II 
114TH CONGRESS 
2D SESSION 
H. R. 4365 
IN THE SENATE OF THE UNITED STATES 
NOVEMBER 15, 2016 
Received 
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 Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Protecting Patient Ac-
cess to Emergency Medications Act of 2016’’. 
SEC. 2. EMERGENCY MEDICAL SERVICES. 
Section 303 of the Controlled Substances Act (21 
U.S.C. 821 et seq.) is amended— 
(1) by redesignating subsection (j) as sub-
section (k); and 
(2) by inserting after subsection (i) the fol-
lowing: 
‘‘(j) EMERGENCY MEDICAL SERVICES THAT ADMIN-
ISTER CONTROLLED SUBSTANCES.— 
‘‘(1) REGISTRATION.—For the purpose of ena-
bling emergency medical services professionals to ad-
minister controlled substances in schedule II, III, 
IV, or V to ultimate users receiving emergency med-
ical 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 appli-
cation 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 reg-
istration if the Attorney General determines 
that the issuance of such registration would be 
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inconsistent with the requirements of this sub-
section or the public interest based on the fac-
tors 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 reg-
istration in each State where the agency administers 
controlled substances in lieu of requiring a separate 
registration for each location of the emergency med-
ical services agency. 
‘‘(3) HOSPITAL-BASED AGENCY.—If a hospital- 
based emergency medical services agency is reg-
istered under subsection (f), the agency may use the 
registration of the hospital to administer controlled 
substances in accordance with this subsection with-
out being registered under this subsection. 
‘‘(4) 
ADMINISTRATION
OUTSIDE
PHYSICAL 
PRESENCE OF MEDICAL DIRECTOR OR AUTHORIZING 
MEDICAL PROFESSIONAL.—Emergency medical serv-
ices professionals of a registered emergency medical 
services agency may administer controlled sub-
stances in schedule II, III, IV, or V outside the 
physical presence of a medical director or author-
izing medical professional in the course of providing 
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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 direc-
tors 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 cas-
ualty incident; or 
‘‘(IV) to ensure the proper care 
and treatment of a specific patient. 
‘‘(5) DELIVERY.—A registered emergency med-
ical services agency may deliver controlled sub-
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stances from a registered location of the agency to 
an unregistered location of the agency only if— 
‘‘(A) the agency designates the unregis-
tered location for such delivery; and 
‘‘(B) notifies the Attorney General at least 
30 days prior to first delivering controlled sub-
stances to the unregistered location. 
‘‘(6) STORAGE.—A registered emergency med-
ical services agency may store controlled sub-
stances— 
‘‘(A) at a registered location of the agency; 
‘‘(B) at any designated location of the 
agency or in an emergency services vehicle situ-
ated at a registered or designated location of 
the agency; or 
‘‘(C) in an emergency medical services ve-
hicle 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 
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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.—Notwith-
standing paragraph (13)(J), a registered emergency 
medical services agency may receive controlled sub-
stances 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 sit-
uated maintains a record of such receipt in ac-
cordance 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.— 
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‘‘(A) IN
GENERAL.—A registered emer-
gency 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 registra-
tion, without regard to subsection 307(c)(1)(B). 
‘‘(B) REQUIREMENTS.—Such records— 
‘‘(i) shall include records of deliveries 
of controlled substances between all loca-
tions of the agency; and 
‘‘(ii) shall be maintained, whether 
electronically or otherwise, at each reg-
istered and designated location of the 
agency where the controlled substances in-
volved are received, administered, or other-
wise disposed of. 
‘‘(10) OTHER
REQUIREMENTS.—A registered 
emergency medical services agency, under the super-
vision of a medical director, shall be responsible for 
ensuring that— 
‘‘(A) all emergency medical services profes-
sionals who administer controlled substances 
using the agency’s registration act in accord-
ance with the requirements of this subsection; 
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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 serv-
ices’ means emergency medical response and 
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emergency mobile medical services provided out-
side of a fixed medical facility. 
‘‘(C) The term ‘emergency medical services 
agency’ means an organization providing emer-
gency medical services, including such an orga-
nization that— 
‘‘(i) is governmental (including fire- 
based and hospital-based agencies), non-
governmental 
(including 
hospital-based 
agencies), private, or volunteer-based; 
‘‘(ii) provides emergency medical serv-
ices 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 pub-
lic 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 respec-
tive emergency medical services agency to pro-
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vide emergency medical services within the 
scope of the professional’s State license or cer-
tification. 
‘‘(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 pur-
pose of providing or facilitating emergency med-
ical care and transport or transporting con-
trolled 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 emer-
gency 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) 
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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 reg-
istration issued to an emergency medical serv-
ices agency under this subsection or subsection 
(f), which shall be where the agency receives 
controlled substances from distributors. 
‘‘(K) The term ‘registered emergency med-
ical services agency’ means— 
‘‘(i) an emergency medical services 
agency that is registered pursuant to this 
subsection; or 
‘‘(ii) a hospital-based emergency med-
ical services agency that is covered by the 
registration of the hospital under sub-
section (f). 
‘‘(L) The term ‘specific State authority’ 
means a governmental agency or other such au-
thority, including a regional oversight and co-
ordinating 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 
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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 di-
rector determines in advance the medical cri-
teria 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 tele-
phone, directly to an emergency medical serv-
ices professional, to contemporaneously admin-
ister a controlled substance to individuals in 
need of emergency medical services outside the 
physical presence of the authorizing medical di-
rector.’’. 
Passed the House of Representatives November 14, 
2016. 
Attest: 
KAREN L. HAAS, 
Clerk. 
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