§811. Authority and criteria for classification of substances — Inbound Citations
21 U.S.C. § 811
Implementing Regulations (Code of Federal Regulations)
Statutory authority for 56 regulations in the Code of Federal Regulations.
Code of Federal Regulations Citations
Cited by 15 regulations in the Code of Federal Regulations.
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For the purposes of this part, the following definitions apply:
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(2) The proximity to a nuclear explosive and/or Category I SNM that allows the opportunity to divert, steal, tamper with, and/or damage the nuclear explosive or material in spite of any controls that have been established to prevent such unauthorized actions.Alcohol means the intoxicating agent in beverage alcohol, ethyl alcohol, or other low molecular weight alcohol.Alcohol abuse means consumption of any beverage, mixture, or preparation, including any medication containing alcohol that results in impaired social or occupational functioning.Alcohol concentration means the alcohol in a volume of breath expressed in terms of grams of alcohol per 210 liters of breath as indicated by a breath test.Alcohol use disorder means a maladaptive pattern in which a person's intake of alcohol is great enough to damage or adversely affect physical or mental health or personal, social, or occupational function; or when alcohol has become a prerequisite to normal function.Case chronology means a written recitation of all actions that support a recommendation to revoke an individual's HRP certification under § 712.19.Certification means the formal action the HRP certifying official takes that permits an individual to perform HRP duties after it is determined that the individual meets the requirements for certification under this part.Contractor means contractors and subcontractors at all tiers and any industrial, educational, commercial, or other entity, grantee, or licensee, including an employee that has executed an agreement with the Federal government for the purpose of performing under a contract, license, or other arrangement.Designated Physician means a licensed doctor of medicine or osteopathy who has been nominated by the Site Occupational Medical Director (SOMD) and approved by the Manager or designee, with the concurrence of the Director, Office of Environment, Health, Safety and Security or his or her designee to provide professional expertise in occupational medicine for the HRP.Designated Psychologist means a licensed Ph.D., or Psy.D., in clinical psychology who has been nominated by the SOMD and approved by the Manager or designee, with the concurrence of the Director, Office of Environment, Health, Safety and Security or his or her designee to provide professional expertise in the area of psychological assessment for the HRP.Diagnostic and Statistical Manual of Mental Disorders means the current version of the American Psychiatric Association's manual containing definitions of psychiatric terms and diagnostic criteria of mental disorders.Director, Office of Environment, Health, Safety and Security means the DOE individual with responsibility for policy and quality assurance for DOE occupational medical programs.Drug abuse means use of an illegal drug or misuse of legal drugs.Evaluative report means the document that sets forth the bases supporting the revocation of an individual's certification.Evidential-grade breath alcohol device means a device that conforms to the model standards for an evidential breath-testing device as listed on the Conforming Products List of Evidential Breath Measurement Devices published by the National Highway Traffic Safety Administration (NHTSA).Flashback means an involuntary, spontaneous recurrence of some aspect of a hallucinatory experience or perceptual distortion that occurs long after taking the hallucinogen that produced the original effect; also referred to as hallucinogen persisting perception disorder.Hallucinogen means a drug or substance that produces hallucinations, distortions in perception of sights and sounds, and disturbances in emotion, judgment, and memory.HRP candidate means an individual being considered for assignment to an HRP position.HRP-certified individual means an individual who has successfully completed the HRP requirements.HRP certifying official means the Manager or the Manager's designee who certifies, recertifies, temporarily removes, reviews the circumstances of an individual's removal from an HRP position, and directs reinstatement.HRP management official means an individual designated by the DOE or a DOE contractor, as appropriate, who has programmatic responsibility for HRP positions.Illegal drug means a controlled substance, as specified in Schedules I through V of the Controlled Substances Act, 21 U.S.C. 811 and 812; the term does not apply to the use of a controlled substance in accordance with the terms of a valid prescription, or other uses authorized by Federal law.Impaired or impairment means a decrease in functional capacity