(a) Manufacturers of controlled substances in schedule I or II The Attorney General shall register an applicant to manufacture controlled substances in schedule I or II if he determines that such registration is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. In determining the public interest, the following factors shall be considered:
(1) maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule I or II compounded therefrom into other than legitimate medical, scientific, research, or industrial channels, by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes;
(2) compliance with applicable State and local law;
(3) promotion of technical advances in the art of manufacturing these substances and the development of new substances;
(4) prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of such substances;
(5) past experience in the manufacture of controlled substances, and the existence in the establishment of effective control against diversion; and
(6) such other factors as may be relevant to and consistent with the public health and safety.
(b) Distributors of controlled substances in schedule I or II The Attorney General shall register an applicant to distribute a controlled substance in schedule I or II unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered:
(1) maintenance of effective control against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels;
(2) compliance with applicable State and local law;
(3) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances;
(4) past experience in the distribution of controlled substances; and
(5) such other factors as may be relevant to and consistent with the public health and safety.
(c) Limits Manufacturers of authorized activities Registration granted under subsections (a) and (b) marijuana for research purposes (1) (A) As it relates to applications to manufacture marijuana for research purposes, when the Attorney General places a notice in the Federal Register to increase the number of entities registered under this section shall not entitle a registrant chapter to (1) manufacture marijuana to supply appropriately registered researchers in the United States, the Attorney General shall, not later than 60 days after the date on which the Attorney General receives a completed application— (i) approve the application; or distribute (ii) request supplemental information. (B) For purposes of subparagraph (A), an application shall be deemed complete when the applicant has submitted documentation showing each of the following: (i) The requirements designated in the notice in the Federal Register are satisfied. (ii) The requirements under this chapter are satisfied. (iii) The applicant will limit the transfer and sale of any marijuana manufactured under this subsection— (I) to researchers who are registered under this chapter to conduct research with controlled substances in schedule I I; and (II) for purposes of use in preclinical research or II other than those specified in a clinical investigation pursuant to an investigational new drug exemption under 355(i) 1 of this title. (iv) The applicant will transfer or sell any marijuana manufactured under this subsection only with prior, written consent for the registration, transfer or (2) sale by the Attorney General. (v) The applicant has completed the application and review process under subsection (a) for the bulk manufacture any quantity of those controlled substances in excess schedule I. (vi) The applicant has established and begun operation of the quota assigned pursuant to a process for storage and handling of controlled substances in schedule I, including for inventory control and monitoring security in accordance with section 826 105 of the Medical Marijuana and Cannabidiol Research Expansion Act. (vii) The applicant is licensed by each State in which the applicant will conduct operations under this title . subsection, to manufacture marijuana, if that State requires such a license. (C) Not later than 30 days after the date on which the Attorney General receives supplemental information requested under subparagraph (A)(ii) with respect to an application, the Attorney General shall approve or deny the application. (2) If an application described in this subsection is denied, the Attorney General shall provide a written explanation of the basis of denial to the applicant.
(d) Manufacturers Limits of controlled substances in schedule III, IV, or V The Attorney General authorized activities Registration granted under subsections (a) and (b) of this section shall register an applicant not entitle a registrant to (1) manufacture controlled substances in schedule III, IV, or V, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered: (1) maintenance of effective controls against diversion of particular distribute controlled substances and any controlled substance in schedule III, IV, I or V compounded therefrom into II other than legitimate medical, scientific, or industrial channels; (2) compliance with applicable State and local law; (3) promotion of technical advances those specified in the art of manufacturing these substances and the development of new substances; (4) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, registration, or dispensing of such substances; (5) past experience in the manufacture, distribution, and dispensing (2) manufacture any quantity of those controlled substances, and the existence substances in the establishment excess of effective controls against diversion; and (6) such other factors as may be relevant to and consistent with the public health and safety. quota assigned pursuant to section 826 of this title .
(e) Distributors Manufacturers of controlled substances in schedule III, IV, or V The Attorney General shall register an applicant to distribute manufacture controlled substances in schedule III, IV, or V, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered: (1) maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule III, IV, or V compounded therefrom into other than legitimate medical, scientific, and or industrial channels; (2) compliance with applicable State and local law; (3) promotion of technical advances in the art of manufacturing these substances and the development of new substances; (4) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances; (4) (5) past experience in the distribution manufacture, distribution, and dispensing of controlled substances; substances, and (5) the existence in the establishment of effective controls against diversion; and (6) such other factors as may be relevant to and consistent with the public health and safety.
