I 

114TH CONGRESS 

2D SESSION H. R. 4365 

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 

A BILL 

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, 

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. FINDINGS. 

7 The Congress finds as follows: 


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1 (1) The use of controlled substances by emer2 gency medical services agencies to administer med3 ical care and medicines to individuals in the field is 

4 essential to save lives, manage pain, and improve 

5 health outcomes. 

6 (2) The unique nature of mobile emergency 

7 medical services is unlike other health care services 

8 governed by the Controlled Substances Act in that 

9 it requires the provision of time-sensitive and mobile 

10 medical care to individuals with critical injuries and 

11 illnesses in the field and movement of such individ12 uals to definitive care. 

13 (3) Regulatory oversight to prevent diversion 

14 should not disrupt the current delivery model of pro15 viding medical care to individuals by emergency 

16 medical services practitioners under the supervision 

17 of a physician medical director. 

18 (4) Such oversight should also recognize the va19 riety of emergency medical services agencies includ20 ing governmental, nongovernmental, private, and 

21 volunteer emergency medical services agencies. 

22 SEC. 3. EMERGENCY MEDICAL SERVICES. 

23 Part C of the Controlled Substances Act (21 U.S.C. 

24 821 et seq.) is amended by adding at the end the fol25 lowing: 


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1 ‘‘SEC. 312. EMERGENCY MEDICAL SERVICES. 

2 ‘‘(a) REGISTRATION.— 

3 ‘‘(1) IN GENERAL.—For the purpose of ena4 bling emergency medical services practitioners to 

5 dispense controlled substances in schedule II, III, 

6 IV, or V to ultimate users receiving emergency med7 ical services, the Attorney General shall, at the re8 quest of the emergency medical services agency em9 ploying such practitioners, register such emergency 

10 medical services agency under section 303(f) in lieu 

11 of registering the individual practitioners or one or 

12 more medical directors of such agency. 

13 ‘‘(2) SINGLE REGISTRATION.—In registering an 

14 emergency medical services agency pursuant to para15 graph (1), the Attorney General shall require a sin16 gle registration per State, not a separate registration 

17 for each location of the emergency medical services 

18 agency. 

19 ‘‘(b) MEDICAL OVERSIGHT.—Notwithstanding sec20 tion 309: 

21 ‘‘(1) A registrant emergency medical services 

22 agency shall have one or more medical directors re23 sponsible for medical oversight of the agency’s provi24 sion of emergency medical services. 

25 ‘‘(2) Controlled substances in schedule II, III, 

26 IV, or V may be administered by the emergency 


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1 medical services practitioners of a registrant emer2 gency medical services agency in the course of pro3 viding emergency medical services pursuant to a 

4 standing order issued by one or more medical direc5 tors of such agency. A registrant emergency medical 

6 services agency shall keep any such standing order 

7 on file and make such standing order available to 

8 the Attorney General upon the Attorney General’s 

9 request. 

10 ‘‘(3) In the case of administering a controlled 

11 substance pursuant to paragraph (2), the medical di12 rectors of the registrant emergency medical services 

13 agency shall not be required— 

14 ‘‘(A) to be present; or 

15 ‘‘(B) to provide a written or oral prescrip16 tion with regard to a known individual before or 

17 at the time of such administering. 

18 ‘‘(c) RECEIPT, MOVEMENT, AND STORAGE OF CON19 TROLLED SUBSTANCES.— 

20 ‘‘(1) RECEIPT.—The registrant emergency med21 ical services agency— 

22 ‘‘(A) may receive controlled substances at 

23 any location of the agency designated by the 

24 agency for such receipt; and 


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1 ‘‘(B) may not receive controlled substances 

2 at any location not so designated. 

3 ‘‘(2) MOVEMENT AND DELIVERY.—The reg4 istrant emergency medical services agency may move 

5 or deliver controlled substances within the possession 

6 of such agency between any locations of such agen7 cy. A registrant emergency medical services agency 

8 shall not be treated as a distributor of controlled 

9 substances under this Act by reason of such move10 ment or distribution. 

11 ‘‘(3) STORAGE.—Such agency— 

12 ‘‘(A) may store controlled substances at 

13 any location of the agency designated by the 

14 agency for such storage; and 

15 ‘‘(B) may not store controlled substances 

16 at any location not so designated. 

17 ‘‘(d) DEFINITIONS.—In this section: 

18 ‘‘(1) The term ‘emergency medical services’ 

19 means emergency medical response, and emergency 

20 mobile medical services, provided outside of a med21 ical facility. 

22 ‘‘(2) The term ‘emergency medical services 

23 agency’ means an organization providing emergency 

24 medical services, including such organizations that— 


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1 ‘‘(A) are governmental (including fire2 based agencies), nongovernmental (including 

3 hospital-based agencies), private, or volunteer4 based; and 

5 ‘‘(B) provide emergency medical services 

6 by ground, air, or otherwise. 

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

8 practitioner’ means a health care practitioner (in9 cluding nurse, paramedic, or emergency medical 

10 technician) licensed or certified by a State and 

11 credentialed by a medical director of the respective 

12 emergency medical services agency to provide emer13 gency medical services to individuals within the 

14 scope of the practitioner’s State license or certifi15 cation. 

16 ‘‘(4) The term ‘medical director’ means a physi17 cian providing medical oversight for an emergency 

18 medical services agency. 

19 ‘‘(5) The term ‘medical oversight’ means super20 vision of medical operations of an emergency medical 

21 services agency. 

22 ‘‘(6) The term ‘standing order’ means a written 

23 medical protocol in which a medical director pre24 scribes in advance the medical criteria to be followed 

25 by emergency medical services practitioners in adVerDate Sep 11 2014 01:20 Jan 13, 2016 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4365.IH H4365

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1 ministering controlled substances to individuals in 

2 need of emergency medical services.’’. 

Æ 


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