of a person that is caused by a physical, mental, emotional, substance abuse, or behavioral disorder.Incident means an unplanned, undesired event that interrupts the completion of an activity and that may include property damage or injury.Job task analysis means the formal process of defining the requirements of a position and identifying the knowledge, skills, and abilities necessary to effectively perform the duties of the position.Manager means the senior Federal line manager at a departmental site or Federal office with HRP-designated positions.Material access area means a type of Security Area that is authorized to contain a Category I quantity of special nuclear material and that has specifically defined physical barriers, is located within a Protected Area, and is subject to specific access controls.Medical assessment means an evaluation of an HRP candidate and HRP-certified individual's present health status and health risk factors by means of:
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(3) Each of the hallucinogenic substances, including 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(d) of this chapter;
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Schedules of controlled substances established by section 202 of the Act (21 U.S.C. 812) and nonnarcotic substances, chemical preparations, veterinary anabolic steroid implant products, prescription products, anabolic steroid products, and cannabis plant material and products made therefrom that contain tetrahydrocannabinols excluded pursuant to section 201 of the Act (21 U.S.C. 811), as they are changed, updated, and republished from time to time, are set forth in this part.
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(d) The Administrator may at any time revoke any exclusion granted pursuant to section 201(g) of the Act (21 U.S.C. 811(g)) by following the procedures set forth in paragraph (c) of this section for handling an application for an exclusion which has been accepted for filing.
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The following nonnarcotic substances which may, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully sold over the counter without a prescription, are excluded from all schedules pursuant to section 201(g) (1) of the Act (21 U.S.C. 811(g) (1)):
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(a) Any person seeking to have any compound, mixture, or preparation containing any nonnarcotic controlled substance listed in § 1308.12(e), or in § 1308.13(b) or (c), or in § 1308.14, or in § 1308.15, exempted from application of all or any part of the Act pursuant to section 201(g)(3)(A), of the Act (21 U.S.C. 811(g)(3)(A)) may apply to the Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.
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In any case where the Administrator shall hold a hearing on the issuance, amendment, or repeal of rules pursuant to section 201 of the Act, the procedures for such hearing and accompanying proceedings shall be governed generally by the rulemaking procedures set forth in the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by section 201 of the Act (21 U.S.C. 811), by §§ 1308.42-1308.51, and by §§ 1316.41-1316.67 of this chapter.
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If requested by any interested person after proceedings are initiated pursuant to § 1308.43, the Administrator shall hold a hearing for the purpose of receiving factual evidence and expert opinion regarding the issues involved in the issuance, amendment or repeal of a rule issuable pursuant to section 201(a) of the Act (21 U.S.C. 811(a)). Extensive argument should not be offered into evidence but rather presented in opening or closing statements of counsel or in memoranda or proposed findings of fact and conclusions of law. Additional information relating to hearings to include waivers or modification of rules, request for hearing, burden of proof, time and place, and final order are set forth in part 1316 of this chapter.
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Pursuant to section 201(d) of the Act (21 U.S.C. 811(d)), where control of a substance is required by U.S. obligations under international treaties, conventions, or protocols in effect on May 1, 1971, the Administrator shall issue and publish in the Federal Register an order controlling such substance under the schedule he deems most appropriate to carry out obligations. Issuance of such an order shall be without regard to the findings required by subsections 201(a) or 202(b) of the Act (21 U.S.C. 811(a) or 812(b)) and without regard to the procedures prescribed by § 1308.41 or subsections 201 (a) and (b) of the Act (21 U.S.C. 811 (a) and (b)). An order controlling a substance shall become effective 30 days from the date of publication in the Federal Register, unless the Administrator finds that conditions of public health or safety necessitate an earlier effective date, in which event the Administrator shall specify in the order his findings as to such conditions.
