21 U.S.C. § 823 — Registration requirements

(a) Manufacturers of schedule I or II substances. The Attorney General must register an applicant to manufacture^* such substances when registration is consistent with the public interest and United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. In deciding the public interest, the Attorney General must consider: (1) effective controls against diversion into nonlegitimate medical, scientific, research, or industrial channels, including limiting importation and bulk manufacture to enough establishments to provide an adequate, uninterrupted, and competitive legitimate supply; (2) compliance with State^* and local law; (3) technical advances and development of new substances; (4) the applicant’s federal and State conviction record for manufacture, distribution, or dispensing; (5) manufacturing experience and effective diversion controls at the establishment; and (6) other factors relevant to and consistent with public health and safety.

(b) Distributors of schedule I or II substances. The Attorney General must register the applicant unless registration would be inconsistent with the public interest. The Attorney General must consider diversion controls, State and local compliance, relevant federal or State convictions, distribution experience, and other relevant public-health-and-safety factors.

(c) Marijuana^* manufacturers for research. (1)(A) When the Attorney General publishes a Federal Register notice seeking more registered marijuana manufacturers to supply registered United States researchers, the Attorney General must, within 60 days after receiving a completed application, approve it or request more information. (B) An application is complete when it shows that the notice requirements and chapter requirements are met; marijuana will be transferred or sold only to schedule I research registrants for preclinical research or a clinical investigation under an investigational-new-drug^* exemption under section 355(i); every transfer or sale will have the Attorney General’s prior written consent; the applicant completed subsection (a) review for bulk schedule I manufacture; the applicant has begun storage, handling, inventory, and security controls required by section 105 of the Medical Marijuana and Cannabidiol Research Expansion Act; and the applicant has each required State manufacturing license. (C) Within 30 days after receiving requested supplemental information, the Attorney General must approve or deny. (2) If denied, the Attorney General must give the applicant a written explanation.

(d) Authorized activities. A registration under (a) or (b) does not allow manufacture or distribution of schedule I or II substances not named in the registration, or manufacture above the quota assigned under section 826.

(e) Manufacturers of schedule III, IV, or V substances. The Attorney General must register the applicant unless registration would be inconsistent with the public interest. The decision must consider diversion controls; State and local compliance; technical advances and new substances; relevant federal and State convictions; past manufacturing, distribution, and dispensing experience and establishment controls; and other relevant public-health-and-safety factors.

(f) Distributors of schedule III, IV, or V substances. The Attorney General must register unless registration would be inconsistent with the public interest. The factors are diversion controls; State and local compliance; relevant convictions; distribution experience; and other relevant public-health-and-safety factors.

(g) Practitioners, pharmacies, and research. (1) The Attorney General must register practitioners, including pharmacies but not pharmacists, to dispense^* or research with schedule II through V substances, and must modify a registered pharmacy’s registration to allow Internet dispensing, if State law authorizes the applicant’s dispensing or research. The Attorney General may deny or refuse the modification if inconsistent with the public interest. The factors are the appropriate State licensing or disciplinary authority’s recommendation; experience dispensing or researching controlled substances; federal and State convictions for manufacture, distribution, or dispensing; compliance with controlled-substance laws; and other conduct threatening public health or safety. A practitioner^* already registered in another capacity does not need a separate research registration for schedule II through V. (2)(A) A schedule I research application goes to the Secretary, who decides the practitioner’s qualifications and competence and the research protocol’s merits, consulting the Attorney General about safeguards against diversion. The Attorney General may deny a qualified bona fide researcher only on a section 824(a) ground. (B) For marijuana research, the Attorney General must register if the protocol was reviewed and allowed by HHS under section 355(i), NIH or another federal research-funding agency, or the specified Code of Federal Regulations procedures, and the applicant shows effective safeguards under section 105, including adequate storage security. Denial is allowed only if inconsistent with the public interest, considering the factors in paragraph (1)(B)-(E) and, when required by State law, (1)(A). The Attorney General must approve or request information within 60 days after a complete application, decide within 30 days after supplemental information, and give a written explanation for denial. A complete application shows the clause (i) requirements. (B)(vi) A registrant may change a protocol without DEA notice or review if the amount or type, source, and storage, tracking, or administration conditions do not change. A change to type, source, or those conditions requires notice by registered mail or permitted electronic means at least 30 days before use. The registrant may proceed if the Attorney General does not expressly object within 30 days. An objection may be based only on need for more security against diversion or abuse. After addressing requested security, the registrant must give another 30-day advance notice and may proceed absent an express objection. A quantity-only change that does not affect source or conditions requires notice identifying the registration number, amount already obtained, additional amount needed, and an attestation that source and conditions are unchanged. The Attorney General must acknowledge receipt within three days. The registrant may proceed when the receipt or electronic acknowledgment arrives. The change is approved unless the Attorney General objects within 10 days because source or conditions are affected or more security is needed. Nothing here limits HHS authority over protocol changes involving administration method, dose, or number of research participants. (3) Article 7 of the Convention on Psychotropic Substances^* does not prohibit or add restrictions to research that follows this subsection and this subchapter.

