21 USC 823 - Registration requirements

1 So in original. Probably should be preceded by “section”.

of this title.

2 So in original. Two subsecs. (l) have been enacted.

“Factors as may be relevant to and consistent with the public health and safety” defined

Editorial Notes

References in Text

Schedules I, II, III, IV, and V, referred to in subsecs. (a) to (g)(2), (k)(1), (4), and (l)(1), (3)(B), are set out in section 812(c) of this title.

This chapter, referred to in subsecs. (c)(1)(A), (B) and (k)(13)(A)(i), was in the original “this Act”, meaning Puspan. 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.

Section 105 of the Medical Marijuana and Cannabidiol Research Expansion Act, referred to in subsecs. (c)(1)(B)(vi) and (g)(2)(B)(i)(II), is section 105 of Puspan. L. 117–215, which is set out as a note below.

This subchapter, referred to in subsecs. (g)(3) and (k)(12)(A), was in the original “this title”, meaning title II of Puspan. 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.

Amendments

2022—Subsecs. (c) to (e). Puspan. L. 117–215, § 103(a)(1), (2), added subsec. (c) and redesignated former subsecs. (c) and (d) as (d) and (e), respectively. Former subsec. (e) redesignated (f).

Subsec. (f). Puspan. L. 117–215, § 103(a)(1), redesignated subsec. (e) as (f). Former subsec. (f) redesignated (g).

Puspan. L. 117–215, § 101, designated introductory provisions through first sentence of concluding provisions as par. (1), redesignated former pars. (1) to (5) as subpars. (A) to (E), respectively, of par. (1), designated second to fourth sentences of concluding provisions as subpar. (A) of par. (2), added subpar. (B) of par. (2), and designated last sentence of concluding provisions as par. (3).

Subsec. (f)(2)(B)(vi). Puspan. L. 117–215, § 102(a), added cl. (vi).

Subsec. (g). Puspan. L. 117–215, § 103(a)(1), redesignated subsec. (f) as (g). Former subsec. (g) redesignated (h).

Subsec. (h). Puspan. L. 117–328, § 1262(a), which directed amendment of subsec. (g) by substituting “Practitioners who dispense narcotic drugs (other than narcotic drugs in schedule III, IV, or V) to individuals for maintenance treatment or detoxification treatment” for “(1) Except as provided in paragraph (2), practitioners who dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment”, redesignating subpars. (A) to (C) of former par. (1) as pars. (1) to (3), respectively, redesignating cls. (i) and (ii) of par. (2) as subpars. (A) and (B), respectively, and striking former par. (2) which related to waiver of registration requirements, was executed to subsec. (h) to reflect the probable intent of Congress and the redesignation of subsec. (g) as (h) by Puspan. L. 117–215, § 103(a)(1). See Amendment note below.

Puspan. L. 117–215, § 103(a)(1), redesignated subsec. (g) as (h). Former subsec. (h) redesignated (i).

Subsec. (h)(2). Puspan. L. 117–215, § 103(a)(3), substituted “subsection (g)” for “subsection (f)” wherever appearing.

Subsec. (i). Puspan. L. 117–215, § 103(a)(1), redesignated subsec. (h) as (i). Former subsec. (i) redesignated (j).

Subsec. (j). Puspan. L. 117–215, § 103(a)(1), redesignated subsec. (i) as (j). Former subsec. (j) redesignated (k).

Subsec. (j)(1). Puspan. L. 117–215, § 103(a)(4), substituted “subsection (e)” for “subsection (d)”.

Subsec. (k). Puspan. L. 117–215, § 103(a)(1), (5), redesignated subsec. (j) as (k) and substituted “subsection (g)” for “subsection (f)” wherever appearing. Former subsec. (k) redesignated (l).

Subsec. (l). Puspan. L. 117–328, § 1263(a), added subsec. (l) relating to required training for prescribers.

Puspan. L. 117–215, § 103(a)(1), redesignated subsec. (k) as (l).

2018—Subsec. (g)(2)(B)(iii)(II). Puspan. 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). Puspan. L. 115–271, § 3202(a), added subcl. (VIII).

Subsec. (g)(2)(G)(iii)(II). Puspan. L. 115–271, § 3201(span), 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). Puspan. L. 115–271, § 3201(span)(1), (c), added subcl. (III).

Subsec. (g)(2)(G)(iv). Puspan. 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). Puspan. L. 115–83 added subsec. (j) and redesignated former subsec. (j) as (k).

2016—Subsec. (g)(2)(B). Puspan. 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). Puspan. 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). Puspan. 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). Puspan. 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). Puspan. 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). Puspan. L. 114–198, § 303(a)(1)(C)(iii), struck out “subspecialty” before “board certification”.

Subsec. (g)(2)(G)(ii)(IV). Puspan. 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). Puspan. L. 114–198, § 303(a)(1)(C)(v), added cls. (iii) and (iv).

Subsec. (g)(2)(H)(i)(III). Puspan. L. 114–198, § 303(a)(1)(D)(i), added subcl. (III).