(f) Research by practitioners; pharmacies; research applications; construction of Article 7 Distributors of the Convention on Psychotropic Substances The Attorney General shall register practitioners (including pharmacies, as distinguished from pharmacists) to dispense, or conduct research with, controlled substances in schedule II, III, IV, or V and The Attorney General shall modify the registrations of pharmacies so registered to authorize them to dispense controlled substances by means of the Internet, if the register an applicant is authorized to dispense, or conduct research with respect to, distribute controlled substances under the laws of the State in which he practices. The Attorney General may deny an application for such registration schedule III, IV, or such modification of registration if the Attorney General V, unless he determines that the issuance of such registration or modification would be is inconsistent with the public interest. In determining the public interest, the following factors shall be considered: (1) The recommendation maintenance of the appropriate State licensing board or professional disciplinary authority. effective controls against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels; (2) The applicant’s experience in dispensing, or conducting research compliance with respect to controlled substances. applicable State and local law; (3) The applicant’s prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances. such substances; (4) Compliance with applicable State, Federal, or local laws relating to past experience in the distribution of controlled substances. substances; and (5) Such such other conduct which factors as may threaten the public health and safety. Separate registration under this part for practitioners engaging in research with controlled substances in schedule II, III, IV, or V, who are already registered under this part in another capacity, shall not be required. Registration applications by practitioners wishing to conduct research with controlled substances in schedule I shall be referred relevant to the Secretary, who shall determine the qualifications and competency of each practitioner requesting registration, as well as the merits of the research protocol. The Secretary, in determining the merits of each research protocol, shall consult with the Attorney General as to effective procedures to adequately safeguard against diversion of such controlled substances from legitimate medical or scientific use. Registration for the purpose of bona fide research consistent with controlled substances in schedule I by a practitioner deemed qualified by the Secretary may be denied by the Attorney General only on a ground specified in section 824(a) of this title . Article 7 of the Convention on Psychotropic Substances shall not be construed to prohibit, or impose additional restrictions upon, research involving drugs or other substances scheduled under the convention which is conducted in conformity with this subsection public health and other applicable provisions of this subchapter. safety.
(g) Practitioners dispensing narcotic drugs for narcotic treatment; annual registration; separate registration; qualifications; waiver Research by practitioners; pharmacies; research applications; construction of Article 7 of the Convention on Psychotropic Substances (1) Except as provided in paragraph (2), practitioners who dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment shall obtain annually a separate registration for that purpose. The Attorney General shall register an applicant to dispense narcotic drugs practitioners (including pharmacies, as distinguished from pharmacists) to individuals for maintenance treatment dispense, or detoxification treatment (or both) (A) if the applicant is a practitioner who is determined by conduct research with, controlled substances in schedule II, III, IV, or V and shall modify the Secretary registrations of pharmacies so registered to be qualified (under standards established by the Secretary) authorize them to engage in dispense controlled substances by means of the treatment with respect to which registration is sought; (B) Internet, if the Attorney General determines that the applicant will comply is authorized to dispense, or conduct research with standards established by respect to, controlled substances under the laws of the State in which he practices. The Attorney General respecting (i) security of stocks of narcotic drugs may deny an application for such treatment, and (ii) the maintenance of records (in accordance with section 827 of this title ) on registration or such drugs; and (C) modification of registration if the Secretary Attorney General determines that the applicant will comply issuance of such registration or modification would be inconsistent with standards established by the Secretary (after consultation with public interest. In determining the Attorney General) respecting public interest, the quantities of narcotic drugs which may following factors shall be provided for unsupervised use by individuals in such treatment. (2) considered: (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 The recommendation of such drugs if the practitioner meets the conditions specified in subparagraph (B) and the narcotic drugs appropriate State licensing board or combinations of such drugs meet the conditions specified in subparagraph (C). professional disciplinary authority. (B) For purposes of subparagraph (A), the conditions specified The applicant’s experience in this subparagraph dispensing, or conducting research with respect to a practitioner are that, before controlled substances. (C) The applicant’s conviction record under Federal or State laws relating to the initial manufacture, distribution, or dispensing of narcotic drugs controlled substances. (D) Compliance with applicable State, Federal, or local laws relating to controlled substances. (E) Such other conduct which may threaten the public health and safety. Separate registration under this part for practitioners engaging in research with controlled substances in schedule II, III, IV, or V or combinations of such drugs V, who are already registered under this part in another capacity, shall not be required. (2) (A) Registration applications by practitioners wishing to patients for maintenance or detoxification treatment, the practitioner submit conduct research with controlled substances in schedule I shall be referred to the Secretary a notification of Secretary, who shall determine the intent qualifications and competency of the each practitioner to begin dispensing the drugs or combinations for such purpose, and that the notification contain requesting registration, as well as the following certifications by merits of the practitioner: (i) research protocol. The practitioner is a qualifying practitioner (as defined Secretary, in subparagraph (G)). (ii) With respect to patients to whom determining the practitioner will provide such drugs or combinations merits of drugs, the practitioner has each research protocol, shall consult with the capacity Attorney General as to provide directly, by referral, or in effective procedures to adequately safeguard against diversion of such other manner as determined by the Secretary— (I) all drugs approved by the Food and Drug Administration controlled substances from legitimate medical or scientific use. Registration for the treatment of opioid use disorder, including for maintenance, detoxification, overdose reversal, and relapse prevention; and (II) appropriate counseling and other appropriate ancillary services. (iii) (I) The total number of such patients purpose of the practitioner at any one time