References in Text
Schedules I, II, III, IV, and V, referred to in subsecs. (a) to (f), (g)(2), and (j)(1), (4), are set out in section 812(c) of this title.
This subchapter, referred to in subsecs. (f) and (j)(12)(A), was in the original “this title”, meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, 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.
The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (g)(2)(C)(i), 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.
The date of enactment of the Opioid Use Disorder Treatment Expansion and Modernization Act, referred to in subsec. (g)(2)(H)(ii), probably means the date of enactment of Pub. L. 114–198, known as the Comprehensive Addiction and Recovery Act of 2016, which was approved July 22, 2016. The Opioid Use Disorder Treatment Expansion and Modernization Act was H.R. 4981 of the 114th Congress, as introduced on Apr. 18, 2016. Amendatory provisions of H.R. 4981 were incorporated into Pub. L. 114–198, but no such Short Title was enacted.
This chapter, referred to in subsec. (j)(13)(A)(i), was in the original “this Act”, meaning Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.
Amendments
2018—Subsec. (g)(2)(B)(iii)(II). Pub. L. 115–271, § 3201(a), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: “The applicable number is 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients.”
Subsec. (g)(2)(G)(ii)(VIII). Pub. L. 115–271, § 3202(a), added subcl. (VIII).
Subsec. (g)(2)(G)(iii)(II). Pub. L. 115–271, § 3201(b), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: “during the period beginning on July 22, 2016, and ending on October 1, 2021, a qualifying other practitioner, as defined in clause (iv).”
Subsec. (g)(2)(G)(iii)(III). Pub. L. 115–271, § 3201(b)(1), (c), added subcl. (III).
Subsec. (g)(2)(G)(iv). Pub. L. 115–271, § 3201(d), substituted “nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant” for “nurse practitioner or physician assistant” wherever appearing.
2017—Subsecs. (j), (k). Pub. L. 115–83 added subsec. (j) and redesignated former subsec. (j) as (k).
2016—Subsec. (g)(2)(B). Pub. L. 114–198, § 303(a)(1)(A), added cls. (i) to (iii) and struck out former cls. (i) to (iii) which read as follows:
“(i) The practitioner is a qualifying physician (as defined in subparagraph (G)).
“(ii) With respect to patients to whom the practitioner will provide such drugs or combinations of drugs, the practitioner has the capacity to refer the patients for appropriate counseling and other appropriate ancillary services.
“(iii) The total number of such patients of the practitioner at any one time will not exceed the applicable number. For purposes of this clause, the applicable number is 30, unless, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. A second notification under this clause shall contain the certifications required by clauses (i) and (ii) of this subparagraph. The Secretary may by regulation change such total number.”
Subsec. (g)(2)(D)(ii). Pub. L. 114–198, § 303(a)(1)(B)(i), substituted “Upon receiving a determination from the Secretary under clause (iii) finding that a practitioner meets all requirements for a waiver under subparagraph (B)” for “Upon receiving a notification under subparagraph (B)”.
Subsec. (g)(2)(D)(iii). Pub. L. 114–198, § 303(a)(1)(B)(ii), inserted “and shall forward such determination to the Attorney General” after “a waiver under subparagraph (B)” and substituted “assign the practitioner” for “assign the physician”.
Subsec. (g)(2)(G)(ii)(I). Pub. L. 114–198, § 303(a)(1)(C)(i), amended subcl. (I) generally. Prior to amendment, subcl. (I) read as follows: “The physician holds a subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties.”
Subsec. (g)(2)(G)(ii)(II). Pub. L. 114–198, § 303(a)(1)(C)(ii), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: “The physician holds an addiction certification from the American Society of Addiction Medicine.”
Subsec. (g)(2)(G)(ii)(III). Pub. L. 114–198, § 303(a)(1)(C)(iii), struck out “subspecialty” before “board certification”.
Subsec. (g)(2)(G)(ii)(IV). Pub. L. 114–198, § 303(a)(1)(C)(iv), amended subcl. (IV) generally. Prior to amendment, subcl. (IV) read as follows: “The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than eight hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or any other organization that the Secretary determines is appropriate for purposes of this subclause.”
Subsec. (g)(2)(G)(iii), (iv). Pub. L. 114–198, § 303(a)(1)(C)(v), added cls. (iii) and (iv).
Subsec. (g)(2)(H)(i)(III). Pub. L. 114–198, § 303(a)(1)(D)(i), added subcl. (III).
Subsec. (g)(2)(H)(ii). Pub. L. 114–198, § 303(a)(1)(D)(ii), amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: “Not later than 120 days after October 17, 2000, the Secretary shall issue a treatment improvement protocol containing best practice guidelines for the treatment and maintenance of opiate-dependent patients. The Secretary shall develop the protocol in consultation with the Director of the National Institute on Drug Abuse, the Administrator of the Drug Enforcement Administration, the Commissioner of Food and Drugs, the Administrator of the Substance Abuse and Mental Health Services Administration and other substance abuse disorder professionals. The protocol shall be guided by science.”
