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 Energy 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. PETERSON, 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. GARRETT, Mr. ROE of Tennessee, Mr. BLUM, Mr. CULBERSON, Mr. DEFAZIO, 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. KILMER, 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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1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Protecting Patient Ac5 cess to Emergency Medications Act of 2016’’. 

6 SEC. 2. EMERGENCY MEDICAL SERVICES. 

7 Section 303 of the Controlled Substances Act (21 

8 U.S.C. 821 et seq.) is amended— 

9 (1) by redesignating subsection (j) as subsection 

10 (k); and 

11 (2) by inserting after subsection (i) the following: 

12 ‘‘(j) EMERGENCY MEDICAL SERVICES THAT ADMIN13 ISTER CONTROLLED SUBSTANCES.— 

14 ‘‘(1) REGISTRATION.—For the purpose of ena15 bling emergency medical services professionals to ad16 minister controlled substances in schedule II, III, IV, 

17 or V to ultimate users receiving emergency medical 

18 services in accordance with the requirements of this 

19 subsection, the Attorney General— 

20 ‘‘(A) shall register an emergency medical 

21 services agency if the agency submits an applica22 tion demonstrating it is authorized to conduct 

23 such activity under the laws of each State in 

24 which the agency practices; and 


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1 ‘‘(B) may deny an application for such reg2 istration if the Attorney General determines that 

3 the issuance of such registration would be incon4 sistent with the requirements of this subsection 

5 or the public interest based on the factors listed 

6 in subsection (f). 

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

8 registering an emergency medical services agency pur9 suant to paragraph (1), the Attorney General shall 

10 allow such agency the option of a single registration 

11 in each State where the agency administers controlled 

12 substances in lieu of requiring a separate registration 

13 for each location of the emergency medical services 

14 agency. 

15 ‘‘(3) HOSPITAL-BASED AGENCY.—If a hospital16 based emergency medical services agency is registered 

17 under subsection (f), the agency may use the registra18 tion of the hospital to administer controlled sub19 stances in accordance with this subsection without 

20 being registered under this subsection. 

21 ‘‘(4) ADMINISTRATION OUTSIDE PHYSICAL PRES22 ENCE OF MEDICAL DIRECTOR OR AUTHORIZING MED23 ICAL PROFESSIONAL.—Emergency medical services 

24 professionals of a registrant emergency medical serv25 ices agency may administer controlled substances in 


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1 schedule II, III, IV, or V outside the physical presence 

2 of a medical director or authorizing medical profes3 sional in the course of providing emergency medical 

4 services if the administration is— 

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

6 which it occurs; and 

7 ‘‘(B) pursuant to— 

8 ‘‘(i) a standing order that is— 

9 ‘‘(I) issued and adopted by 1 or 

10 more medical directors of the agency; 

11 or 

12 ‘‘(II) developed by a specific State 

13 authority; or 

14 ‘‘(ii) a verbal order that is— 

15 ‘‘(I) issued in accordance with a 

16 policy of the agency; 

17 ‘‘(II) provided by an authorizing 

18 medical professional in response to a 

19 request by the emergency medical serv20 ices professional with respect to a spe21 cific patient; 

22 ‘‘(III) in the case of a mass cas23 ualty incident; or 

24 ‘‘(IV) to ensure the proper care 

25 and treatment of a specific patient. 


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1 ‘‘(5) DELIVERY.—A registrant emergency med2 ical services agency may deliver controlled substances 

3 from a registered location of the agency to an unregis4 tered location of the agency only if— 

5 ‘‘(A) the agency designates the unregistered 

6 location for such delivery; and 

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

8 30 days prior to first delivering controlled sub9 stances to the unregistered location. 

10 ‘‘(6) STORAGE.—A registrant emergency medical 

11 services agency may store controlled substances— 

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

13 ‘‘(B) at any designated location of the agen14 cy or in an emergency services vehicle situated at 

15 a registered or designated location of the agency; 

16 or 

17 ‘‘(C) in an emergency medical services vehi18 cle used by the agency that is— 

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

20 registered or designated location of the 

21 agency in the course of responding to an 

22 emergency; or 

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

24 agency. 


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1 ‘‘(7) NO TREATMENT AS DISTRIBUTION.—The de2 livery of controlled substances by a registrant emer3 gency medical services agency pursuant to this sub4 section shall not be treated as distribution for pur5 poses of section 308. 

6 ‘‘(8) RESTOCKING OF EMERGENCY MEDICAL

7 SERVICES VEHICLES AT A HOSPITAL.—Notwith8 standing paragraph (13)(J), a registrant emergency 

9 medical services agency may receive controlled sub10 stances from a hospital for purposes of restocking an 

11 emergency medical services vehicle following an emer12 gency response, and without being subject to the re13 quirements of section 308, provided all of the fol14 lowing conditions are satisfied: 

15 ‘‘(A) The registered or designated location of 

16 the agency where the vehicle is primarily situ17 ated maintains a record of such receipt in ac18 cordance with paragraph (9). 

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

20 such delivery to the agency in accordance with 

21 section 307. 

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

23 a designated location, such location notifies the 

24 registered location of the agency within 72 hours 

25 of the vehicle receiving the controlled substances. 


