[115th Congress Public Law 83]
[From the U.S. Government Publishing Office]
[[Page 131 STAT. 1267]]
Public Law 115-83
115th Congress
An Act
To amend the Controlled Substances Act with regard to the provision of
emergency medical services. <<NOTE: Nov. 17, 2017 - [H.R. 304]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Protecting
Patient Access to Emergency Medications Act of 2017. 21 USC 801 note.>>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Protecting Patient Access to
Emergency Medications Act of 2017''.
SEC. 2. EMERGENCY MEDICAL SERVICES.
Section 303 of the Controlled Substances Act (21 U.S.C. 823) is
amended--
(1) by redesignating subsection (j) as subsection (k); and
(2) by inserting after subsection (i) the following:
``(j) Emergency Medical Services That Administer Controlled
Substances.--
``(1) Registration.--For the purpose of enabling emergency
medical services professionals to administer controlled
substances in schedule II, III, IV, or V to ultimate users
receiving emergency medical services in accordance with the
requirements of this subsection, the Attorney General--
``(A) shall register an emergency medical services
agency if the agency submits an application
demonstrating it is authorized to conduct such activity
under the laws of each State in which the agency
practices; and
``(B) may deny an application for such registration
if the Attorney General determines that the issuance of
such registration would be inconsistent with the
requirements of this subsection or the public interest
based on the factors listed in subsection (f).
``(2) Option for single registration.--In registering an
emergency medical services agency pursuant to paragraph (1), the
Attorney General shall allow such agency the option of a single
registration in each State where the agency administers
controlled substances in lieu of requiring a separate
registration for each location of the emergency medical services
agency.
``(3) Hospital-based agency.--If a hospital-based emergency
medical services agency is registered under subsection (f), the
agency may use the registration of the hospital to administer
controlled substances in accordance with this subsection without
being registered under this subsection.
``(4) Administration outside physical presence of medical
director or authorizing medical professional.--Emergency medical
services professionals of a registered emergency
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medical services agency may administer controlled substances in
schedule II, III, IV, or V outside the physical presence of a
medical director or authorizing medical professional in the
course of providing emergency medical services if the
administration is--
``(A) authorized by the law of the State in which it
occurs; and
``(B) pursuant to--
``(i) a standing order that is issued and
adopted by one or more medical directors of the
agency, including any such order that may be
developed by a specific State authority; or
``(ii) a verbal order that is--
``(I) issued in accordance with a
policy of the agency; and
``(II) provided by a medical
director or authorizing medical
professional in response to a request by
the emergency medical services
professional with respect to a specific
patient--
``(aa) in the case of a mass
casualty incident; or
``(bb) to ensure the proper
care and treatment of a specific
patient.
``(5) Delivery.--A registered emergency medical services
agency may deliver controlled substances from a registered
location of the agency to an unregistered location of the agency
only if the agency--
``(A) designates the unregistered location for such
delivery; and
``(B) <<NOTE: Notification. Time period.>> notifies
the Attorney General at least 30 days prior to first
delivering controlled substances to the unregistered
location.
``(6) Storage.--A registered emergency medical services
agency may store controlled substances--
``(A) at a registered location of the agency;
``(B) at any designated location of the agency or in
an emergency services vehicle situated at a registered
or designated location of the agency; or
``(C) in an emergency medical services vehicle used
by the agency that is--
``(i) traveling from, or returning to, a
registered or designated location of the agency in
the course of responding to an emergency; or
``(ii) otherwise actively in use by the agency
under circumstances that provide for security of
the controlled substances consistent with the
requirements established by regulations of the
Attorney General.
``(7) No treatment as distribution.--The delivery of
controlled substances by a registered emergency medical services
agency pursuant to this subsection shall not be treated as
distribution for purposes of section 308.
``(8) <<NOTE: Records.>> Restocking of emergency medical
services vehicles at a hospital.--Notwithstanding paragraph
(13)(J), a registered emergency medical services agency may
receive controlled substances from a hospital for purposes of
restocking an emergency medical services vehicle following an
emergency
[[Page 131 STAT. 1269]]
response, and without being subject to the requirements of
section 308, provided all of the following conditions are
satisfied:
``(A) The registered or designated location of the
agency where the vehicle is primarily situated maintains
a record of such receipt in accordance with paragraph
(9).
``(B) The hospital maintains a record of such
delivery to the agency in accordance with section 307.
``(C) <<NOTE: Notification. Deadline.>> If the
vehicle is primarily situated at a designated location,
such location notifies the registered location of the
agency within 72 hours of the vehicle receiving the
controlled substances.
``(9) Maintenance of records.--
``(A) In general.--A registered emergency medical
services agency shall maintain records in accordance
with subsections (a) and (b) of section 307 of all
controlled substances that are received, administered,
or otherwise disposed of pursuant to the agency's
registration, without regard to subsection 307(c)(1)(B).
``(B) Requirements.--Such records--
``(i) shall include records of deliveries of
controlled substances between all locations of the
agency; and
``(ii) shall be maintained, whether
electronically or otherwise, at each registered
and designated location of the agency where the
controlled substances involved are received,
administered, or otherwise disposed of.
