114TH CONGRESS 

2D SESSION H. R. 4365 

AN ACT 

To amend the Controlled Substances Act with regard to 

the provision of emergency medical services. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Protecting Patient Ac3 cess to Emergency Medications Act of 2016’’. 

4 SEC. 2. EMERGENCY MEDICAL SERVICES. 

5 Section 303 of the Controlled Substances Act (21 

6 U.S.C. 821 et seq.) is amended— 

7 (1) by redesignating subsection (j) as sub8 section (k); and 

9 (2) by inserting after subsection (i) the fol10 lowing: 

11 ‘‘(j) EMERGENCY MEDICAL SERVICES THAT ADMIN12 ISTER CONTROLLED SUBSTANCES.— 

13 ‘‘(1) REGISTRATION.—For the purpose of ena14 bling emergency medical services professionals to ad15 minister controlled substances in schedule II, III, 

16 IV, or V to ultimate users receiving emergency med17 ical services in accordance with the requirements of 

18 this subsection, the Attorney General— 

19 ‘‘(A) shall register an emergency medical 

20 services agency if the agency submits an appli21 cation demonstrating it is authorized to conduct 

22 such activity under the laws of each State in 

23 which the agency practices; and 

24 ‘‘(B) may deny an application for such reg25 istration if the Attorney General determines 

26 that the issuance of such registration would be 
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1 inconsistent with the requirements of this sub2 section or the public interest based on the fac3 tors listed in subsection (f). 

4 ‘‘(2) OPTION FOR SINGLE REGISTRATION.—In 

5 registering an emergency medical services agency 

6 pursuant to paragraph (1), the Attorney General 

7 shall allow such agency the option of a single reg8 istration in each State where the agency administers 

9 controlled substances in lieu of requiring a separate 

10 registration for each location of the emergency med11 ical services agency. 

12 ‘‘(3) HOSPITAL-BASED AGENCY.—If a hospital13 based emergency medical services agency is reg14 istered under subsection (f), the agency may use the 

15 registration of the hospital to administer controlled 

16 substances in accordance with this subsection with17 out being registered under this subsection. 

18 ‘‘(4) ADMINISTRATION OUTSIDE PHYSICAL

19 PRESENCE OF MEDICAL DIRECTOR OR AUTHORIZING

20 MEDICAL PROFESSIONAL.—Emergency medical serv21 ices professionals of a registered emergency medical 

22 services agency may administer controlled sub23 stances in schedule II, III, IV, or V outside the 

24 physical presence of a medical director or author25 izing medical professional in the course of providing 
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1 emergency medical services if the administration 

2 is— 

3 ‘‘(A) authorized by the law of the State in 

4 which it occurs; and 

5 ‘‘(B) pursuant to— 

6 ‘‘(i) a standing order that is issued 

7 and adopted by one or more medical direc8 tors of the agency, including any such 

9 order that may be developed by a specific 

10 State authority; or 

11 ‘‘(ii) a verbal order that is— 

12 ‘‘(I) issued in accordance with a 

13 policy of the agency; 

14 ‘‘(II) provided by an authorizing 

15 medical professional in response to a 

16 request by the emergency medical 

17 services professional with respect to a 

18 specific patient; 

19 ‘‘(III) in the case of a mass cas20 ualty incident; or 

21 ‘‘(IV) to ensure the proper care 

22 and treatment of a specific patient. 

23 ‘‘(5) DELIVERY.—A registered emergency med24 ical services agency may deliver controlled sub-
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1 stances from a registered location of the agency to 

2 an unregistered location of the agency only if— 

3 ‘‘(A) the agency designates the unregis4 tered location for such delivery; and 

5 ‘‘(B) notifies the Attorney General at least 

6 30 days prior to first delivering controlled sub7 stances to the unregistered location. 

8 ‘‘(6) STORAGE.—A registered emergency med9 ical services agency may store controlled sub10 stances— 

11 ‘‘(A) at a registered location of the agency; 

12 ‘‘(B) at any designated location of the 

13 agency or in an emergency services vehicle situ14 ated at a registered or designated location of 

15 the agency; or 

16 ‘‘(C) in an emergency medical services ve17 hicle used by the agency that is— 

18 ‘‘(i) traveling from, or returning to, a 

19 registered or designated location of the 

20 agency in the course of responding to an 

21 emergency; or 

22 ‘‘(ii) otherwise actively in use by the 

23 agency. 

