HHS 21 CFR PART 1300-2011 DEFINITIONS《定义》.pdf

1、5 PART 1300DEFINITIONS Sec. 1300.01 Definitions relating to controlled substances. 1300.02 Definitions relating to listed chemi-cals. 1300.03 Definitions relating to electronic or-ders for controlled substances and elec-tronic prescriptions for controlled sub-stances. Definitions relating to elec-tr

2、onic orders for controlled substances and electronic prescriptions for con-trolled substances. 1300.04 Definitions relating to the dis-pensing of controlled substances by means of the Internet. AUTHORITY: 21 U.S.C. 802, 821, 829, 871(b), 951, 958(f). SOURCE: 62 FR 13941, Mar. 24, 1997, unless otherw

3、ise noted. 1300.01 Definitions relating to con-trolled substances. (a) Any term not defined in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802), except that certain terms used in part 1316 of this chapter are defined at the beginning of each subpart of that par

4、t. (b) As used in parts 1301 through 1308 and part 1312 of this chapter, the fol-lowing terms shall have the meanings specified: (1) The term Act means the Con-trolled Substances Act, as amended (84 Stat. 1242; 21 U.S.C. 801) and/or the Con-trolled Substances Import and Export Act, as amended (84 St

5、at. 1285; 21 U.S.C. 951). (2) The term Administration means the Drug Enforcement Administration. (3) The term Administrator means the Administrator of the Drug Enforce-ment Administration. The Adminis-trator has been delegated authority under the Act by the Attorney General (28 CFR 0.100). (4) The t

6、erm anabolic steroid means any drug or hormonal substance, chemically and pharmacologically re-lated to testosterone (other than estro-gens, progestins, corticosteroids, and dehydroepiandrosterone), and includes: (i) 3b,17-dihydroxy-5a-androstane (ii) 3a,17b-dihydroxy-5a-androstane (iii) 5a-androsta

7、n-3,17-dione (iv) 1-androstenediol (3b,17b- dihydroxy-5a-androst-1-ene) (v) 1-androstenediol (3a,17b- dihydroxy-5a-androst-1-ene) (vi) 4-androstenediol (3b,17b- dihydroxy-androst-4-ene) (vii) 5-androstenediol (3b,17b- dihydroxy-androst-5-ene) (viii) 1-androstenedione (5a-androst- 1-en-3,17-dione) (i

8、x) 4-androstenedione (androst-4-en- 3,17-dione) (x) 5-androstenedione (androst-5-en- 3,17-dione) (xi) bolasterone (7a,17a-dimethyl-17b- hydroxyandrost-4-en-3-one) (xii) boldenone (17b-hydroxyandrost- 1,4,-diene-3-one) (xiii) boldione (androsta-1,4-diene- 3,17-dione) (xiv) calusterone (7b,17a-dimethy

9、l- 17b-hydroxyandrost-4-en-3-one) (xv) clostebol (4-chloro-17b- hydroxyandrost-4-en-3-one) (xvi) dehydrochloromethyltestosterone (4- chloro-17b-hydroxy-17a-methyl- androst-1,4-dien-3-one) (xvii) D1-dihydrotestosterone (a.k.a. 1-testosterone) (17b-hydroxy-5a- androst-1-en-3-one) (xviii) 4-dihydrotest

10、osterone (17b-hy-droxy-androstan-3-one) (xix) drostanolone (17b-hydroxy-2a- methyl-5a-androstan-3-one) (xx) ethylestrenol (17a-ethyl-17b- hydroxyestr-4-ene) (xxi) fluoxymesterone (9-fluoro-17a- methyl-11b,17b-dihydroxyandrost-4-en- 3-one) (xxii) formebolone (2-formyl-17a- methyl-11a,17b-dihydroxyand

11、rost-1,4- dien-3-one) (xxiii) furazabol (17a-methyl-17b- hydroxyandrostano2,3-c-furazan) (xxiv) 13b-ethyl-17b-hydroxygon-4-en- 3-one (xxv) 4-hydroxytestosterone (4,17b- dihydroxy-androst-4-en-3-one) (xxvi) 4-hydroxy-19-nortestosterone (4,17b-dihydroxy-estr-4-en-3-one) (xvii) desoxymethyltestosterone

12、 (17a- methyl-5a-androst-2-en-17b-ol) (a.k.a., madol) (xxviii) mestanolone (17a-methyl-17b- hydroxy-5-androstan-3-one) (xxix) mesterolone (1amethyl-17b-hy-droxy-5a-androstan-3-one) (xxx) methandienone (17a-methyl-17b- hydroxyandrost-1,4-dien-3-one) VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00

13、000 Frm 00015 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-6 21 CFR Ch. II (4111 Edition) 1300.01 (xxxi) methandriol (17a-methyl- 3b,17b-dihydroxyandrost-5-ene) (xxxii) meth