``(10) Other requirements.--A registered emergency medical
services agency, under the supervision of a medical director,
shall be responsible for ensuring that--
``(A) all emergency medical services professionals
who administer controlled substances using the agency's
registration act in accordance with the requirements of
this subsection;
``(B) the recordkeeping requirements of paragraph
(9) are met with respect to a registered location and
each designated location of the agency;
``(C) the applicable physical security requirements
established by regulation of the Attorney General are
complied with wherever controlled substances are stored
by the agency in accordance with paragraph (6); and
``(D) the agency maintains, at a registered location
of the agency, a record of the standing orders issued or
adopted in accordance with paragraph (9).
``(11) Regulations.--The Attorney General may issue
regulations--
``(A) specifying, with regard to delivery of
controlled substances under paragraph (5)--
``(i) the types of locations that may be
designated under such paragraph; and
``(ii) the manner in which a notification
under paragraph (5)(B) must be made;
``(B) specifying, with regard to the storage of
controlled substances under paragraph (6), the manner in
which such substances must be stored at registered and
designated locations, including in emergency medical
service vehicles; and
``(C) addressing the ability of hospitals, emergency
medical services agencies, registered locations, and
designated
[[Page 131 STAT. 1270]]
locations to deliver controlled substances to each other
in the event of--
``(i) shortages of such substances;
``(ii) a public health emergency; or
``(iii) a mass casualty event.
``(12) Rule of construction.--Nothing in this subsection
shall be construed--
``(A) to limit the authority vested in the Attorney
General by other provisions of this title to take
measures to prevent diversion of controlled substances;
or
``(B) to override the authority of any State to
regulate the provision of emergency medical services
consistent with this subsection.
``(13) Definitions.--In this section:
``(A) The term `authorizing medical professional'
means an emergency or other physician, or another
medical professional (including an advanced practice
registered nurse or physician assistant)--
``(i) who is registered under this Act;
``(ii) who is acting within the scope of the
registration; and
``(iii) whose scope of practice under a State
license or certification includes the ability to
provide verbal orders.
``(B) The term `designated location' means a
location designated by an emergency medical services
agency under paragraph (5).
``(C) The term `emergency medical services' means
emergency medical response and emergency mobile medical
services provided outside of a fixed medical facility.
``(D) The term `emergency medical services agency'
means an organization providing emergency medical
services, including such an organization that--
``(i) is governmental (including fire-based
and hospital-based agencies), nongovernmental
(including hospital-based agencies), private, or
volunteer-based;
``(ii) provides emergency medical services by
ground, air, or otherwise; and
``(iii) is authorized by the State in which
the organization is providing such services to
provide emergency medical care, including the
administering of controlled substances, to members
of the general public on an emergency basis.
``(E) The term `emergency medical services
professional' means a health care professional
(including a nurse, paramedic, or emergency medical
technician) licensed or certified by the State in which
the professional practices and credentialed by a medical
director of the respective emergency medical services
agency to provide emergency medical services within the
scope of the professional's State license or
certification.
``(F) The term `emergency medical services vehicle'
means an ambulance, fire apparatus, supervisor truck, or
other vehicle used by an emergency medical services
agency for the purpose of providing or facilitating
emergency medical care and transport or transporting
controlled substances to and from the registered and
designated locations.
[[Page 131 STAT. 1271]]
``(G) The term `hospital-based' means, with respect
to an agency, owned or operated by a hospital.
``(H) The term `medical director' means a physician
who is registered under subsection (f) and provides
medical oversight for an emergency medical services
agency.
``(I) The term `medical oversight' means supervision
of the provision of medical care by an emergency medical
services agency.
``(J) The term `registered emergency medical
services agency' means--
``(i) an emergency medical services agency
that is registered pursuant to this subsection; or
``(ii) a hospital-based emergency medical
services agency that is covered by the
registration of the hospital under subsection (f).
``(K) The term `registered location' means a
location that appears on the certificate of registration
issued to an emergency medical services agency under
this subsection or subsection (f), which shall be where
the agency receives controlled substances from
distributors.
``(L) The term `specific State authority' means a
governmental agency or other such authority, including a
regional oversight and coordinating body, that, pursuant
to State law or regulation, develops clinical protocols
regarding the delivery of emergency medical services in
the geographic jurisdiction of such agency or authority
within the State that may be adopted by medical
directors.
``(M) The term `standing order' means a written
medical protocol in which a medical director determines
in advance the medical criteria that must be met before
administering controlled substances to individuals in
need of emergency medical services.
``(N) The term `verbal order' means an oral
directive that is given through any method of
communication including by radio or telephone, directly
to an emergency medical services professional, to
contemporaneously administer a controlled substance to
individuals in need of emergency medical services
outside the physical presence of the medical director or
authorizing medical professional.''.
Approved November 17, 2017.
LEGISLATIVE HISTORY--H.R. 304:
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CONGRESSIONAL RECORD, Vol. 163 (2017):
Jan. 9, considered and passed House.
Oct. 24, considered and passed Senate, amended.
Nov. 2, House concurred in Senate amendment.
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