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[115th Congress Public Law 83]
[From the U.S. Government Publishing Office]

[[Page 131 STAT. 1267]]

Public Law 115-83
115th Congress

                                 An Act

 
 To amend the Controlled Substances Act with regard to the provision of 
   emergency medical services. <<NOTE: Nov. 17, 2017 -  [H.R. 304]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Protecting 
Patient Access to Emergency Medications Act of 2017. 21 USC 801 note.>> 
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Protecting Patient Access to 
Emergency Medications Act of 2017''.
SEC. 2. EMERGENCY MEDICAL SERVICES.

    Section 303 of the Controlled Substances Act (21 U.S.C. 823) is 
amended--
            (1) by redesignating subsection (j) as subsection (k); and
            (2) by inserting after subsection (i) the following:

    ``(j) Emergency Medical Services That Administer Controlled 
Substances.--
            ``(1) Registration.--For the purpose of enabling emergency 
        medical services professionals to administer controlled 
        substances in schedule II, III, IV, or V to ultimate users 
        receiving emergency medical services in accordance with the 
        requirements of this subsection, the Attorney General--
                    ``(A) shall register an emergency medical services 
                agency if the agency submits an application 
                demonstrating it is authorized to conduct such activity 
                under the laws of each State in which the agency 
                practices; and
                    ``(B) may deny an application for such registration 
                if the Attorney General determines that the issuance of 
                such registration would be inconsistent with the 
                requirements of this subsection or the public interest 
                based on the factors listed in subsection (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 
        registration for each location of the emergency medical services 
        agency.
            ``(3) Hospital-based agency.--If a hospital-based emergency 
        medical services agency is registered under subsection (f), the 
        agency may use the registration of the hospital to administer 
        controlled substances in accordance with this subsection without 
        being registered under this subsection.
            ``(4) Administration outside physical presence of medical 
        director or authorizing medical professional.--Emergency medical 
        services professionals of a registered emergency

[[Page 131 STAT. 1268]]

        medical services agency may administer controlled substances in 
        schedule II, III, IV, or V outside the physical presence of a 
        medical director or authorizing medical professional in the 
        course of providing emergency medical services if the 
        administration is--
                    ``(A) authorized by the law of the State in which it 
                occurs; and
                    ``(B) pursuant to--
                          ``(i) a standing order that is issued and 
                      adopted by one or more medical directors of the 
                      agency, including any such order that may be 
                      developed by a specific State authority; or
                          ``(ii) a verbal order that is--
                                    ``(I) issued in accordance with a 
                                policy of the agency; and
                                    ``(II) provided by a medical 
                                director or authorizing medical 
                                professional in response to a request by 
                                the emergency medical services 
                                professional with respect to a specific 
                                patient--
                                            ``(aa) in the case of a mass 
                                        casualty incident; or
                                            ``(bb) to ensure the proper 
                                        care and treatment of a specific 
                                        patient.
            ``(5) Delivery.--A registered emergency medical services 
        agency may deliver controlled substances from a registered 
        location of the agency to an unregistered location of the agency 
        only if the agency--
                    ``(A) designates the unregistered location for such 
                delivery; and
                    ``(B) <<NOTE: Notification. Time period.>>  notifies 
                the Attorney General at least 30 days prior to first 
                delivering controlled substances to the unregistered 
                location.
            ``(6) Storage.--A registered emergency medical services 
        agency may store controlled substances--
                    ``(A) at a registered location of the agency;
                    ``(B) at any designated location of the agency or in 
                an emergency services vehicle situated at a registered 
                or designated location of the agency; or
                    ``(C) in an emergency medical services vehicle used 
                by the agency that is--
                          ``(i) traveling from, or returning to, a 
                      registered or designated location of the agency in 
                      the course of responding to an emergency; or
                          ``(ii) otherwise actively in use by the agency 
                      under circumstances that provide for security of 
                      the controlled substances consistent with the 
                      requirements established by regulations of the 
                      Attorney General.
            ``(7) No treatment as distribution.--The delivery of 
        controlled substances by a registered emergency medical services 
        agency pursuant to this subsection shall not be treated as 
        distribution for purposes of section 308.
            ``(8) <<NOTE: Records.>>  Restocking of emergency medical 
        services vehicles at a hospital.--Notwithstanding paragraph 
        (13)(J), a registered emergency medical services agency may 
        receive controlled substances from a hospital for purposes of 
        restocking an emergency medical services vehicle following an 
        emergency

