II 

Calendar No. 46 

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, Mr. FRANKEN, Mr. 

ALEXANDER, Ms. MURKOWSKI, and Mrs. MURRAY) introduced the following bill; which was read twice and referred to the Committee on 

Health, Education, Labor, and Pensions 

MAY 1, 2017 

Reported by Mr. ALEXANDER, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

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’’. 


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1 SEC. 2. EMERGENCY MEDICAL SERVICES. 

2 Section 303 of the Controlled Substances Act (21 

3 U.S.C. 823) is amended— 

4 (1) by redesignating subsection (j) as sub5 section (k); and 

6 (2) by inserting after subsection (i) the fol7 lowing: 

8 ‘‘(j) EMERGENCY MEDICAL SERVICES THAT ADMIN9 ISTER CONTROLLED SUBSTANCES.— 

10 ‘‘(1) REGISTRATION.—For the purpose of ena11 bling emergency medical services professionals to ad12 minister controlled substances in schedule II, III, 

13 IV, or V to ultimate users receiving emergency med14 ical services in accordance with the requirements of 

15 this subsection, the Attorney General— 

16 ‘‘(A) shall register an emergency medical 

17 services agency if the agency submits an appli18 cation demonstrating it is authorized to conduct 

19 such activity under the laws of each State in 

20 which the agency practices; and 

21 ‘‘(B) may deny an application for such reg22 istration if the Attorney General determines 

23 that the issuance of such registration would be 

24 inconsistent with the requirements of this sub25 section or the public interest based on the fac26 tors listed in subsection (f). 


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

2 registering an emergency medical services agency 

3 pursuant to paragraph (1), the Attorney General 

4 shall allow such agency the option of a single reg5 istration in each State where the agency administers 

6 controlled substances in lieu of requiring a separate 

7 registration for each location of the emergency med8 ical services agency. 

9 ‘‘(3) HOSPITAL-BASED AGENCY.—If a hospital10 based emergency medical services agency is reg11 istered under subsection (f), the agency may use the 

12 registration of the hospital to administer controlled 

13 substances in accordance with this subsection with14 out being registered under this subsection. 

15 ‘‘(4) ADMINISTRATION OUTSIDE PHYSICAL

16 PRESENCE OF MEDICAL DIRECTOR OR AUTHORIZING

17 MEDICAL PROFESSIONAL.—Emergency medical serv18 ices professionals of a registered emergency medical 

19 services agency may administer controlled sub20 stances in schedule II, III, IV, or V outside the 

21 physical presence of a medical director or author22 izing medical professional in the course of providing 

23 emergency medical services if the administration 

24 is— 


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

2 which it occurs; and 

3 ‘‘(B) pursuant to— 

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

5 and adopted by one or more medical direc6 tors of the agency, including any such 

7 order that may be developed by a specific 

8 State authority; or 

9 ‘‘(ii) a verbal order that is— 

10 ‘‘(I) issued in accordance with a 

11 policy of the agency; and 

12 ‘‘(II) provided by a medical direc13 tor or authorizing medical professional 

14 in response to a request by the emer15 gency medical services professional 

16 with respect to a specific patient— 

17 ‘‘(aa) in the case of a mass 

18 casualty incident; or 

19 ‘‘(bb) to ensure the proper 

20 care and treatment of a specific 

21 patient. 

22 ‘‘(5) DELIVERY.—A registered emergency med23 ical services agency may deliver controlled sub24 stances from a registered location of the agency to 

25 an unregistered location of the agency only if— 


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1 ‘‘(A) the agency designates the unregis2 tered location for such delivery; and 

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

4 30 days prior to first delivering controlled sub5 stances to the unregistered location. 

6 ‘‘(6) STORAGE.—A registered emergency med7 ical services agency may store controlled sub8 stances— 

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

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

11 agency or in an emergency services vehicle situ12 ated at a registered or designated location of 

13 the agency; or 

14 ‘‘(C) in an emergency medical services ve15 hicle used by the agency that is— 

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

17 registered or designated location of the 

18 agency in the course of responding to an 

19 emergency; or 

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

21 agency under circumstances that provide 

22 for security of the controlled substances 

23 consistent with the requirements estab24 lished by regulations of the Attorney Gen25 eral. 


