Sec. 303 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 40

Sec. 303 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 40 

(e) The Attorney General shall register an applicant to dis- tribute controlled substances in schedule III, IV, or V, unless he de- termines 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 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 dis- pensing of such substances; 

(4) past experience in the distribution of controlled sub- stances; and 

(5) such other factors as may be relevant to and consistent with the public health and safety.
(f) The Attorney General shall register practitioners (including 

pharmacies, as distinguished from pharmacists) to dispense, or con- duct research with, controlled substances in schedule II, III, IV, or V and shall modify the registrations of pharmacies so registered to authorize them to dispense controlled substances by means of the Internet, if the applicant is authorized to dispense, or conduct re- search with respect to, controlled substances under the laws of the State in which he practices. The Attorney General may deny an ap- plication for such registration or such modification of registration if the Attorney General determines that the issuance of such reg- istration or modification would be inconsistent with the public in- terest. In determining the public interest, the following factors shall be considered: 

(1) The recommendation of the appropriate State licensing board or professional disciplinary authority. 

(2) The applicant’s experience in dispensing, or conducting research with respect to controlled substances. 

(3) The applicant’s conviction record under Federal or State laws relating to the manufacture, distribution, or dis- pensing of controlled substances. 

(4) Compliance with applicable State, Federal, or local laws relating to controlled substances. 

(5) 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, 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 to the Seretary, who shall determine the quali- fications and competency of each practitioner requesting registra- tion, 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 le- gitimate medical or scientific use. Registration for the purpose of bona fide research with controlled substances in schedule I by a practitioner deemed qualified by the Secretary may be denied by 

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41 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 303 

the Attorney General only on a ground specified in section 304(a). Article 7 of the Convention on Psychotrophic Substances shall not be construed to prohibit, or impose additional restrictions upon, re- search involving drugs or other substances scheduled under the convention which is conducted in conformity with this subsection and other applicable provisions of this title. 

(g)(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 reg- istration for that purpose. The Attorney General shall register an applicant to dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment (or both)— 

(A) if the applicant is a 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; 

(B) if the Attorney General determines that the applicant will comply with standards established by the Attorney Gen- eral respecting (i) security of stocks of narcotic drugs for such treatment, and (ii) the maintenance of records (in accordance with section 307) on such drugs; and 

(C) if the Secretary determines that the applicant will com- ply with standards established by the Secretary (after con- sultation with the Attorney General) respecting the quantities of narcotic drugs which may be provided for unsupervised use by individuals in such treatment.
(2)(A) Subject to subparagraphs (D) and (J), the requirements 

of paragraph (1) are waived in the case of the dispensing (including the prescribing), by a practitioner, of narcotic drugs in schedule III, IV, or V or combinations of such drugs if the practitioner meets the conditions specified in subparagraph (B) and the narcotic drugs or combinations of such drugs meet the conditions specified in sub- paragraph (C). 

(B) For purposes of subparagraph (A), the conditions specified in this subparagraph with respect to a practitioner are that, before the initial dispensing of narcotic drugs in schedule III, IV, or V or combinations of such drugs to patients for maintenance or detoxi- fication treatment, the practitioner submit to the Secretary a notifi- cation of the intent of the practitioner to begin dispensing the drugs or combinations for such purpose, and that the notification contain the following certifications by the practitioner: 

(i) The practitioner is a qualifying practitioner (as defined in subparagraph (G)). 

(ii) With respect to patients to whom the practitioner will provide such drugs or combinations of drugs, the practitioner has the capacity to provide directly, by referral, or in such other manner as determined by the Secretary— 

(I) all drugs approved by the Food and Drug Adminis- tration for the treatment of opioid use disorder, including for maintenance, detoxification, overdose reversal, and re- lapse prevention; and 

(II) appropriate counseling and other appropriate an- cillary services. 

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(iii)(I) The total number of such patients of the practitioner at any one time will not exceed the applicable number. Except as provided in subclause (II), the applicable number is 30. 

