I 
115TH CONGRESS 
2D SESSION 
H. R. 6600 
To amend the Controlled Substances Act to require that orders subject 
to review be submitted through a clearinghouse, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 26, 2018 
Mr. LANCE (for himself and Ms. MATSUI) 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 deter-
mined 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 require that 
orders subject to review be submitted through a clearing-
house, and for other purposes. 
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 ‘‘DEA Order Clearing-
house Act of 2018’’. 
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SEC. 2. REQUIRED CLEARINGHOUSE FOR REGISTRANT OR-
DERS. 
(a) IN GENERAL.—The Controlled Substances Act 
(21 U.S.C. 801 et seq.) is amended— 
(1) in section 303(f), in the matter preceding 
paragraph (1), by striking ‘‘The Attorney General’’ 
and inserting ‘‘Subject to section 303A, the Attorney 
General’’; and 
(2) by inserting after section 303 the following: 
‘‘SEC. 303A. REQUIRED CLEARINGHOUSE FOR REGISTRANT 
ORDERS. 
‘‘(a) IN GENERAL.—Not later than 2 years after the 
date of enactment of this section, the Attorney General 
shall— 
‘‘(1) establish a clearinghouse that would sub-
ject all orders of controlled substances and listed 
chemicals to the clearinghouse for recording and re-
view, prior to final review by the registrant; 
‘‘(2) amend the regulations relative to con-
trolled substances in schedule II ordering require-
ments that would allow for uniform electronic order-
ing of controlled substances in schedule II, III, IV, 
and V electronically to the clearinghouse; and 
‘‘(3) may deny, suspend, or revoke a registra-
tion issued under section 303(f), or the registration 
of a distributor under section 303(b) or 303(e), if 
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the practitioner or distributor, as applicable, is not 
substantially in compliance with the requirements of 
this section. 
‘‘(b) CLEARINGHOUSE.— 
‘‘(1) IN GENERAL.—An order for a controlled 
substance may not be filled by the registrant un-
less— 
‘‘(A) the order is first transmitted elec-
tronically to the Attorney General, acting 
through the Administrator of the Drug En-
forcement Administration (referred to in this 
section as the ‘Administrator’); 
‘‘(B) the Administrator uses the algorithm 
described in paragraph (2) to determine if the 
order is an outlier and is potentially suspicious; 
‘‘(C) the Administrator relays the order to 
the registrant with whom the order is placed, 
regardless of whether the algorithm was exceed-
ed, for further analysis of the order under sec-
tion 1301.74(b) of title 21, Code of Federal 
Regulations; and 
‘‘(D) the registrant has received a waiver 
from the Administrator exempting the reg-
istrant from this section. 
‘‘(2) ALGORITHM.— 
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‘‘(A) IN GENERAL.—The clearinghouse es-
tablished under this section shall use an input- 
based algorithm, including techniques such as 
artificial intelligence, machine learning, and 
other methods of analyzing large data, that— 
‘‘(i) automatically identifies orders 
that exceed the metrics of the algorithm; 
‘‘(ii) notifies the registrant if the 
order is an outlier and is potentially sus-
picious; 
‘‘(iii) is informed by all data available 
to the Administrator and uses pharmacy 
best practices; 
‘‘(iv) takes into consideration existing 
State and Federal law; and 
‘‘(v) establishes different parameters 
for different registrants using relevant in-
formation based on pharmacy type, loca-
tion, and size. 
‘‘(B) REFINEMENT.—The Administrator of 
the Drug Enforcement Administration (referred 
to in this section as the ‘Administrator’) shall 
review, update, and revise the algorithm bian-
nually based on feedback from industry and rel-
evant stakeholders to ensure functionality. 
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‘‘(3) CONSULTATION.—The Administrator shall 
consult with the Director of the National Institute of 
Standards and Technology for technical assistance 
in establishing the clearinghouse. 
‘‘(c) RESPONSIBILITIES OF DISTRIBUTORS AND MAN-
UFACTURERS REGARDING SUSPICIOUS ORDERS.—This 
section may not be construed as relieving any distributor 
or manufacturer from the requirements established in sec-
tion 1301.74(b) of title 21, Code of Federal Regulations, 
or any successor regulation, with respect to suspicious or-
ders. 
‘‘(d) CONTRACTOR REGARDING DATA ANALYTICS.— 
‘‘(1) IN
GENERAL.—The Administrator shall 
award a contract to a public or private entity ena-
bling the Administrator to carry out the techno-
logical aspects of tracking, processing and evaluating 
orders under this section. 
‘‘(2) ELIGIBLE ENTITIES.—An entity is eligible 
for an award under paragraph (1) if the entity has 
significant experience in data analytics and in proc-
essing the volume of electronic data involved in re-
viewing orders under this section within the time-
frame required in subsection (c). 
‘‘(3) CAPABILITIES.—A contract awarded under 
paragraph (1) shall— 
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‘‘(A) provide a data management and 
configurable visual analytics solution capable of 
ingesting and managing data entities, including 
manufacturers, and distributors, retail dis-
pensers across relevant data maintained by the 
Administrator; 
‘‘(B) standardize the data format, with the 
ability to flexibly model data for analyses and 
link data across sources; and 
‘‘(C) provide an environment for analysis 
that is interoperable. 
‘‘(4) COMMERCIAL ITEMS.—The Administrator 
shall comply with section 3307 of title 41, United 
States Code, in awarding a contract under para-
graph (1). The Administrator may not enter into a 
contract for any capabilities sought under paragraph 
(1) that are not for commercial items unless the Ad-
ministrator first determines in writing that no com-
mercial items are suitable to meet the needs of the 
Drug Enforcement Administration. 
‘‘(5) TIMELINE OF CONTRACT.—Any contract 
awarded under paragraph (1) for a data manage-
ment and visual analytics solution shall require the 
public or private entity awarded such contract to de-
liver a functioning solution sufficient to fulfill the 
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purposes of this section not later than 180 days 
after the date on which the contract is awarded, un-
less the Administrator grants an extension for 
unforseen delays. 
‘‘(6) FEDERAL ACQUISITION REGULATION.—A 
contract awarded under this subsection shall be in 
accordance with the Federal Acquisition Regulation. 
‘‘(7) ACCESS
TO
DATA.—An entity that is 
awarded a contract under this subsection shall have 
access to the relevant data to create the system. 
‘‘(e) WAIVER.— 
‘‘(1) IN GENERAL.—Beginning on the date on 
which the 36-month period described in subsection 
(b)(1)(A)(ii) expires, a pharmacy may submit to the 
Administrator an application for a waiver from the 
requirements of subsection (b)(1)(A) if the phar-
macy is unable to transmit orders electronically. 
‘‘(2) RESPONSE.—The Administrator shall ap-
prove or deny an application submitted under para-
graph (1) not later than the 90-day period beginning 
on the date on which the application is received. 
‘‘(3) LIABILITY.—No waiver issued under para-
graph (1) shall mitigate the liability of the pharmacy 
for any drugs diverted that did not pass through the 
clearinghouse. 
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