14、enolone (1-methyl-17b- hydroxy-5a-androst-1-en-3-one) (xxxiii) 17a-methyl-3b, 17b-dihydroxy- 5a-androstane (xxxiv) 17a-methyl-3a,17b-dihydroxy- 5a-androstane (xxxv) 17a-methyl-3b,17b- dihydroxyandrost-4-ene (xxxvi) 17a-methyl-4- hydroxynandrolone (17a-methyl-4-hy-droxy-17b-hydroxyestr-4-en-3-one) (x

15、xxvii) methyldienolone (17a-meth-yl-17b-hydroxyestra-4,9(10)-dien-3-one) (xxxviii) methyltrienolone (17a-meth-yl-17b-hydroxyestra-4,9-11-trien-3-one) (xxxix) methyltestosterone (17a- methyl-17b-hydroxyandrost-4-en-3-one) (xl) mibolerone (7a,17a-dimethyl-17b- hydroxyestr-4-en-3-one) (xli) 17a-methyl-

16、D1- dihydrotestosterone (17bb-hydroxy-17a- methyl-5a-androst-1-en-3-one) (a.k.a. 17-a-methyl-1-testosterone) (xlii) nandrolone (17b-hydroxyestr-4- en-3-one) (xliii) 19-nor-4-androstenediol (3b, 17b- dihydroxyestr-4-ene) (xliv) 19-nor-4-androstenediol (3a, 17b- dihydroxyestr-4-ene) (xlv) 19-nor-5-and

17、rostenediol (3b, 17b- dihydroxyestr-5-ene) (xlvi) 19-nor-5-androstenediol (3a, 17b- dihydroxyestr-5-ene) (xlvii) 19-nor-4,9(10)- androstadienedione (estra-4,9(10)-diene- 3,17-dione) (xlviii) 19-nor-4-androstenedione (estr-4-en-3,17-dione) (xlix) 19-nor-5-androstenedione (estr- 5-en-3,17-dione (l) no

18、rbolethone (13b, 17a-diethyl-17b- hydroxygon-4-en-3-one) (li) norclostebol (4-chloro-17b- hydroxyestr-4-en-3-one) (lii) norethandrolone (17a-ethyl-17b- hydroxyestr-4-en-3-one) (liii) normethandrolone (17a-methyl- 17b-hydroxyestr-4-en-3-one) (liv) oxandrolone (17a-methyl-17b-hy-droxy-2-oxa-5a-androst

19、an-3-one) (lv) oxymesterone (17a-methyl-4,17b- dihydroxyandrost-4-en-3-one) (lvi) oxymetholone (17a-methyl-2- hydroxymethylene-17b-hydroxy-5a- androstan-3-one) (lvii) stanozolol (17a-methyl-17b-hy-droxy-5a-androst-2-eno3,2-c-pyr-azole) (lviii) stenbolone (17b-hydroxy-2- methyl-5a-androst-1-en-3-one)

20、 (lix) testolactone (13-hydroxy-3-oxo- 13,17-secoandrosta-1,4-dien-17-oic acid lactone) (lx) testosterone (17b- hydroxyandrost-4-en-3-one) (lxi) tetrahydrogestrinone (13b, 17a- diethyl-17b-hydroxygon-4,9,11-trien-3- one) (lxii) trenbolone (17b-hydroxyestr- 4,9,11-trien-3-one) (lxiii) Any salt, ester

21、 or ether of a drug or substance described in this paragraph. Except such term does not include an anabolic steroid that is ex-pressly intended for administration through implants to cattle or other nonhuman species and that has been approved by the Secretary of Health and Human Services for such a

22、dminis-tration. If any person prescribes, dis-penses, or distributes such steroid for human use, the person shall be consid-ered to have prescribed, dispensed, or distributed an anabolic steroid within the meaning of this paragraph. (5) The term basic class means, as to controlled substances listed

23、in Sched-ules I and II: (i) Each of the opiates, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, listed in 1308.11(b) of this chapter; (ii) E

24、ach of the opium derivatives, in-cluding its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, listed in 1308.11(c) of this chapter; (iii) Each of the hallucinogenic sub-stances, including it

25、s salts, isomers, and salts of isomers whenever the ex-istence of such salts, isomers, and salts of isomers is possible within the spe-cific chemical designation, listed in 1308.11(d) of this chapter; (iv) Each of the following substances, whether produced directly or indirectly by extraction from s

26、ubstances of vege-table origin, or independently by means of chemical synthesis, or by a VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00016 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted wit

27、hout license from IHS-,-,-7 Drug Enforcement Administration, Justice 1300.01 combination of extraction and chem-ical synthesis: (A) Opium, including raw opium, opium extracts, opium fluid extracts, powdered opium, granulated opium, de-odorized opium and tincture of opium; (B) Apomorphine; (C) Codein

28、e; (D) Etorphine hydrochloride; (E) Ethylmorphine; (F) Hydrocodone; (G) Hydromorphone; (H) Metopon; (I) Morphine; (J) Oxycodone; (K) Oxymorphone; (L) Thebaine; (M) Mixed alkaloids of opium listed in Section 1308.12(b)(2) of this chapter; (N) Cocaine; and (O) Ecgonine; (v) Each of the opiates, includ

