IB 
Union Calendar No. 628 
114TH CONGRESS 
2D SESSION 
H. R. 4365 
[Report No. 114–804, Part I] 
To amend the Controlled Substances Act with regard to the provision of 
emergency medical services. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 12, 2016 
Mr. 
HUDSON
(for 
himself, 
Mr. 
BUTTERFIELD, 
Mr. 
COHEN, 
Mr. 
FARENTHOLD, Mr. HECK of Nevada, Mr. RUIZ, and Mr. WESTERMAN) 
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce, and in addition to the Committee on the Judiciary, 
for a period to be subsequently determined by the Speaker, in each case 
for consideration of such provisions as fall within the jurisdiction of the 
committee concerned 
NOVEMBER 14, 2016 
Additional sponsors: Mr. BLUMENAUER, Ms. JENKINS of Kansas, Mr. PETER-
SON, Mr. FITZPATRICK, Mr. HARRIS, Mr. SCHRADER, Mr. DAVID SCOTT 
of Georgia, Ms. MICHELLE LUJAN GRISHAM of New Mexico, Mr. 
ASHFORD, Mr. BURGESS, Mr. LONG, Mrs. BROOKS of Indiana, Mr. 
KIND, Mr. CARTWRIGHT, Mr. BILIRAKIS, Mr. SMITH of Texas, Mr. 
POCAN, Mr. SENSENBRENNER, Mr. TIPTON, Mr. YOUNG of Alaska, Mr. 
ZINKE, Ms. GABBARD, Mr. BRENDAN F. BOYLE of Pennsylvania, Mr. 
WALDEN, Mr. WESTMORELAND, Mr. DIAZ-BALART, Ms. ESHOO, Mr. 
LANGEVIN, Mr. COLLINS of New York, Mr. ABRAHAM, Mr. WALZ, Mr. 
CRAMER, Mr. CLAWSON of Florida, Ms. FRANKEL of Florida, Mr. 
NUGENT, Mr. DUNCAN of Tennessee, Mr. GRAVES of Missouri, Mr. 
YODER, Mr. LUETKEMEYER, Mr. DESJARLAIS, Mr. MULLIN, Mr. GAR-
RETT, Mr. ROE of Tennessee, Mr. BLUM, Mr. CULBERSON, Mr. DEFA-
ZIO, Mr. BOUSTANY, Ms. PINGREE, Mrs. BLACKBURN, Mr. FLEMING, Ms. 
MOORE, Mr. WILLIAMS, Mrs. KIRKPATRICK, Mr. HUELSKAMP, Mr. 
ALLEN, Mr. LUCAS, Mr. YOUNG of Iowa, Mr. POMPEO, Mr. SMITH of 
Washington, Mr. EMMER of Minnesota, Ms. BONAMICI, Mr. COSTELLO 
of Pennsylvania, Mr. ROUZER, Mr. JOYCE, Mr. GRAVES of Louisiana, Mr. 
WENSTRUP, Mr. BUCSHON, Mr. GRAVES of Georgia, Ms. SCHAKOWSKY, 
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Mr. JOLLY, Mr. VAN HOLLEN, Mr. BEYER, Mr. RIGELL, Mr. BROOKS 
of Alabama, Mr. MARCHANT, Mr. CONYERS, Mr. BARR, Mr. LANCE, Mr. 
ROSKAM, Mrs. MCMORRIS
RODGERS, Mr. CARTER
of Texas, Mr. 
FORBES, Mrs. WAGNER, Mr. TED LIEU of California, Mr. CUMMINGS, 
Mrs. WALORSKI, Ms. DELBENE, Mr. WALBERG, Mr. MCCAUL, Mr. KIL-
MER, Ms. BROWNLEY of California, Mr. DOLD, Mr. DONOVAN, Mr. 
WELCH, Mr. GUINTA, Mr. RICHMOND, Ms. GRANGER, Mr. PITTENGER, 
Mr. ELLISON, Ms. HERRERA BEUTLER, Mr. RENACCI, Mr. LABRADOR, 
Mr. ROGERS of Kentucky, Mr. PAULSEN, Mr. BABIN, Mr. STIVERS, Mr. 
SMITH of Missouri, Ms. CASTOR of Florida, Mr. BISHOP of Michigan, Ms. 
GRAHAM, Mr. GOSAR, Mr. MCHENRY, Mr. ROTHFUS, Mr. DUNCAN of 
South Carolina, Mrs. BEATTY, Mr. GUTHRIE, Mrs. NOEM, Mr. BRADY 
of Pennsylvania, Ms. HAHN, Mrs. ELLMERS of North Carolina, Mr. 