will not exceed the applicable number. Except as provided bona fide research with controlled substances 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 schedule I by a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. (III) The Secretary may deemed qualified by regulation change such applicable number. (IV) The the Secretary may exclude from the applicable number patients to whom such drugs or combinations of drugs are directly administered be denied by the qualifying practitioner in the office setting. (C) For purposes of subparagraph (A), the conditions Attorney General only on a ground specified in this subparagraph with respect to narcotic drugs in schedule III, IV, or V or combinations of such drugs are as follows: (i) The drugs or combinations of drugs have, under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.] or section 262 824(a) of this title 42 , been approved for use in maintenance or detoxification treatment. (ii) . (B) (i) The drugs or combinations of drugs have not Attorney General shall register a practitioner to conduct research with marijuana (including any derivative, extract, preparation, and compound thereof) if— (I) the applicant’s research protocol has been reviewed and allowed— (aa) by the subject Secretary of an adverse determination. For purposes Health and Human Services under section 355(i) of this clause, an adverse determination is a determination published in the Federal Register and made title ; (bb) by the Secretary, after consultation with the Attorney General, that the use National Institutes of the drugs Health or combinations of drugs for maintenance another Federal agency that funds scientific research; or detoxification treatment requires additional standards respecting the qualifications of practitioners (cc) pursuant to provide such treatment, or requires standards respecting the quantities sections 1301.18 and 1301.32 of title 21, Code of Federal Regulations, or any successors thereto; and (II) the drugs that may be provided for unsupervised use. (D) (i) A waiver under subparagraph (A) with respect to a practitioner is not in effect unless (in addition applicant has demonstrated to conditions under subparagraphs (B) and (C)) the following conditions Attorney General that there are met: (I) The notification under subparagraph (B) is effective procedures in writing and states the name place to adequately safeguard against diversion of the practitioner. (II) The notification identifies the registration issued controlled substance for the practitioner legitimate medical or scientific use pursuant to subsection (f). (III) If the practitioner is a member of a group practice, the notification states the names section 105 of the other practitioners in the practice Medical Marijuana and identifies Cannabidiol Research Expansion Act, including demonstrating that the registrations issued security measures are adequate for storing the other practitioners pursuant quantity of marijuana the applicant would be authorized to subsection (f). possess. (ii) Upon receiving a determination from the Secretary under clause (iii) finding that a practitioner meets all requirements The Attorney General may deny an application for a waiver registration under this subparagraph (B), only if the Attorney General shall assign determines that the practitioner involved an identification number under this paragraph for inclusion with issuance of the registration issued for would be inconsistent with the practitioner pursuant to subsection (f). The identification number so assigned public interest. In determining the public interest, the Attorney General shall be appropriate to preserve consider the confidentiality factors listed in— (I) subparagraphs (B) through (E) of patients for whom paragraph (1); and (II) subparagraph (A) of paragraph (1), if the practitioner has dispensed narcotic drugs under applicable State requires practitioners conducting research to register with a waiver under board or authority described in such subparagraph (A). (iii) (I) Not later than 45 60 days after the date on which the Secretary Attorney General receives a notification under subparagraph (B), the Secretary shall make a determination of whether the practitioner involved meets all requirements complete application for a waiver registration under subparagraph (B) and shall forward such determination to this subparagraph, the Attorney General. If the Secretary fails to make such determination by General shall— (aa) approve the end application; or (bb) request supplemental information. (II) For purposes of subclause (I), an application shall be deemed complete when the such 45-day period, applicant has submitted documentation showing that the requirements under clause (i) are satisfied. (iv) Not later than 30 days after the date on which the Attorney General shall assign the practitioner an identification number receives supplemental information as 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 (iii)(I)(bb) in subparagraphs (B) through (D), dispenses narcotic drugs connection with an application described in schedule III, IV, or V or combinations of such drugs for maintenance treatment or detoxification treatment, this subparagraph, the Attorney General may, for purposes of section 824(a)(4) of this title , consider shall approve or deny the practitioner to have committed application. (v) If an act that renders application described in this subparagraph is denied, the registration Attorney General shall provide a written explanation of the practitioner pursuant to subsection (f) basis of denial to be inconsistent with the public interest. (ii) applicant. (vi) (I) Upon If the expiration of 45 days from Attorney General grants an application for registration under clause (i), the date on which registrant may amend or supplement the Secretary receives a notification under subparagraph (B), a practitioner who in good faith submits a research protocol without notification under subparagraph (B) and reasonably believes that to, or review by, the conditions specified in subparagraphs (B) through (D) have been met shall, in dispensing narcotic drugs in schedule III, IV, Drug Enforcement Administration if the registrant does not change— (aa) the quantity or V type of marijuana or combinations cannabidiol (including any derivative, extract, preparation, and compound thereof); (bb) the source of such drugs for maintenance treatment marijuana or detoxification treatment, be considered to have a waiver under subparagraph (A) until notified otherwise by cannabidiol; or (cc) the Secretary, except that conditions under which such marijuana or cannabidiol is stored, tracked, or administered. (II) (aa) If a practitioner may commence registrant under clause (i) seeks to prescribe change the type of marijuana or dispense such narcotic drugs for such purposes prior to cannabidiol (including any derivative, extract, preparation, and compound thereof), the expiration source of such 45-day period if it facilitates marijuana or cannabidiol, or the treatment of an individual patient and both conditions under which such marijuana or cannabidiol is stored, tracked, or administered, the Secretary and registrant shall notify the Attorney General are notified by the practitioner of the intent to commence prescribing via registered mail, or dispensing such narcotic drugs. (II) For purposes of subclause (I), the publication in the Federal Register of an adverse determination electronic means permitted by the Secretary pursuant to subparagraph (C)(ii) shall (with respect to the narcotic drug Attorney General, not later than 30 days before implementing an amended or combination involved) be considered to be a notification