IB 
Union Calendar No. 46 
118TH CONGRESS 
1ST SESSION 
H. R. 501 
[Report No. 118–66, Part I] 
To amend the Controlled Substances Act to require registrants to decline 
to fill certain suspicious orders, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 25, 2023 
Mrs. HARSHBARGER (for herself and Mrs. DINGELL) 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 subse-
quently determined by the Speaker, in each case for consideration of such 
provisions as fall within the jurisdiction of the committee concerned 
MAY 17, 2023 
Additional sponsors: Mrs. HINSON, Ms. LEE of Nevada, Ms. TOKUDA, Mr. 
CISCOMANI, Ms. SCHRIER, and Mr. MOLINARO 
MAY 17, 2023 
Reported from the Committee on Energy and Commerce with an amendment 
[Strike out all after the enacting clause and insert the part printed in italic] 
MAY 17, 2023 
Committee on the Judiciary discharged; committed to the Committee of the 
Whole House on the State of the Union and ordered to be printed 
[For text of introduced bill, see copy of bill as introduced on January 25, 2023] 
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A BILL 
To amend the Controlled Substances Act to require reg-
istrants to decline to fill certain suspicious orders, and 
for other purposes. 
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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 ‘‘Block, Report, and Sus-
pend Suspicious Shipments Act’’. 
SEC. 2. BLOCK, REPORT, AND SUSPEND SUSPICIOUS OR-
DERS. 
(a) CLARIFICATION OF PROCESS FOR REGISTRANTS 
TO EXERCISE DUE DILIGENCE UPON DISCOVERING A SUS-
PICIOUS ORDER.—Section 312(a) of the Controlled Sub-
stances Act (21 U.S.C. 832(a)) is amended— 
(1) in paragraph (2), by striking ‘‘and’’ at the 
end; and 
(2) by striking paragraph (3) and inserting the 
following paragraphs: 
‘‘(3) determine whether an order or series of or-
ders is suspicious, taking into consideration— 
‘‘(A) any unusual size, pattern, or fre-
quency of the order or series of orders; and 
‘‘(B) any customer business model, dis-
pensing patterns, prior orders, or other charac-
teristics that may indicate the order or series of 
orders is suspicious, despite the particular order 
or series of orders not exhibiting an unusual size, 
pattern, or frequency; and 
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‘‘(II) if the due diligence does dispel all 
such indicators, fill the order or series of or-
ders; 
‘‘(ii) establish and maintain (for not 
less than a period to be determined by the 
Administrator of the Drug Enforcement Ad-
ministration) a record of the order or series 
of orders and the due diligence that was 
performed; and 
‘‘(iii) notify the Administrator of the 
Drug Enforcement Administration for the 
purpose of including information on such 
order or series of orders in the centralized 
database established under subsection (b)(1), 
including any indicators giving rise to the 
suspicion that, if the order or series of or-
ders is filled, the drugs that are the subject 
of the order or series of orders are likely to 
be diverted.’’. 
(b) REGULATIONS.—Not later than 1 year after the 
date of enactment of this Act, for purposes of section 
312(a)(4) of the Controlled Substances Act, as inserted by 
subsection (a), the Attorney General of the United States 
shall promulgate a final regulation specifying— 
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(1) the indicators that give rise to a suspicion 
that, if an order or series of orders is filled, the drugs 
that are the subject of the order or series of orders are 
likely to be diverted; 
(2) a definition of due diligence; and 
(3) in the case of a registrant that dispels all of 
the indicators giving rise to a suspicious order or se-
ries of orders, the circumstances in which the reg-
istrant is not required to file the notification under 
such section 312(a)(4). 
(c) PENALTY.—Section 402(a)(5) of the Controlled 
Substances Act (21 U.S.C. 842(a)(5)) is amended by insert-
ing before the semicolon at the end the following: ‘‘, includ-
ing any such violation of section 312(a)(4)’’. 
(d) APPLICABILITY.—Section 312(a)(4) of the Con-
trolled Substances Act, as inserted by subsection (a), shall 
apply beginning on the day that is 1 year after the date 
of enactment of this Act. Until such day, section 312(a)(3) 
of the Controlled Substances Act shall apply as such section 
312(a)(3) was in effect on the day before the date of enact-
ment of this Act. 
(e) SENSE OF CONGRESS.—It is the sense of Congress 
that— 
(1) medications for opioid use disorder signifi-
cantly reduce the risk of overdose death; and 
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(2) the requirements of this Act are not intended 
to impair access to controlled substances primarily 
used to treat opioid use disorder. 
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Union Calendar No. 46 
118TH CONGRESS 
1ST SESSION 
H. R. 501 
[Report No. 118–66, Part I] 
A BILL 
To amend the Controlled Substances Act to require 
registrants to decline to fill certain suspicious or-
ders, and for other purposes. 
MAY 17, 2023 
Reported from the Committee on Energy and Commerce 
with an amendment 
MAY 17, 2023 
Committee on the Judiciary discharged; committed to the 
Committee of the Whole House on the State of the 
Union and ordered to be printed 
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00:48 May 18, 2023
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