(II) The applicable number is 100 if, not sooner than 1 year after the date on which the practitioner submitted the ini- tial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. 

(III) The Secretary may by regulation change such applica- ble number. 

(IV) The Secretary may exclude from the applicable num- ber patients to whom such drugs or combinations of drugs are directly administered by the qualifying practitioner in the of- fice setting.
(C) For purposes of subparagraph (A), the conditions 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 or section 351 of the Public Health Service Act, been approved for use in mainte- nance or detoxification treatment. 

(ii) The drugs or combinations of drugs have not been the subject of an adverse determination. For purposes of this clause, an adverse determination is a determination published in the Federal Register and made by the Secretary, after con- sultation with the Attorney General, that the use of the drugs or combinations of drugs for maintenance or detoxification treatment requires additional standards respecting the quali- fications of practitioners to provide such treatment, or requires standards respecting the quantities of the drugs that may be provided for unsupervised use.
(D)(i) A waiver under subparagraph (A) with respect to a prac- 

titioner is not in effect unless (in addition to conditions under sub- paragraphs (B) and (C)) the following conditions are met: 

(I) The notification under subparagraph (B) is in writing and states the name of the practitioner. 

(II) The notification identifies the registration issued for the practitioner pursuant to subsection (f). 

(III) If the practitioner is a member of a group practice, the notification states the names of the other practitioners in the practice and identifies the registrations issued for the other practitioners pursuant to subsection (f).
(ii) Upon receiving a determination from the Secretary under 

clause (iii) finding that a practitioner meets all requirements for a waiver under subparagraph (B), the Attorney General shall assign the practitioner involved an identification number under this para- graph for inclusion with the registration issued for the practitioner pursuant to subsection (f). The identification number so assigned shall be appropriate to preserve the confidentiality of patients for whom the practitioner has dispensed narcotic drugs under a waiver under subparagraph (A). 

(iii) Not later than 45 days after the date on which the Sec- retary receives a notification under subparagraph (B), the Sec- retary shall make a determination of whether the practitioner in- 

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43 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 303 

volved meets all requirements for a waiver under subparagraph (B) and shall forward such determination to the Attorney General. If the Secretary fails to make such determination by the end of the such 45-day period, the Attorney General shall assign the practi- tioner an identification number described in clause (ii) at the end of such period. 

(E)(i) If a practitioner is not registered under paragraph (1) and, in violation of the conditions specified in subparagraphs (B) through (D), dispenses narcotic drugs in schedule III, IV, or V or combinations of such drugs for maintenance treatment or detoxi- fication treatment, the Attorney General may, for purposes of sec- tion 304(a)(4), consider the practitioner to have committed an act that renders the registration of the practitioner pursuant to sub- section (f) to be inconsistent with the public interest. 

(ii)(I) Upon the expiration of 45 days from the date on which the Secretary receives a notification under subparagraph (B), a practitioner who in good faith submits a notification under sub- paragraph (B) and reasonably believes that the conditions specified in subparagraphs (B) through (D) have been met shall, in dis- pensing narcotic drugs in schedule III, IV, or V or combinations of such drugs for maintenance treatment or detoxification treatment, be considered to have a waiver under subparagraph (A) until noti- fied otherwise by the Secretary, except that such a practitioner may commence to prescribe or dispense such narcotic drugs for such purposes prior to the expiration of such 45-day period if it fa- cilitates the treatment of an individual patient and both the Sec- retary and the Attorney General are notified by the practitioner of the intent to commence prescribing or dispensing such narcotic drugs. 

(II) For purposes of subclause (I), the publication in the Fed- eral Register of an adverse determination by the Secretary pursu- ant to subparagraph (C)(ii) shall (with respect to the narcotic drug or combination involved) be considered to be a notification provided by the Secretary to practitioners, effective upon the expiration of the 30-day period beginning on the date on which the adverse de- termination is so published. 

