Source: https://casetext.com/statute/united-states-code/title-21-food-and-drugs/chapter-13-drug-abuse-prevention-and-control/subchapter-i-control-and-enforcement/part-c-registration-of-manufacturers-distributors-and-dispensers-of-controlled-substances/823-registration-requirements?ref=AsVVwS!71E8XX
Timestamp: 2019-04-20 21:02:41+00:00

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(c) Limits of authorized activities Registration granted under subsections (a) and (b) of this section shall not entitle a registrant to (1) manufacture or distribute controlled substances in schedule I or II other than those specified in the registration, or (2) manufacture any quantity of those controlled substances in excess of the quota assigned pursuant to section 826 of this title.
(A) Subject to subparagraphs (D) and (J), the requirements of paragraph (1) are waived in the case of the dispensing (including the prescribing), by a practitioner, of narcotic drugs in schedule III, IV, or V or combinations of such drugs if the practitioner meets the conditions specified in subparagraph (B) and the narcotic drugs or combinations of such drugs meet the conditions specified in subparagraph (C).
(I) The total number of such patients of the practitioner at any one time will not exceed the applicable number. Except as provided in subclause (II), the applicable number is 30.
(dd) 275 if the practitioner meets the requirements specified in sections 8.610 through 8.655 of title 42, Code of Federal Regulations (or successor regulations).
(i) If a practitioner is not registered under paragraph (1) and, in violation of the conditions specified in subparagraphs (B) through (D), dispenses narcotic drugs in schedule III, IV, or V or combinations of such drugs for maintenance treatment or detoxification treatment, the Attorney General may, for purposes of section 824(a)(4) of this title, consider the practitioner to have committed an act that renders the registration of the practitioner pursuant to subsection (f) to be inconsistent with the public interest.
(I) Upon the expiration of 45 days from the date on which the Secretary receives a notification under subparagraph (B), a practitioner who in good faith submits a notification under subparagraph (B) and reasonably believes that the conditions specified in subparagraphs (B) through (D) have been met shall, in dispensing narcotic drugs in schedule III, IV, or V or combinations of such drugs for maintenance treatment or detoxification treatment, be considered to have a waiver under subparagraph (A) until notified otherwise by the Secretary, except that such a practitioner may commence to prescribe or dispense such narcotic drugs for such purposes prior to the expiration of such 45-day period if it facilitates the treatment of an individual patient and both the Secretary and the Attorney General are notified by the practitioner of the intent to commence prescribing or dispensing such narcotic drugs.
(i) With respect to the dispensing of narcotic drugs in schedule III, IV, or V or combinations of such drugs to patients for maintenance or detoxification treatment, a practitioner may, in his or her discretion, dispense such drugs or combinations for such treatment under a registration under paragraph (1) or a waiver under subparagraph (A) (subject to meeting the applicable conditions).
(i) The term “group practice” has the meaning given such term in section 1395nn(h)(4) of title 42.
(BB) training with respect to any other best practice the Secretary determines should be included in the curriculum, which may include training on pain management, including assessment and appropriate use of opioid and non-opioid alternatives.
(III) for the period beginning on October 1, 2018, and ending on October 1, 2023, a qualifying other practitioner, as defined in clause (iv), who is a clinical nurse specialist, certified registered nurse anesthetist, or certified nurse midwife.
(I) The nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant is licensed under State law to prescribe schedule III, IV, or V medications for the treatment of pain.
(bb) has such other training or experience as the Secretary determines will demonstrate the ability of the nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant to treat and manage opiate-dependent patients.
(III) The nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant is supervised by, or works in collaboration with, a qualifying physician, if the nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant is required by State law to prescribe medications for the treatment of opioid use disorder in collaboration with or under the supervision of a physician.
(ii) Not later than 18 months after the date of enactment of the Opioid Use Disorder Treatment Expansion and Modernization Act,See References in Text note below. the Secretary shall update the treatment improvement protocol containing best practice guidelines for the treatment of opioid-dependent patients in office-based settings. The Secretary shall update such protocol in consultation with experts in opioid use disorder research and treatment.
(2) Option for single registration In registering an emergency medical services agency pursuant to paragraph (1), the Attorney General shall allow such agency the option of a single registration in each State where the agency administers controlled substances in lieu of requiring a separate registration for each location of the emergency medical services agency.
(3) Hospital-based agency If a hospital-based emergency medical services agency is registered under subsection (f), the agency may use the registration of the hospital to administer controlled substances in accordance with this subsection without being registered under this subsection.
(7) No treatment as distribution The delivery of controlled substances by a registered emergency medical services agency pursuant to this subsection shall not be treated as distribution for purposes of section 828 of this title.