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

2 delivery of controlled substances by a registered 

3 emergency medical services agency pursuant to this 

4 subsection shall not be treated as distribution for 

5 purposes of section 308. 

6 ‘‘(8) RESTOCKING OF EMERGENCY MEDICAL

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

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

11 an emergency medical services vehicle following an 

12 emergency response, and without being subject to 

13 the requirements of section 308, provided all of the 

14 following conditions are satisfied: 

15 ‘‘(A) The registered or designated location 

16 of the agency where the vehicle is primarily sit17 uated 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 


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1 hours of the vehicle receiving the controlled 

2 substances. 

3 ‘‘(9) MAINTENANCE OF RECORDS.— 

4 ‘‘(A) IN GENERAL.—A registered emer5 gency medical services agency shall maintain 

6 records in accordance with subsections (a) and 

7 (b) of section 307 of all controlled substances 

8 that are received, administered, or otherwise 

9 disposed of pursuant to the agency’s registra10 tion, without regard to subsection 307(c)(1)(B). 

11 ‘‘(B) REQUIREMENTS.—Such records— 

12 ‘‘(i) shall include records of deliveries 

13 of controlled substances between all loca14 tions of the agency; and 

15 ‘‘(ii) shall be maintained, whether 

16 electronically or otherwise, at each reg17 istered and designated location of the 

18 agency where the controlled substances in19 volved are received, administered, or other20 wise disposed of. 

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

22 emergency medical services agency, under the super23 vision of a medical director, shall be responsible for 

24 ensuring that— 


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1 ‘‘(A) all emergency medical services profes2 sionals who administer controlled substances 

3 using the agency’s registration act in accord4 ance with the requirements of this subsection; 

5 ‘‘(B) the recordkeeping requirements of 

6 paragraph (9) are met with respect to a reg7 istered location and each designated location of 

8 the agency; 

9 ‘‘(C) the applicable physical security re10 quirements established by regulation of the At11 torney General are complied with wherever con12 trolled substances are stored by the agency in 

13 accordance with paragraph (6); and 

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

15 location of the agency, a record of the standing 

16 orders issued or adopted in accordance with 

17 paragraph (9). 

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

19 may issue regulations— 

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

21 controlled substances under paragraph (5)— 

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

23 designated under such paragraph; and 


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1 ‘‘(ii) the manner in which a notifica2 tion under paragraph (5)(B) must be 

3 made; 

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

5 of controlled substances under paragraph (6), 

6 the manner in which such substances must be 

7 stored at registered and designated locations, 

8 including in emergency medical service vehicles; 

9 and 

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

11 emergency medical services agencies, registered 

12 locations, and designated locations to deliver 

13 controlled substances to each other in the event 

14 of— 

15 ‘‘(i) shortages of such substances; 

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

17 ‘‘(iii) a mass casualty event. 

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

19 this subsection shall be construed— 

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

21 Attorney General by other provisions of this 

22 title to take measures to prevent diversion of 

23 controlled substances; or 


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

2 to regulate the provision of emergency medical 

3 services consistent with this subsection. 

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

5 ‘‘(A) The term ‘authorizing medical profes6 sional’ means an emergency or other physician, 

7 or another medical professional (including an 

8 advanced practice registered nurse or physician 

9 assistant) who is— 

10 ‘‘(i) registered under this Act; 

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

12 registration; and 

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

14 State license or certification includes the 

15 ability to provide verbal orders. 

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

17 a location designated by an emergency medical 

18 services agency under paragraph (5). 

19 ‘‘(C) The term ‘emergency medical serv20 ices’ means emergency medical response and 

21 emergency mobile medical services provided out22 side of a fixed medical facility. 