24 ‘‘(7) NO TREATMENT AS DISTRIBUTION.—The 

25 delivery of controlled substances by a registered 
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1 emergency medical services agency pursuant to this 

2 subsection shall not be treated as distribution for 

3 purposes of section 308. 

4 ‘‘(8) RESTOCKING OF EMERGENCY MEDICAL

5 SERVICES VEHICLES AT A HOSPITAL.—Notwith6 standing paragraph (13)(J), a registered emergency 

7 medical services agency may receive controlled sub8 stances from a hospital for purposes of restocking 

9 an emergency medical services vehicle following an 

10 emergency response, and without being subject to 

11 the requirements of section 308, provided all of the 

12 following conditions are satisfied: 

13 ‘‘(A) The registered or designated location 

14 of the agency where the vehicle is primarily sit15 uated maintains a record of such receipt in ac16 cordance with paragraph (9). 

17 ‘‘(B) The hospital maintains a record of 

18 such delivery to the agency in accordance with 

19 section 307. 

20 ‘‘(C) If the vehicle is primarily situated at 

21 a designated location, such location notifies the 

22 registered location of the agency within 72 

23 hours of the vehicle receiving the controlled 

24 substances. 

25 ‘‘(9) MAINTENANCE OF RECORDS.— 
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1 ‘‘(A) IN GENERAL.—A registered emer2 gency medical services agency shall maintain 

3 records in accordance with subsections (a) and 

4 (b) of section 307 of all controlled substances 

5 that are received, administered, or otherwise 

6 disposed of pursuant to the agency’s registra7 tion, without regard to subsection 307(c)(1)(B). 

8 ‘‘(B) REQUIREMENTS.—Such records— 

9 ‘‘(i) shall include records of deliveries 

10 of controlled substances between all loca11 tions of the agency; and 

12 ‘‘(ii) shall be maintained, whether 

13 electronically or otherwise, at each reg14 istered and designated location of the 

15 agency where the controlled substances in16 volved are received, administered, or other17 wise disposed of. 

18 ‘‘(10) OTHER REQUIREMENTS.—A registered 

19 emergency medical services agency, under the super20 vision of a medical director, shall be responsible for 

21 ensuring that— 

22 ‘‘(A) all emergency medical services profes23 sionals who administer controlled substances 

24 using the agency’s registration act in accord25 ance with the requirements of this subsection; 
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1 ‘‘(B) the recordkeeping requirements of 

2 paragraph (9) are met with respect to a reg3 istered location and each designated location of 

4 the agency; 

5 ‘‘(C) the applicable physical security re6 quirements established by regulation of the At7 torney General are complied with wherever con8 trolled substances are stored by the agency in 

9 accordance with paragraph (6); and 

10 ‘‘(D) the agency maintains, at a registered 

11 location of the agency, a record of the standing 

12 orders issued or adopted in accordance with 

13 paragraph (9). 

14 ‘‘(11) REGULATIONS.—The Attorney General 

15 may issue regulations— 

16 ‘‘(A) specifying, with regard to delivery of 

17 controlled substances under paragraph (5)— 

18 ‘‘(i) the types of locations that may 

19 designated under such paragraph; and 

20 ‘‘(ii) the manner in which a notifica21 tion under paragraph (5)(B) must be 

22 made; 

23 ‘‘(B) specifying, with regard to the storage 

24 of controlled substances under paragraph (6), 

25 the manner in which such substances must be 
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1 stored at registered and designated locations, 

2 including in emergency medical service vehicles; 

3 and 

4 ‘‘(C) addressing the ability of hospitals, 

5 registered locations, and designated locations to 

6 deliver controlled substances to each other in 

7 the event of— 

8 ‘‘(i) shortages of such substances; 

9 ‘‘(ii) a public health emergency; or 

10 ‘‘(iii) a mass casualty event. 

11 ‘‘(12) RULE OF CONSTRUCTION.—Nothing in 

12 this subsection shall be construed— 

13 ‘‘(A) to limit the authority vested in the 

14 Attorney General by other provisions of this 

15 title to take measures to prevent diversion of 

16 controlled substances; or 

17 ‘‘(B) to override the authority of any State 

18 to regulate the provision of emergency medical 

19 services. 

