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from the application of this title and title III 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; and (B) a distribution, importation, or exportation of a tableting machine or encapsulating machine.

(40) The term "chemical mixture" means a combination of two or more chemical substances, at least one of which is not a list I chemical or a list II chemical, except that such term does not include any combination of a list I chemical or a list II chemical with another chemical that is present solely as an impurity.

(41)

(A) 1, 2 The term "anabolic steroid" means any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone), and includes(i) androstanediol

(I) 3ẞ,17ẞ-dihydroxy-5α-androstane; and
(II) 3a,17ẞ-dihydroxy-5a-androstane;

(ii) androstanedione (5a-androstan-3,17-dione);
(iii) androstenediol-

(I) 1-androstenediol (3ẞ,17ẞ-dihydroxy-5α-androst-1ene);

ene);

(II) 1-androstenediol (3a,17ẞ-dihydroxy-5α-androst-1

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(I) 1-androstenedione ([5a]-androst-1-en-3,17-dione);
(II) 4-androstenedione (androst-4-en-3,17-dione); and
(III) 5-androstenedione (androst-5-en-3,17-dione);

(v) bolasterone (7a,17a-dimethyl-17ẞ-hydroxyandrost-4-en3-one);

(vi) boldenone (17ẞ-hydroxyandrost-1,4,-diene-3-one); (vii) calusterone (7ẞ,17a-dimethyl-17ẞ-hydroxyandrost-4en-3-one);

(viii) clostebol (4-chloro-17ẞ-hydroxyandrost-4-en-3-one); (ix) dehydrochloromethyltestosterone

hydroxy-17a-methyl-androst-1,4-dien-3-one);

(4-chloro-17ẞ

(x) ▲ 1-dihydrotestosterone (a.k.a. "1-testosterone") (17ẞhydroxy-5α-androst-1-en-3-one);

(xi) 4-dihydrotestosterone (17ẞ-hydroxy-androstan-3-one); (xii) drostanolone (17ẞ-hydroxy-2a-methyl-5α-androstan-3one);

(xiii) ethylestrenol (17a-ethyl-17ẞ-hydroxyestr-4-ene);

1 Separate indentation of subparagraph (A) is so in law. See section 2(a)(1)(B) of Public Law 108-358 (118 Stat. 1661).

2 Subparagraph (A) as shown above reflects the amendment made by subsection (a)(1)(B) of section 2 of Public Law 108-358. Subsection (d) of such section provides that "the amendments made by this section shall take effect 90 days after the date of enactment of this Act". Such Public Law was enacted October 22, 2004.

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(xvi) furazabol (17a-methyl-17ẞ-hydroxyandrostano[2,3-c]furazan); (xvii) 13ẞ-ethyl-17a-hydroxygon-4-en-3-one;

(xviii) 4-hydroxytestosterone (4,17ẞ-dihydroxy-androst-4en-3-one);

(xix) 4-hydroxy-19-nortestosterone (4,17ẞ-dihydroxy-estr-4en-3-one); (xx) mestanolone (17a-methyl-17ẞ-hydroxy-5α-androstan-3one); (xxi) mesterolone (1a-methyl-17ẞ-hydroxy-[50]-androstan3-one); (xxii) methandienone (17a-methyl-17ẞ-hydroxyandrost-1,4dien-3-one); (xxiii) methandriol (17a-methyl-3ẞ, 17ẞ-dihydroxyandrost-5ene); (xxiv) methenolone (1-methyl-17ẞ-hydroxy-5α-androst-1-en3-one);

(xxv) 17α-methyl-3ẞ, 17ẞ-dihydroxy-5α-androstane;
(xxvi) 17α-methyl-3a, 17ẞ-dihydroxy-5α-androstane;
(xxvii) 17α-methyl-3ẞ,17ẞ-dihydroxyandrost-4-ene.
(xxviii) 17α-methyl-4-hydroxynandrolone (17a-methyl-4-

hydroxy-17ẞ-hydroxyestr-4-en-3-one);
(xxix) methyldienolone

4,9(10)-dien-3-one);

(17α-methyl-17ẞ-hydroxyestra

(xxx) methyltrienolone (17a-methyl-17ẞ-hydroxyestra-4,911-trien-3-one);

(xxxi) methyltestosterone (17a-methyl-17ẞ-hydroxyandrost4-en-3-one);