(F)(i) With respect to the dispensing of narcotic drugs in sched- ule III, IV, or V or combinations of such drugs to patients for main- tenance or detoxification treatment, a practitioner may, in his or her discretion, dispense such drugs or combinations for such treat- ment under a registration under paragraph (1) or a waiver under subparagraph (A) (subject to meeting the applicable conditions). 

(ii) This paragraph may not be construed as having any legal effect on the conditions for obtaining a registration under para- graph (1), including with respect to the number of patients who may be served under such a registration. 

(G) For purposes of this paragraph:
(i) The term ‘‘group practice’’ has the meaning given such 

term in section 1877(h)(4) of the Social Security Act.
(ii) The term ‘‘qualifying physician’’ means a physician who is licensed under State law and who meets one or more of the 

following conditions: 

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(I)29 The physician holds a board certification in addiction psychiatry or addiction medicine from the American Board of Medical Specialties. 

(II) 29 The physician holds an addiction certifi- cation or board certification from the American Society of Addiction Medicine or the American Board of Addiction Medicine. 

(III) The physician holds a board certification in addic- tion medicine from the American Osteopathic Association. (IV) The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than 8 hours of training (through classroom situa- tions, seminars at professional society meetings, electronic communications, or otherwise) that is provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or any other organiza- tion that the Secretary determines is appropriate for pur- 

poses of this subclause. Such training shall include—
(aa) opioid maintenance and detoxification;
(bb) appropriate clinical use of all drugs approved 

by the Food and Drug Administration for the treat- ment of opioid use disorder; 

(cc) initial and periodic patient assessments (in- cluding substance use monitoring); 

(dd) individualized treatment planning, overdose reversal, and relapse prevention; 

(ee) counseling and recovery support services;
(ff) staffing roles and considerations;
(gg) diversion control; and
(hh) other best practices, as identified by the Sec- 

retary. 

(V) The physician has participated as an investigator in one or more clinical trials leading to the approval of a narcotic drug in schedule III, IV, or V for maintenance or detoxification treatment, as demonstrated by a statement submitted to the Secretary by the sponsor of such ap- proved drug. 

(VI) The physician has such other training or experi- ence as the State medical licensing board (of the State in which the physician will provide maintenance or detoxi- fication treatment) considers to demonstrate the ability of the physician to treat and manage opiate-dependent pa- tients. 

(VII) The physician has such other training or experi- ence as the Secretary considers to demonstrate the ability of the physician to treat and manage opiate-dependent pa- tients. Any criteria of the Secretary under this subclause shall be established by regulation. Any such criteria are ef- fective only for 3 years after the date on which the criteria are promulgated, but may be extended for such additional 

29 Margins for subclauses (I) and (II) are so in law. 

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discrete 3-year periods as the Secretary considers appro- priate for purposes of this subclause. Such an extension of criteria may only be effectuated through a statement pub- lished in the Federal Register by the Secretary during the 30-day period preceding the end of the 3-year period in- volved. 

(iii) The term ‘‘qualifying practitioner’’ means—
(I) a qualifying physician, as defined in clause (ii); or (II) during the period beginning on the date of enact- 

ment of the Comprehensive Addiction and Recovery Act of 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 fol- lowing: 

(I) The nurse practitioner or physician assistant is li- censed 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 pro- fessional society meetings, electronic communications, or otherwise) provided by the American Society of Ad- diction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Nurses Credentialing Center, the American Psy- chiatric Association, the American Association of Nurse Practitioners, the American Academy of Physi- cian 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 En- forcement 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 no- tice and comment rulemaking) or issue practice guidelines to ad- dress the following: 

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(I) Approval of additional credentialing bodies and the re- sponsibilities 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 serv- ices are provided. 

(ii) Not later than 18 months after the date of enactment of the Opioid Use Disorder Treatment Expansion and Modernization Act30, the Secretary shall update the treatment improvement pro- tocol containing best practice guidelines for the treatment of opioid- dependent patients in office-based settings. The Secretary shall up- date such protocol in consultation with experts in opioid use dis- order research and treatment. 

