[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 304 Enrolled Bill (ENR)]

        H.R.304

                     One Hundred Fifteenth Congress

                                 of the

                        United States of America


                          AT THE FIRST SESSION

          Begun and held at the City of Washington on Tuesday,
          the third day of January, two thousand and seventeen


                                 An Act


 
 To amend the Controlled Substances Act with regard to the provision of 
                       emergency medical services.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,
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 medical services 
    agency may administer controlled substances in schedule II, III, 
    IV, or V outside the physical presence of a medical director or 
    authorizing medical professional in the course of providing 
    emergency medical services if the administration is--
            ``(A) authorized by the law of the State in which it 
        occurs; and
            ``(B) pursuant to--
                ``(i) a standing order that is issued and adopted by 
            one or more medical directors of the agency, including any 
            such order that may be developed by a specific State 
            authority; or
                ``(ii) a verbal order that is--

                    ``(I) issued in accordance with a policy of the 
                agency; and
                    ``(II) provided by a medical director or 
                authorizing medical professional in response to a 
                request by the emergency medical services professional 
                with respect to a specific patient--

                        ``(aa) in the case of a mass casualty incident; 
                    or
                        ``(bb) to ensure the proper care and treatment 
                    of a specific patient.
        ``(5) Delivery.--A registered emergency medical services agency 
    may deliver controlled substances from a registered location of the 
    agency to an unregistered location of the agency only if the 
    agency--
            ``(A) designates the unregistered location for such 
        delivery; and
            ``(B) notifies the Attorney General at least 30 days prior 
        to first delivering controlled substances to the unregistered 
        location.
        ``(6) Storage.--A registered emergency medical services agency 
    may store controlled substances--
            ``(A) at a registered location of the agency;
            ``(B) at any designated location of the agency or in an 
        emergency services vehicle situated at a registered or 
        designated location of the agency; or
            ``(C) in an emergency medical services vehicle used by the 
        agency that is--
                ``(i) traveling from, or returning to, a registered or 
            designated location of the agency in the course of 
            responding to an emergency; or
                ``(ii) otherwise actively in use by the agency under 
            circumstances that provide for security of the controlled 
            substances consistent with the requirements established by 
            regulations of the Attorney General.
        ``(7) No treatment as distribution.--The delivery of controlled 
    substances by a registered emergency medical services agency 
    pursuant to this subsection shall not be treated as distribution 
    for purposes of section 308.
        ``(8) Restocking of emergency medical services vehicles at a 
    hospital.--Notwithstanding paragraph (13)(J), a registered 
    emergency medical services agency may receive controlled substances 
    from a hospital for purposes of restocking an emergency medical 
    services vehicle following an emergency response, and without being 
    subject to the requirements of section 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 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 
        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.
            ``(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.''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.