```

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 916 Reported in Senate (RS)]

<DOC>

                                                        Calendar No. 46
115th CONGRESS
  1st Session
                                 S. 916

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

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             April 24, 2017

   Mr. Cassidy (for himself, Mr. Bennet, Mr. Blunt, Mr. Franken, Mr. 
  Alexander, Ms. Murkowski, and Mrs. Murray) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

                              May 1, 2017

              Reported by Mr. Alexander, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL

 
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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Protecting Patient Access 
to Emergency Medications Act of 2017''.</DELETED>

<DELETED>SEC. 2. EMERGENCY MEDICAL SERVICES.</DELETED>

<DELETED>    Section 303 of the Controlled Substances Act (21 U.S.C. 
823) is amended--</DELETED>
        <DELETED>    (1) by redesignating subsection (j) as subsection 
        (k); and</DELETED>
        <DELETED>    (2) by inserting after subsection (i) the 
        following:</DELETED>
<DELETED>    ``(j) Emergency Medical Services That Administer 
Controlled Substances.--</DELETED>
        <DELETED>    ``(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--
        </DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) authorized by the law of the State 
                in which it occurs; and</DELETED>
                <DELETED>    ``(B) pursuant to--</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(ii) a verbal order that is--
                        </DELETED>
                                <DELETED>    ``(I) issued in accordance 
                                with a policy of the agency; 
                                and</DELETED>
                                <DELETED>    ``(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--</DELETED>
                                        <DELETED>    ``(aa) in the case 
                                        of a mass casualty incident; 
                                        or</DELETED>
                                        <DELETED>    ``(bb) to ensure 
                                        the proper care and treatment 
                                        of a specific 
                                        patient.</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) the agency designates the 
                unregistered location for such delivery; and</DELETED>
                <DELETED>    ``(B) notifies the Attorney General at 
                least 30 days prior to first delivering controlled 
                substances to the unregistered location.</DELETED>
        <DELETED>    ``(6) Storage.--A registered emergency medical 
        services agency may store controlled substances--</DELETED>
                <DELETED>    ``(A) at a registered location of the 
                agency;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(C) in an emergency medical services 
                vehicle used by the agency that is--</DELETED>
                        <DELETED>    ``(i) traveling from, or returning 
                        to, a registered or designated location of the 
                        agency in the course of responding to an 
                        emergency; or</DELETED>
                        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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:</DELETED>
                <DELETED>    ``(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).</DELETED>
                <DELETED>    ``(B) The hospital maintains a record of 
                such delivery to the agency in accordance with section 
                307.</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(9) Maintenance of records.--</DELETED>
                <DELETED>    ``(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).</DELETED>
                <DELETED>    ``(B) Requirements.--Such records--
                </DELETED>
                        <DELETED>    ``(i) shall include records of 
                        deliveries of controlled substances between all 
                        locations of the agency; and</DELETED>
                        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(10) Other requirements.--A registered emergency 
        medical services agency, under the supervision of a medical 
        director, shall be responsible for ensuring that--</DELETED>
                <DELETED>    ``(A) all emergency medical services 
                professionals who administer controlled substances 
                using the agency's registration act in accordance with 
                the requirements of this subsection;</DELETED>
                <DELETED>    ``(B) the recordkeeping requirements of 
                paragraph (9) are met with respect to a registered 
                location and each designated location of the 
                agency;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(11) Regulations.--The Attorney General may 
        issue regulations--</DELETED>
                <DELETED>    ``(A) specifying, with regard to delivery 
                of controlled substances under paragraph (5)--
                </DELETED>
                        <DELETED>    ``(i) the types of locations that 
                        may be designated under such paragraph; 
                        and</DELETED>
                        <DELETED>    ``(ii) the manner in which a 
                        notification under paragraph (5)(B) must be 
                        made;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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--
                </DELETED>
                        <DELETED>    ``(i) shortages of such 
                        substances;</DELETED>
                        <DELETED>    ``(ii) a public health emergency; 
                        or</DELETED>
                        <DELETED>    ``(iii) a mass casualty 
                        event.</DELETED>
        <DELETED>    ``(12) Rule of construction.--Nothing in this 
        subsection shall be construed--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(B) to override the authority of any 
                State to regulate the provision of emergency medical 
                services consistent with this subsection.</DELETED>
        <DELETED>    ``(13) Definitions.--In this section:</DELETED>
                <DELETED>    ``(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) who 
