II 

115TH CONGRESS 

1ST SESSION S. 916 

To amend the Controlled Substances Act with regard to the provision of 

emergency medical services. 

IN THE SENATE OF THE UNITED STATES 

APRIL 24, 2017 

Mr. CASSIDY (for himself, Mr. BENNET, Mr. BLUNT, and Mr. FRANKEN) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

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 2017’’. 

6 SEC. 2. EMERGENCY MEDICAL SERVICES. 

7 Section 303 of the Controlled Substances Act (21 

8 U.S.C. 823) is amended— 

9 (1) by redesignating subsection (j) as sub10 section (k); and 


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1 (2) by inserting after subsection (i) the fol2 lowing: 

3 ‘‘(j) EMERGENCY MEDICAL SERVICES THAT ADMIN4 ISTER CONTROLLED SUBSTANCES.— 

5 ‘‘(1) REGISTRATION.—For the purpose of ena6 bling emergency medical services professionals to ad7 minister controlled substances in schedule II, III, 

8 IV, or V to ultimate users receiving emergency med9 ical services in accordance with the requirements of 

10 this subsection, the Attorney General— 

11 ‘‘(A) shall register an emergency medical 

12 services agency if the agency submits an appli13 cation demonstrating it is authorized to conduct 

14 such activity under the laws of each State in 

15 which the agency practices; and 

16 ‘‘(B) may deny an application for such reg17 istration if the Attorney General determines 

18 that the issuance of such registration would be 

19 inconsistent with the requirements of this sub20 section or the public interest based on the fac21 tors listed in subsection (f). 

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

23 registering an emergency medical services agency 

24 pursuant to paragraph (1), the Attorney General 

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1 istration in each State where the agency administers 

2 controlled substances in lieu of requiring a separate 

3 registration for each location of the emergency med4 ical services agency. 

5 ‘‘(3) HOSPITAL-BASED AGENCY.—If a hospital6 based emergency medical services agency is reg7 istered under subsection (f), the agency may use the 

8 registration of the hospital to administer controlled 

9 substances in accordance with this subsection with10 out being registered under this subsection. 

11 ‘‘(4) ADMINISTRATION OUTSIDE PHYSICAL

12 PRESENCE OF MEDICAL DIRECTOR OR AUTHORIZING

13 MEDICAL PROFESSIONAL.—Emergency medical serv14 ices professionals of a registered emergency medical 

15 services agency may administer controlled sub16 stances in schedule II, III, IV, or V outside the 

17 physical presence of a medical director or author18 izing medical professional in the course of providing 

19 emergency medical services if the administration 

20 is— 

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

22 which it occurs; and 

23 ‘‘(B) pursuant to— 

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

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1 tors of the agency, including any such 

2 order that may be developed by a specific 

3 State authority; or 

4 ‘‘(ii) a verbal order that is— 

5 ‘‘(I) issued in accordance with a 

6 policy of the agency; and 

7 ‘‘(II) provided by a medical direc8 tor or authorizing medical professional 

9 in response to a request by the emer10 gency medical services professional 

11 with respect to a specific patient— 

12 ‘‘(aa) in the case of a mass 

13 casualty incident; or 

14 ‘‘(bb) to ensure the proper 

15 care and treatment of a specific 

16 patient. 

17 ‘‘(5) DELIVERY.—A registered emergency med18 ical services agency may deliver controlled sub19 stances from a registered location of the agency to 

20 an unregistered location of the agency only if— 

21 ‘‘(A) the agency designates the unregis22 tered location for such delivery; and 

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

24 30 days prior to first delivering controlled sub25 stances to the unregistered location. 


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1 ‘‘(6) STORAGE.—A registered emergency med2 ical services agency may store controlled sub3 stances— 

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

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

6 agency or in an emergency services vehicle situ7 ated at a registered or designated location of 

8 the agency; or 

9 ‘‘(C) in an emergency medical services ve10 hicle used by the agency that is— 

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

12 registered or designated location of the 

13 agency in the course of responding to an 

14 emergency; or 

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

16 agency under circumstances that provide 

17 for security of the controlled substances 

18 consistent with the requirements estab19 lished by regulations of the Attorney Gen20 eral. 

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

22 delivery of controlled substances by a registered 

23 emergency medical services agency pursuant to this 

24 subsection shall not be treated as distribution for 

25 purposes of section 308. 


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1 ‘‘(8) RESTOCKING OF EMERGENCY MEDICAL

2 SERVICES VEHICLES AT A HOSPITAL.—Notwith3 standing paragraph (13)(J), a registered emergency 

4 medical services agency may receive controlled sub5 stances from a hospital for purposes of restocking 

6 an emergency medical services vehicle following an 

7 emergency response, and without being subject to 

8 the requirements of section 308, provided all of the 

9 following conditions are satisfied: 

10 ‘‘(A) The registered or designated location 

11 of the agency where the vehicle is primarily sit12 uated maintains a record of such receipt in ac13 cordance with paragraph (9). 