(h) Narcotic treatment. A practitioner dispensing narcotic drugs other than schedule III-V drugs for maintenance or detoxification must obtain a separate annual registration. The Attorney General must register the applicant if the Secretary finds the practitioner qualified; the Attorney General finds compliance with security and section 827 record standards; and the Secretary finds compliance with standards, set after consulting the Attorney General, for quantities allowed for unsupervised use.

(i) List I chemical^* distributors. The Attorney General must register the applicant unless inconsistent with the public interest. No registration is required for a drug product exempted under section 802(39)(A)(iv) or (v). The decision must consider controls against diversion, federal, State, and local compliance, controlled-substance or controlled-chemical convictions, chemical manufacturing and distribution experience, and other relevant public-health-and-safety factors.

(j) Manufacturing for clinical trials. For an application under subsection (e) to manufacture a controlled substance^* only for a clinical trial, within 180 days after accepting the application for filing, the Attorney General must register the applicant or serve an order to show cause under section 824(c). For an application under subsection (a) to manufacture a controlled substance only for a clinical trial, the Attorney General must issue a notice of application within 90 days after accepting it for filing, as required by the Attorney General’s regulations. Within 90 days after the notice’s comment period ends, the Attorney General must register the applicant or serve an order to show cause under section 824(c), unless the Attorney General has granted a hearing under section 958(i).

(k) Emergency medical services that administer controlled substances. (1) To allow emergency medical services professionals to administer schedule II, III, IV, or V controlled substances to ultimate users receiving emergency medical services, the Attorney General must register an emergency medical services agency that applies and shows that the laws of every State where it practices authorize this activity. The Attorney General may deny the application if registration would not meet this subsection’s requirements or would be inconsistent with the public interest, based on the factors in subsection (g).

(2) When registering an agency, the Attorney General must let it choose one registration in each State where it administers controlled substances instead of requiring a separate registration for every agency location.

(3) A hospital-based emergency medical services agency covered by the hospital’s subsection (g) registration may use that hospital registration to administer controlled substances under this subsection without registering under this subsection.

(4) Professionals of a registered agency may administer schedule II, III, IV, or V controlled substances outside the physical presence of a medical director or authorizing medical professional while providing emergency medical services if State law allows it and the administration follows either a standing order issued and adopted by one or more of the agency’s medical directors, including an order developed by a specific State authority, or a verbal order. The verbal order must follow an agency policy and be given by a medical director or authorizing medical professional in response to the professional’s request about a specific patient, either during a mass-casualty incident or to ensure that patient’s proper care and treatment.

(5) An agency may deliver^* controlled substances from a registered location to an unregistered agency location only if it designates the unregistered location for delivery^* and tells the Attorney General at least 30 days before the first delivery there.