[[Page 131 STAT. 1269]]

        response, and without being subject to the requirements of 
        section 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) <<NOTE: Notification. Deadline.>>  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 substances that are received, administered, 
                or otherwise disposed of pursuant to the agency's 
                registration, without regard 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 medical 
        services agency, under the supervision of a medical director, 
        shall be responsible for ensuring that--
                    ``(A) all emergency medical services professionals 
                who administer controlled substances using the agency's 
                registration act in accordance with the requirements of 
                this subsection;
                    ``(B) the recordkeeping requirements of paragraph 
                (9) are met with respect to a registered location and 
                each designated location of the agency;
                    ``(C) the applicable physical security requirements 
                established by regulation of the Attorney General are 
                complied with wherever controlled substances are stored 
                by the agency in accordance with paragraph (6); and
                    ``(D) the agency maintains, at a registered location 
                of the agency, a record of the standing orders issued or 
                adopted in accordance with paragraph (9).
            ``(11) Regulations.--The Attorney General may issue 
        regulations--
                    ``(A) specifying, with regard to delivery of 
                controlled substances under paragraph (5)--
                          ``(i) the types of locations that may be 
                      designated under such paragraph; and
                          ``(ii) the manner in which a notification 
                      under paragraph (5)(B) must be made;
                    ``(B) specifying, with regard to the storage of 
                controlled substances under paragraph (6), the manner in 
                which such substances must be stored at registered and 
                designated locations, including in emergency medical 
                service vehicles; and
                    ``(C) addressing the ability of hospitals, emergency 
                medical services agencies, registered locations, and 
                designated

[[Page 131 STAT. 1270]]

                locations to deliver controlled substances to each other 
                in the event of--
                          ``(i) shortages of such substances;
                          ``(ii) a public health emergency; or
                          ``(iii) a mass casualty event.
            ``(12) Rule of construction.--Nothing in this subsection 
        shall be construed--
                    ``(A) to limit the authority vested in the Attorney 
                General by other provisions of this 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 professional (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 
                      registration; and
                          ``(iii) whose scope of practice under a State 
                      license or certification includes the ability to 
                      provide verbal orders.
                    ``(B) The term `designated location' means a 
                location designated by an emergency medical services 
                agency under paragraph (5).
                    ``(C) The term `emergency medical services' means 
                emergency medical response and emergency mobile medical 
                services provided outside of a fixed medical facility.
                    ``(D) The term `emergency medical services agency' 
                means an organization providing emergency medical 
                services, including such an organization that--
                          ``(i) is governmental (including fire-based 
                      and hospital-based agencies), nongovernmental 
                      (including hospital-based agencies), private, or 
                      volunteer-based;
                          ``(ii) provides emergency medical services by 
                      ground, air, or otherwise; and
                          ``(iii) is authorized by the State in which 
                      the organization is providing such services to 
                      provide emergency medical care, including the 
                      administering of controlled substances, to members 
                      of the general public on an emergency basis.
                    ``(E) The term `emergency medical services 
                professional' means a health care professional 
                (including a nurse, paramedic, or emergency medical 
                technician) licensed or certified by the State in which 
                the professional practices and credentialed by a medical 
                director of the respective emergency medical services 
                agency to provide emergency medical services within the 
                scope of the professional's State license or 
                certification.
                    ``(F) The term `emergency medical services vehicle' 
                means an ambulance, fire apparatus, supervisor truck, or 
                other vehicle used by an emergency medical services 
                agency for the purpose of providing or facilitating 
                emergency medical care and transport or transporting 
                controlled substances to and from the registered and 
                designated locations.

[[Page 131 STAT. 1271]]

                    ``(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 hospital under subsection (f).
                    ``(K) The term `registered location' means a 
                location that appears on the certificate of registration 
                issued to an emergency medical services agency under 
                this subsection or subsection (f), which shall be where 
                the agency receives controlled substances from 
                distributors.
                    ``(L) The term `specific State authority' means a 
                governmental agency or other such authority, including a 
                regional oversight and coordinating body, that, pursuant 
                to State law or regulation, develops clinical protocols 
                regarding the delivery of emergency medical services in 
                the geographic jurisdiction of such agency or authority 
                within the State that may be adopted by medical 
                directors.
                    ``(M) The term `standing order' means a written 
                medical protocol in which a medical director determines 
                in advance the medical criteria that must be met before 
                administering controlled substances to individuals in 
                need of emergency medical services.
                    ``(N) The term `verbal order' means an oral 
                directive that is given through any method of 
                communication including by radio or telephone, directly 
                to an emergency medical services professional, to 
                contemporaneously administer a controlled substance to 
                individuals in need of emergency medical services 
                outside the physical presence of the medical director or 
                authorizing medical professional.''.

    Approved November 17, 2017.

LEGISLATIVE HISTORY--H.R. 304:
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CONGRESSIONAL RECORD, Vol. 163 (2017):
            Jan. 9, considered and passed House.
            Oct. 24, considered and passed Senate, amended.
            Nov. 2, House concurred in Senate amendment.

                                  <all>
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