provided by the Secretary to practitioners, effective upon supplemental research protocol. (bb) A registrant may proceed with an amended or supplemental research protocol described in item (aa) if the expiration of Attorney General does not explicitly object during the 30-day period beginning on the date on which the adverse determination is so published. (F) (i) With respect to Attorney General receives the dispensing of narcotic drugs in schedule III, IV, or V or combinations of such drugs notice under item (aa). (cc) The Attorney General may only object to patients for maintenance or detoxification treatment, a practitioner may, in his or her discretion, dispense such drugs an amended or combinations for such treatment under a registration supplemental research protocol under paragraph (1) this subclause if additional security measures are needed to safeguard against diversion or abuse. (dd) If a waiver registrant under subparagraph (A) (subject clause (i) seeks to meeting address additional security measures identified by the applicable conditions). (ii) This paragraph Attorney General under item (cc), the registrant shall notify the Attorney General via registered mail, or an electronic means permitted by the Attorney General, not later than 30 days before implementing an amended or supplemental research protocol. (ee) A registrant may proceed with an amended or supplemental research protocol described in item (dd) if the Attorney General does not be construed as having any legal effect explicitly object during the 30-day period beginning on the conditions for obtaining a registration under paragraph (1), including with respect to date on which the number of patients who may be served Attorney General receives the notice under such item (dd). (III) (aa) If a registration. (G) For purposes of this paragraph: registrant under clause (i) The term “group practice” has seeks to change the meaning given such term in section 1395nn(h)(4) quantity of title 42 . (ii) The term “qualifying physician” means a physician who is licensed under State law marijuana needed for research and who meets one the change in quantity does not impact the factors described in item (bb) or more (cc) of the following conditions: subclause (I) The physician holds a board certification in addiction psychiatry of this clause, the registrant shall notify the Attorney General via registered mail or addiction medicine from using an electronic means permitted by the American Board Attorney General. (bb) A notification under item (aa) shall include— (AA) the Drug Enforcement Administration registration number of Medical Specialties. (II) The physician holds an addiction certification or board certification from the American Society registrant; (BB) the quantity of Addiction Medicine marijuana or cannabidiol already obtained; (CC) the American Board quantity of Addiction Medicine. (III) The physician holds a board certification in addiction medicine from the American Osteopathic Association. (IV) The physician has, with respect additional marijuana or cannabidiol needed to complete the treatment research; and management of opiate-dependent patients, completed not less than 8 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) (DD) an attestation that is provided by the American Society of Addiction Medicine, change in quantity does not impact the American Academy source of Addiction Psychiatry, the American Medical Association, marijuana or cannabidiol or the American Osteopathic Association, conditions under which the American Psychiatric Association, marijuana or any other organization that the Secretary determines cannabidiol is appropriate for purposes of this subclause. Such training stored, tracked, or administered. (cc) The Attorney General shall include— ensure that— (AA) any registered mail return receipt with respect to a notification under item (aa) opioid maintenance and detoxification; (bb) appropriate clinical use is submitted for delivery to the registrant providing the notification not later than 3 days after receipt of all drugs approved the notification by the Food Attorney General; and Drug Administration for (BB) notice of receipt of a notification using an electronic means permitted under item (aa) is provided to the treatment registrant providing the notification not later than 3 days after receipt of opioid use disorder; (cc) initial and periodic patient assessments (including substance use monitoring); the notification by the Attorney General. (dd) individualized treatment planning, overdose reversal, and relapse prevention; (ee) counseling and recovery support services; (ff) staffing roles and considerations; (gg) diversion control; (AA) On and (hh) other best practices, as identified by after the Secretary. (V) The physician has participated as an investigator date described in one or more clinical trials leading to the approval of subitem (BB), a narcotic drug in schedule III, IV, or V for maintenance or detoxification treatment, as demonstrated by registrant that submits a statement submitted to notification in accordance with item (aa) may proceed with the Secretary by research as if the sponsor of such approved drug. (VI) The physician change in quantity has been approved on such other training or experience as date, unless the State medical licensing board (of Attorney General notifies the State registrant of an objection described in item (ee). (BB) The date described in this subitem is the date on which a registrant submitting a notification under item (aa) receives the physician will provide maintenance or detoxification treatment) considers registered mail return receipt with respect to demonstrate the ability of the physician to treat and manage opiate-dependent patients. (VII) The physician has such other training notification or experience as the Secretary considers to demonstrate date on which the ability of registrant receives notice that the physician to treat and manage opiate-dependent patients. Any criteria of notification using an electronic means permitted under item (aa) was received by the Secretary Attorney General, as the case may be. (ee) A notification submitted under this subclause item (aa) shall be established by regulation. Any such criteria are effective only for 3 years deemed to be approved unless the Attorney General, not later than 10 days after receiving the date notification, explicitly objects based on a finding that the change in quantity— (AA) does impact the source of the marijuana or cannabidiol or the conditions under which the criteria are promulgated, but may be extended for such marijuana or cannabidiol is stored, tracked, or administered; or (BB) necessitates that the registrant implement additional discrete 3-year periods as security measures to safeguard against diversion or abuse. (IV) Nothing in this clause shall limit the authority of the Secretary considers appropriate for purposes of this subclause. Such an extension Health and Human Services over requirements related to research protocols, including changes in— (aa) the method of criteria may only be effectuated through a statement published in administration of marijuana or cannabidiol; (bb) the Federal Register by dosing of marijuana or cannabidiol; and (cc) the Secretary during number of individuals or patients involved in research. (3) Article 7 of the 30-day period preceding Convention on Psychotropic Substances shall not be construed to prohibit, or impose additional restrictions upon, research involving drugs or other substances scheduled under the end convention which is conducted in conformity with this subsection and other applicable provisions of the 3-year period involved. this subchapter.