(6) An agency may store controlled substances at a registered location; at a designated location or in an emergency medical services vehicle situated at a registered or designated location; or in an agency vehicle traveling from or returning to a registered or designated location while responding to an emergency, or otherwise actively used by the agency under circumstances that secure the substances as required by the Attorney General’s regulations.

(7) Delivery under this subsection is not distribution for purposes of section 828.

(8) Despite paragraph (13)(J), an agency may receive controlled substances from a hospital to restock an emergency medical services vehicle after an emergency response without the section 828 requirements if: (A) the agency’s registered or designated location where the vehicle is primarily situated records the receipt under paragraph (9); (B) the hospital records the delivery to the agency under section 827; and (C) if the vehicle is primarily at a designated location, that location tells the agency’s registered location within 72 hours after the vehicle receives the substances.

(9) (A) An agency must keep records under section 827(a) and (b) of every controlled substance received, administered, or otherwise disposed of under its registration, despite section 827(c)(1)(B). (B) The records must include deliveries between all agency locations and must be kept, electronically or otherwise, at every registered and designated location where the substances are received, administered, or otherwise disposed of.

(10) Under a medical director’s supervision, an agency must ensure that: (A) every professional administering controlled substances under its registration follows this subsection; (B) paragraph (9)’s recordkeeping rules are met at the registered location and every designated location; (C) Attorney General physical-security regulations are followed wherever the agency stores substances under paragraph (6); and (D) a registered location keeps the standing orders issued or adopted under paragraph (9).

(11) The Attorney General may issue regulations that: (A) specify which kinds of locations may be designated under paragraph (5) and how the paragraph (5)(B) notice must be given; (B) specify how substances must be stored at registered and designated locations, including in emergency medical services vehicles; and (C) address deliveries among hospitals, agencies, registered locations, and designated locations during shortages, a public health emergency, or a mass-casualty event.

(12) Nothing in this subsection limits the Attorney General’s authority under other parts of this subchapter to prevent diversion of controlled substances or overrides a State’s authority to regulate emergency medical services consistently with this subsection.

(13) In this section: “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, acts within that registration, and has a State license or certification allowing verbal orders. “Designated location” means a location designated by an agency under paragraph (5). “Emergency medical services” means emergency medical response and mobile emergency medical services provided outside a fixed medical facility. “Emergency medical services agency” means a governmental organization, including a fire-based or hospital-based agency, or a nongovernmental, private, or volunteer organization that provides emergency medical services by ground, air, or otherwise and that its State authorizes to provide emergency medical care, including administering controlled substances, to the general public on an emergency basis. “Emergency medical services professional” means a health-care professional, including a nurse, paramedic, or emergency medical technician, licensed or certified by the State where the professional practices and credentialed by the agency’s medical director to provide emergency medical services within that license or certification. “Emergency medical services vehicle” means an ambulance, fire apparatus, supervisor truck, or other vehicle an agency uses to provide or facilitate emergency medical care and transport, or to transport controlled substances to or from registered and designated locations. “Hospital-based” means owned or operated by a hospital. “Medical director” means a physician registered under subsection (g) who provides medical oversight for an agency. “Medical oversight” means supervision of an agency’s medical care. “Registered emergency medical services agency” means an agency registered under this subsection or a hospital-based agency covered by a hospital’s subsection (g) registration. “Registered location” means a location listed on the agency’s certificate of registration under this subsection or subsection (g), where the agency receives controlled substances from distributors. “Specific State authority” means a governmental agency or similar authority, including a regional oversight and coordinating body, that under State law or regulation develops clinical protocols for delivering emergency medical services in its geographic area that medical directors may adopt. “Standing order” means a written medical protocol in which a medical director decides in advance the medical criteria that must be met before controlled substances are administered to people needing emergency medical services. “Verbal order” means an oral directive given by any communication method, including radio or telephone, directly to an emergency medical services professional to administer a controlled substance at the same time to people needing 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” means factors relevant to and consistent with the findings in section 801.