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

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1 gency medical services, including such an orga2 nization that— 

3 ‘‘(i) is governmental (including fire4 based and hospital-based agencies), non5 governmental (including hospital-based 

6 agencies), private, or volunteer-based; 

7 ‘‘(ii) provides emergency medical serv8 ices by ground, air, or otherwise; and 

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

10 which the organization is providing such 

11 services to provide emergency medical care, 

12 including the administering of controlled 

13 substances, to members of the general pub14 lic on an emergency basis. 

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

16 professional’ means a health care professional 

17 (including a nurse, paramedic, or emergency 

18 medical technician) licensed or certified by the 

19 State in which the professional practices and 

20 credentialed by a medical director of the respec21 tive emergency medical services agency to pro22 vide emergency medical services within the 

23 scope of the professional’s State license or cer24 tification. 


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

2 vehicle’ means an ambulance, fire apparatus, 

3 supervisor truck, or other vehicle used by an 

4 emergency medical services agency for the pur5 pose of providing or facilitating emergency med6 ical care and transport or transporting con7 trolled substances to and from the registered 

8 and designated locations. 

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

10 with respect to an agency, owned or operated by 

11 a hospital. 

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

13 physician who is registered under subsection (f) 

14 and provides medical oversight for an emer15 gency medical services agency. 

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

17 supervision of the provision of medical care by 

18 an emergency medical services agency. 

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

20 a location that appears on the certificate of reg21 istration issued to an emergency medical serv22 ices agency under this subsection or subsection 

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

24 controlled substances from distributors. 


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1 ‘‘(K) The term ‘registered emergency med2 ical services agency’ means— 

3 ‘‘(i) an emergency medical services 

4 agency that is registered pursuant to this 

5 subsection; or 

6 ‘‘(ii) a hospital-based emergency med7 ical services agency that is covered by the 

8 registration of the hospital under sub9 section (f). 

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

11 means a governmental agency or other such au12 thority, including a regional oversight and co13 ordinating body, that, pursuant to State law or 

14 regulation, develops clinical protocols regarding 

15 the delivery of emergency medical services in 

16 the geographic jurisdiction of such agency or 

17 authority within the State that may be adopted 

18 by medical directors. 

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

20 written medical protocol in which a medical di21 rector determines in advance the medical cri22 teria that must be met before administering 

23 controlled substances to individuals in need of 

24 emergency medical services. 


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

2 oral directive that is given through any method 

3 of communication including by radio or tele4 phone, directly to an emergency medical serv5 ices professional, to contemporaneously admin6 ister a controlled substance to individuals in 

7 need of emergency medical services outside the 

8 physical presence of the medical director or au9 thorizing medical professional.’’. 

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

11 PHARMACY TO AN ADMINISTERING PRACTI12 TIONER. 

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

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

15 the following: 

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

17 PHARMACY TO AN ADMINISTERING PRACTI18 TIONER. 

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

20 deliver a controlled substance to a practitioner in accord21 ance with a prescription that meets the requirements of 

22 this Act and the regulations issued by the Attorney Gen23 eral under this Act, for the purpose of administering of 

24 the controlled substance by the practitioner if— 


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

2 pharmacy to the prescribing practitioner or the prac3 titioner administering the controlled substance, as 

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

5 certificate of registration issued under this Act; 

6 ‘‘(2)(A) in the case of administering of the con7 trolled substance for the purpose of maintenance or 

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

9 ‘‘(i) the practitioner who issued the pre10 scription is a qualifying practitioner authorized 

11 under, and acting within the scope of that sec12 tion; and 

13 ‘‘(ii) the controlled substance is to be ad14 ministered by injection, implantation, or use of 

15 an intrathecal pump; or 

16 ‘‘(B) in the case of administering of the con17 trolled substance for a purpose other than mainte18 nance or detoxification treatment, the controlled 

19 substance is to be administered by a practitioner 

20 through use of an intrathecal pump; 

21 ‘‘(3) the pharmacy and the practitioner are au22 thorized to conduct the activities specified in this 