(xxxii) mibolerone (7a,17a-dimethyl-17ẞ-hydroxyestr-4-en3-one); (xxxiii) 17a-methyl-A 1-dihydrotestosterone (17ẞ-hydroxy17a-methyl-5a-androst-1-en-3-one) (a.k.a. "17-a-methyl-1-tes

tosterone");

(xxxiv) nandrolone (17ẞ-hydroxyestr-4-en-3-one);
(xxxv) norandrostenediol

ene);

(I) 19-nor-4-androstenediol (3ẞ, 17ẞ-dihydroxyestr-4

(II) 19-nor-4-androstenediol (3α, 17ẞ-dihydroxyestr-4ene);

(III) 19-nor-5-androstenediol (3ẞ, 17ẞ-dihydroxyestr-5ene); and

(IV) 19-nor-5-androstenediol (3a, 17ẞ-dihydroxyestr-5ene);

(xxxvi) norandrostenedione

and

(I)

19-nor-4-androstenedione

(estr-4-en-3,17-dione);

(II) 19-nor-5-androstenedione (estr-5-en-3,17-dione; (xxxvii) norbolethone (13ẞ,17a-diethyl-17ẞ-hydroxygon-4en-3-one);

(xxxviii) norclostebol (4-chloro-17ẞ-hydroxyestr-4-en-3-one);

one);

one);

(xxxix) norethandrolone (17a-ethyl-17ẞ-hydroxyestr-4-en-3

(xl) normethandrolone (17a-methyl-17ẞ-hydroxyestr-4-en-3

(xli) oxandrolone

androstan-3-one);

(17α-methyl-17ẞ-hydroxy-2-oxa-[50]

(xlii) oxymesterone (17a-methyl-4,17ẞ-dihydroxyandrost-4en-3-one);

(xliii) oxymetholone (17a-methyl-2-hydroxymethylene-17ẞhydroxy-[50]-androstan-3-one);

(xliv) stanozolol (17a-methyl-17a-hydroxy-[50]-androst-2eno[3,2-c]-pyrazole);

(xlv) stenbolone (17ẞ-hydroxy-2-methyl-[5a]-androst-1-en-3one);

(xlvi) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta1,4-dien-17-oic acid lactone);

(xlvii) testosterone (17ẞ-hydroxyandrost-4-en-3-one);

(xlviii)

tetrahydrogestrinone

hydroxygon-4,9,11-trien-3-one);

(13ẞ,17a-diethyl-17ẞ

(xlix) trenbolone (17ẞ-hydroxyestr-4,9,11-trien-3-one); and (xlx) any salt, ester, or ether of a drug or substance described in this paragraph.

The substances excluded under this subparagraph may at any time be scheduled by the Attorney General in accordance with the authority and requirements of subsections (a) through (c) of section 201.

(B)(i) Except as provided in clause (ii), such term does not include an anabolic steroid which is expressly intended for administration through implants to cattle or other nonhuman species and which has been approved by the Secretary of Health and Human Services for such administration.

(ii) If any person prescribes, dispenses, or distributes such steroid for human use, such person shall be considered to have prescribed, dispensed, or distributed an anabolic steroid within the meaning of subparagraph (A).

(42) The term "international transaction" means a transaction involving the shipment of a listed chemical across an international border (other than a United States border) in which a broker or trader located in the United States participates.

(43) The terms "broker" and "trader" mean a person that assists in arranging an international transaction in a listed chemical by

(A) negotiating contracts;

(B) serving as an agent or intermediary; or

(C) bringing together a buyer and seller, a buyer and transporter, or a seller and transporter.

(44) 1 The term "felony drug offense" means an offense that is punishable by imprisonment for more than one year under any law of the United States or of a State or foreign country that prohibits

1 Paragraph (44) as shown above reflects the amendment made by subsection (a)(2) of section 2 of Public Law 108-358 (118 Stat. 1663). Subsection (d) of such section provides that "the amendments made by this section shall take effect 90 days after the date of enactment of this Act". Such Public Law was enacted October 22, 2004.

or restricts conduct relating to narcotic drugs, marihuana, anabolic steroids, or depressant or stimulant substances.