                is--</DELETED>
                        <DELETED>    ``(i) registered under this 
                        Act;</DELETED>
                        <DELETED>    ``(ii) acting within the scope of 
                        the registration; and</DELETED>
                        <DELETED>    ``(iii) whose scope of practice 
                        under a State license or certification includes 
                        the ability to provide verbal orders.</DELETED>
                <DELETED>    ``(B) The term `designated location' means 
                a location designated by an emergency medical services 
                agency under paragraph (5).</DELETED>
                <DELETED>    ``(C) The term `emergency medical 
                services' means emergency medical response and 
                emergency mobile medical services provided outside of a 
                fixed medical facility.</DELETED>
                <DELETED>    ``(D) The term `emergency medical services 
                agency' means an organization providing emergency 
                medical services, including such an organization that--
                </DELETED>
                        <DELETED>    ``(i) is governmental (including 
                        fire-based and hospital-based agencies), 
                        nongovernmental (including hospital-based 
                        agencies), private, or volunteer-
                        based;</DELETED>
                        <DELETED>    ``(ii) provides emergency medical 
                        services by ground, air, or otherwise; 
                        and</DELETED>
                        <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(G) The term `hospital-based' means, 
                with respect to an agency, owned or operated by a 
                hospital.</DELETED>
                <DELETED>    ``(H) The term `medical director' means a 
                physician who is registered under subsection (f) and 
                provides medical oversight for an emergency medical 
                services agency.</DELETED>
                <DELETED>    ``(I) The term `medical oversight' means 
                supervision of the provision of medical care by an 
                emergency medical services agency.</DELETED>
                <DELETED>    ``(J) 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.</DELETED>
                <DELETED>    ``(K) The term `registered emergency 
                medical services agency' means--</DELETED>
                        <DELETED>    ``(i) an emergency medical 
                        services agency that is registered pursuant to 
                        this subsection; or</DELETED>
                        <DELETED>    ``(ii) a hospital-based emergency 
                        medical services agency that is covered by the 
                        registration of the hospital under subsection 
                        (f).</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 3. DELIVERY OF A CONTROLLED SUBSTANCE BY A PHARMACY TO AN 
              ADMINISTERING PRACTITIONER.</DELETED>

<DELETED>    (a) In General.--The Controlled Substance Act is amended 
by inserting after section 309 (21 U.S.C. 829) the following:</DELETED>

<DELETED>``SEC. 309A. DELIVERY OF A CONTROLLED SUBSTANCE BY A PHARMACY 
              TO AN ADMINISTERING PRACTITIONER.</DELETED>

<DELETED>    ``Notwithstanding section 102(10), a pharmacy may deliver 
a controlled substance to a practitioner in accordance with a 
prescription that meets the requirements of this Act and the 
regulations issued by the Attorney General under this Act, for the 
purpose of administering of the controlled substance by the 
practitioner if--</DELETED>
        <DELETED>    ``(1) the controlled substance is delivered by the 
        pharmacy to the prescribing practitioner or the practitioner 
        administering the controlled substance, as applicable, at the 
        location listed on the practitioner's certificate of 
        registration issued under this Act;</DELETED>
        <DELETED>    ``(2)(A) in the case of administering of the 
        controlled substance for the purpose of maintenance or 
        detoxification treatment under section 303(g)(2)--</DELETED>
                <DELETED>    ``(i) the practitioner who issued the 
                prescription is a qualifying practitioner authorized 
                under, and acting within the scope of that section; 
                and</DELETED>
                <DELETED>    ``(ii) the controlled substance is to be 
                administered by injection, implantation, or use of an 
                intrathecal pump; or</DELETED>
        <DELETED>    ``(B) in the case of administering of the 
        controlled substance for a purpose other than maintenance or 
        detoxification treatment, the controlled substance is to be 
        administered by a practitioner through use of an intrathecal 
        pump;</DELETED>
        <DELETED>    ``(3) the pharmacy and the practitioner are 
        authorized to conduct the activities specified in this section 
        under the law of the State in which such activities take 
        place;</DELETED>
        <DELETED>    ``(4) the prescription is not issued to supply any 
        practitioner with a stock of controlled substances for the 
        purpose of general dispensing to patients;</DELETED>
        <DELETED>    ``(5) the controlled substance is to be 
        administered only to the patient named on the prescription not 
        later than 7 days, or longer if extended by the Attorney 
        General, after the date of receipt of the controlled substance 
        by the practitioner; and</DELETED>
        <DELETED>    ``(6) notwithstanding any exceptions under section 
        307, the prescribing practitioner, and the practitioner 
        administering the controlled substance, as applicable, maintain 
        complete and accurate records of all controlled substances 
        delivered, received, administered, or otherwise disposed of 
        under this section, including the persons to whom controlled 
        substances were delivered and such other information as may be 
        required by regulations of the Attorney General.''.</DELETED>
<DELETED>    (b) Technical and Conforming Amendment.--The table of 
contents for the Comprehensive Drug Abuse Prevention and Control Act of 
1970 is amended by inserting after the item relating to section 309 the 
following:</DELETED>

<DELETED>``Sec. 309A. Delivery of a controlled substance by a pharmacy 
                            to an administering practitioner.''.