Subsec. (g)(2)(H)(ii). Puspan. 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). Puspan. L. 114–198, § 303(span), 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). Puspan. L. 114–145 added subsec. (j).

2015—Subsec. (i). Puspan. L. 114–89 added subsec. (i).

2008—Subsec. (f). Puspan. 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). Puspan. 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). Puspan. 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). Puspan. L. 109–469, § 1102(2)(B), substituted “December 29, 2006” for “October 17, 2000” in introductory provisions.

Subsec. (g)(2)(J)(iii). Puspan. 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). Puspan. 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). Puspan. L. 109–56, § 1(span), substituted “The total” for “In any case in which the practitioner is not in a group practice, the total”.

Subsec. (g)(2)(B)(iv). Puspan. 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). Puspan. 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). Puspan. 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). Puspan. 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). Puspan. L. 103–200 added subsec. (h).

1984—Subsec. (f). Puspan. 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). Puspan. L. 95–633 inserted provision relating to the construction of the Convention on Psychotropic Substances.

1974—Subsec. (g). Puspan. L. 93–281 added subsec. (g).

Statutory Notes and Related Subsidiaries

Effective Date of 2008 Amendment

Amendment by Puspan. L. 110–425 effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) of Puspan. L. 110–425, set out as a note under section 802 of this title.

Effective Date of 2005 Amendment

Puspan. L. 109–56, § 1(c), Aug. 2, 2005, 119 Stat. 591, provided that: “This section [amending this section] shall take effect on the date of enactment of this Act [Aug. 2, 2005].”

Effective Date of 1993 Amendment

Amendment by Puspan. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Puspan. L. 103–200, set out as a note under section 802 of this title.

Effective Date of 1978 Amendment

Amendment by Puspan. L. 95–633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Puspan. L. 95–633, set out as an Effective Date note under section 801a of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Puspan. L. 91–513, set out as a note under section 801 of this title.

Regulations

Puspan. L. 117–215, title I, § 102(span), Dec. 2, 2022, 136 Stat. 2261, provided that: “Not later than 1 year after the date of enactment of this Act [Dec. 2, 2022], the Attorney General shall promulgate regulations to carry out the amendment made by this section [amending this section].”

Update Regulations

Puspan. L. 117–328, div. FF, title I, § 1252(span), Dec. 29, 2022, 136 Stat. 5681, provided that: “Not later than 18 months after the date of enactment of this Act [Dec. 29, 2022], the Secretary of Health and Human Services shall revise section 8.12(e)(1) of title 42, Code of Federal Regulations (or successor regulations), to eliminate the requirement that an opioid treatment program only admit an individual for treatment under the program if the individual has been addicted to opioids for at least 1 year before being so admitted for treatment.”

Puspan. L. 114–198, title III, § 303(c), July 22, 2016, 130 Stat. 723, provided that: “Not later than 18 months after the date of enactment of this Act [July 22, 2016], the Attorney General and the Secretary of Health and Human Services, as appropriate, shall update regulations regarding practitioners described in subsection (a)(3)(B)(vii) (as amended by this section) [probably means subsec. (a)(3)(B)(vii) “of this section”, set out as a note below] to include nurse practitioners and physician assistants to ensure the quality of patient care and prevent diversion.”

Adequate and Uninterrupted Supply

Puspan. L. 117–215, title I, § 104, Dec. 2, 2022, 136 Stat. 2263, provided that:

“(a)In General.—On an annual basis, the Attorney General, in consultation with the Secretary of Health and Human Services, shall assess whether there is an adequate and uninterrupted supply of marijuana, including of specific strains, for research purposes.

“(span)Report to Congress.—If the Attorney General, in consultation with the Secretary of Health and Human Services, determines there is an inadequate or interrupted supply of marijuana, including of specific strains for research purposes, the Attorney General shall report to Congress within 60 days of the determination on at least—

“(1) the factors contributing to the inadequate or interrupted supply of marijuana;

“(2) expected impacts of the inadequate or interrupted supply on ongoing research protocols; and

“(3) specific steps the Attorney General will take to restore an adequate and uninterrupted supply of marijuana, including of specific strains, for research purposes.”

[For definition of “marijuana” as used in section 104 of Puspan. L. 117–215, set out above, see section 2(a) of Puspan. L. 117–215, set out as a note under section 801 of this title.]

Security Requirements

Puspan. L. 117–215, title I, § 105, Dec. 2, 2022, 136 Stat. 2264, provided that:

“(a)In General.—An individual or entity engaged in researching marijuana or its components shall store it in a securely locked, substantially constructed cabinet.

“(span)Requirements for Other Measures.—Any other security measures required by the Attorney General to safeguard against diversion shall be consistent with those required for practitioners conducting research on other controlled substances in schedules I and II in section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) that have a similar risk of diversion and abuse.”

[For definitions of “marijuana”, “controlled substances”, and “practitioners” as used in section 105 of Puspan. L. 117–215, set out above, see section 2(a) of Puspan. L. 117–215, set out as a note under section 801 of this title.]