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

15 such delivery to the agency in accordance with 

16 section 307. 

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

18 a designated location, such location notifies the 

19 registered location of the agency within 72 

20 hours of the vehicle receiving the controlled 

21 substances. 

22 ‘‘(9) MAINTENANCE OF RECORDS.— 

23 ‘‘(A) IN GENERAL.—A registered emer24 gency medical services agency shall maintain 

25 records in accordance with subsections (a) and 


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1 (b) of section 307 of all controlled substances 

2 that are received, administered, or otherwise 

3 disposed of pursuant to the agency’s registra4 tion, without regard to subsection 307(c)(1)(B). 

5 ‘‘(B) REQUIREMENTS.—Such records— 

6 ‘‘(i) shall include records of deliveries 

7 of controlled substances between all loca8 tions of the agency; and 

9 ‘‘(ii) shall be maintained, whether 

10 electronically or otherwise, at each reg11 istered and designated location of the 

12 agency where the controlled substances in13 volved are received, administered, or other14 wise disposed of. 

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

16 emergency medical services agency, under the super17 vision of a medical director, shall be responsible for 

18 ensuring that— 

19 ‘‘(A) all emergency medical services profes20 sionals who administer controlled substances 

21 using the agency’s registration act in accord22 ance with the requirements of this subsection; 

23 ‘‘(B) the recordkeeping requirements of 

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1 istered location and each designated location of 

2 the agency; 

3 ‘‘(C) the applicable physical security re4 quirements established by regulation of the At5 torney General are complied with wherever con6 trolled substances are stored by the agency in 

7 accordance with paragraph (6); and 

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

9 location of the agency, a record of the standing 

10 orders issued or adopted in accordance with 

11 paragraph (9). 

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

13 may issue regulations— 

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

15 controlled substances under paragraph (5)— 

16 ‘‘(i) the types of locations that may be 

17 designated under such paragraph; and 

18 ‘‘(ii) the manner in which a notifica19 tion under paragraph (5)(B) must be 

20 made; 

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

22 of controlled substances under paragraph (6), 

23 the manner in which such substances must be 

24 stored at registered and designated locations, 


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1 including in emergency medical service vehicles; 

2 and 

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

4 emergency medical services agencies, registered 

5 locations, and designated locations to deliver 

6 controlled substances to each other in the event 

7 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 consistent with this subsection. 

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

21 ‘‘(A) The term ‘authorizing medical profes22 sional’ means an emergency or other physician, 

23 or another medical professional (including an 

24 advanced practice registered nurse or physician 

25 assistant) who is— 


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1 ‘‘(i) registered under this Act; 

2 ‘‘(ii) acting within the scope of the 

3 registration; and 

4 ‘‘(iii) whose scope of practice under a 

5 State license or certification includes the 

6 ability to provide verbal orders. 

7 ‘‘(B) The term ‘designated location’ means 

8 a location designated by an emergency medical 

9 services agency under paragraph (5). 

10 ‘‘(C) The term ‘emergency medical serv11 ices’ means emergency medical response and 

12 emergency mobile medical services provided out13 side of a fixed medical facility. 

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

15 agency’ means an organization providing emer16 gency medical services, including such an orga17 nization that— 

18 ‘‘(i) is governmental (including fire19 based and hospital-based agencies), non20 governmental (including hospital-based 

21 agencies), private, or volunteer-based; 

22 ‘‘(ii) provides emergency medical serv23 ices by ground, air, or otherwise; and 

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

25 which the organization is providing such 


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1 services to provide emergency medical care, 

2 including the administering of controlled 

3 substances, to members of the general pub4 lic on an emergency basis. 

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

6 professional’ means a health care professional 

7 (including a nurse, paramedic, or emergency 

8 medical technician) licensed or certified by the 

9 State in which the professional practices and 

10 credentialed by a medical director of the respec11 tive emergency medical services agency to pro12 vide emergency medical services within the 

13 scope of the professional’s State license or cer14 tification. 

15 ‘‘(F) The term ‘emergency medical services 

16 vehicle’ means an ambulance, fire apparatus, 

17 supervisor truck, or other vehicle used by an 

18 emergency medical services agency for the pur19 pose of providing or facilitating emergency med20 ical care and transport or transporting con21 trolled substances to and from the registered 

22 and designated locations. 

23 ‘‘(G) The term ‘hospital-based’ means, 

24 with respect to an agency, owned or operated by 

25 a hospital. 


