I 

115TH CONGRESS 

2D SESSION H. R. 5202 

To amend the Controlled Substances Act to provide for the delivery of 

a controlled substance by a pharmacy to an administering practitioner. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 7, 2018 

Mr. COSTELLO of Pennsylvania (for himself and Mr. NOLAN) 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 to provide for the 

delivery of a controlled substance by a pharmacy to an 

administering practitioner. 

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 ‘‘Ensuring Patient Ac5 cess to Substance Use Disorder Treatments Act of 2018’’. 


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1 SEC. 2. DELIVERY OF A CONTROLLED SUBSTANCE BY A 

2 PHARMACY TO BE ADMINISTERED BY INJEC3 TION, IMPLANTATION, OR INTRATHECAL 

4 PUMP. 

5 (a) IN GENERAL.—The Controlled Substances Act is 

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

7 the following: 

8 ‘‘DELIVERY OF A CONTROLLED SUBSTANCE BY A

9 PHARMACY TO AN ADMINISTERING PRACTITIONER

10 ‘‘SEC. 309A. (a) IN GENERAL.—Notwithstanding 

11 section 102(10), a pharmacy may deliver (pursuant to a 

12 registration under subsection (f) or (g) of section 303, as 

13 applicable) a controlled substance to a practitioner in ac14 cordance with a prescription that meets the requirements 

15 of this title and the regulations issued by the Attorney 

16 General under this title, for the purpose of administering 

17 of the controlled substance by the practitioner if— 

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

19 pharmacy to the prescribing practitioner or the prac20 titioner administering the controlled substance, as 

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

22 certificate of registration issued under this title; 

23 ‘‘(2)(A) in the case of administering of the con24 trolled substance for the purpose of maintenance or 

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


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1 ‘‘(i) the practitioner who issued the pre2 scription is a qualifying practitioner authorized 

3 under, and acting within the scope of, that sec4 tion; and 

5 ‘‘(ii) the controlled substance is to be ad6 ministered by injection or implantation; or 

7 ‘‘(B) in the case of administering of the con8 trolled substance for a purpose other than mainte9 nance or detoxification treatment, the controlled 

10 substance is to be administered by a practitioner 

11 through use of an intrathecal pump; 

12 ‘‘(3) the pharmacy and the practitioner are au13 thorized to conduct the activities specified in this 

14 section under the law of the State in which such ac15 tivities take place; 

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

17 practitioner with a stock of controlled substances for 

18 the purpose of general dispensing to patients; 

19 ‘‘(5) except as provided in subsection (b), the 

20 controlled substance is to be administered only to 

21 the patient named on the prescription not later than 

22 14 days after the date of receipt of the controlled 

23 substance by the practitioner; and 

24 ‘‘(6) notwithstanding any exceptions under sec25 tion 307, the prescribing practitioner, and the pracVerDate Sep 11 2014 21:40 Mar 14, 2018 Jkt 079200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5202.IH H5202

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1 titioner administering the controlled substance, as 

2 applicable, maintain complete and accurate records 

3 of all controlled substances delivered, received, ad4 ministered, or otherwise disposed of under this sec5 tion, including the persons to whom controlled sub6 stances were delivered and such other information as 

7 may be required by regulations of the Attorney Gen8 eral. 

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

10 WHICH CONTROLLED SUBSTANCE SHALL BE ADMINIS11 TERED.— 

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

13 year period beginning on the date of enactment of 

14 this section, the Attorney General, in coordination 

15 with the Secretary, may reduce the number of days 

16 described in subsection (a)(5) if the Attorney Gen17 eral determines that such reduction will— 

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

19 ‘‘(B) protect the public health. 

20 ‘‘(2) MODIFICATIONS AFTER SUBMISSION OF

21 REPORT.—After the date on which the report de22 scribed in subsection (c) is submitted, the Attorney 

23 General, in coordination with the Secretary, may 

24 modify the number of days described in subsection 

25 (a)(5). 


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1 ‘‘(3) MINIMUM NUMBER OF DAYS.—A modifica2 tion under this subsection may not modify the num3 ber of days specified in subsection (a)(5) to fewer 

4 than 7.’’. 

5 (b) STUDY AND REPORT.—Not later than 2 years 

6 after the date of enactment of this Act, the Comptroller 

7 General of the United States shall conduct a study and 

8 submit to Congress a report on access to and potential 

9 diversion of controlled substances administered by injec10 tion, implantation, or through the use of an intrathecal 

11 pump. 

12 (c) TECHNICAL AND CONFORMING AMENDMENT.— 

13 The table of contents for the Comprehensive Drug Abuse 

14 Prevention and Control Act of 1970 is amended by insert15 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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