[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.