[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 501 Reported in House (RH)]
<DOC>
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 subsequently 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]
_______________________________________________________________________
A BILL
To amend the Controlled Substances Act to require registrants to
decline to fill certain suspicious orders, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Block, Report, and Suspend
Suspicious Shipments Act''.
SEC. 2. BLOCK, REPORT, AND SUSPEND SUSPICIOUS ORDERS.
(a) Clarification of Process for Registrants To Exercise Due
Diligence Upon Discovering a Suspicious Order.--Section 312(a) of the
Controlled Substances 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 orders is
suspicious, taking into consideration--
``(A) any unusual size, pattern, or frequency of
the order or series of orders; and
``(B) any customer business model, dispensing
patterns, prior orders, or other characteristics 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
``(4) upon discovering suspicious circumstances regarding
an order or series of orders, and in a manner consistent with
the other requirements of this section--
``(A) decline to fill the order or series of
orders, establish and maintain (for not less than a
period to be determined by the Administrator of the
Drug Enforcement Administration) a record of the order
or series of orders, and 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); or
``(B) exercise due diligence as appropriate and--
``(i)(I) if the due diligence fails to
dispel all of the indicators that give rise to
the suspicion that, if the 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, decline to fill the
order or series of orders; or
``(II) if the due diligence does dispel all
such indicators, fill the order or series of
orders;
``(ii) establish and maintain (for not less
than a period to be determined by the
Administrator of the Drug Enforcement
Administration) 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 orders 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--
(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 series of
orders, the circumstances in which the registrant 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 inserting before the semicolon at
the end the following: ``, including any such violation of section
312(a)(4)''.
(d) Applicability.--Section 312(a)(4) of the Controlled 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 enactment
of this Act.
(e) Sense of Congress.--It is the sense of Congress that--
(1) medications for opioid use disorder significantly
reduce the risk of overdose death; and
(2) the requirements of this Act are not intended to impair
access to controlled substances primarily used to treat opioid
use disorder.
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 orders, 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