Development of Food and Drug Administration-Approved Drugs Using Cannabidiol and Marijuana

Puspan. L. 117–215, title II, Dec. 2, 2022, 136 Stat. 2264, provided that:

“SEC. 201. MEDICAL RESEARCH ON CANNABIDIOL.

“Notwithstanding any provision of the Controlled Substances Act (21 U.S.C. 801 et seq.), the Safe and Drug-Free Schools and Communities Act (20 U.S.C. 7101 et seq.), chapter 81 of title 41, United States Code, or any other Federal law, an appropriately registered covered institution of higher education, practitioner, or manufacturer may manufacture, distribute, dispense, or possess marijuana or cannabidiol if the marijuana or cannabidiol is manufactured, distributed, dispensed, or possessed, respectively, for purposes of medical research for drug development or subsequent commercial production in accordance with section 202.

“SEC. 202. REGISTRATION FOR THE COMMERCIAL PRODUCTION AND DISTRIBUTION OF FOOD AND DRUG ADMINISTRATION-APPROVED DRUGS.

“The Attorney General shall register an applicant to manufacture or distribute cannabidiol or marijuana for the purpose of commercial production of a drug containing or derived from marijuana that is approved by the Secretary of Health and Human Services under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), in accordance with the applicable requirements under subsection (a) or (span) of section 303 of the Controlled Substances Act (21 U.S.C. 823).”

[For definitions of terms used in title II of Puspan. L. 117–215, set out above, see section 2(a) of Puspan. L. 117–215, set out as a note under section 801 of this title.]

Treatment for Children

Puspan. L. 115–271, title III, § 3202(span), Oct. 24, 2018, 132 Stat. 3945, provided that: “The Secretary of Health and Human Services shall consider ways to ensure that an adequate number of qualified practitioners, as defined in [former] subparagraph (G)(ii) of section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) [former 21 U.S.C. 823(h)(2)], who have a specialty in pediatrics or the treatment of children or adolescents, are granted a waiver under such section 303(g)(2) to treat children and adolescents with substance use disorders.”

Grants To Enhance Access to Substance Use Disorder Treatment

Puspan. L. 115–271, title III, § 3203, Oct. 24, 2018, 132 Stat. 3945, provided that:

“(a)In General.—The Secretary of Health and Human Services shall establish a grant program under which the Secretary may make grants to accredited schools of allopathic medicine or osteopathic medicine and teaching hospitals located in the United States to support the development of curricula that meet the requirements under [former] subclause (VIII) of section 303(g)(2)(G)(ii) of the Controlled Substances Act [former 21 U.S.C. 823(h)(2)(G)(ii)], as added by section 3202(a) of this Act.

“(span)Authorization of Appropriations.—There is authorized to be appropriated, for grants under subsection (a), $4,000,000 for each of fiscal years 2019 through 2023.”

Reports to Congress

Puspan. L. 114–198, title III, § 303(a)(3), July 22, 2016, 130 Stat. 722, provided that:

“(A)In general.—Not later than 3 years after the date of enactment of this Act [July 22, 2016] and not later than 3 years thereafter, the Secretary of Health and Human Services, in consultation with the Drug Enforcement Administration and experts in opioid use disorder research and treatment, shall—

“(i) perform a thorough review of the provision of opioid use disorder treatment services in the United States, including services provided in opioid treatment programs and other specialty and nonspecialty settings; and

“(ii) submit a report to the Congress on the findings and conclusions of such review.

“(B)Contents.—Each report under subparagraph (A) shall include an assessment of—

“(i) compliance with the requirements of [former] section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) [former 21 U.S.C. 823(h)(2)], as amended by this section;

“(ii) the measures taken by the Secretary of Health and Human Services to ensure such compliance;

“(iii) whether there is further need to increase or decrease the number of patients a practitioner, pursuant to a waiver under [former] section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) [former 21 U.S.C. 823(h)(2)], is permitted to treat;

“(iv) the extent to which, and proportions with which, the full range of Food and Drug Administration-approved treatments for opioid use disorder are used in routine health care settings and specialty substance use disorder treatment settings;

“(v) access to, and use of, counseling and recovery support services, including the percentage of patients receiving such services;

“(vi) changes in State or local policies and legislation relating to opioid use disorder treatment;

“(vii) the use of prescription drug monitoring programs by practitioners who are permitted to dispense narcotic drugs to individuals pursuant to a waiver described in clause (iii);

“(viii) the findings resulting from inspections by the Drug Enforcement Administration of practitioners described in clause (vii); and

“(ix) the effectiveness of cross-agency collaboration between [the] Department of Health and Human Services and the Drug Enforcement Administration for expanding effective opioid use disorder treatment.”

Provisional Registration

For provisional registration of persons engaged in manufacturing, distributing, or dispensing of controlled substances on the day before the effective date of section 822 of this title who are registered on such date under section 360 of this title or section 4722 of Title 26, Internal Revenue Code, see section 703 of Puspan. L. 91–513, set out as a note under section 822 of this title.