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--
                    ``(A) the agency 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) who is--
                            ``(i) registered under this Act;
                            ``(ii) 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 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.
                    ``(K) 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).
                    ``(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.''.

SEC. 3. DELIVERY OF A CONTROLLED SUBSTANCE BY A PHARMACY TO AN 
              ADMINISTERING PRACTITIONER.

    (a) In General.--The Controlled Substance Act is amended by 
inserting after section 309 (21. U.S.C. 829) the following:

``SEC. 309A. DELIVERY OF A CONTROLLED SUBSTANCE BY A PHARMACY TO AN 
              ADMINISTERING PRACTITIONER.

    ``(a) In General.--Notwithstanding section 102(10), a pharmacy may 
deliver a controlled substance to a practitioner in accordance with a 
prescription that meets the requirements of this Act and the 
regulations issued by the Attorney General under this Act, for the 
purpose of administering of the controlled substance by the 
practitioner if--
            ``(1) the controlled substance is delivered by the pharmacy 
        to the prescribing practitioner or the practitioner 
        administering the controlled substance, as applicable, at the 
        location listed on the practitioner's certificate of 
        registration issued under this Act;
            ``(2)(A) in the case of administering of the controlled 
        substance for the purpose of maintenance or detoxification 
        treatment under section 303(g)(2)--
                    ``(i) the practitioner who issued the prescription 
                is a qualifying practitioner authorized under, and 
                acting within the scope of that section; and
                    ``(ii) the controlled substance is to be 
                administered by injection, implantation, or through the 
                use of an intrathecal pump; or
            ``(B) in the case of administering of the controlled 
        substance for a purpose other than maintenance or 
        detoxification treatment, the controlled substance is to be 
        administered by a practitioner through use of an intrathecal 
        pump;
            ``(3) the pharmacy and the practitioner are authorized to 
        conduct the activities specified in this section under the law 
        of the State in which such activities take place;
            ``(4) the prescription is not issued to supply any 
        practitioner with a stock of controlled substances for the 
        purpose of general dispensing to patients;
            ``(5) except as provided in subsection (b), the controlled 
        substance is to be administered only to the patient named on 
        the prescription not later than 14 days after the date of 
        receipt of the controlled substance by the practitioner; and
            ``(6) notwithstanding any exceptions under section 307, the 
        prescribing practitioner, and the practitioner administering 
        the controlled substance, as applicable, maintain complete and 
        accurate records of all controlled substances delivered, 
        received, administered, or otherwise disposed of under this 
        section, including the persons to whom controlled substances 
        were delivered and such other information as may be required by 
        regulations of the Attorney General.
    ``(b) Modification of Number of Days Before Which Controlled 
Substance Shall Be Administered.--
            ``(1) Initial 2-year period.--During the 2-year period 
        beginning on the date of enactment of this section, the 
        Attorney General, in coordination with the Secretary, may 
        reduce the number of days described in subsection (a)(5) if the 
        Attorney General determines that such reduction will--
                    ``(A) reduce the risk of diversion; or
                    ``(B) protect the public health.
            ``(2) Modifications after submission of report.--After the 
        date on which the report described in subsection (c) is 
        submitted, the Attorney General, in coordination with the 
        Secretary, may modify the number of days described in 
        subsection (a)(5).
            ``(3) Minimum number of days.--Any modification under this 
        subsection shall be for a period of not less than 7 days.
    ``(c) Study and Report.--Not later than 2 years after the date of 
enactment of this section, the Comptroller General of the United States 
shall conduct a study and submit to Congress a report on access to and 
potential diversion of controlled substances administered by injection, 
implantation, or through the use of an intrathecal pump.''.
    (b) Technical and Conforming Amendment.--The table of contents for 
the Comprehensive Drug Abuse Prevention and Control Act of 1970 is 
amended by inserting after the item relating to section 309 the 
following:

``Sec. 309A. Delivery of a controlled substance by a pharmacy to an 
                            administering practitioner.''.
                                                        Calendar No. 46

115th CONGRESS

  1st Session

                                 S. 916

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                              May 1, 2017

                       Reported with an amendment
```