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 Com-
merce, and in addition to the Committee on the Judiciary, for a period 
to be subsequently determined by the Speaker, in each case for consider-
ation 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Ensuring Patient Ac-
cess to Substance Use Disorder Treatments Act of 2018’’. 
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SEC. 2. DELIVERY OF A CONTROLLED SUBSTANCE BY A 
PHARMACY TO BE ADMINISTERED BY INJEC-
TION, 
IMPLANTATION, 
OR 
INTRATHECAL 
PUMP. 
(a) IN GENERAL.—The Controlled Substances Act is 
amended by inserting after section 309 (21 U.S.C. 829) 
the following: 
‘‘DELIVERY OF A CONTROLLED SUBSTANCE BY A 
PHARMACY TO AN ADMINISTERING PRACTITIONER 
‘‘SEC. 309A. (a) IN GENERAL.—Notwithstanding 
section 102(10), a pharmacy may deliver (pursuant to a 
registration under subsection (f) or (g) of section 303, as 
applicable) a controlled substance to a practitioner in ac-
cordance with a prescription that meets the requirements 
of this title and the regulations issued by the Attorney 
General under this title, for the purpose of administering 
of the controlled substance by the practitioner if— 
‘‘(1) the controlled substance is delivered by the 
pharmacy to the prescribing practitioner or the prac-
titioner administering the controlled substance, as 
applicable, at the location listed on the practitioner’s 
certificate of registration issued under this title; 
‘‘(2)(A) in the case of administering of the con-
trolled substance for the purpose of maintenance or 
detoxification treatment under section 303(g)(2)— 
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‘‘(i) the practitioner who issued the pre-
scription is a qualifying practitioner authorized 
under, and acting within the scope of, that sec-
tion; and 
‘‘(ii) the controlled substance is to be ad-
ministered by injection or implantation; or 
‘‘(B) in the case of administering of the con-
trolled substance for a purpose other than mainte-
nance or detoxification treatment, the controlled 
substance is to be administered by a practitioner 
through use of an intrathecal pump; 
‘‘(3) the pharmacy and the practitioner are au-
thorized to conduct the activities specified in this 
section under the law of the State in which such ac-
tivities take place; 
‘‘(4) the prescription is not issued to supply any 
practitioner with a stock of controlled substances for 
the purpose of general dispensing to patients; 
‘‘(5) except as provided in subsection (b), the 
controlled substance is to be administered only to 
the patient named on the prescription not later than 
14 days after the date of receipt of the controlled 
substance by the practitioner; and 
‘‘(6) notwithstanding any exceptions under sec-
tion 307, the prescribing practitioner, and the prac-
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titioner administering the controlled substance, as 
applicable, maintain complete and accurate records 
of all controlled substances delivered, received, ad-
ministered, or otherwise disposed of under this sec-
tion, including the persons to whom controlled sub-
stances were delivered and such other information as 
may be required by regulations of the Attorney Gen-
eral. 
‘‘(b) MODIFICATION OF NUMBER OF DAYS BEFORE 
WHICH CONTROLLED SUBSTANCE SHALL BE ADMINIS-
TERED.— 
‘‘(1) INITIAL 2-YEAR PERIOD.—During the 2- 
year period beginning on the date of enactment of 
this section, the Attorney General, in coordination 
with the Secretary, may reduce the number of days 
described in subsection (a)(5) if the Attorney Gen-
eral determines that such reduction will— 
‘‘(A) reduce the risk of diversion; or 
‘‘(B) protect the public health. 
‘‘(2) MODIFICATIONS
AFTER
SUBMISSION
OF 
REPORT.—After the date on which the report de-
scribed in subsection (c) is submitted, the Attorney 
General, in coordination with the Secretary, may 
modify the number of days described in subsection 
(a)(5). 
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‘‘(3) MINIMUM NUMBER OF DAYS.—A modifica-
tion under this subsection may not modify the num-
ber of days specified in subsection (a)(5) to fewer 
than 7.’’. 
(b) STUDY AND REPORT.—Not later than 2 years 
after the date of enactment of this Act, the Comptroller 
General of the United States shall conduct a study and 
submit to Congress a report on access to and potential 
diversion of controlled substances administered by injec-
tion, implantation, or through the use of an intrathecal 
pump. 
(c) TECHNICAL AND CONFORMING AMENDMENT.— 
The table of contents for the Comprehensive Drug Abuse 
Prevention and Control Act of 1970 is amended by insert-
ing after the item relating to section 309 the following: 
‘‘Sec. 309A. Delivery of a controlled substance by a pharmacy to an admin-
istering practitioner.’’. 
Æ 
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