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1 ‘‘(H) The term ‘medical director’ means a 

2 physician who is registered under subsection (f) 

3 and provides medical oversight for an emer4 gency medical services agency. 

5 ‘‘(I) The term ‘medical oversight’ means 

6 supervision of the provision of medical care by 

7 an emergency medical services agency. 

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

9 a location that appears on the certificate of reg10 istration issued to an emergency medical serv11 ices agency under this subsection or subsection 

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

13 controlled substances from distributors. 

14 ‘‘(K) The term ‘registered emergency med15 ical services agency’ means— 

16 ‘‘(i) an emergency medical services 

17 agency that is registered pursuant to this 

18 subsection; or 

19 ‘‘(ii) a hospital-based emergency med20 ical services agency that is covered by the 

21 registration of the hospital under sub22 section (f). 

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

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1 ordinating body, that, pursuant to State law or 

2 regulation, develops clinical protocols regarding 

3 the delivery of emergency medical services in 

4 the geographic jurisdiction of such agency or 

5 authority within the State that may be adopted 

6 by medical directors. 

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

8 written medical protocol in which a medical di9 rector determines in advance the medical cri10 teria that must be met before administering 

11 controlled substances to individuals in need of 

12 emergency medical services. 

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

14 oral directive that is given through any method 

15 of communication including by radio or tele16 phone, directly to an emergency medical serv17 ices professional, to contemporaneously admin18 ister a controlled substance to individuals in 

19 need of emergency medical services outside the 

20 physical presence of the medical director or au21 thorizing medical professional.’’. 


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1 SEC. 3. DELIVERY OF A CONTROLLED SUBSTANCE BY A 

2 PHARMACY TO AN ADMINISTERING PRACTI3 TIONER. 

4 (a) IN GENERAL.—The Controlled Substance Act is 

5 amended by inserting after section 309 (21 U.S.C. 829) 

6 the following: 

7 ‘‘SEC. 309A. DELIVERY OF A CONTROLLED SUBSTANCE BY A 

8 PHARMACY TO AN ADMINISTERING PRACTI9 TIONER. 

10 ‘‘Notwithstanding section 102(10), a pharmacy may 

11 deliver a controlled substance to a practitioner in accord12 ance with a prescription that meets the requirements of 

13 this Act and the regulations issued by the Attorney Gen14 eral under this Act, for the purpose of administering of 

15 the controlled substance by the practitioner if— 

16 ‘‘(1) the controlled substance is delivered by the 

17 pharmacy to the prescribing practitioner or the prac18 titioner administering the controlled substance, as 

19 applicable, at the location listed on the practitioner’s 

20 certificate of registration issued under this Act; 

21 ‘‘(2)(A) in the case of administering of the con22 trolled substance for the purpose of maintenance or 

23 detoxification treatment under section 303(g)(2)— 

24 ‘‘(i) the practitioner who issued the pre25 scription is a qualifying practitioner authorized 


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1 under, and acting within the scope of that sec2 tion; and 

3 ‘‘(ii) the controlled substance is to be ad4 ministered by injection, implantation, or use of 

5 an intrathecal pump; or 

6 ‘‘(B) in the case of administering of the con7 trolled substance for a purpose other than mainte8 nance or detoxification treatment, the controlled 

9 substance is to be administered by a practitioner 

10 through use of an intrathecal pump; 

11 ‘‘(3) the pharmacy and the practitioner are au12 thorized to conduct the activities specified in this 

13 section under the law of the State in which such ac14 tivities take place; 

15 ‘‘(4) the prescription is not issued to supply any 

16 practitioner with a stock of controlled substances for 

17 the purpose of general dispensing to patients; 

18 ‘‘(5) the controlled substance is to be adminis19 tered only to the patient named on the prescription 

20 not later than 7 days, or longer if extended by the 

21 Attorney General, after the date of receipt of the 

22 controlled substance by the practitioner; and 

23 ‘‘(6) notwithstanding any exceptions under sec24 tion 307, the prescribing practitioner, and the prac25 titioner administering the controlled substance, as 


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1 applicable, maintain complete and accurate records 

2 of all controlled substances delivered, received, ad3 ministered, or otherwise disposed of under this sec4 tion, including the persons to whom controlled sub5 stances were delivered and such other information as 

6 may be required by regulations of the Attorney Gen7 eral.’’. 

8 (b) TECHNICAL AND CONFORMING AMENDMENT.— 

9 The table of contents for the Comprehensive Drug Abuse 

10 Prevention and Control Act of 1970 is amended by insert11 ing after the item relating to section 309 the following: 

‘‘Sec. 309A. Delivery of a controlled substance by a pharmacy to an administering practitioner.’’. 

Æ 


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