23 section under the law of the State in which such ac24 tivities take place; 


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

2 practitioner with a stock of controlled substances for 

3 the purpose of general dispensing to patients; 

4 ‘‘(5) the controlled substance is to be adminis5 tered only to the patient named on the prescription 

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

7 Attorney General, after the date of receipt of the 

8 controlled substance by the practitioner; and 

9 ‘‘(6) notwithstanding any exceptions under sec10 tion 307, the prescribing practitioner, and the prac11 titioner administering the controlled substance, as 

12 applicable, maintain complete and accurate records 

13 of all controlled substances delivered, received, ad14 ministered, or otherwise disposed of under this sec15 tion, including the persons to whom controlled sub16 stances were delivered and such other information as 

17 may be required by regulations of the Attorney Gen18 eral.’’. 

19 (b) TECHNICAL AND CONFORMING AMENDMENT.— 

20 The table of contents for the Comprehensive Drug Abuse 

21 Prevention and Control Act of 1970 is amended by insert22 ing after the item relating to section 309 the following: 

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


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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 2017’’. 

4 SEC. 2. EMERGENCY MEDICAL SERVICES. 

5 Section 303 of the Controlled Substances Act (21 

6 U.S.C. 823) is amended— 

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

8 (k); and 

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

10 ‘‘(j) EMERGENCY MEDICAL SERVICES THAT ADMIN11 ISTER CONTROLLED SUBSTANCES.— 

12 ‘‘(1) REGISTRATION.—For the purpose of ena13 bling emergency medical services professionals to ad14 minister controlled substances in schedule II, III, IV, 

15 or V to ultimate users receiving emergency medical 

16 services in accordance with the requirements of this 

17 subsection, the Attorney General— 

18 ‘‘(A) shall register an emergency medical 

19 services agency if the agency submits an applica20 tion demonstrating it is authorized to conduct 

21 such activity under the laws of each State in 

22 which the agency practices; and 

23 ‘‘(B) may deny an application for such reg24 istration if the Attorney General determines that 

25 the issuance of such registration would be incon26 sistent with the requirements of this subsection 


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1 or the public interest based on the factors listed 

2 in subsection (f). 

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

4 registering an emergency medical services agency pur5 suant to paragraph (1), the Attorney General shall 

6 allow such agency the option of a single registration 

7 in each State where the agency administers controlled 

8 substances in lieu of requiring a separate registration 

9 for each location of the emergency medical services 

10 agency. 

11 ‘‘(3) HOSPITAL-BASED AGENCY.—If a hospital12 based emergency medical services agency is registered 

13 under subsection (f), the agency may use the registra14 tion of the hospital to administer controlled sub15 stances in accordance with this subsection without 

16 being registered under this subsection. 

17 ‘‘(4) ADMINISTRATION OUTSIDE PHYSICAL PRES18 ENCE OF MEDICAL DIRECTOR OR AUTHORIZING MED19 ICAL PROFESSIONAL.—Emergency medical services 

20 professionals of a registered emergency medical serv21 ices agency may administer controlled substances in 

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

23 of a medical director or authorizing medical profes24 sional in the course of providing emergency medical 

25 services if the administration is— 


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

2 which it occurs; and 

3 ‘‘(B) pursuant to— 

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

5 and adopted by one or more medical direc6 tors of the agency, including any such order 

7 that may be developed by a specific State 

8 authority; or 

9 ‘‘(ii) a verbal order that is— 

10 ‘‘(I) issued in accordance with a 

11 policy of the agency; and 

12 ‘‘(II) provided by a medical direc13 tor or authorizing medical professional 

14 in response to a request by the emer15 gency medical services professional 

16 with respect to a specific patient— 

17 ‘‘(aa) in the case of a mass 

18 casualty incident; or 

19 ‘‘(bb) to ensure the proper 

20 care and treatment of a specific 

21 patient. 

