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 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] 


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•HR 501 RH

A BILL 

To amend the Controlled Substances Act to require registrants to decline to fill certain suspicious orders, and 

for other purposes. 


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•HR 501 RH

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Block, Report, and Sus5 pend Suspicious Shipments Act’’. 

6 SEC. 2. BLOCK, REPORT, AND SUSPEND SUSPICIOUS OR7 DERS. 

8 (a) CLARIFICATION OF PROCESS FOR REGISTRANTS

9 TO EXERCISE DUE DILIGENCE UPON DISCOVERING A SUS10 PICIOUS ORDER.—Section 312(a) of the Controlled Sub11 stances Act (21 U.S.C. 832(a)) is amended— 

12 (1) in paragraph (2), by striking ‘‘and’’ at the 

13 end; and 

14 (2) by striking paragraph (3) and inserting the 

15 following paragraphs: 

16 ‘‘(3) determine whether an order or series of or17 ders is suspicious, taking into consideration— 

18 ‘‘(A) any unusual size, pattern, or fre19 quency of the order or series of orders; and 

20 ‘‘(B) any customer business model, dis21 pensing patterns, prior orders, or other charac22 teristics that may indicate the order or series of 

23 orders is suspicious, despite the particular order 

24 or series of orders not exhibiting an unusual size, 

25 pattern, or frequency; and 


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•HR 501 RH

1 ‘‘(4) upon discovering suspicious circumstances 

2 regarding an order or series of orders, and in a man3 ner consistent with the other requirements of this sec4 tion— 

5 ‘‘(A) decline to fill the order or series of or6 ders, establish and maintain (for not less than a 

7 period to be determined by the Administrator of 

8 the Drug Enforcement Administration) a record 

9 of the order or series of orders, and notify the 

10 Administrator of the Drug Enforcement Admin11 istration for the purpose of including informa12 tion on such order or series of orders in the cen13 tralized database established under subsection 

14 (b)(1); or 

15 ‘‘(B) exercise due diligence as appropriate 

16 and— 

17 ‘‘(i)(I) if the due diligence fails to dis18 pel all of the indicators that give rise to the 

19 suspicion that, if the order or series of or20 ders is filled, the drugs that are the subject 

21 of the order or series of orders are likely to 

22 be diverted, decline to fill the order or series 

23 of orders; or 


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1 ‘‘(II) if the due diligence does dispel all 

2 such indicators, fill the order or series of or3 ders; 

4 ‘‘(ii) establish and maintain (for not 

5 less than a period to be determined by the 

6 Administrator of the Drug Enforcement Ad7 ministration) a record of the order or series 

8 of orders and the due diligence that was 

9 performed; and 

10 ‘‘(iii) notify the Administrator of the 

11 Drug Enforcement Administration for the 

12 purpose of including information on such 

13 order or series of orders in the centralized 

14 database established under subsection (b)(1), 

15 including any indicators giving rise to the 

16 suspicion that, if the order or series of or17 ders is filled, the drugs that are the subject 

18 of the order or series of orders are likely to 

19 be diverted.’’. 

20 (b) REGULATIONS.—Not later than 1 year after the 

21 date of enactment of this Act, for purposes of section 

22 312(a)(4) of the Controlled Substances Act, as inserted by 

23 subsection (a), the Attorney General of the United States 

24 shall promulgate a final regulation specifying— 


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1 (1) the indicators that give rise to a suspicion 

2 that, if an order or series of orders is filled, the drugs 

3 that are the subject of the order or series of orders are 

4 likely to be diverted; 

5 (2) a definition of due diligence; and 

6 (3) in the case of a registrant that dispels all of 

7 the indicators giving rise to a suspicious order or se8 ries of orders, the circumstances in which the reg9 istrant is not required to file the notification under 

10 such section 312(a)(4). 

11 (c) PENALTY.—Section 402(a)(5) of the Controlled 

12 Substances Act (21 U.S.C. 842(a)(5)) is amended by insert13 ing before the semicolon at the end the following: ‘‘, includ14 ing any such violation of section 312(a)(4)’’. 

15 (d) APPLICABILITY.—Section 312(a)(4) of the Con16 trolled Substances Act, as inserted by subsection (a), shall 

17 apply beginning on the day that is 1 year after the date 

18 of enactment of this Act. Until such day, section 312(a)(3) 

19 of the Controlled Substances Act shall apply as such section 

20 312(a)(3) was in effect on the day before the date of enact21 ment of this Act. 

22 (e) SENSE OF CONGRESS.—It is the sense of Congress 

23 that— 

24 (1) medications for opioid use disorder signifi25 cantly reduce the risk of overdose death; and 


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•HR 501 RH

1 (2) the requirements of this Act are not intended 

2 to impair access to controlled substances primarily 

3 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 

ders, and for other purposes. registrants to decline to fill certain suspicious orMAY 17, 2023 

Reported from the Committee on Energy and Commerce 

with an amendment 

MAY 17, 2023 

Committee on the Judiciary discharged; committed to the 

Union and ordered to be printed Committee of the Whole House on the State of the 


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