§1300.01. Definitions relating to controlled substances. — Inbound Citations
21 C.F.R. § 1300.01
Statutory Authority
Cited by 12 regulations in release Current.
Citations to 21 C.F.R. § 1300.01 as a whole
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(c) As a condition on registration under this part and section 303 of the Act (21 U.S.C. 823) to dispense controlled substances in schedule II, III, IV, or V, qualified practitioners, as defined in § 1300.01 of this chapter, must meet the training requirements set forth in section 303(m) of the Act (21 U.S.C. 823(m)). No qualified practitioner is required to complete the training more than once. This requirement applies from the first registration or renewal of registration by a qualified practitioner that occurs on or after June 27, 2023.
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(4) A freight forwarding facility, as defined in § 1300.01 of this part, provided that the distributing registrant operating the facility has submitted written notice of intent to operate the facility by registered mail, return receipt requested (or other suitable means of documented delivery) and such notice has been approved. The notice shall be submitted to the Special Agent in Charge of the Administration's offices in both the area in which the facility is located and each area in which the distributing registrant maintains a registered location that will transfer controlled substances through the facility. The notice shall detail the registered locations that will utilize the facility, the location of the facility, the hours of operation, the individual(s) responsible for the controlled substances, the security and recordkeeping procedures that will be employed, and whether controlled substances returns will be processed through the facility. The notice must also detail what state licensing requirements apply to the facility and the registrant's actions to comply with any such requirements. The Special Agent in Charge of the DEA Office in the area where the freight forwarding facility will be operated will provide written notice of approval or disapproval to the person within thirty days after confirmed receipt of the notice. Registrants that are currently operating freight forwarding facilities under a memorandum of understanding with the Administration must provide notice as required by this section no later than September 18, 2000 and receive written approval from the Special Agent in Charge of the DEA Office in the area in which the freight forwarding facility is operated in order to continue operation of the facility.
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(a) A retail pharmacy may install and operate automated dispensing systems, as defined in § 1300.01 of this chapter, at long term care facilities, under the requirements of § 1301.17. No person other than a registered retail pharmacy may install and operate an automated dispensing system at a long term care facility.
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(2) An automated dispensing machine as defined in § 1300.01; which is(ii) Installed and operated by the emergency medical services agency;(iii) Not used to directly dispense controlled substances to an ultimate user; and is
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Any term contained in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or § 1300.01, § 1300.03, § 1300.04, or § 1300.05 of this chapter.
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(d) Delivery from a central fill pharmacy, as defined in § 1300.01 of this chapter, to a retail pharmacy.
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(f) Unless specifically excepted or unless listed in another schedule, any substance meeting the definition of anabolic steroid as set forth in § 1300.01 of this chapter, including any material, compound, mixture or preparation containing any quantity of the following substances, including its salts, esters and ethers (4000):(1) 5α-androstan-3,17-dione;(2) 5α-androstan-3,6,17-trione;(3) 1-androstenediol (3β,17β-dihydroxy-5α-androst-1-ene);(4) 1-androstenediol (3α,17β-dihydroxy-5α-androst-1-ene);(5) 4-androstenediol (3β,17β-dihydroxy-androst-4-ene);(6) 5-androstenediol (3β,17β-dihydroxy-androst-5-ene);(7) 1-androstenedione (5α-androst-1-en-3,17-dione);(8) 4-androstenedione (androst-4-en-3,17-dione);(9) 5-androstenedione (androst-5-en-3,17-dione);(10) bolasterone (7α,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);(11) boldenone (17β-hydroxyandrost-1,4-diene-3-one);(12) boldione (androsta-1,4-diene-3,17-dione);(13) 6-bromo-androsta-1,4-diene-3,17-dione;(14) 6-bromo-androstan-3,17-dione;(15) calusterone (7β,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);(16) 4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol;(17) 4-chloro-17α-methyl-androst-4-ene-3β,17β-diol;(18) 