(A) In general A registered emergency medical services agency shall maintain records in accordance with subsections (a) and (b) of section 827 of this title of all controlled substances that are received, administered, or otherwise disposed of pursuant to the agency’s registration, without regard to subsection 827(c)(1)(B) of this title.
(B) The term “designated location” means a location designated by an emergency medical services agency under paragraph (5).
(C) The term “emergency medical services” means emergency medical response and emergency mobile medical services provided outside of a fixed medical facility.
(E) The term “emergency medical services professional” means a health care professional (including a nurse, paramedic, or emergency medical technician) licensed or certified by the State in which the professional practices and credentialed by a medical director of the respective emergency medical services agency to provide emergency medical services within the scope of the professional’s State license or certification.
(F) The term “emergency medical services vehicle” means an ambulance, fire apparatus, supervisor truck, or other vehicle used by an emergency medical services agency for the purpose of providing or facilitating emergency medical care and transport or transporting controlled substances to and from the registered and designated locations.
(G) The term “hospital-based” means, with respect to an agency, owned or operated by a hospital.
(H) The term “medical director” means a physician who is registered under subsection (f) and provides medical oversight for an emergency medical services agency.
(I) The term “medical oversight” means supervision of the provision of medical care by an emergency medical services agency.
(K) The term “registered location” means a location that appears on the certificate of registration issued to an emergency medical services agency under this subsection or subsection (f), which shall be where the agency receives controlled substances from distributors.
(L) The term “specific State authority” means a governmental agency or other such authority, including a regional oversight and coordinating body, that, pursuant to State law or regulation, develops clinical protocols regarding the delivery of emergency medical services in the geographic jurisdiction of such agency or authority within the State that may be adopted by medical directors.
(M) The term “standing order” means a written medical protocol in which a medical director determines in advance the medical criteria that must be met before administering controlled substances to individuals in need of emergency medical services.
(N) The term “verbal order” means an oral directive that is given through any method of communication including by radio or telephone, directly to an emergency medical services professional, to contemporaneously administer a controlled substance to individuals in need of emergency medical services outside the physical presence of the medical director or authorizing medical professional.
(k) “Factors as may be relevant to and consistent with the public health and safety” defined In this section, the phrase “factors as may be relevant to and consistent with the public health and safety” means factors that are relevant to and consistent with the findings contained in section 801 of this title.
(Pub. L. 91-513, title II, § 303, Oct. 27, 1970, 84 Stat. 1253; Pub. L. 93-281, § 3, May 14, 1974, 88 Stat. 124; Pub. L. 95-633, title I, § 109, Nov. 10, 1978, 92 Stat. 3773; Pub. L. 98-473, title II, § 511, Oct. 12, 1984, 98 Stat. 2073; Pub. L. 103-200, § 3(c), Dec. 17, 1993, 107 Stat. 2336; Pub. L. 106-310, div. B, title XXXV, § 3502(a), Oct. 17, 2000, 114 Stat. 1222; Pub. L. 107-273, div. B, title II, § 2501, Nov. 2, 2002, 116 Stat. 1803; Pub. L. 109-56, § 1(a), (b), Aug. 2, 2005, 119 Stat. 591; Pub. L. 109-177, title VII, § 712(a)(3), Mar. 9, 2006, 120 Stat. 263; Pub. L. 109-469, title XI, § 1102, Dec. 29, 2006, 120 Stat. 3540; Pub. L. 110-425, § 3(b), Oct. 15, 2008, 122 Stat. 4824; Pub. L. 114-89, § 3, Nov. 25, 2015, 129 Stat. 701; Pub. L. 114-145, § 2(a)(1), Apr. 19, 2016, 130 Stat. 354; Pub. L. 114-198, title III, § 303(a)(1), (b), July 22, 2016, 130 Stat. 720, 723; Pub. L. 115-83, § 2, Nov. 17, 2017, 131 Stat. 1267; Pub. L. 115-271, title III, §§ 3201(a)-(d), 3202(a), Oct. 24, 2018, 132 Stat. 3943, 3944.) 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. 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). Amendment by Pub. L. 110-425 effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) of Pub. L. 110-425, set out as a note under section 802 of this title. Pub. 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].” Amendment by Pub. L. 103-200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103-200, set out as a note under section 802 of this title. Amendment by Pub. 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 Pub. L. 95-633, set out as an Effective Date note under section 801a of this title. Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91-513, set out as a note under section 801 of this title. Pub. 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.” Pub. L. 115-271, title III, § 3202(b), 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 subparagraph (G)(ii) of section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(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.” Pub. 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 subclause (VIII) of section 303(g)(2)(G)(ii) of the Controlled Substances Act [21 U.S.C. 823(g)(2)(G)(ii)], as added by section 3202(a) of this Act. “(b) 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.” Pub. 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 section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(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 section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(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.” 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 Pub. L. 91-513, set out as a note under section 822 of this title.

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