22 ‘‘(5) DELIVERY.—A registered emergency medical 

23 services agency may deliver controlled substances from 

24 a registered location of the agency to an unregistered 

25 location of the agency only if— 


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1 ‘‘(A) the agency designates the unregistered 

2 location for such delivery; and 

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

4 30 days prior to first delivering controlled sub5 stances to the unregistered location. 

6 ‘‘(6) STORAGE.—A registered emergency medical 

7 services agency may store controlled substances— 

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

9 ‘‘(B) at any designated location of the agen10 cy or in an emergency services vehicle situated at 

11 a registered or designated location of the agency; 

12 or 

13 ‘‘(C) in an emergency medical services vehi14 cle used by the agency that is— 

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

16 registered or designated location of the 

17 agency in the course of responding to an 

18 emergency; or 

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

20 agency under circumstances that provide for 

21 security of the controlled substances con22 sistent with the requirements established by 

23 regulations of the Attorney General. 

24 ‘‘(7) NO TREATMENT AS DISTRIBUTION.—The de25 livery of controlled substances by a registered emerVerDate Sep 11 2014 21:42 May 01, 2017 Jkt 069200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6203 E:\BILLS\S916.RS S916

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1 gency medical services agency pursuant to this sub2 section shall not be treated as distribution for pur3 poses 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 an 

9 emergency medical services vehicle following an emer10 gency response, and without being subject to the re11 quirements of section 308, provided all of the fol12 lowing conditions are satisfied: 

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

14 the agency where the vehicle is primarily situ15 ated 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 hours 

23 of the vehicle receiving the controlled substances. 

24 ‘‘(9) MAINTENANCE OF RECORDS.— 


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1 ‘‘(A) IN GENERAL.—A registered emergency 

2 medical services agency shall maintain records 

3 in accordance with subsections (a) and (b) of sec4 tion 307 of all controlled substances that are re5 ceived, administered, or otherwise disposed of 

6 pursuant to the agency’s registration, without re7 gard to subsection 307(c)(1)(B). 

8 ‘‘(B) REQUIREMENTS.—Such records— 

9 ‘‘(i) shall include records of deliveries 

10 of controlled substances between all locations 

11 of the agency; and 

12 ‘‘(ii) shall be maintained, whether elec13 tronically or otherwise, at each registered 

14 and designated location of the agency where 

15 the controlled substances involved are re16 ceived, administered, or otherwise disposed 

17 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 accordance 

25 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 Attor7 ney General are complied with wherever con8 trolled substances are stored by the agency in ac9 cordance 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 be 

19 designated under such paragraph; and 

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

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

23 of controlled substances under paragraph (6), the 

24 manner in which such substances must be stored 


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1 at registered and designated locations, including 

2 in emergency medical service vehicles; 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 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 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 reg3 istration; 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 a 

8 location designated by an emergency medical 

9 services agency under paragraph (5). 

10 ‘‘(C) The term ‘emergency medical services’ 

11 means emergency medical response and emer12 gency mobile medical services provided outside of 

13 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 public 

4 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 scope 

13 of the professional’s State license or certification. 

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

15 vehicle’ means an ambulance, fire apparatus, su16 pervisor truck, or other vehicle used by an emer17 gency medical services agency for the purpose of 

18 providing or facilitating emergency medical care 

19 and transport or transporting controlled sub20 stances to and from the registered and designated 

21 locations. 

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

23 respect to an agency, owned or operated by a 

24 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 emergency 

4 medical services agency. 

5 ‘‘(I) The term ‘medical oversight’ means su6 pervision of the provision of medical care by an 

7 emergency medical services agency. 

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

9 location that appears on the certificate of reg10 istration issued to an emergency medical services 

11 agency under this subsection or subsection (f), 

12 which shall be where the agency receives con13 trolled 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 subsection 

22 (f). 