(iii) The term “qualifying practitioner” means—
(I) a qualifying physician, as defined in clause (ii); or
(II) during the period beginning on July 22, 2016 and ending on October 1, 2021, a qualifying other practitioner, as defined in clause (iv).
(iv) The term “qualifying other practitioner” means a nurse practitioner or physician assistant who satisfies each of the following:
(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.
(II) The nurse practitioner or physician assistant has—
(aa) completed not fewer than 24 hours of initial training addressing each of the topics listed in clause (ii)(IV) (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Nurses Credentialing Center, the American Psychiatric Association, the American Association of Nurse Practitioners, the American Academy of Physician Assistants, or any other organization that the Secretary determines is appropriate for purposes of this subclause; or
(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.
(H) (i) In consultation with the Administrator of the Drug Enforcement Administration, the Administrator of the Substance Abuse and Mental Health Services Administration, the Director of the National Institute on Drug Abuse, and the Commissioner of Food and Drugs, the Secretary shall issue regulations (through notice and comment rulemaking) or issue practice guidelines to address the following:
(I) Approval of additional credentialing bodies and the responsibilities of additional credentialing bodies.
(II) Additional exemptions from the requirements of this paragraph and any regulations under this paragraph.
(III) Such other elements of the requirements under this paragraph as the Secretary determines necessary for purposes of implementing such requirements.
Nothing in such regulations or practice guidelines may authorize any Federal official or employee to exercise supervision or control over the practice of medicine or the manner in which medical services are provided.
(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.
(I) Notwithstanding section 903 of this title, nothing in this paragraph shall be construed to preempt any State law that—
(i) permits a qualifying practitioner to dispense narcotic drugs in schedule III, IV, or V, or combinations of such drugs, for maintenance or detoxification treatment in accordance with this paragraph to a total number of patients that is more than 30 or less than the total number applicable to the qualifying practitioner under subparagraph (B)(iii)(II) if a State enacts a law modifying such total number and the Attorney General is notified by the State of such modification; or
(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.
(h) Applicants Practitioners dispensing narcotic drugs for distribution of list I chemicals narcotic treatment; annual registration; separate registration; qualifications Practitioners who dispense narcotic drugs (other than narcotic drugs in schedule III, IV, or V) to individuals for maintenance treatment or detoxification treatment shall obtain annually a separate registration for that purpose. The Attorney General shall register an applicant to distribute dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment (or both)— (1) if the applicant is a list I chemical unless practitioner who is determined by the Secretary to be qualified (under standards established by the Secretary) to engage in the treatment with respect to which registration is sought; (2) if the Attorney General determines that registration of the applicant is inconsistent will comply with standards established by the public interest. Registration under this subsection shall not be required Attorney General respecting (A) security of stocks of narcotic drugs for such treatment, and (B) the distribution of a drug product that is exempted under clause (iv) or (v) maintenance of records (in accordance with section 802(39)(A) 827 of this title . In determining the public interest for the purposes of this subsection, ) on such drugs; and (3) if the Attorney General shall consider— (1) maintenance by Secretary determines that the applicant of effective controls against diversion of listed chemicals into other than legitimate channels; (2) compliance will comply with standards established by the applicant Secretary (after consultation with applicable Federal, State, and local law; (3) any prior conviction record of the applicant under Federal or State laws relating to controlled substances or to chemicals controlled under Federal or State law; (4) any past experience of the applicant in Attorney General) respecting the manufacture and distribution quantities of chemicals; and (5) narcotic drugs which may be provided for unsupervised use by individuals in such other factors as are relevant to and consistent with the public health and safety. treatment.
