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[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
```