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

24 means a governmental agency or other such au25 thority, including a regional oversight and coVerDate Sep 11 2014 21:42 May 01, 2017 Jkt 069200 PO 00000 Frm 00027 Fmt 6652 Sfmt 6203 E:\BILLS\S916.RS S916

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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 the 

4 geographic jurisdiction of such agency or author5 ity within the State that may be adopted by 

6 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 criteria 

10 that must be met before administering controlled 

11 substances to individuals in need of emergency 

12 medical services. 

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

14 directive that is given through any method of 

15 communication including by radio or telephone, 

16 directly to an emergency medical services profes17 sional, to contemporaneously administer a con18 trolled substance to individuals in need of emer19 gency medical services outside the physical pres20 ence of the medical director or authorizing med21 ical 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) the 

6 following: 

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

8 PHARMACY TO AN ADMINISTERING PRACTI9 TIONER. 

10 ‘‘(a) IN GENERAL.—Notwithstanding section 102(10), 

11 a pharmacy may deliver a controlled substance to a practi12 tioner in accordance with a prescription that meets the re13 quirements of this Act and the regulations issued by the 

14 Attorney General under this Act, for the purpose of admin15 istering of 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 ap19 plicable, 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 

5 through the use of 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 sub9 stance is to be administered by a practitioner through 

10 use of an intrathecal pump; 

11 ‘‘(3) the pharmacy and the practitioner are au12 thorized to conduct the activities specified in this sec13 tion under the law of the State in which such activi14 ties 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) except as provided in subsection (b), the 

19 controlled substance is to be administered only to the 

20 patient named on the prescription not later than 14 

21 days after the date of receipt of the controlled sub22 stance by the practitioner; and 

23 ‘‘(6) notwithstanding any exceptions under sec24 tion 307, the prescribing practitioner, and the practi25 tioner administering the controlled substance, as apVerDate Sep 11 2014 21:42 May 01, 2017 Jkt 069200 PO 00000 Frm 00030 Fmt 6652 Sfmt 6203 E:\BILLS\S916.RS S916

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1 plicable, maintain complete and accurate records of 

2 all controlled substances delivered, received, adminis3 tered, or otherwise disposed of under this section, in4 cluding the persons to whom controlled substances 

5 were delivered and such other information as may be 

6 required by regulations of the Attorney General. 

7 ‘‘(b) MODIFICATION OF NUMBER OF DAYS BEFORE

8 WHICH CONTROLLED SUBSTANCE SHALL BE ADMINIS9 TERED.— 

10 ‘‘(1) INITIAL 2-YEAR PERIOD.—During the 2- 

11 year period beginning on the date of enactment of this 

12 section, the Attorney General, in coordination with 

13 the Secretary, may reduce the number of days de14 scribed in subsection (a)(5) if the Attorney General 

15 determines that such reduction will— 

16 ‘‘(A) reduce the risk of diversion; or 

17 ‘‘(B) protect the public health. 

18 ‘‘(2) MODIFICATIONS AFTER SUBMISSION OF RE19 PORT.—After the date on which the report described 

20 in subsection (c) is submitted, the Attorney General, 

21 in coordination with the Secretary, may modify the 

22 number of days described in subsection (a)(5). 

23 ‘‘(3) MINIMUM NUMBER OF DAYS.—Any modi24 fication under this subsection shall be for a period of 

25 not less than 7 days. 


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1 ‘‘(c) STUDY AND REPORT.—Not later than 2 years 

2 after the date of enactment of this section, the Comptroller 

3 General of the United States shall conduct a study and sub4 mit to Congress a report on access to and potential diver5 sion of controlled substances administered by injection, im6 plantation, or through the use of an intrathecal pump.’’. 

7 (b) TECHNICAL AND CONFORMING AMENDMENT.—The 

8 table of contents for the Comprehensive Drug Abuse Preven9 tion and Control Act of 1970 is amended by inserting after 

10 the item relating to section 309 the following: 

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


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Calendar No. 46 

115TH CONGRESS 

1ST SESSION S. 916 

A BILL 

To amend the Controlled Substances Act with reices. gard to the provision of emergency medical servMAY 1, 2017 

Reported with an amendment 


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