(i) Registration to manufacture certain controlled substances Applicants for use only in a clinical trial (1) For purposes distribution of registration to manufacture a controlled substance under subsection (d) for use only in a clinical trial, the list I chemicals The Attorney General shall register the applicant, or serve an order applicant to show cause upon distribute a list I chemical unless the Attorney General determines that registration of the applicant in accordance is inconsistent with the public interest. Registration under this subsection shall not be required for the distribution of a drug product that is exempted under clause (iv) or (v) of section 824(c) 802(39)(A) of this title , not later than 180 days after the date on which . In determining the application is accepted public interest for filing. (2) For the purposes of registration to manufacture a controlled substance under subsection (a) for use only in a clinical trial, this subsection, the Attorney General shall, in accordance with the regulations issued shall consider— (1) maintenance by the Attorney General, issue a notice applicant of application not later than 90 days after the application is accepted for filing. Not later effective controls against diversion of listed chemicals into other than 90 days after legitimate channels; (2) compliance by the date on which applicant with applicable Federal, State, and local law; (3) any prior conviction record of the period for comment pursuant applicant under Federal or State laws relating to such notice ends, the Attorney General shall register the applicant, controlled substances or serve an order to show cause upon chemicals controlled under Federal or State law; (4) any past experience of 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) manufacture and distribution of this title . chemicals; and (5) such other factors as are relevant to and consistent with the public health and safety.
(j) “Factors as may be relevant Registration to and consistent with manufacture certain controlled substances for use only in a clinical trial (1) For purposes of registration to manufacture a controlled substance under subsection (e) for use only in a clinical trial, the public health and safety” defined In this section, Attorney General shall register the phrase “factors as may be relevant applicant, or serve an order to and consistent show cause upon the applicant in accordance with section 824(c) of this title , not later than 180 days after the public health and safety” means factors that are relevant date on which the application is accepted for filing. (2) For purposes of registration to and consistent manufacture a controlled substance under subsection (a) for use only in a clinical trial, the Attorney General shall, in accordance with the findings contained 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 801 824(c) of this title , unless the Attorney General has granted a hearing on the application under section 958(i) of this title .
(k) Emergency medical services that administer controlled substances (1) Registration For the purpose of enabling emergency medical services professionals to administer controlled substances in schedule II, III, IV, or V to ultimate users receiving emergency medical services in accordance with the requirements of this subsection, the Attorney General—
(A) shall register an emergency medical services agency if the agency submits an application demonstrating it is authorized to conduct such activity under the laws of each State in which the agency practices; and
(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 (g).
(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 (g), the agency may use the registration of the hospital to administer controlled substances in accordance with this subsection without being registered under this subsection.
(4) Administration outside physical presence of medical director or authorizing medical professional Emergency medical services professionals of a registered emergency medical services agency may administer controlled substances in schedule II, III, IV, or V outside the physical presence of a medical director or authorizing medical professional in the course of providing emergency medical services if the administration is—
(A) authorized by the law of the State in which it occurs; and
(B) pursuant to—
(i) a standing order that is issued and adopted by one or more medical directors of the agency, including any such order that may be developed by a specific State authority; or
(ii) a verbal order that is—
(I) issued in accordance with a policy of the agency; and
(II) provided by a medical director or authorizing medical professional in response to a request by the emergency medical services professional with respect to a specific patient—
(aa) in the case of a mass casualty incident; or
(bb) to ensure the proper care and treatment of a specific patient.
(5) Delivery A registered emergency medical services agency may deliver controlled substances from a registered location of the agency to an unregistered location of the agency only if the agency—
(A) designates the unregistered location for such delivery; and
(B) notifies the Attorney General at least 30 days prior to first delivering controlled substances to the unregistered location.
(6) Storage A registered emergency medical services agency may store controlled substances—
(A) at a registered location of the agency;
(B) at any designated location of the agency or in an emergency services vehicle situated at a registered or designated location of the agency; or
(C) in an emergency medical services vehicle used by the agency that is—
(i) traveling from, or returning to, a registered or designated location of the agency in the course of responding to an emergency; or
(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.
(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.
(8) Restocking of emergency medical services vehicles at a hospital Notwithstanding paragraph (13)(J), a registered emergency medical services agency may receive controlled substances from a hospital for purposes of restocking an emergency medical services vehicle following an emergency response, and without being subject to the requirements of section 828 of this title, provided all of the following conditions are satisfied:
(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).
(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.
(9) Maintenance of records (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) Requirements Such records—
(i) shall include records of deliveries of controlled substances between all locations of the agency; and
(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.
(10) Other requirements A registered emergency medical services agency, under the supervision of a medical director, shall be responsible for ensuring that—
(A) all emergency medical services professionals who administer controlled substances using the agency’s registration act in accordance with the requirements of this subsection;
(B) the recordkeeping requirements of paragraph (9) are met with respect to a registered location and each designated location of the agency;
(C) the applicable physical security requirements established by regulation of the Attorney General are complied with wherever controlled substances are stored by the agency in accordance with paragraph (6); and
(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).
(11) Regulations The Attorney General may issue regulations—
(A) specifying, with regard to delivery of controlled substances under paragraph (5)—
(i) the types of locations that may be designated under such paragraph; and
(ii) the manner in which a notification under paragraph (5)(B) must be made;
(B) specifying, with regard to the storage of controlled substances under paragraph (6), the manner in which such substances must be stored at registered and designated locations, including in emergency medical service vehicles; and
(C) addressing the ability of hospitals, emergency medical services agencies, registered locations, and designated locations to deliver controlled substances to each other in the event of—
(i) shortages of such substances;
(ii) a public health emergency; or
(iii) a mass casualty event.