The

(45) 1 term "ordinary over-the-counter pseudoephedrine or phenylpropanolamine product" means any product containing pseudoephedrine or phenylpropanolamine that is

(A) regulated pursuant to this title; and

(B)(i) except for liquids, sold in package sizes of not more than 3.0 grams of pseudoephedrine base or 3.0 grams of phenylpropanolamine base, and that is packaged in blister packs, each blister containing not more than two dosage units, or where the use of blister packs is technically infeasible, that is packaged in unit dose packets or pouches; and

(ii) for liquids, sold in package sizes of not more than 3.0 grams of pseudoephedrine base or 3.0 grams of phenylpropanolamine base.

(46)(A) The term "retail distributor" means a grocery store, general merchandise store, drug store, or other entity or person whose activities as a distributor relating to pseudoephedrine or phenylpropanolamine products are limited almost exclusively to sales for personal use, both in number of sales and volume of sales, either directly to walk-in customers or in face-to-face transactions by direct sales.

(B) For purposes of this paragraph, sale for personal use means the sale of below-threshold quantities in a single transaction to an individual for legitimate medical use.

(C) For purposes of this paragraph, entities are defined by reference to the Standard Industrial Classification (SIC) code, as follows:

(i) A grocery store is an entity within SIC code 5411. (ii) A general merchandise store is an entity within SIC codes 5300 through 5399 and 5499.

(iii) A drug store is an entity within SIC code 5912.

PART B-AUTHORITY TO CONTROL; STANDARDS AND SCHEDULES

AUTHORITY AND CRITERIA FOR CLASSIFICATION OF SUBSTANCES

SEC. 201. [21 U.S.C. 811] (a) The Attorney General shall apply the provisions of this title to the controlled substances listed in the schedules established by section 202 of this title and to any other drug or other substance added to such schedules under this title. Except as provided in subsections (d) and (e), the Attorney General may by rule

(1) add to such a schedule or transfer between such schedules any drug or other substance if he

(A) finds that such drug or other substance has a potential for abuse, and

(B) makes with respect to such drug or other substance the findings prescribed by subsection (b) of section 202 for the schedule in which such drug is to be placed;

or

1 Indentation so in law. See section 401(b)(4) of Public Law 104-237.

(2) remove any drug or other substance from the schedules if he finds that the drug or other substance does not meet the requirements for inclusion in any schedule.

Rules of the Attorney General under this subsection shall be made on the record after opportunity for a hearing pursuant to the rulemaking procedures prescribed by subchapter II of chapter 5 of title 5 of the United States Code. Proceedings for the issuance, amendment, or repeal of such rules may be initiated by the Attorney General (1) on his own motion, (2) at the request of the Secretary, or (3) on the petition of any interested party.

(b) The Attorney General shall, before initiating proceedings under subsection (a) to control a drug or other substance or to remove a drug or other substance entirely from the schedules, and after gathering the necessary data, request from the Secretary a scientific and medical evaluation, and his recommendations, as to whether such drug or other substance should be so controlled or removed as a controlled substance. In making such evaluation and recommendations, the Secretary shall consider the factors listed in paragraphs (2), (3), (6), (7), and (8) of subsection (c) and any scientific or medical considerations involved in paragraphs (1), (4), and (5) of such subsection. The recommendations of the Secretary shall include recommendations with respect to the appropriate schedule, if any, under which such drug or other substance should be listed. The evaluation and the recommendations of the Secretary shall be made in writing and submitted to the Attorney General within a reasonable time. The recommendations of the Secretary to the Attorney General shall be binding on the Attorney General as to such scientific and medical matters, and if the Secretary recommends that a drug or other substance not be controlled, the Attorney General shall not control the drug or other substance. If the Attorney General determines that these facts and all other relevant data constitute substantial evidence of potential for abuse such as to warrant control or substantial evidence that the drug or other substance should be removed entirely from the schedules, he shall initiate proceedings for control or removal, as the case may be, under subsection (a).

(c) In making any finding under subsection (a) of this section or under subsection (b) of section 202, the Attorney General shall consider the following factors with respect to each drug or other substance proposed to be controlled or removed from the schedules: (1) Its actual or relative potential for abuse.

(2) Scientific evidence of its pharmacological effect, if

known.

(3) The state of current scientific knowledge regarding the drug or other substance.

(4) Its history and current pattern of abuse.

(5) The scope, duration, and significance of abuse.

(6) What, if any, risk there is to the public health.

(7) Its psychic or physiological dependence liability.

(8) Whether the substance is an immediate precursor of a substance already controlled under this title.

(d)(1) If control is required by United States obligations under international treaties, conventions, or protocols in effect on the effective date of this part, the Attorney General shall issue an

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