21 U.S.C. § 823
Section 823 · Registration requirements
Current version, with additions and removals from the July 22, 2016 version.
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:
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;
compliance with applicable State and local law;
promotion of technical advances in the art of manufacturing these substances and the development of new substances;
prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of such substances;
past experience in the manufacture of controlled substances, and the existence in the establishment of effective control against diversion; and
such other factors as may be relevant to and consistent with the public health and safety.
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:
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;
compliance with applicable State and local law;
promotion of technical advances in the art of manufacturing these substances and the development of new substances;
prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of such substances;
past experience in the manufacture of controlled substances, and the existence in the establishment of effective control against diversion; and
such other factors as may be relevant to and consistent with the public health and safety.
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:
maintenance of effective control against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels;
compliance with applicable State and local law;
prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances;
past experience in the distribution of controlled substances; and
such other factors as may be relevant to and consistent with the public health and safety.
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:
maintenance of effective control against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels;
compliance with applicable State and local law;
prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances;
past experience in the distribution of controlled substances; and
such other factors as may be relevant to and consistent with the public health and safety.
The term “qualifying practitioner” means—
a qualifying physician, as defined in clause (ii); or
during the period beginning on July 22, 2016 and ending on October 1, 2021, a qualifying other practitioner, as defined in clause (iv).
The term “qualifying other practitioner” means a nurse practitioner or physician assistant who satisfies each of the following:
The nurse practitioner or physician assistant is licensed under State law to prescribe schedule III, IV, or V medications for the treatment of pain.
The nurse practitioner or physician assistant has—
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
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.
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.
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:
Approval of additional credentialing bodies and the responsibilities of additional credentialing bodies.
Additional exemptions from the requirements of this paragraph and any regulations under this paragraph.
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.
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.
Notwithstanding section 903 of this title, nothing in this paragraph shall be construed to preempt any State law that—
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
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.
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—
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
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).
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 (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.
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—
authorized by the law of the State in which it occurs; and
pursuant to—
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
a verbal order that is—
issued in accordance with a policy of the agency; and
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—
in the case of a mass casualty incident; or
to ensure the proper care and treatment of a specific patient.
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—
designates the unregistered location for such delivery; and
notifies the Attorney General at least 30 days prior to first delivering controlled substances to the unregistered location.
A registered emergency medical services agency may store controlled substances—
at a registered location of the agency;
at any designated location of the agency or in an emergency services vehicle situated at a registered or designated location of the agency; or
in an emergency medical services vehicle used by the agency that is—
traveling from, or returning to, a registered or designated location of the agency in the course of responding to an emergency; or
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.
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:
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).
The hospital maintains a record of such delivery to the agency in accordance with section 827 of this title.
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.
Such records—
shall include records of deliveries of controlled substances between all locations of the agency; and
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.
A registered emergency medical services agency, under the supervision of a medical director, shall be responsible for ensuring that—
all emergency medical services professionals who administer controlled substances using the agency’s registration act in accordance with the requirements of this subsection;
the recordkeeping requirements of paragraph (9) are met with respect to a registered location and each designated location of the agency;
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
the agency maintains, at a registered location of the agency, a record of the standing orders issued or adopted in accordance with paragraph (9).
The Attorney General may issue regulations—
specifying, with regard to delivery of controlled substances under paragraph (5)—
the types of locations that may be designated under such paragraph; and
the manner in which a notification under paragraph (5)(B) must be made;
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
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—
shortages of such substances;
a public health emergency; or
a mass casualty event.
Nothing in this subsection shall be construed—
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
to override the authority of any State to regulate the provision of emergency medical services consistent with this subsection.
In this section:
The term “authorizing medical professional” means an emergency or other physician, or another medical professional (including an advanced practice registered nurse or physician assistant)—
who is registered under this chapter;
who is acting within the scope of the registration; and
whose scope of practice under a State license or certification includes the ability to provide verbal orders.
The term “designated location” means a location designated by an emergency medical services agency under paragraph (5).
The term “emergency medical services” means emergency medical response and emergency mobile medical services provided outside of a fixed medical facility.
The term “emergency medical services agency” means an organization providing emergency medical services, including such an organization that—
is governmental (including fire-based and hospital-based agencies), nongovernmental (including hospital-based agencies), private, or volunteer-based;
provides emergency medical services by ground, air, or otherwise; and
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.
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.
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.
The term “hospital-based” means, with respect to an agency, owned or operated by a hospital.
The term “medical director” means a physician who is registered under subsection (g) and provides medical oversight for an emergency medical services agency.
The term “medical oversight” means supervision of the provision of medical care by an emergency medical services agency.
The term “registered emergency medical services agency” means—
an emergency medical services agency that is registered pursuant to this subsection; or
a hospital-based emergency medical services agency that is covered by the registration of the hospital under subsection (g).
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.
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.
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.
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.
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:
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:
The physician holds a board certification in addiction psychiatry or addiction medicine from the American Board of Medical Specialties.
The physician holds a board certification from the American Board of Addiction Medicine.
The physician holds a board certification in addiction medicine from the American Osteopathic Association.
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—
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;
any organization accredited by a State medical society accreditor that is recognized by the ACCME or the CCEPR;
any organization accredited by the American Osteopathic Association or the American Academy of Family Physicians to provide continuing medical education; or
any organization approved by the Assistant Secretary for Mental Health and Substance Use, the ACCME, or the CCEPR.
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—
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
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.
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:
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.
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.
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.
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).
Nothing in this subsection shall be construed—
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
to preempt any additional requirements by a State related to the dispensing of controlled substances under schedule II, III, IV, or V.
In this section:
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.
In this subsection, the term “qualified practitioner” means a practitioner who—
is licensed under State law to prescribe controlled substances; and
is not solely a veterinarian.
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.
Research described in this paragraph is research that—
is with respect to a drug that is the subject of an investigational use exemption under section 355(i) of this title; or
is—
conducted by the Department of Health and Human Services, the Department of Defense, or the Department of Veterans Affairs; or
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.
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:
The chemical name of the substance.
The quantity of the substance to be used in the research.
Demonstration that the research is in the category described in paragraph (2), which demonstration may be satisfied—
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
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.
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.
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).
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.
The Attorney General shall—
treat notice received under clause (i) as a sufficient application for a research registration; and
not later than 45 days of receiving such a notice that contains all information required under subparagraph (A)(i)—
register the applicant; or
serve an order to show cause upon the applicant in accordance with section 824(c) of this title.
The Attorney General shall provide a means to permit a practitioner to submit a notification under paragraph (3) electronically.
A practitioner conducting research with a schedule I substance under this subsection may only possess the amounts of schedule I substance identified in—
the notification to the Attorney General under paragraph (3); or
a supplemental notification that the practitioner may send if the practitioner needs additional amounts for the research, which supplemental notification shall include—
the name of the practitioner;
the additional quantity needed of the substance; and
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).
Nothing in this subsection alters the requirements of subchapter II, regarding the importation and exportation of controlled substances.
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.
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—
the identities of all substances for which such determinations have been made;
the process and criteria that shall be applied to applications to conduct research with those substances; and
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.
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.