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Pursuant to section 201(e) of the Act (21 U.S.C. 811(e)), the Administrator may, without regard to the findings required by subsection 201(a) or 202 (b) of the Act (21 U.S.C. 811(a) or 812(b)) and without regard to the procedures prescribed by § 1308.41 or subsections 201 (a) and (b) of the Act (21 U.S.C. 811(a) and (b)), issue and publish in the Federal Register an order controlling an immediate precursor. The order shall designate the schedule in which the immediate precursor is to be placed, which shall be the same schedule in which the controlled substance of which it is an immediate precursor is placed or any other schedule with a higher numerical designation. An order controlling an immediate precursor shall become effective 30 days from the date of publication in the Federal Register, unless the Administrator finds that conditions of public health or safety necessitate an earlier effective date, in which event the Administrator shall specify in the order his findings as to such conditions.
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(b) An order issued under this section will be vacated upon the conclusion of a subsequent rulemaking proceeding initiated under section 201(a) (21 U.S.C. 811(a)) with respect to such substance or at the end of two years from the effective date of the order scheduling the substance, except that during the pendency of proceedings under section 201(a) (21 U.S.C. 811(a)) with respect to the substance, the Administration may extend the temporary scheduling for up to one year.
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The following Schedule III, IV, and V non-narcotic controlled substances have been specifically designated by the Administrator of the Drug Enforcement Administration as requiring import and export permits pursuant to sections 201(d)(1), 1002(b)(2), and 1003(e)(3) of the Act (21 U.S.C. 811(d)(1), 952(b)(2), and 953(e)(3)):
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(2) This section does not apply to any petition submitted regarding the classification of substances pursuant to the Controlled Substances Act, 21 U.S.C. 811. Such petitions are governed by 21 CFR 1308.43 and 1310.02(d) through (h).
United States Code Citations
Cited by 15 provisions in release 119-102.
Citations to 21 U.S.C. § 811 as a whole
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(A) 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) 3β,17β-dihydroxy-5α-androstane; and(II) 3α,17β-dihydroxy-5α-androstane;(ii) androstanedione (5α-androstan-3,17-dione);(iii) androstenediol—(I) 1-androstenediol (3β,17β-dihydroxy-5α-androst-1-ene);(II) 1-androstenediol (3α,17β-dihydroxy-5α-androst-1-ene);(III) 4-androstenediol (3β,17β-dihydroxy-androst-4-ene); and(IV) 5-androstenediol (3β,17β-dihydroxy-androst-5-ene);(iv) androstenedione—(I) 1-androstenedione ([5α]-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 (7α,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);(vi) boldenone (17β-hydroxyandrost-1,4,-diene-3-one);(vii) calusterone (7β,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);(viii) clostebol (4-chloro-17β-hydroxyandrost-4-en-3-one);(ix) dehydrochloromethyltestosterone (4-chloro-17β-hydroxy-17α-methyl-androst-1,4-dien-3-one);(x) *1-dihydrotestosterone (a.k.a. “1-testosterone”) (17β-hydroxy-5α-androst-1-en-3-one);(xi) 4-dihydrotestosterone (17β-hydroxy-androstan-3-one);(xii) drostanolone (17β-hydroxy-2α-methyl-5α-androstan-3-one);(xiii) ethylestrenol (17α-ethyl-17β-hydroxyestr-4-ene);(xiv) fluoxymesterone (9-fluoro-17α-methyl-11β,17β-dihydroxyandrost-4-en-3-one);(xv) formebolone (2-formyl-17α-methyl-11α,17β-dihydroxyandrost-1,4-dien-3-one);(xvi) furazabol (17α-methyl-17β-hydroxyandrostano[2,3-c]-furazan);(xvii) 13β-ethyl-17β-hydroxygon-4-en-3-one;(xviii) 4-hydroxytestosterone (4,17β-dihydroxy-androst-4-en-3-one);(xix) 4-hydroxy-19-nortestosterone (4,17β-dihydroxy-estr-4-en-3-one);(xx) mestanolone (17α-methyl-17β-hydroxy-5α-androstan-3-one);(xxi) mesterolone (1α-methyl-17β-hydroxy-[5α]-androstan-3-one);(xxii) methandienone (17α-methyl-17β-hydroxyandrost-1,4-dien-3-one);(xxiii) methandriol (17α-methyl-3β,17β-dihydroxyandrost-5-ene);(xxiv) methenolone (1-methyl-17β-hydroxy-5α-androst-1-en-3-one);(xxv) 17α-methyl-3β, 17β-dihydroxy-5α-androstane;(xxvi) 17α-methyl-3α,17β-dihydroxy-5α-androstane;(xxvii) 17α-methyl-3β,17β-dihydroxyandrost-4-ene.