STEWART, Mr. DENT, Mrs. BUSTOS, Mr. COURTNEY, Mr. LIPINSKI, Miss 
RICE of New York, Mr. SCHWEIKERT, and Ms. MCSALLY 
NOVEMBER 14, 2016 
Reported from the Committee on Energy and Commerce with an amendment 
[Strike out all after the enacting clause and insert the part printed in italic] 
NOVEMBER 14, 2016 
The Committee on the Judiciary discharged; committed to the Committee of 
the Whole House on the State of the Union and ordered to be printed 
[For text of introduced bill, see copy of bill as introduced on January 12, 2016] 
A BILL 
To amend the Controlled Substances Act with regard to 
the provision of emergency medical services. 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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 subsection 
(k); and 
(2) by inserting after subsection (i) the following: 
‘‘(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 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 applica-
tion demonstrating it is authorized to conduct 
such activity under the laws of each State in 
which the agency practices; and 
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‘‘(B) may deny an application for such reg-
istration if the Attorney General determines that 
the issuance of such registration would be incon-
sistent 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 pur-
suant 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 registra-
tion of the hospital to administer controlled sub-
stances in accordance with this subsection without 
being registered under this subsection. 
‘‘(4) ADMINISTRATION OUTSIDE PHYSICAL PRES-
ENCE OF MEDICAL DIRECTOR OR AUTHORIZING MED-
ICAL
PROFESSIONAL.—Emergency medical services 
professionals of a registrant emergency medical serv-
ices agency may administer controlled substances in 
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schedule II, III, IV, or V outside the physical presence 
of a medical director or authorizing medical profes-
sional 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— 
‘‘(I) issued and adopted by 1 or 
more medical directors of the agency; 
or 
‘‘(II) 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 serv-
ices professional with respect to a spe-
cific patient; 
‘‘(III) in the case of a mass cas-
ualty incident; or 
‘‘(IV) to ensure the proper care 
and treatment of a specific patient. 
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‘‘(5) DELIVERY.—A registrant emergency med-
ical services agency may deliver controlled substances 
from a registered location of the agency to an unregis-
tered 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 sub-
stances to the unregistered location. 
‘‘(6) STORAGE.—A registrant emergency medical 
services agency may store controlled substances— 
‘‘(A) at a registered location of the agency; 
‘‘(B) at any designated location of the agen-
cy or in an emergency services vehicle situated at 
a registered or designated location of the agency; 
or 
‘‘(C) in an emergency medical services vehi-
cle 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. 
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‘‘(7) NO TREATMENT AS DISTRIBUTION.—The de-
livery of controlled substances by a registrant emer-
gency medical services agency pursuant to this sub-
section shall not be treated as distribution for pur-
poses of section 308. 
‘‘(8) RESTOCKING
OF
EMERGENCY
MEDICAL 
SERVICES
VEHICLES
AT
A
HOSPITAL.—Notwith-
standing paragraph (13)(J), a registrant emergency 
medical services agency may receive controlled sub-
stances from a hospital for purposes of restocking an 
emergency medical services vehicle following an emer-
gency response, and without being subject to the re-
quirements of section 308, provided all of the fol-
lowing conditions are satisfied: 
‘‘(A) The registered or designated location of 
the agency where the vehicle is primarily situ-
ated 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. 
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‘‘(9) MAINTENANCE OF RECORDS.— 
‘‘(A) IN GENERAL.—A registrant emergency 
medical services agency shall maintain records 
in accordance with subsections (a) and (b) of sec-
tion 307 of all controlled substances that are re-
ceived, administered, or otherwise disposed of 
pursuant to the agency’s registration, without re-
gard 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 elec-
tronically or otherwise, at each registered 
and designated location of the agency where 
the controlled substances involved are re-
ceived, administered, or otherwise disposed 
of. 
‘‘(10) OTHER
REQUIREMENTS.—A registrant 
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 
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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 reg-
istered location and each designated location of 
the agency; 
‘‘(C) the applicable physical security re-
quirements established by regulation of the Attor-
ney General are complied with wherever con-
trolled substances are stored by the agency in ac-
cordance 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 
designated under such paragraph; and 
‘‘(ii) the manner in which a notifica-
tion under paragraph (5)(B) must be made; 
‘‘(B) specifying, with regard to the storage 
of controlled substances under paragraph (6), the 
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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, reg-
istered locations, and designated locations to de-
liver 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 At-
torney 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 emer-
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gency mobile medical services provided outside 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 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 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 certification. 
‘‘(E) The term ‘emergency medical services 
vehicle’ means an ambulance, fire apparatus, su-
pervisor truck, or other vehicle owned or operated 
by an emergency medical services agency for the 
purpose of providing or facilitating emergency 
medical 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 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 
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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 services 
agency under this subsection or subsection (f), 
which shall be where the agency receives con-
trolled substances from distributors. 
‘‘(K) The term ‘registrant 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 subsection 
(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 author-
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ity 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 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 profes-
sional, to contemporaneously administer a con-
trolled substance to individuals in need of emer-
gency medical services outside the physical pres-
ence of the authorizing medical director.’’. 
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Union Calendar No. 628 
114TH CONGRESS 
2D SESSION 
H. R. 4365 
[Report No. 114–804, Part I] 
A BILL 
To amend the Controlled Substances Act with re-
gard to the provision of emergency medical serv-
ices. 
NOVEMBER 14, 2016 
Reported from the Committee on Energy and Commerce 
with an amendment 
NOVEMBER 14, 2016 
The Committee on the Judiciary discharged; committed 
to the Committee of the Whole House on the State of 
the Union and ordered to be printed 
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