(m) Required training for prescribers. (1) As a condition of registering under this section to dispense schedule II, III, IV, or V controlled substances, the Attorney General must require each qualified practitioner, starting with the practitioner’s first applicable registration, to meet these requirements. (A) A physician, as defined in section 1395x(r) of title 42, qualifies if the physician meets at least one of these conditions: (i) board certification in addiction psychiatry or addiction medicine from the American Board of Medical Specialties; (ii) board certification from the American Board of Addiction Medicine; (iii) board certification in addiction medicine from the American Osteopathic Association; (iv) at least 8 hours of training about treating and managing patients with opioid^* or other substance-use disorders, or safely managing dental pain with drugs and screening, briefly intervening, and referring patients who have or may develop those disorders. The training may be in a classroom, at professional-society seminars, through electronic communications, or in another way, and must be provided by the organizations or accredited or approved organizations listed in the statute; or (v) graduation in good standing from an accredited United States school of allopathic medicine, osteopathic medicine, podiatric medicine, dental surgery, or dental medicine during the 5-year period immediately before the date the physician first registers or renews under this section, plus successful completion of a qualifying comprehensive curriculum or accredited residency that included at least 8 hours of training on treating and managing patients with opioid or other substance-use disorders, including the appropriate clinical use of all Food and Drug Administration-approved drugs for treating a substance-use disorder, or on safe pharmacological dental-pain management and screening, brief intervention, and referral for appropriate treatment of patients who have or may develop opioid or other substance-use disorders. The organizations listed for clause (iv) are the American Society of Addiction Medicine, American Academy of Addiction Psychiatry, American Medical Association, American Osteopathic Association, American Dental Association, American Association of Oral and Maxillofacial Surgeons, American Psychiatric Association, American Academy of Family Physicians, American Podiatric Medical Association, Academy of General Dentistry, American Optometric Association, and organizations accredited by ACCME, CCEPR, or the Council on Podiatric Medical Education; organizations accredited by a State medical-society accreditor recognized by ACCME or CCEPR; organizations accredited by the American Osteopathic Association or American Academy of Family Physicians to provide continuing medical education; and organizations approved by the Assistant Secretary for Mental Health and Substance Use, ACCME, or CCEPR.

(B) A practitioner who is not a physician must be legally authorized by the State to dispense schedule II, III, IV, or V controlled substances and must dispense them in that State under all applicable State laws. The practitioner must also meet at least one of these conditions: (i) at least 8 hours of training about treating and managing patients with opioid or other substance-use disorders, provided through the listed professional organizations or by an organization approved or accredited by the listed authorities; or (ii) graduation in good standing from an accredited physician-assistant school, advanced-practice-nursing school, or pharmacy school in the United States during the 5-year period immediately before the date the practitioner first registers or renews under this section, plus successful completion of a comprehensive physician-assistant or advanced-practice-nursing curriculum that included at least 8 hours of training on treating and managing patients with opioid and other substance-use disorders, including the appropriate clinical use of all Food and Drug Administration-approved drugs for treating a substance-use disorder.

(2) (A) The Attorney General may not require a qualified practitioner to complete the physician training in paragraph (1)(A)(iv) or (v), or the nonphysician training in paragraph (1)(B)(i) or (ii), more than once. (B) Within 90 days after December 29, 2022, the Attorney General must give qualified practitioners one written electronic notice of that training.

(3) This subsection does not prevent a qualified practitioner from using training received under it to meet State registration requirements or another lawful purpose. It also does not preempt additional State requirements about dispensing schedule II, III, IV, or V controlled substances.

(4) In this section: “First applicable registration” means the first registration or renewal by a qualified practitioner under this section on or after the date 180 days after December 29, 2022. In this subsection, “qualified practitioner” means a practitioner who is licensed under State law to prescribe controlled substances and is not solely a veterinarian.