(I) Notwithstanding section 708, 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 addi- tional requirements relating to the dispensing of narcotic drugs in schedule III, IV, or V, or combinations of such drugs, includ- ing requirements relating to the practice setting in which the qualifying practitioner practices and education, training, and reporting requirements.
(h) The Attorney General shall register an applicant to dis- 

tribute a list I chemical unless the Attorney General determines that registration of the applicant is inconsistent with the public in- terest. 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 102(39)(A). In determining the public interest for the purposes of this subsection, the Attorney General shall con- sider— 

(1) maintenance by the applicant of effective controls against diversion of listed chemicals into other than legitimate channels; 

(2) compliance by the applicant with applicable Federal, State, and local law; 

30 The date of enactment of the Opioid Use Disorder Treatment Expansion and Modernization Act, referred to in subsection (g)(2)(H)(ii), probably means the date of enactment of Pub. L. 114– 198, known as the Comprehensive Addiction and Recovery Act of 2016, which was approved July 22, 2016. The Opioid Use Disorder Treatment Expansion and Modernization Act was H.R. 4981 of the 114th Congress, as introduced on Apr. 18, 2016. Amendatory provisions of H.R. 4981 were incorporated into Pub. L. 114–198, but no such short title was enacted. 

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(3) any prior conviction record of the applicant under Fed- eral or State laws relating to controlled substances or to chemi- cals controlled under Federal or State law; 

(4) any past experience of the applicant in the manufac- ture and distribution of chemicals; and 

(5) such other factors as are relevant to and consistent with the public health and safety.
(i)(1) For purposes of registration to manufacture a controlled 

January 16, 2018 

substance under subsection (d) for use only in a clinical trial, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with section 304(c), not later than 180 days after the date on which the application is accepted for filing. 

(2) For purposes of registration to manufacture a controlled substance under subsection (a) for use only in a clinical trial, the Attorney General shall, in accordance with the regulations issued by the Attorney General, issue a notice of application not later than 90 days after the application is accepted for filing. Not later than 90 days after the date on which the period for comment pur- suant 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 304(c), unless the Attorney General has granted a hearing on the application under section 1008(i) of the Controlled Substances Import and Export Act. 

(j) EMERGENCY MEDICAL SERVICES THAT ADMINISTER CON- TROLLED SUBSTANCES.— 

(1) REGISTRATION.—For the purpose of enabling emergency medical services professionals to administer controlled sub- stances in schedule II, III, IV, or V to ultimate users receiving emergency medical services in accordance with the require- ments of this subsection, the Attorney General— 

(A) shall register an emergency medical services agen- cy 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 fac- tors listed in subsection (f).
(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 registra- tion for each location of the emergency medical services agen- cy. 

(3) HOSPITAL-BASED AGENCY.—If a hospital-based emer- gency medical services agency is registered under subsection (f), the agency may use the registration of the hospital to ad- minister controlled substances in accordance with this sub- section without being registered under this subsection. 

(4) ADMINISTRATION OUTSIDE PHYSICAL PRESENCE OF MED- ICAL DIRECTOR OR AUTHORIZING MEDICAL PROFESSIONAL.— 

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Emergency medical services professionals of a registered emer- gency medical services agency may administer controlled sub- stances in schedule II, III, IV, or V outside the physical pres- ence of a medical director or authorizing medical professional in the course of providing emergency medical services if the ad- ministration is— 

(A) authorized by the law of the State in which it oc- curs; 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 author- 

izing 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 inci- dent; or 

(bb) to ensure the proper care and treat- ment of a specific patient. 

(5) DELIVERY.—A registered emergency medical services agency may deliver controlled substances from a registered lo- cation of the agency to an unregistered location of the agency only if the agency— 

(A) designates the unregistered location for such deliv- ery; 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 des- ignated 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 re- sponding to an emergency; or 

(ii) otherwise actively in use by the agency under circumstances that provide for security of the con- trolled substances consistent with the requirements established by regulations of the Attorney General. 