(12) Rule of construction Nothing in this subsection shall be construed—
(A) to limit the authority vested in the Attorney General by other provisions of this subchapter to take measures to prevent diversion of controlled substances; or
(B) to override the authority of any State to regulate the provision of emergency medical services consistent with this subsection.
(13) Definitions In this section:
(A) The term “authorizing medical professional” means an emergency or other physician, or another medical professional (including an advanced practice registered nurse or physician assistant)—
(i) who is registered under this chapter;
(ii) who is acting within the scope of the registration; and
(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.
(D) The term “emergency medical services agency” means an organization providing emergency medical services, including such an organization that—
(i) is governmental (including fire-based and hospital-based agencies), nongovernmental (including hospital-based agencies), private, or volunteer-based;
(ii) provides emergency medical services by ground, air, or otherwise; and
(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 (g) 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.
(J) The term “registered emergency medical services agency” means—
(i) an emergency medical services agency that is registered pursuant to this subsection; or
(ii) a hospital-based emergency medical services agency that is covered by the registration of the hospital under subsection (g).
(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 (g), 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.
(l) “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.
(m) Required training for prescribers (1) Training required As a condition on registration under this section to dispense controlled substances in schedule II, III, IV, or V, the Attorney General shall require any qualified practitioner, beginning with the first applicable registration for the practitioner, to meet the following:
(A) If the practitioner is a physician (as defined under section 1395x(r) of title 42) and the practitioner meets one or more of the following conditions:
(i) The physician holds a board certification in addiction psychiatry or addiction medicine from the American Board of Medical Specialties.
(ii) The physician holds a board certification from the American Board of Addiction Medicine.
(iii) The physician holds a board certification in addiction medicine from the American Osteopathic Association.
(iv) The physician has, with respect to the treatment and management of patients with opioid or other substance use disorders, or the safe pharmacological management of dental pain and screening, brief intervention, and referral for appropriate treatment of patients with or at risk of developing opioid or other substance use disorders, completed not less than 8 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by—
(I) the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Dental Association, the American Association of Oral and Maxillofacial Surgeons, the American Psychiatric Association, the American Academy of Family Physicians, the American Podiatric Medical Association, the Academy of General Dentistry, the American Optometric Association, or any other organization accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Commission for Continuing Education Provider Recognition (CCEPR), or the Council on Podiatric Medical Education;
(II) any organization accredited by a State medical society accreditor that is recognized by the ACCME or the CCEPR;
(III) any organization accredited by the American Osteopathic Association or the American Academy of Family Physicians to provide continuing medical education; or
(IV) any organization approved by the Assistant Secretary for Mental Health and Substance Use, the ACCME, or the CCEPR.
(v) The physician graduated in good standing from an accredited school of allopathic medicine, osteopathic medicine, podiatric medicine, dental surgery, or dental medicine in the United States during the 5-year period immediately preceding the date on which the physician first registers or renews under this section and has successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited medical residency or dental surgery or dental or podiatric medicine curriculum that included not less than 8 hours of training on—
(I) treating and managing patients with opioid or other substance use disorders, including the appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of a substance use disorder; or
(II) the safe pharmacological management of dental pain and screening, brief intervention, and referral for appropriate treatment of patients with or at risk of developing opioid and other substance use disorders.
(B) If the practitioner is not a physician (as defined under section 1395x(r) of title 42), the practitioner is legally authorized by the State to dispense controlled substances under schedule II, III, IV, or V and is dispensing such substances within such State in accordance with all applicable State laws, and the practitioner meets one or more of the following conditions:
(i) The practitioner has completed not fewer than 8 hours of training with respect to the treatment and management of patients with opioid or other substance use disorders (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Nurses Credentialing Center, the American Psychiatric Association, the American Association of Nurse Practitioners, the American Academy of Physician Associates, the American Pharmacists Association, the Accreditation Council on Pharmacy Education, the American Psychiatric Nurses Association, the American Academy of Nursing, the American Academy of Family Physicians, or any other organization approved or accredited by the Assistant Secretary for Mental Health and Substance Use, the American Academy of Family Physicians, or the Accreditation Council for Continuing Medical Education.
(ii) The practitioner has graduated in good standing from an accredited physician assistant school, an accredited school of advanced practice nursing, or an accredited school of pharmacy in the United States during the 5-year period immediately preceding the date on which the practitioner first registers or renews under this section and has successfully completed a comprehensive physician assistant or advanced practice nursing curriculum that included not fewer than 8 hours of training on treating and managing patients with opioid and other substance use disorders, including the appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of a substance use disorder.
(2) One-time training (A) In general The Attorney General shall not require any qualified practitioner to complete the training described in clause (iv) or (v) of paragraph (1)(A) or clause (i) or (ii) of paragraph (1)(B) more than once.
