attorney General
shall issue regulations implementing this section not later than 45
days after the date of enactment of this Act [Nov. 29, 1990],
except that the regulations required under section 3(a) [former
1903(a)] shall be issued not later than 180 days after the date of
enactment of this Act."
(!1) So in original. Probably should be "(l)".