21 U.S.C. 823: Registration requirements

2022

• Pub. 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). (Medical Marijuana and Cannabidiol Research Expansion Act) Law text · (c), (d), (e)
• Pub. L. 117–215, §103(a)(1), redesignated subsec. (e) as (f). Former subsec. (f) redesignated (g). (Medical Marijuana and Cannabidiol Research Expansion Act) Law text · (f)
• Pub. 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), a… (Medical Marijuana and Cannabidiol Research Expansion Act) Law text · (f)
• Pub. L. 117–215, §102(a), added cl. (vi). (Medical Marijuana and Cannabidiol Research Expansion Act) Law text · (f)
• Pub. L. 117–215, §103(a)(1), redesignated subsec. (f) as (g). Former subsec. (g) redesignated (h). (Medical Marijuana and Cannabidiol Research Expansion Act) Law text · (g)
• Pub. 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 parag… (Consolidated Appropriations Act, 2023) Law text · (h)
• Pub. L. 117–215, §103(a)(1), redesignated subsec. (g) as (h). Former subsec. (h) redesignated (i). (Medical Marijuana and Cannabidiol Research Expansion Act) Law text · (h)
• Pub. L. 117–215, §103(a)(3), substituted "subsection (g)" for "subsection (f)" wherever appearing. (Medical Marijuana and Cannabidiol Research Expansion Act) Law text · (h)
• Pub. L. 117–215, §103(a)(1), redesignated subsec. (h) as (i). Former subsec. (i) redesignated (j). (Medical Marijuana and Cannabidiol Research Expansion Act) Law text · (i)
• Pub. L. 117–215, §103(a)(1), redesignated subsec. (i) as (j). Former subsec. (j) redesignated (k). (Medical Marijuana and Cannabidiol Research Expansion Act) Law text · (j)
• Pub. L. 117–215, §103(a)(4), substituted "subsection (e)" for "subsection (d)". (Medical Marijuana and Cannabidiol Research Expansion Act) Law text · (j)
• Pub. 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). (Medical Marijuana and Cannabidiol Research Expansion Act) Law text · (k)
• Pub. L. 117–328, §1263(a), added subsec. (l) relating to required training for prescribers. (Consolidated Appropriations Act, 2023) Law text · (l)
• Pub. L. 117–215, §103(a)(1), redesignated subsec. (k) as (l). (Medical Marijuana and Cannabidiol Research Expansion Act) Law text · (l)

2018

• 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 sec… (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (g)
• Pub. L. 115–271, §3202(a), added subcl. (VIII). (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (g)
• 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)." (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (g)
• Pub. L. 115–271, §3201(b)(1), (c), added subcl. (III). (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (g)
• 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. (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (g)

2017

• Pub. L. 115–83 added subsec. (j) and redesignated former subsec. (j) as (k). (Protecting Patient Access to Emergency Medications Act of 2017) Law text · (j), (k)

2016

• 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: (Comprehensive Addiction and Recovery Act of 2016) Law text · (g)
• 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)". (Comprehensive Addiction and Recovery Act of 2016) Law text · (g)
• 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". (Comprehensive Addiction and Recovery Act of 2016) Law text · (g)
• 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." (Comprehensive Addiction and Recovery Act of 2016) Law text · (g)
• 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." (Comprehensive Addiction and Recovery Act of 2016) Law text · (g)
• Pub. L. 114–198, §303(a)(1)(C)(iii), struck out "subspecialty" before "board certification". (Comprehensive Addiction and Recovery Act of 2016) Law text · (g)
• 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 clas… (Comprehensive Addiction and Recovery Act of 2016) Law text · (g)
• Pub. L. 114–198, §303(a)(1)(C)(v), added cls. (iii) and (iv). (Comprehensive Addiction and Recovery Act of 2016) Law text · (g), (iv)
• Pub. L. 114–198, §303(a)(1)(D)(i), added subcl. (III). (Comprehensive Addiction and Recovery Act of 2016) Law text · (g)
• 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 … (Comprehensive Addiction and Recovery Act of 2016) Law text · (g)
• 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 Secreta… (Comprehensive Addiction and Recovery Act of 2016) Law text · (g), (J)
• Pub. L. 114–145 added subsec. (j). (Ensuring Patient Access and Effective Drug Enforcement Act of 2016) Law text · (j)

2015

• Pub. L. 114–89 added subsec. (i). (Improving Regulatory Transparency for New Medical Therapies Act) Law text · (i)

2008

• 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 i… (Ryan Haight Online Pharmacy Consumer Protection Act of 2008) Law text · (f)

2006

• 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 p… (Office of National Drug Control Policy Reauthorization Act of 2006) Law text · (g)
• 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)." (Office of National Drug Control Policy Reauthorization Act of 2006) Law text · (g)
• Pub. L. 109–469, §1102(2)(B), substituted "December 29, 2006" for "October 17, 2000" in introductory provisions. (Office of National Drug Control Policy Reauthorization Act of 2006) Law text · (g)
• 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 "thi… (Office of National Drug Control Policy Reauthorization Act of 2006) Law text · (g)
• 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. (USA PATRIOT Improvement and Reauthorization Act of 2005) Law text · (h)

2005

• 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". Law text · (g)
• 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 app… Law text · (g)

2002

• 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… (21st Century Department of Justice Appropriations Authorization Act) Law text · (g)
• 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,… (21st Century Department of Justice Appropriations Authorization Act) Law text · (g)

2000

• 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 sub… (Children's Health Act of 2000) Law text · (g)

1993

• Pub. L. 103–200 added subsec. (h). · (h)

1984

• 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 … · (f)

1978

• Pub. L. 95–633 inserted provision relating to the construction of the Convention on Psychotropic Substances. · (f)

1974

• Pub. L. 93–281 added subsec. (g). · (g)