[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 304 Engrossed in House (EH)]
<DOC>
115th CONGRESS
1st Session
H. R. 304
_______________________________________________________________________
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;
``(II) provided by an authorizing
medical professional in response to a
request by the emergency medical
services professional with respect to a
specific patient;
``(III) in the case of a mass
casualty incident; or
``(IV) 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.
``(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,
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.
``(13) Definitions.--In this section:
``(A) The term `designated location' means a
location designated by an emergency medical services
agency under paragraph (5).
``(B) The term `emergency medical services' means
emergency medical response and emergency mobile medical
services provided outside of a fixed medical facility.
``(C) 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.
``(D) 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.
``(E) 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.
``(F) The term `hospital-based' means, with respect
to an agency, owned or operated by a hospital.
``(G) The term `medical director' means a physician
who is registered under subsection (f) and provides
medical oversight for an emergency medical services
agency.
``(H) The term `medical oversight' means
supervision of the provision of medical care by an
emergency medical services agency.
``(I) The term `medical professional' means an
emergency or other physician, or another medical
professional (including an advanced practice registered
nurse or physician assistant) whose scope of practice
under a State license or certification includes the
ability to provide verbal orders.
``(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 authorizing
medical director.''.
Passed the House of Representatives January 9, 2017.
Attest:
Clerk.
115th CONGRESS
1st Session
H. R. 304
_______________________________________________________________________
AN ACT
To amend the Controlled Substances Act with regard to the provision of
emergency medical services.