4-chloro-17α-methyl-17β-hydroxy-androst-4-en-3-one;(19) 4-chloro-17α-methyl-17β-hydroxy-androst-4-ene-3,11-dione;(20) clostebol (4-chloro-17β-hydroxyandrost-4-en-3-one);(21) dehydrochloromethyltestosterone (4-chloro-17β-hydroxy-17α-methyl-androst-1,4-dien-3-one);(22) desoxymethyltestosterone (17α-methyl-5α-androst-2-en-17β-ol) (a.k.a. “madol”);(23) 4-dihydrotestosterone (17β-hydroxy-androstan-3-one);(24) Δ1-dihydrotestosterone (a.k.a. “1-testosterone”) (17β-hydroxy-5α-androst-1-en-3-one);(25) 3β,17β-dihydroxy-5α-androstane;(26) 3α,17β-dihydroxy-5α-androstane;(27) 2α,17α-dimethyl-17β-hydroxy-5β-androstan-3-one;(28) drostanolone (17β-hydroxy-2α-methyl-5α-androstan-3-one);(29) 2α,3α-epithio-17α-methyl-5α-androstan-17β-ol;(30) estra-4,9,11-triene-3,17-dione;(31) 13β-ethyl-17β-hydroxygon-4-en-3-one;(32) ethylestrenol (17α-ethyl-17β-hydroxyestr-4-ene);(33) fluoxymesterone (9-fluoro-17α-methyl-11β,17β-dihydroxyandrost-4-en-3-one);(34) formebolone (2-formyl-17α-methyl-11α,17β-dihydroxyandrost-1,4-dien-3-one);(35) furazabol (17α-methyl-17β-hydroxyandrostano[2,3-c]furazan);(36) [3,2-c]furazan-5α-androstan-17β-ol;(37) 18a-homo-3-hydroxy-estra-2,5(10)-dien-17-one;(38) 4-hydroxy-19-nortestosterone (4,17β-dihydroxy-estr-4-en-3-one);(39) 4-hydroxy-androst-4-ene-3,17-dione;(40) 17β-hydroxy-androstano[2,3-d]isoxazole;(41) 17β-hydroxy-androstano[3,2-c]isoxazole;(42) 3β-hydroxy-estra-4,9,11-trien-17-one;(43) 4-hydroxytestosterone (4,17β-dihydroxy-androst-4-en-3-one);(44) mestanolone (17α-methyl-17β-hydroxy-5α-androstan-3-one);(45) mesterolone (1α-methyl-17β-hydroxy-5α-androstan-3-one);(46) methandienone (17α-methyl-17β-hydroxyandrost-1,4-dien-3-one);(47) methandriol (17α-methyl-3β,17β-dihydroxyandrost-5-ene);(48) methasterone (2α,17α-dimethyl-5α-androstan-17β-ol-3-one or 2α,17α-dimethyl-17β-hydroxy-5α-androstan-3-one);(49) methenolone (1-methyl-17β-hydroxy-5α-androst-1-en-3-one);(50) 17α-methyl-androsta-1,4-diene-3,17β-diol;(51) 17α-methyl-5α-androstan-17β-ol;(52) 17α-methyl-androstan-3-hydroxyimine-17β-ol;(53) 6α-methyl-androst-4-ene-3,17-dione;(54) 17α-methyl-androst-2-ene-3,17β-diol;(55) 17α-methyl-3β,17β-dihydroxy-5α-androstane;(56) 17α-methyl-3α,17β-dihydroxy-5α-androstane;(57) 17α-methyl-3β,17β-dihydroxyandrost-4-ene;(58) 17α-methyl-4-hydroxynandrolone (17α-methyl-4-hydroxy-17β-hydroxyestr-4-en-3-one);(59) methyldienolone (17α-methyl-17β-hydroxyestra-4,9(10)-dien-3-one);(60) 17α-methyl-Δ1-dihydrotestosterone (17β-hydroxy-17α-methyl-5α-androst-1-en-3-one) (a.k.a. “17-α-methyl-1-testosterone”);(61) methyltestosterone (17α-methyl-17β-hydroxyandrost-4-en-3-one);(62) methyltrienolone (17α-methyl-17β-hydroxyestra-4,9,11-trien-3-one);(63) mibolerone (7α,17α-dimethyl-17β-hydroxyestr-4-en-3-one);(64) nandrolone (17β-hydroxyestr-4-en-3-one);(65) 19-nor-4-androstenediol (3β,17β-dihydroxyestr-4-ene);(66) 19-nor-4-androstenediol (3α,17β-dihydroxyestr-4-ene);(67) 19-nor-5-androstenediol (3β,17β-dihydroxyestr-5-ene);(68) 19-nor-5-androstenediol (3α,17β-dihydroxyestr-5-ene);(69) 19-nor-4,9(10)-androstadienedione (estra-4,9(10)-diene-3,17-dione);(70) 19-nor-4-androstenedione (estr-4-en-3,17-dione);(71) 19-nor-5-androstenedione (estr-5-en-3,17-dione);(72) norbolethone (13β,17α-diethyl-17β-hydroxygon-4-en-3-one);(73) norclostebol (4-chloro-17β-hydroxyestr-4-en-3-one);(74) norethandrolone (17α-ethyl-17β-hydroxyestr-4-en-3-one);(75) normethandrolone (17α-methyl-17β-hydroxyestr-4-en-3-one);(76) oxandrolone (17α-methyl-17β-hydroxy-2-oxa-5α-androstan-3-one);(77) oxymesterone (17α-methyl-4,17β-dihydroxyandrost-4-en-3-one);(78) oxymetholone (17α-methyl-2-hydroxymethylene-17β-hydroxy-5α-androstan-3-one);(79) prostanozol (17β-hydroxy-5α-androstano[3,2-c]pyrazole or [3,2-c]pyrazole-5α-androstan-17β-ol);(80) [3,2-c]pyrazole-androst-4-en-17β-ol;(81) stanozolol (17α-methyl-17β-hydroxy-5α-androst-2-eno[3,2-c]-pyrazole);(82) stenbolone (17β-hydroxy-2-methyl-5α-androst-1-en-3-one);(83) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid lactone);(84) testosterone (17β-hydroxyandrost-4-en-3-one);(85) tetrahydrogestrinone (13β,17α-diethyl-17β-hydroxygon-4,9,11-trien-3-one); and(86) trenbolone (17β-hydroxyestr-4,9,11-trien-3-one).
Citations to §1300.01(b)(1)
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(6) Methamphetamine, its salts, isomers, and salts of its isomers;
Citations to §1300.01(b)(2)
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(6) Methamphetamine, its salts, isomers, and salts of its isomers;
Citations to §1300.01(b)(3)
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(6) Methamphetamine, its salts, isomers, and salts of its isomers;
Citations to §1300.01(b)(4)
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(6) Methamphetamine, its salts, isomers, and salts of its isomers;
Citations to §1300.01(b)(5)
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(6) Methamphetamine, its salts, isomers, and salts of its isomers;