(B) Notification Not later than 90 days after December 29, 2022, the Attorney General shall provide to qualified practitioners a single written, electronic notification of the training described in clauses (iv) and (v) of paragraph (1)(A) or clauses (i) and (ii) of paragraph (1)(B).
(3) Rule of construction Nothing in this subsection shall be construed—
(A) to preclude the use, by a qualified practitioner, of training received pursuant to this subsection to satisfy registration requirements of a State or for some other lawful purpose; or
(B) to preempt any additional requirements by a State related to the dispensing of controlled substances under schedule II, III, IV, or V.
(4) Definitions In this section:
(A) First applicable registration The term “first applicable registration” means the first registration or renewal of registration by a qualified practitioner under this section that occurs on or after the date that is 180 days after December 29, 2022.
(B) Qualified practitioner In this subsection, the term “qualified practitioner” means a practitioner who—
(i) is licensed under State law to prescribe controlled substances; and
(ii) is not solely a veterinarian.
(n) Special provisions for practitioners conducting certain research with schedule I controlled substances (1) In general Notwithstanding subsection (g), a practitioner may conduct research described in paragraph (2) of this subsection with 1 or more schedule I substances in accordance with subparagraph (A) or (B) of paragraph (3) of this subsection.
(2) Research subject to expedited procedures Research described in this paragraph is research that—
(B) is—
(i) conducted by the Department of Health and Human Services, the Department of Defense, or the Department of Veterans Affairs; or
(ii) funded partly or entirely by a grant, contract, cooperative agreement, or other transaction from the Department of Health and Human Services, the Department of Defense, or the Department of Veterans Affairs.
(3) Expedited procedures (A) Researcher with a current schedule I or II research registration (i) In general If a practitioner is registered to conduct research with a controlled substance in schedule I or II, the practitioner may conduct research under this subsection on and after the date that is 30 days after the date on which the practitioner sends a notice to the Attorney General containing the following information, with respect to each substance with which the practitioner will conduct the research:
(I) The chemical name of the substance.
(II) The quantity of the substance to be used in the research.
(III) Demonstration that the research is in the category described in paragraph (2), which demonstration may be satisfied—
(aa) in the case of a grant, contract, cooperative agreement, or other transaction, or intramural research project, by identifying the sponsoring agency and supplying the number of the grant, contract, cooperative agreement, other transaction, or project; or
(bb) in the case of an application under section 355(i) of this title, by supplying the application number and the sponsor of record on the application.
(IV) Demonstration that the researcher is authorized to conduct research with respect to the substance under the laws of the State in which the research will take place.
(ii) Verification of information by HHS or VA Upon request from the Attorney General, the Secretary of Health and Human Services, the Department of Defense, or the Secretary of Veterans Affairs, as appropriate, shall verify information submitted by an applicant under clause (i)(III).
(B) Researcher without a current schedule I or II research registration (i) In general If a practitioner is not registered to conduct research with a controlled substance in schedule I or II, the practitioner may send a notice to the Attorney General containing the information listed in subparagraph (A)(i), with respect to each substance with which the practitioner will conduct the research.
(ii) Attorney General action The Attorney General shall—
(I) treat notice received under clause (i) as a sufficient application for a research registration; and
(II) not later than 45 days of receiving such a notice that contains all information required under subparagraph (A)(i)—
(aa) register the applicant; or
(4) Electronic submissions The Attorney General shall provide a means to permit a practitioner to submit a notification under paragraph (3) electronically.
(5) Limitation on amounts A practitioner conducting research with a schedule I substance under this subsection may only possess the amounts of schedule I substance identified in—
(A) the notification to the Attorney General under paragraph (3); or
(B) a supplemental notification that the practitioner may send if the practitioner needs additional amounts for the research, which supplemental notification shall include—
(i) the name of the practitioner;
(ii) the additional quantity needed of the substance; and
(iii) an attestation that the research to be conducted with the substance is consistent with the scope of the research that was the subject of the notification under paragraph (3).
(6) Importation and exportation requirements not affected Nothing in this subsection alters the requirements of subchapter II, regarding the importation and exportation of controlled substances.
(7) Inspector General report Not later than 1 year after July 16, 2025, the Inspector General of the Department of Justice shall complete a study, and submit to Congress a report thereon, about research described in paragraph (2) of this subsection with fentanyl.
(o) Transparency regarding special procedures (1) In general If the Attorney General determines, with respect to a controlled substance, that an application by a practitioner to conduct research with the substance should be considered under a process, or subject to criteria, different from the process or criteria applicable to applications to conduct research with other controlled substances in the same schedule, the Attorney General shall make public, including by posting on the website of the Drug Enforcement Administration—
(A) the identities of all substances for which such determinations have been made;
(B) the process and criteria that shall be applied to applications to conduct research with those substances; and
(C) how the process and criteria described in subparagraph (B) differ from the process and criteria applicable to applications to conduct research with other controlled substances in the same schedule.
(2) Timing of posting The Attorney General shall make information described in paragraph (1) public upon making a determination described in that paragraph, regardless of whether a practitioner has submitted such an application at that time.
1 See References So in Text note below. original. Probably should be preceded by “section”.