Subsec. (g)(2)(I), (J). Pub. L. 114–198, § 303(b), added subpar. (I) and struck out former subpars. (I) and (J) which limited a State’s ability to preclude a practitioner from dispensing or prescribing certain approved drugs and provided the effective date of the paragraph and authorized the Secretary and the Attorney General to make certain determinations.
Subsec. (j). Pub. L. 114–145 added subsec. (j).
2015—Subsec. (i). Pub. L. 114–89 added subsec. (i).
2008—Subsec. (f). Pub. L. 110–425, in introductory provisions, inserted “and shall modify the registrations of pharmacies so registered to authorize them to dispense controlled substances by means of the Internet” after “schedule II, III, IV, or V” and substituted “or such modification of registration if the Attorney General determines that the issuance of such registration or modification” for “if he determines that the issuance of such registration”.
2006—Subsec. (g)(2)(B)(iii). Pub. L. 109–469, § 1102(1), substituted “unless, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. A second notification under this clause shall contain the certifications required by clauses (i) and (ii) of this subparagraph. The” for “except that the”.
Subsec. (g)(2)(J)(i). Pub. L. 109–469, § 1102(2)(A), substituted “thereafter.” for “thereafter except as provided in clause (iii) (relating to a decision by the Secretary or the Attorney General that this paragraph should not remain in effect).”
Subsec. (g)(2)(J)(ii). Pub. L. 109–469, § 1102(2)(B), substituted “December 29, 2006” for “October 17, 2000” in introductory provisions.
Subsec. (g)(2)(J)(iii). Pub. L. 109–469, § 1102(2)(C), substituted “subparagraph (B)(iii) should be applied by limiting the total number of patients a practitioner may treat to 30, then the provisions in such subparagraph (B)(iii) permitting more than 30 patients shall not apply, effective” for “this paragraph should not remain in effect, this paragraph ceases to be in effect”.
Subsec. (h). Pub. L. 109–177 substituted “clause (iv) or (v) of section 802(39)(A) of this title” for “section 802(39)(A)(iv) of this title” in introductory provisions.
2005—Subsec. (g)(2)(B)(iii). Pub. L. 109–56, § 1(b), substituted “The total” for “In any case in which the practitioner is not in a group practice, the total”.
Subsec. (g)(2)(B)(iv). Pub. L. 109–56, § 1(a), struck out cl. (iv) which read as follows: “In any case in which the practitioner is in a group practice, the total number of such patients of the group practice at any one time will not exceed the applicable number. For purposes of this clause, the applicable number is 30, except that the Secretary may by regulation change such total number, and the Secretary for such purposes may by regulation establish different categories on the basis of the number of practitioners in a group practice and establish for the various categories different numerical limitations on the number of such patients that the group practice may have.”
2002—Subsec. (g)(2)(I). Pub. L. 107–273, § 2501(1), which directed the substitution of “on the date of approval by the Food and Drug Administration of a drug in schedule III, IV, or V, a State may not preclude a practitioner from dispensing or prescribing such drug, or combination of such drugs,” for “on October 17, 2000, a State may not preclude a practitioner from dispensing or prescribing drugs in schedule III, IV, or V, or combinations of such drugs,”, was executed by making the substitution for the phrase which in the original began with “on the date of the enactment of the Drug Addiction Treatment Act of 2000,” rather than the editorial translation “on October 17, 2000,” to reflect the probable intent of Congress.
Subsec. (g)(2)(J)(i). Pub. L. 107–273, § 2501(2), which directed the substitution of “the date referred to in subparagraph (I),” for “October 17, 2000,” was executed by making the substitution for text which in the original read “the date of the enactment of the Drug Addiction Treatment Act of 2000,” rather than the editorial translation “October 17, 2000,” to reflect the probable intent of Congress.
2000—Subsec. (g). Pub. L. 106–310 designated existing provisions as par. (1), substituted “Except as provided in paragraph (2), practitioners who dispense” for “Practitioners who dispense”, redesignated former pars. (1) to (3) as subpars. (A) to (C), respectively, of par. (1) and redesignated former subpars. (A) and (B) of former par. (2) as cls. (i) and (ii), respectively, of subpar. (B) of par. (1), and added par. (2).
1993—Subsec. (h). Pub. L. 103–200 added subsec. (h).
1984—Subsec. (f). Pub. L. 98–473 amended subsec. (f) generally, substituting provisions relating to registration authority of Attorney General respecting dispensation or conduct of research with controlled research, and separate authority of Secretary respecting registration, for provisions relating to general registration requirements respecting dispensation or conduct of research with controlled or nonnarcotic controlled substances.
1978—Subsec. (f). Pub. L. 95–633 inserted provision relating to the construction of the Convention on Psychotropic Substances.
1974—Subsec. (g). Pub. L. 93–281 added subsec. (g).