Source: https://www.deadiversion.usdoj.gov/21cfr/21usc/823.htm
Timestamp: 2019-04-23 20:47:34+00:00

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(i) The practitioner is a qualifying practitioner (as defined in subparagraph (G)).
(II) appropriate counseling and other appropriate ancillary services.
(iii)(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.
(II) 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.
(III) The Secretary may by regulation change such applicable number.
(IV) The Secretary may exclude from the applicable number patients to whom such drugs or combinations of drugs are directly administered by the qualifying practitioner in the office setting.
(II) The notification identifies the registration issued for the practitioner pursuant to subsection (f).
(III) If the practitioner is a member of a group practice, the notification states the names of the other practitioners in the practice and identifies the registrations issued for the other practitioners pursuant to subsection (f).
(ii) Upon receiving a determination from the Secretary under clause (iii) finding that a practitioner meets all requirements for a waiver under subparagraph (B), the Attorney General shall assign the practitioner involved an identification number under this paragraph for inclusion with the registration issued for the practitioner pursuant to subsection (f). The identification number so assigned shall be appropriate to preserve the confidentiality of patients for whom the practitioner has dispensed narcotic drugs under a waiver under subparagraph (A).
(iii) Not later than 45 days after the date on which the Secretary receives a notification under subparagraph (B), the Secretary shall make a determination of whether the practitioner involved meets all requirements for a waiver under subparagraph (B) and shall forward such determination to the Attorney General. If the Secretary fails to make such determination by the end of the such 45-day period, the Attorney General shall assign the practitioner an identification number described in clause (ii) at the end of such period.
(E)(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) The physician holds a board certification in addiction psychiatry or addiction medicine from the American Board of Medical Specialties.
(II) The physician holds an addiction certification or board certification from the American Society of Addiction Medicine or the American Board of Addiction Medicine.
(III) The physician holds a board certification in addiction medicine from the American Osteopathic Association.
(hh) other best practices, as identified by the Secretary.
(II) during the period beginning on July 22, 2016, and ending on October 1, 2021, a qualifying other practitioner, as defined in clause (iv).
(I) The nurse practitioner 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 or physician assistant to treat and manage opiate-dependent patients.
(III) The nurse practitioner or physician assistant is supervised by, or works in collaboration with, a qualifying physician, if the nurse practitioner 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.
The Secretary may, by regulation, revise the requirements for being a qualifying other practitioner under this clause.
(III) Such other elements of the requirements under this paragraph as the Secretary determines necessary for purposes of implementing such requirements.
(ii) Not later than 18 months after the date of enactment of the Opioid Use Disorder Treatment Expansion and Modernization Act,\1\ 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.
(ii) requires a qualifying practitioner to comply with additional requirements relating to the dispensing of narcotic drugs in schedule III, IV, or V, or combinations of such drugs, including requirements relating to the practice setting in which the qualifying practitioner practices and education, training, and reporting requirements.
(1) For purposes of registration to manufacture a controlled substance under subsection (d) for use only in a clinical trial, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with section 824(c) of this title, not later than 180 days after the date on which the application is accepted for filing.
(2) For purposes of registration to manufacture a controlled substance under subsection (a) for use only in a clinical trial, the Attorney General shall, in accordance with the regulations issued by the Attorney General, issue a notice of application not later than 90 days after the application is accepted for filing. Not later than 90 days after the date on which the period for comment pursuant to such notice ends, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with section 824(c) of this title, unless the Attorney General has granted a hearing on the application under section 958(i) of this title.
(B) may deny an application for such registration if the Attorney General determines that the issuance of such registration would be inconsistent with the requirements of this subsection or the public interest based on the factors listed in subsection (f).
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.
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.
(bb) to ensure the proper care and treatment of a specific patient.
(B) notifies the Attorney General at least 30 days prior to first delivering controlled substances to the unregistered location.
(ii) otherwise actively in use by the agency under circumstances that provide for security of the controlled substances consistent with the requirements established by regulations of the Attorney General.
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) The registered or designated location of the agency where the vehicle is primarily situated maintains a record of such receipt in accordance with paragraph (9).
(B) The hospital maintains a record of such delivery to the agency in accordance with section 827 of this title.
(C) If the vehicle is primarily situated at a designated location, such location notifies the registered location of the agency within 72 hours of the vehicle receiving the controlled substances.
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.
(ii) shall be maintained, whether electronically or otherwise, at each registered and designated location of the agency where the controlled substances involved are received, administered, or otherwise disposed of.
(D) the agency maintains, at a registered location of the agency, a record of the standing orders issued or adopted in accordance with paragraph (9).
(iii) a mass casualty event.
(B) to override the authority of any State to regulate the provision of emergency medical services consistent with this subsection.
(iii) whose scope of practice under a State license or certification includes the ability to provide verbal orders.
(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.
(iii) is authorized by the State in which the organization is providing such services to provide emergency medical care, including the administering of controlled substances, to members of the general public on an emergency basis.
(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.
(ii) a hospital-based emergency medical services agency that is covered by the registration of the hospital under subsection (f).
(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.
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.
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.
2017—Subsecs. (j), (k). Pub. L. 115–83 added subsec. (j) and redesignated former subsec. (j) as (k).
"(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.
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]."
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."
"(ii) submit a report to the Congress on the findings and conclusions of such review.
"(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."

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