What This Bill Does
This bill changes how drug companies and pharmacies must handle suspicious orders for controlled substances (drugs regulated by the government because of abuse potential). The bill requires these businesses to either refuse suspicious orders or do thorough research to verify the orders are legitimate before filling them.
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Who It Affects
Drug manufacturers, wholesalers, and pharmacies that are registered to handle controlled substances. The Drug Enforcement Administration (the federal agency that oversees controlled substance laws) will also be affected as it must create and maintain a database of suspicious orders.
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Key Provisions
* Registrants must determine if an order or series of orders appears suspicious by looking at the size, pattern, or frequency of the orders and the customer's normal business practices (Sec. 2(a)(3))
* When a registrant discovers suspicious circumstances, they must either decline to fill the order and report it to the Drug Enforcement Administration, or do thorough research to verify the order is legitimate (Sec. 2(a)(4))
* Registrants must keep records of suspicious orders for a period determined by the Drug Enforcement Administration (Sec. 2(a)(4))
* The Attorney General must create detailed regulations specifying what counts as a suspicious order and what "due diligence" (thorough research) means (Sec. 2(b))
* Violating these new requirements is now a penalty offense under existing law (Sec. 2(c))
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What Changes
Registrants gain new specific requirements to refuse or investigate suspicious orders before filling them. Previously, the law was less clear about exactly what steps registrants must take. The bill also creates penalties for failing to follow these new requirements.
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Important Definitions
The bill does not explicitly define "suspicious order," "due diligence," or "diverted" (when drugs go to illegal uses instead of legitimate medical purposes). The bill states these definitions will be created in regulations.
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Effective Date
These new requirements take effect 1 year after the bill becomes law (Sec. 2(d)).
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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•HR 501 RH
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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•HR 501 RH
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Block, Report, and Sus-
4
pend Suspicious Shipments Act’’.
5
SEC. 2. BLOCK, REPORT, AND SUSPEND SUSPICIOUS OR-
6
DERS.
7
(a) CLARIFICATION OF PROCESS FOR REGISTRANTS
8
TO EXERCISE DUE DILIGENCE UPON DISCOVERING A SUS-
9
PICIOUS ORDER.—Section 312(a) of the Controlled Sub-
10
stances Act (21 U.S.C. 832(a)) is amended—
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(1) in paragraph (2), by striking ‘‘and’’ at the
12
end; and
13
(2) by striking paragraph (3) and inserting the
14
following paragraphs:
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‘‘(3) determine whether an order or series of or-
16
ders is suspicious, taking into consideration—
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‘‘(A) any unusual size, pattern, or fre-
18
quency of the order or series of orders; and
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‘‘(B) any customer business model, dis-
20
pensing patterns, prior orders, or other charac-
21
teristics that may indicate the order or series of
22
orders is suspicious, despite the particular order
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or series of orders not exhibiting an unusual size,
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pattern, or frequency; and
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•HR 501 RH
‘‘(4) upon discovering suspicious circumstances
1
regarding an order or series of orders, and in a man-
2
ner consistent with the other requirements of this sec-
3
tion—
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‘‘(A) decline to fill the order or series of or-
5
ders, establish and maintain (for not less than a
6
period to be determined by the Administrator of
7
the Drug Enforcement Administration) a record
8
of the order or series of orders, and notify the
9
Administrator of the Drug Enforcement Admin-
10
istration for the purpose of including informa-
11
tion on such order or series of orders in the cen-
12
tralized database established under subsection
13
(b)(1); or
14
‘‘(B) exercise due diligence as appropriate
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and—
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‘‘(i)(I) if the due diligence fails to dis-
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pel all of the indicators that give rise to the
18
suspicion that, if the order or series of or-
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ders is filled, the drugs that are the subject
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of the order or series of orders are likely to
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be diverted, decline to fill the order or series
22
of orders; or
23
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•HR 501 RH
‘‘(II) if the due diligence does dispel all
1
such indicators, fill the order or series of or-
2
ders;
3
‘‘(ii) establish and maintain (for not
4
less than a period to be determined by the
5
Administrator of the Drug Enforcement Ad-
6
ministration) a record of the order or series
7
of orders and the due diligence that was
8
performed; and
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‘‘(iii) notify the Administrator of the
10
Drug Enforcement Administration for the
11
purpose of including information on such
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order or series of orders in the centralized
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database established under subsection (b)(1),
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including any indicators giving rise to the
15
suspicion that, if the order or series of or-
16
ders is filled, the drugs that are the subject
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of the order or series of orders are likely to
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be diverted.’’.
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(b) REGULATIONS.—Not later than 1 year after the
20
date of enactment of this Act, for purposes of section
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312(a)(4) of the Controlled Substances Act, as inserted by
22
subsection (a), the Attorney General of the United States
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shall promulgate a final regulation specifying—
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•HR 501 RH
(1) the indicators that give rise to a suspicion
1
that, if an order or series of orders is filled, the drugs
2
that are the subject of the order or series of orders are
3
likely to be diverted;
4
(2) a definition of due diligence; and
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(3) in the case of a registrant that dispels all of
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the indicators giving rise to a suspicious order or se-
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ries of orders, the circumstances in which the reg-
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istrant is not required to file the notification under
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such section 312(a)(4).
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(c) PENALTY.—Section 402(a)(5) of the Controlled
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Substances Act (21 U.S.C. 842(a)(5)) is amended by insert-
12
ing before the semicolon at the end the following: ‘‘, includ-
13
ing any such violation of section 312(a)(4)’’.
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(d) APPLICABILITY.—Section 312(a)(4) of the Con-
15
trolled Substances Act, as inserted by subsection (a), shall
16
apply beginning on the day that is 1 year after the date
17
of enactment of this Act. Until such day, section 312(a)(3)
18
of the Controlled Substances Act shall apply as such section
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312(a)(3) was in effect on the day before the date of enact-
20
ment of this Act.
21
(e) SENSE OF CONGRESS.—It is the sense of Congress
22
that—
23
(1) medications for opioid use disorder signifi-
24
cantly reduce the risk of overdose death; and
25
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•HR 501 RH
(2) the requirements of this Act are not intended
1
to impair access to controlled substances primarily
2
used to treat opioid use disorder.
3
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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
VerDate Sep 11 2014
00:48 May 18, 2023
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