(n) Certain schedule I research. (1) Despite (g), a practitioner may conduct paragraph (2) research with one or more schedule I substances under paragraph (3). (2) The research must concern a drug with an investigational-use exemption under section 355(i), or be conducted or funded partly or entirely by HHS, Defense, or Veterans Affairs. (3)(A) A practitioner with a current schedule I or II research registration may begin 30 days after notifying the Attorney General of each substance’s chemical name, quantity, proof of qualifying research (by sponsor and grant, contract, agreement, or project number, or application number and sponsor), and State authorization. On request, HHS, Defense, or VA must verify the relevant information. (B) A practitioner without such registration may send the same notice. The Attorney General must treat it as a sufficient application and within 45 days either register the applicant or serve an order to show cause under section 824(c). (4) The Attorney General must allow electronic submissions. (5) A schedule I researcher may possess only the amount in the notice or a supplemental notice. The supplemental notice must state the practitioner’s name, added quantity, and an attestation that the research remains within the original research scope. (6) This subsection does not change subchapter II import or export requirements. (7) Within one year after July 16, 2025, the Justice Department Inspector General must study and report to Congress on qualifying fentanyl research.

(o) Transparency. (1) If the Attorney General decides an application to research a controlled substance will use a different process or criteria from other substances in the same schedule, the Attorney General must publicly post, including on the DEA website, every affected substance, the process and criteria, and how they differ. (2) The information must be made public when the decision is made, whether or not an application has yet been filednn(i) List I chemical distributors. The Attorney General must register an applicant to distribute^* a list I chemical unless registration is inconsistent with the public interest. Registration is not required for a drug product exempted under section 802(39)(A)(iv) or (v). The Attorney General must consider the applicant’s diversion controls; federal, State, and local compliance; convictions involving controlled substances or controlled chemicals; past chemical manufacturing and distribution experience; and other factors relevant to and consistent with public health and safety.nn(j) Clinical-trial manufacturing. For an application under subsection (e) to manufacture a controlled substance only for a clinical trial, within 180 days after accepting it the Attorney General must register the applicant or serve an order to show cause under section 824(c). For an application under subsection (a), within 90 days the Attorney General must issue a notice of application under the Attorney General’s regulations. Within 90 days after the comment period ends, the Attorney General must register the applicant or serve an order to show cause, unless the Attorney General granted a hearing under section 958(i).nn(k) Emergency medical services. The Attorney General must register an emergency medical services agency that applies and demonstrates State authorization so its professionals can administer schedule II-V substances to emergency patients. The agency must have a medical director and registered locations, may designate other locations, and may deliver and store substances there and in emergency vehicles under the notice, storage, security, and State-law requirements. Professionals may administer substances under standing or verbal orders, within their licenses, certifications, credentialing, and applicable protocols. The agency must keep section 827(a)-(b) records of every substance received, administered, or disposed of under its registration, including transfers between all locations, at each location where the activity occurs, despite section 827(c)(1)(B). Under the medical director’s supervision, it must ensure professional compliance, recordkeeping, physical security, and a registered-location record of standing orders. The Attorney General may regulate designated-location types, notice methods, storage including vehicle storage, and deliveries among hospitals, agencies, and locations during shortages, public-health emergencies, or mass-casualty events. Nothing here limits federal diversion-prevention authority or overrides consistent State regulation. The terms “authorizing medical professional,” “designated location,” “emergency medical services,” “emergency medical services agency,” “emergency medical services professional,” “emergency medical services vehicle,” “hospital-based,” “medical director,” “medical oversight,” “registered emergency medical services agency,” “registered location,” “specific State authority,” “standing order,” and “verbal order” have the meanings stated in paragraph (13): respectively, the listed registered professionals able to give verbal orders; an agency-designated place; emergency response and mobile care outside a fixed facility; an authorized governmental, nongovernmental, private, or volunteer provider; a State-licensed or certified professional credentialed by the director; a vehicle used for emergency care, transport, or substance transport; hospital ownership or operation; the registered physician providing oversight; supervision of agency care; an agency registered under this subsection or covered by a hospital registration; a certificate-listed place receiving substances from distributors; a State-law authority developing adoptable clinical protocols; a written advance administration protocol; and an oral directive directly communicated to a professional while the authorized person is not physically present..