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 (§ 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.

2006—Par. (41)(A)(xvii). Pub. L. 109–162, § 1180(1), substituted “13b-ethyl-17b-hydroxygon-4-en-3-one;” for “13b-ethyl-17a-hydroxygon-4-en-3-one;”.

Par. (41)(A)(xliv). Pub. L. 109–162, § 1180(2), substituted “(17a-methyl-17b-hydroxy-[5a]-androst-2-eno[3,2-c]-pyrazole);” for “(17a-methyl-17a-hydroxy-[5a]-androst-2-eno[3,2-c]-pyrazole);”.

2004—Par. (41). Pub. L. 108–358, § 2(a)(1), realigned margins, added subpar. (A), and struck out former subpar. (A) which defined “anabolic steroid”.

Par. (44). Pub. L. 108–358, § 2(a)(2), inserted “anabolic steroids,” after “marihuana,”.

2002—Pars. (43), (44). Pub. L. 107–273 repealed Pub. L. 104–294, §§ 604(b)(4), 607 (j)(2). See 1996 Amendment note below.

2000—Par. (32)(A). Pub. L. 106–172, § 5(a)(1), substituted “subparagraph (C)” for “subparagraph (B)” in introductory provisions.

Par. (32)(B), (C). Pub. L. 106–172, § 5(a)(2), (3), added subpar. (B) and redesignated former subpar. (B) as (C).

Par. (34)(X), (Y). Pub. L. 106–172, § 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, § 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, § 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, § 209(2), amended subpar. (G) generally, inserting “(or Methyl Ethyl Ketone)” before period at end.

Par. (35)(I), (J). Pub. L. 104–237, § 204(a), added subpars. (I) and (J).

Par. (39)(A)(iv)(I)(aa). Pub. L. 104–237, § 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, § 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, §§ 604(b)(4), 607 (j)(2), which provided for amendment to section identical to Pub. L. 104–237, § 401(b)(3), below, were repealed by Pub. L. 107–273, § 4002(c)(1).

Pub. L. 104–237, § 401(b)(3), redesignated par. (43), relating to felony drug offense, as (44).

Pars. (45), (46). Pub. L. 104–237, § 401(b)(4), added pars. (45) and (46).

1994—Par. (34)(V), (W). Pub. L. 103–322, § 330024(b), realigned margins and capitalized first letter.

Par. (35). Pub. L. 103–322, § 330024(d)(1), made technical correction to directory language of Pub. L. 103–200, § 2(a)(4)(B). See 1993 Amendment note below.

Par. (39)(A)(iv)(II). Pub. L. 103–322, § 330024(a), substituted “; or” for period at end.

Par. (43). Pub. L. 103–322, § 90105(d), added par. (43) defining “felony drug offense”.

1993—Par. (33). Pub. L. 103–200, § 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, § 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, § 2(a)(3), inserted “, its esters,” before “and”.

Par. (34)(O). Pub. L. 103–200, § 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, § 8(2), redesignated subpars. (Q) to (T) as (P) to (S), respectively. Former subpar. (P) redesignated (O).

Par. (34)(T). Pub. L. 103–200, § 8(2), redesignated subpar. (V) as (T). Former subpar. (T) redesignated (S).

Par. (34)(U). Pub. L. 103–200, § 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, § 8(2), (4), added subpar. (V) and redesignated former subpar. (V) as (T).

Par. (34)(W). Pub. L. 103–200, § 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, § 8(2), (3), redesignated subpar. (Y) as (X) and substituted “through (U)” for “through (X)”.

Par. (34)(Y). Pub. L. 103–200, § 8(2), redesignated subpar. (Y) as (X).

Par. (35). Pub. L. 103–200, § 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, § 2(a)(4)(B), as amended by Pub. L. 103–322, § 330024(d)(1), inserted “(other than a list I chemical)” before “specified” the first time appearing.

Par. (37). Pub. L. 103–200, § 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, § 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, §§ 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, § 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, § 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, § 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, § 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, § 2(a)(8), added pars. (42) and (43).

1990—Par. (32)(A). Pub. L. 101–647, § 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, § 2301(a), added subpars. (M) to (Y).

Par. (35)(E). Pub. L. 101–647, § 2301(b), struck out subpar. (E) “Hydriodic acid.”

Par. (41). Pub. L. 101–647, § 1902(b), added par. (41).

1988—Par. (8). Pub. L. 100–690, § 6054(1), inserted “or a listed chemical” after “a controlled substance”.

Par. (11). Pub. L. 100–690, § 6054(2), inserted “or a listed chemical” after “a controlled substance” in two places.

Pars. (33) to (40). Pub. L. 100–690, § 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, § 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, § 1003(b)(1), added par. (25). Former par. (25) redesignated (26).

Pars. (26) to (31). Pub. L. 99–570, § 1003(b)(2), redesignated pars. (25) to (30) as (26) to (31), respectively.

Par. (32). Pub. L. 99–570, § 1203, added par. (32).

1984—Pars. (14) to (16). Pub. L. 98–473, § 507(a), added par. (14) and redesignated former pars. (14) to (16) as (15) to (17), respectively.

Par. (17). Pub. L. 98–473, § 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, § 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, § 507(a), redesignated former par. (28) as (29). Former par. (29) redesignated (30).

Par. (30). Pub. L. 98–473, § 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).

“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.

Pub. L. 108–358, § 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].”

Pub. L. 107–273, div. B, title IV, § 4002(c)(1), Nov. 2, 2002, 116 Stat. 1808, provided that the amendment made by section 4002 (c)(1) is effective Oct. 11, 1996.

Pub. L. 106–310, div. B, title XXXVI, § 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].”

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.

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.”

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].”

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].”

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].”

Section 6061 of title VI of Pub. L. 100–690 provided that: “Except as otherwise provided in this subtitle, this subtitle [subtitle A (§§ 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].”

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.

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).”

Pub. L. 106–310, div. B, title XXXVI, § 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.”

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.”

Pub. L. 101–647, title XIX, § 1903, Nov. 29, 1990, 104 Stat. 4853, as amended by Pub. L. 108–358, § 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.”