[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