(xxviii) 17α-methyl-4-hydroxynandrolone (17α-methyl-4-hydroxy-17β-hydroxyestr-4-en-3-one);(xxix) methyldienolone (17α-methyl-17β-hydroxyestra-4,9(10)-dien-3-one);(xxx) methyltrienolone (17α-methyl-17β-hydroxyestra-4,9-11-trien-3-one);(xxxi) methyltestosterone (17α-methyl-17β-hydroxyandrost-4-en-3-one);(xxxii) mibolerone (7α,17α-dimethyl-17β-hydroxyestr-4-en-3-one);(xxxiii) 17α-methyl-*1-dihydrotestosterone (17β-hydroxy-17α-methyl-5α-androst-1-en-3-one) (a.k.a. “17-α-methyl-1-testosterone”);(xxxiv) nandrolone (17β-hydroxyestr-4-en-3-one);(xxxv) norandrostenediol—(I) 19-nor-4-androstenediol (3β, 17β-dihydroxyestr-4-ene);(II) 19-nor-4-androstenediol (3α, 17β-dihydroxyestr-4-ene);(III) 19-nor-5-androstenediol (3β, 17β-dihydroxyestr-5-ene); and(IV) 19-nor-5-androstenediol (3α, 17β-dihydroxyestr-5-ene);(xxxvi) norandrostenedione—(I) 19-nor-4-androstenedione (estr-4-en-3,17-dione); and(II) 19-nor-5-androstenedione (estr-5-en-3,17-dione;(xxxvii) norbolethone (13β,17α-diethyl-17β-hydroxygon-4-en-3-one);(xxxviii) norclostebol (4-chloro-17β-hydroxyestr-4-en-3-one);(xxxix) norethandrolone (17α-ethyl-17β-hydroxyestr-4-en-3-one);(xl) normethandrolone (17α-methyl-17β-hydroxyestr-4-en-3-one);(xli) oxandrolone (17α-methyl-17β-hydroxy-2-oxa-[5α]-androstan-3-one);(xlii) oxymesterone (17α-methyl-4,17β-dihydroxyandrost-4-en-3-one);(xliii) oxymetholone (17α-methyl-2-hydroxymethylene-17β-hydroxy-[5α]-androstan-3-one);(xliv) stanozolol (17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole);(xlv) stenbolone (17β-hydroxy-2-methyl-[5α]-androst-1-en-3-one);(xlvi) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid lactone);(xlvii) testosterone (17β-hydroxyandrost-4-en-3-one);(xlviii) tetrahydrogestrinone (13β,17α-diethyl-17β-hydroxygon-4,9,11-trien-3-one);(xlix) trenbolone (17β-hydroxyestr-4,9,11-trien-3-one);(l) 5α-Androstan-3,6,17-trione;(li) 6-bromo-androstan-3,17-dione;(lii) 6-bromo-androsta-1,4-diene-3,17-dione;(liii) 4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol;(liv) 4-chloro-17α-methyl-androst-4-ene-3β,17β-diol;(lv) 4-chloro-17α-methyl-17β-hydroxy-androst-4-en-3-one;(lvi) 4-chloro-17α-methyl-17β-hydroxy-androst-4-ene-3,11-dione;(lvii) 4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol;(lviii) 2α,17α-dimethyl-17β-hydroxy-5α-androstan-3-one;(lix) 2α,17α-dimethyl-17β-hydroxy-5β-androstan-3-one;(lx) 2α,3α-epithio-17α-methyl-5α-androstan-17β-ol;(lxi) [3,2-c]-furazan-5α-androstan-17β-ol;(lxii) 3β-hydroxy-estra-4,9,11-trien-17-one;(lxiii) 17α-methyl-androst-2-ene-3,17β-diol;(lxiv) 17α-methyl-androsta-1,4-diene-3,17β-diol;(lxv) Estra-4,9,11-triene-3,17-dione;(lxvi) 18a-Homo-3-hydroxy-estra-2,5(10)-dien-17-one;(lxvii) 6α-Methyl-androst-4-ene-3,17-dione;(lxviii) 17α-Methyl-androstan-3-hydroxyimine-17β-ol;(lxix) 17α-Methyl-5α-androstan-17β-ol;(lxx) 17β-Hydroxy-androstano[2,3-d]isoxazole;(lxxi) 17β-Hydroxy-androstano[3,2-c]isoxazole;(lxxii) 4-Hydroxy-androst-4-ene-3,17-dione[3,2-c]pyrazole-5α-androstan-17β-ol;(lxxiii) [3,2-c]pyrazole-androst-4-en-17β-ol;(lxxiv) [3,2-c]pyrazole-5α-androstan-17β-ol; and(lxxv) 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 811 of this title.
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(c) Schedules I, II, III, IV, and V shall, unless and until amended pursuant to section 811 of this title, consist of the following drugs or other substances,1 by whatever official name, common or usual name, chemical name, or brand name designated:
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(A) is controlled by action of the Attorney General under section 811 of this title; or
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(6) studies or special projects to develop information necessary to carry out his functions under section 811 of this title.
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(C) A description of whether each country identified pursuant to subparagraph (A) has adopted and utilizes scheduling or other procedures for illicit drugs that are similar in effect to the procedures authorized under title II1 of the Controlled Substances Act (21 U.S.C. 811 et seq.) for adding drugs and other substances to the controlled substances schedules;
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(B) designate each country, if any, identified under section 2291h(a)(10) of this title that has failed to adopt and utilize scheduling procedures for illicit drugs that are comparable to the procedures authorized under title II1 of the Controlled Substances Act (21 U.S.C. 811 et seq.) for adding drugs and other substances to the controlled substances schedules;
Citations to §811(a)
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(B) Such term does not include a product described in subparagraph (A) if the product contains a chemical specified in such subparagraph that the Attorney General has under section 811(a) of this title added to any of the schedules under section 812(c) of this title. In the absence of such scheduling by the Attorney General, a chemical specified in such subparagraph may not be considered to be a controlled substance.
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Whenever the Attorney General determines that there is evidence that—
Citations to §811(f)
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Whenever the Attorney General determines that there is evidence that—
Citations to §811(j)
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(1) In the case of an application under subsection (b) with respect to a drug for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].
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(1) In the case of an application under subsection (b) with respect to a drug for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].
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(A) In the case of an application under subsection (a) with respect to a drug for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], conditional approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].
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(k) In the case of a request under subsection (d) to add a drug to the index under subsection (a) with respect to a drug for which the Secretary provides notice to the person filing the request that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], a determination to grant the request to add such drug to the index shall not take effect until the interim final rule controlling the drug is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].
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(3) For purposes of determining the 7-year period of exclusivity under paragraph (1) for a drug for which the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], the drug shall not be considered approved or conditionally approved until the date that the interim final rule controlling the drug is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].
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(1) In the case of an application under subsection (a) with respect to a biological product for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], approval of such application shall not take effect until the interim final rule controlling the biological product is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].