29、ing its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, listed in 1308.12(c) of this chapter; and (vi) Methamphetamine, its salts, iso-mers, and salts of i

30、ts isomers; (vii) Amphetamine, its salts, optical isomers, and salts of its optical iso-mers; (viii) Phenmetrazine and its salts; (ix) Methylphenidate; (x) Each of the substances having a depressant effect on the central nerv-ous system, including its salts, iso-mers, and salts of isomers whenever t

31、he existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, list-ed in 1308.12(e) of this chapter. (6) The term commercial container means any bottle, jar, tube, ampule, or other receptacle in which a substance is held for distribution or dispensin

32、g to an ultimate user, and in addition, any box or package in which the receptacle is held for distribution or dispensing to an ultimate user. The term commercial container does not include any package liner, package insert or other material kept with or within a commercial con-tainer, nor any carto

33、n, crate, drum, or other package in which commercial containers are stored or are used for shipment of controlled substances. (7) The term compounder means any person engaging in maintenance or de-toxification treatment who also mixes, prepares, packages or changes the dos-age form of a narcotic dru

34、g listed in Schedules II, III, IV or V for use in maintenance or detoxification treat-ment by another narcotic treatment program. (8) The term controlled substance has the meaning given in section 802(6) of Title 21, United States Code (U.S.C.). (9) The term customs territory of the United States me

35、ans the several States, the District of Columbia, and Puerto Rico. (10) The term detoxification treatment means the dispensing, for a period of time as specified below, of a narcotic drug or narcotic drugs in decreasing doses to an individual to alleviate ad-verse physiological or psychological ef-f

36、ects incident to withdrawal from the continuous or sustained use of a nar-cotic drug and as a method of bringing the individual to a narcotic drug-free state within such period of time. There are two types of detoxification treat-ment: Short-term detoxification treat-ment and long-term detoxificatio

37、n treatment. (i) Short-term detoxification treat-ment is for a period not in excess of 30 days. (ii) Long-term detoxification treat-ment is for a period more than 30 days but not in excess of 180 days. (11) The term dispenser means an in-dividual practitioner, institutional practitioner, pharmacy or

38、 pharmacist who dispenses a controlled substance. (12) The term export means, with re-spect to any article, any taking out or removal of such article from the juris-diction of the United States (whether or not such taking out or removal con-stitutes an exportation within the meaning of the customs a

39、nd related laws of the United States). (13) The term exporter includes every person who exports, or who acts as an export broker for exportation of, con-trolled substances listed in any sched-ule. (14) The term hearing means: (i) In part 1301 of this chapter, any hearing held for the granting, denia

40、l, revocation, or suspension of a registra-tion pursuant to sections 303, 304, and VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00017 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without l

41、icense from IHS-,-,-8 21 CFR Ch. II (4111 Edition) 1300.01 1008 of the Act (21 U.S.C. 823, 824 and 958). (ii) In part 1303 of this chapter, any hearing held regarding the determina-tion of aggregate production quota or the issuance, adjustment, suspension, or denial of a procurement quota or an indi

42、vidual manufacturing quota. (iii) In part 1308 of this chapter, any hearing held for the issuance, amend-ment, or repeal of any rule issuable pursuant to section 201 of the Act (21 U.S.C. 811). (15) The term import means, with re-spect to any article, any bringing in or introduction of such article

43、into either the jurisdiction of the United States or the customs territory of the United States, and from the jurisdiction of the United States into the customs terri-tory of the United States (whether or not such bringing in or introduction constitutes an importation within the meaning of the tarif

44、f laws of the United States). (16) The term importer includes every person who imports, or who acts as an import broker for importation of, con-trolled substances listed in any sched-ule. (17) The term individual practitioner means a physician, dentist, veteri-narian, or other individual licensed, r

45、egistered, or otherwise permitted, by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice, but does not in-clude a pharmacist, a pharmacy, or an institutional practitioner. (18) The term institutional practitioner

46、 means a hospital or other person (other than an individual) licensed, reg-istered, or otherwise permitted, by the United States or the jurisdiction in which it practices, to dispense a con-trolled substance in the course of pro-fessional practice, but does not include a pharmacy. (19) The term inte

47、rested person means any person adversely affected or ag-grieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811). (20) The term inventory means all fac-tory and branch stocks in finished form of a basic class of controlled substance manufactured or otherwise a

48、cquired by a registrant, whether in bulk, commer-cial containers, or contained in phar-maceutical preparations in the posses-sion of the registrant (including stocks held by the registrant under separate registration as a manufacturer, im-porter, exporter, or distributor). (21) (i) The term isomer m

49、eans the op-tical isomer, except as used in 1308.11(d) and 1308.12(b)(4) of this chapter. As used in 1308.11(d) of this chapter, the term isomer means any optical, positional, or geometric iso-mer. As used in 1308.12(b)(4) of this chapter, the term isomer means any optical or geometric isomer. (ii) As used in 1308.11(d) of this chap-ter, the term positional isomer means any substance possessing the same molecular formula and core structure and havi