(7) NO TREATMENT AS DISTRIBUTION.—The delivery of con- trolled substances by a registered emergency medical services agency pursuant to this subsection shall not be treated as dis- tribution for purposes of section 308. 

(8) RESTOCKING OF EMERGENCY MEDICAL SERVICES VEHI- CLES AT A HOSPITAL.—Notwithstanding paragraph (13)(J), a 

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registered emergency medical services agency may receive con- trolled substances from a hospital for purposes of restocking an emergency medical services vehicle following an emergency re- sponse, and without being subject to the requirements of sec- tion 308, 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). 

(B) The hospital maintains a record of such delivery to the agency in accordance with section 307. 

(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 307 of all controlled sub- stances that are received, administered, or otherwise dis- posed of pursuant to the agency’s registration, without re- gard to subsection 307(c)(1)(B). 

(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 med- ical services agency, under the supervision of a medical direc- 

tor, shall be responsible for ensuring that—
(A) all emergency medical services professionals who 

administer controlled substances using the agency’s reg- istration 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 des- ignated location of the agency; 

(C) the applicable physical security requirements es- tablished by regulation of the Attorney General are com- plied 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 regu- 

lations—
(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 para- 

graph (5)(B) must be made; 

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(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 lo- cations, including in emergency medical service vehicles; and 

(C) addressing the ability of hospitals, emergency med- ical 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 Gen- eral by other provisions of this title 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 pro- fessional (including an advanced practice registered nurse or physician assistant)— 

(i) who is registered under this Act; 

(ii) who is acting within the scope of the registra- tion; 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 med- ical services provided outside of a fixed medical facility. 

(D) The term ‘‘emergency medical services agency’’ means an organization providing emergency medical serv- ices, including such an organization that— 

(i) is governmental (including fire-based and hos- pital-based agencies), nongovernmental (including hos- pital-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 orga- nization is providing such services to provide emer- gency medical care, including the administering of controlled substances, to members of the general pub- lic on an emergency basis. 

(E) The term ‘‘emergency medical services profes- sional’’ means a health care professional (including a nurse, paramedic, or emergency medical technician) li- censed or certified by the State in which the professional 

As Amended Through P.L. 115-91, Enacted December 12, 2017 

January 16, 2018 

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TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 303 

practices and credentialed by a medical director of the re- spective emergency medical services agency to provide emergency medical services within the scope of the profes- sional’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 agen- cy for the purpose of providing or facilitating emergency medical care and transport or transporting controlled sub- stances to and from the registered and designated loca- tions. 

(G) The term ‘‘hospital-based’’ means, with respect to an agency, owned or operated by a hospital. 

(H) The term ‘‘medical director’’ means a physician who is registered under subsection (f) and provides medical oversight for an emergency medical services agency. 

(I) The term ‘‘medical oversight’’ means supervision of the provision of medical care by an emergency medical services agency. 

(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 hos- pital under subsection (f).
(K) The term ‘‘registered location’’ means a location 

that appears on the certificate of registration issued to an emergency medical services agency under this subsection or subsection (f), which shall be where the agency receives controlled substances from distributors. 

(L) The term ‘‘specific State authority’’ means a gov- ernmental agency or other such authority, including a re- gional oversight and coordinating body, that, pursuant to State law or regulation, develops clinical protocols regard- ing the delivery of emergency medical services in the geo- graphic jurisdiction of such agency or authority within the State that may be adopted by medical directors. 

(M) The term ‘‘standing order’’ means a written med- ical protocol in which a medical director determines in ad- vance the medical criteria that must be met before admin- istering 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 in- cluding by radio or telephone, directly to an emergency medical services professional, to contemporaneously ad- minister a controlled substance to individuals in need of emergency medical services outside the physical presence of the medical director or authorizing medical professional. 

(k) 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 101. 

January 16, 2018 As Amended Through P.L. 115-91, Enacted December 12, 2017 

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