20 ‘‘(13) DEFINITIONS.—In this section: 

21 ‘‘(A) The term ‘designated location’ means 

22 a location designated by an emergency medical 

23 services agency under paragraph (5). 

24 ‘‘(B) The term ‘emergency medical serv25 ices’ means emergency medical response and 
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1 emergency mobile medical services provided out2 side of a fixed medical facility. 

3 ‘‘(C) The term ‘emergency medical services 

4 agency’ means an organization providing emer5 gency medical services, including such an orga6 nization that— 

7 ‘‘(i) is governmental (including fire8 based and hospital-based agencies), non9 governmental (including hospital-based 

10 agencies), private, or volunteer-based; 

11 ‘‘(ii) provides emergency medical serv12 ices by ground, air, or otherwise; and 

13 ‘‘(iii) is authorized by the State in 

14 which the organization is providing such 

15 services to provide emergency medical care, 

16 including the administering of controlled 

17 substances, to members of the general pub18 lic on an emergency basis. 

19 ‘‘(D) The term ‘emergency medical services 

20 professional’ means a health care professional 

21 (including a nurse, paramedic, or emergency 

22 medical technician) licensed or certified by the 

23 State in which the professional practices and 

24 credentialed by a medical director of the respec25 tive emergency medical services agency to pro-
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1 vide emergency medical services within the 

2 scope of the professional’s State license or cer3 tification. 

4 ‘‘(E) The term ‘emergency medical services 

5 vehicle’ means an ambulance, fire apparatus, 

6 supervisor truck, or other vehicle used by an 

7 emergency medical services agency for the pur8 pose of providing or facilitating emergency med9 ical care and transport or transporting con10 trolled substances to and from the registered 

11 and designated locations. 

12 ‘‘(F) The term ‘hospital-based’ means, 

13 with respect to an agency, owned or operated by 

14 a hospital. 

15 ‘‘(G) The term ‘medical director’ means a 

16 physician who is registered under subsection (f) 

17 and provides medical oversight for an emer18 gency medical services agency. 

19 ‘‘(H) The term ‘medical oversight’ means 

20 supervision of the provision of medical care by 

21 an emergency medical services agency. 

22 ‘‘(I) The term ‘medical professional’ means 

23 an emergency or other physician, or another 

24 medical professional (including an advanced 

25 practice registered nurse or physician assistant) 
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1 whose scope of practice under a State license or 

2 certification includes the ability to provide 

3 verbal orders. 

4 ‘‘(J) The term ‘registered location’ means 

5 a location that appears on the certificate of reg6 istration issued to an emergency medical serv7 ices agency under this subsection or subsection 

8 (f), which shall be where the agency receives 

9 controlled substances from distributors. 

10 ‘‘(K) The term ‘registered emergency med11 ical services agency’ means— 

12 ‘‘(i) an emergency medical services 

13 agency that is registered pursuant to this 

14 subsection; or 

15 ‘‘(ii) a hospital-based emergency med16 ical services agency that is covered by the 

17 registration of the hospital under sub18 section (f). 

19 ‘‘(L) The term ‘specific State authority’ 

20 means a governmental agency or other such au21 thority, including a regional oversight and co22 ordinating body, that, pursuant to State law or 

23 regulation, develops clinical protocols regarding 

24 the delivery of emergency medical services in 

25 the geographic jurisdiction of such agency or 
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1 authority within the State that may be adopted 

2 by medical directors. 

3 ‘‘(M) The term ‘standing order’ means a 

4 written medical protocol in which a medical di5 rector determines in advance the medical cri6 teria that must be met before administering 

7 controlled substances to individuals in need of 

8 emergency medical services. 

9 ‘‘(N) The term ‘verbal order’ means an 

10 oral directive that is given through any method 

11 of communication including by radio or tele12 phone, directly to an emergency medical serv13 ices professional, to contemporaneously admin14 ister a controlled substance to individuals in 

15 need of emergency medical services outside the 

16 physical presence of the authorizing medical di17 rector.’’. 

Passed the House of Representatives November 14, 

2016. 

Attest: 

Clerk. 
114TH CONGRESS 

2D SESSION H. R. 4365 

AN ACT 

To amend the Controlled Substances Act with reices. gard to the provision of emergency medical serv-