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1 ‘‘(9) MAINTENANCE OF RECORDS.— 

2 ‘‘(A) IN GENERAL.—A registrant emergency 

3 medical services agency shall maintain records 

4 in accordance with subsections (a) and (b) of sec5 tion 307 of all controlled substances that are re6 ceived, administered, or otherwise disposed of 

7 pursuant to the agency’s registration, without re8 gard to subsection 307(c)(1)(B). 

9 ‘‘(B) REQUIREMENTS.—Such records— 

10 ‘‘(i) shall include records of deliveries 

11 of controlled substances between all locations 

12 of the agency; and 

13 ‘‘(ii) shall be maintained, whether elec14 tronically or otherwise, at each registered 

15 and designated location of the agency where 

16 the controlled substances involved are re17 ceived, administered, or otherwise disposed 

18 of. 

19 ‘‘(10) OTHER REQUIREMENTS.—A registrant 

20 emergency medical services agency, under the super21 vision of a medical director, shall be responsible for 

22 ensuring that— 

23 ‘‘(A) all emergency medical services profes24 sionals who administer controlled substances 


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1 using the agency’s registration act in accordance 

2 with the requirements of this subsection; 

3 ‘‘(B) the recordkeeping requirements of 

4 paragraph (9) are met with respect to a reg5 istered location and each designated location of 

6 the agency; 

7 ‘‘(C) the applicable physical security re8 quirements established by regulation of the Attor9 ney General are complied with wherever con10 trolled substances are stored by the agency in ac11 cordance with paragraph (6); and 

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

13 location of the agency, a record of the standing 

14 orders issued or adopted in accordance with 

15 paragraph (9). 

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

17 may issue regulations— 

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

19 controlled substances under paragraph (5)— 

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

21 designated under such paragraph; and 

22 ‘‘(ii) the manner in which a notifica23 tion under paragraph (5)(B) must be made; 

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

25 of controlled substances under paragraph (6), the 


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1 manner in which such substances must be stored 

2 at registered and designated locations, including 

3 in emergency medical service vehicles; and 

4 ‘‘(C) addressing the ability of hospitals, reg5 istered locations, and designated locations to de6 liver controlled substances to each other in the 

7 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 this 

12 subsection shall be construed— 

13 ‘‘(A) to limit the authority vested in the At14 torney General by other provisions of this title to 

15 take measures to prevent diversion of controlled 

16 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 a 

22 location designated by an emergency medical 

23 services agency under paragraph (5). 

24 ‘‘(B) The term ‘emergency medical services’ 

25 means emergency medical response and emerVerDate Sep 11 2014 23:55 Nov 14, 2016 Jkt 069200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6203 E:\BILLS\H4365.RH H4365

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1 gency mobile medical services provided outside of 

2 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 public 

18 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 proVerDate Sep 11 2014 23:55 Nov 14, 2016 Jkt 069200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6203 E:\BILLS\H4365.RH H4365

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1 vide emergency medical services within the scope 

2 of the professional’s State license or certification. 

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

4 vehicle’ means an ambulance, fire apparatus, su5 pervisor truck, or other vehicle owned or operated 

6 by an emergency medical services agency for the 

7 purpose of providing or facilitating emergency 

8 medical care and transport or transporting con9 trolled substances to and from the registered and 

10 designated locations. 

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

12 respect to an agency, owned or operated by a 

13 hospital. 

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

15 physician who is registered under subsection (f) 

16 and provides medical oversight for an emergency 

17 medical services agency. 

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

19 supervision of the provision of medical care by 

20 an emergency medical services agency. 

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

22 an emergency or other physician, or another 

23 medical professional (including an advanced 

24 practice registered nurse or physician assistant) 

25 whose scope of practice under a State license or 


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1 certification includes the ability to provide 

2 verbal orders. 

3 ‘‘(J) The term ‘registered location’ means a 

4 location that appears on the certificate of reg5 istration issued to an emergency medical services 

6 agency under this subsection or subsection (f), 

7 which shall be where the agency receives con8 trolled substances from distributors. 

9 ‘‘(K) The term ‘registrant emergency med10 ical services agency’ means— 

11 ‘‘(i) an emergency medical services 

12 agency that is registered pursuant to this 

13 subsection; or 

14 ‘‘(ii) a hospital-based emergency med15 ical services agency that is covered by the 

16 registration of the hospital under subsection 

17 (f). 

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

19 means a governmental agency or other such au20 thority, including a regional oversight and co21 ordinating body, that, pursuant to State law or 

22 regulation, develops clinical protocols regarding 

23 the delivery of emergency medical services in the 

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1 ity within the State that may be adopted by 

2 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 criteria 

6 that must be met before administering controlled 

7 substances to individuals in need of emergency 

8 medical services. 

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

10 directive that is given through any method of 

11 communication including by radio or telephone, 

12 directly to an emergency medical services profes13 sional, to contemporaneously administer a con14 trolled substance to individuals in need of emer15 gency medical services outside the physical pres16 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 reices. gard to the provision of emergency medical servNOVEMBER 14, 2016 

Reported from the Committee on Energy and Commerce 

N

with an amendment 

OVEMBER 14, 2016 

The Committee on the Judiciary discharged; committed 

the Union and ordered to be printed to the Committee of the Whole House on the State of 


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