I 

116TH CONGRESS 

1ST SESSION H. R. 4814 

To improve reporting of the distribution of controlled substances, and for 

other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 23, 2019 

Ms. MATSUI (for herself and Mr. JOHNSON of Ohio) 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 

A BILL 

To improve reporting of the distribution of controlled 

substances, and for other purposes. 

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 ‘‘Suspicious Order Iden5 tification Act of 2019’’. 

6 SEC. 2. STRENGTHENING ARCOS. 

7 Section 307(d) of the Controlled Substances Act (21 

8 U.S.C. 827(d)) is amended to read as follows: 


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1 ‘‘(1)(A) Every registrant under section 303 shall and 

2 in such form as the Attorney General may require, make 

3 reports in electronic format to the Attorney General of 

4 every sale, delivery, or other disposal (other than by dis5 pensing by a practitioner) by the registrant of any con6 trolled substance, identifying by the registration number 

7 assigned under this title the person or establishment (un8 less exempt from registration under section 302(d)) to 

9 whom such sale, delivery, or other disposal was made. 

10 ‘‘(B) Every registrant shall make each report re11 quired under subparagraph (A)— 

12 ‘‘(i) not later than 30 days after the sale, deliv13 ery, or other disposal; or 

14 ‘‘(ii) after the date on which the real-time re15 porting system is established under section 3(e)(3) 

16 of the Suspicious Order Identification Act of 2019 

17 is implemented, in real time.’’. 

18 SEC. 3. SUSPICIOUS ORDERS TASK FORCE. 

19 (a) DEFINITIONS.—In this section: 

20 (1) ADMINISTRATOR.—The term ‘‘Adminis21 trator’’ means the Administrator of the Drug En22 forcement Administration. 

23 (2) CONTROLLED SUBSTANCE; DISTRIBUTOR; 

24 MANUFACTURER.—The terms ‘‘controlled sub25 stance’’, ‘‘distributor’’, and ‘‘manufacturer’’ have the 


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1 meanings given those terms in section 102 of the 

2 Controlled Substances Act (21 U.S.C. 802). 

3 (3) REAL TIME.—The term ‘‘real time’’ means 

4 with as little delay as technically and economically 

5 feasible, as determined by the Attorney General fol6 lowing the program designed under subsection 

7 (e)(1), but not to exceed 24 hours. 

8 (4) REGISTRANT.—The term ‘‘registrant’’— 

9 (A) means a person registered under sec10 tion 303 of the Controlled Substances Act (21 

11 U.S.C. 823); and 

12 (B) does not include practitioner. 

13 (b) ESTABLISHMENT.—The Attorney General, in 

14 consultation with the Director of the Office of National 

15 Drug Control Policy and the Secretary of Health and 

16 Human Services, shall establish a Suspicious Order Moni17 toring Task Force (referred to in this section as the ‘‘Task 

18 Force’’). 

19 (c) COMPOSITION.— 

20 (1) IN GENERAL.—The Task Force shall be 

21 composed of appropriate personnel from— 

22 (A) the Department of Justice; 

23 (B) the Drug Enforcement Administration; 

24 (C) the Office of National Drug Control 

25 Policy; 


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1 (D) the National Institute of Standards 

2 and Technology; and 

3 (E) other appropriate Federal, State, and 

4 local law enforcement and regulatory agencies 

5 with experience in investigating and prosecuting 

6 illegal transactions of controlled substances as 

7 determined by the Attorney General, in con8 sultation with the Secretary of Health and 

9 Human Services. 

10 (2) CONSULTANTS.—The Task Force shall con11 sult with— 

12 (A) industry members, including— 

13 (i) data analytic professionals; 

14 (ii) community pharmacies that dis15 pense controlled substances; 

16 (iii) chain pharmacies that dispense 

17 controlled substances; 

18 (iv) distributors of controlled sub19 stances; 

20 (v) manufacturers of controlled sub21 stances; 

22 (vi) State and local public health offi23 cials; and 

24 (vii) other relevant industry profes25 sionals; and 


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1 (B) relevant industry regulators and enti2 ties that utilize real-time reporting of trans3 actions, orders, or other activities with the goal 

4 of identifying suspicious activity, such as appro5 priate personnel from the Financial Crimes En6 forcement Network and money transfer indus7 try professionals. 

8 (d) MEETINGS.— 

9 (1) IN GENERAL.—The Task Force shall meet 

10 not less frequently than 4 times per year and at 

11 such other times as may be determined necessary by 

12 the Task Force. 

13 (2) INITIAL MEETING.—Not later than 60 days 

14 after the date of enactment of this Act, the Task 

15 Force shall hold the initial meeting of the Task 

16 Force. 

17 (e) PRELIMINARY ORDER EVALUATION PROGRAM.— 

18 (1) IN GENERAL.— 

19 (A) DESIGN.—Not later than 60 days after 

20 the date on which the Task Force holds the ini21 tial meeting required under subsection (d)(2), 

22 the Task Force shall begin to design a program 

23 in accordance with paragraph (2). 

24 (B) PURPOSE.—The program described in 

25 subparagraph (A) shall be designed to share 


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1 necessary data, in a limited capacity, with reg2 istrants in order to provide registrants with in3 formation to identify suspicious ordering in real 

4 time. 

5 (C) DEADLINE FOR COMPLETION.—Not 

6 later than 8 months after the date of enactment 

7 of this Act, the Task Force shall complete the 

8 design required under subparagraph (A). 

9 (2) REQUIREMENTS.— 

10 (A) IN GENERAL.—The program required 

11 under paragraph (1) shall establish a process 

12 for— 

13 (i) transitioning to a requirement to 

14 report in real time to the Attorney General 

15 under section 307(d) of the Controlled 

16 Substances Act (21 U.S.C. 827(d)) every 

17 sale, delivery, or other disposal by a reg18 istrant of any controlled substance; 

19 (ii) limited sharing in real time of Au20 tomation of Reports and Consolidated Or21 ders System (commonly known as 

22 ‘‘ARCOS’’) data with registrants to share 

23 necessary data, in a limited capacity, with 

24 registrants in order to provide registrants 


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1 with information to identify suspicious or2 dering in real time; and 

3 (iii) ensuring data privacy, data de4 identification, protection of trade secrets 

5 and purchasing history. 

6 (B) OTHER CONSIDERATIONS.—In design7 ing the program under paragraph (1), the Task 

8 Force shall take into consideration— 

9 (i) the inclusion of a waiver process 

10 for pharmacies and other registrants un11 able to transmit orders electronically on 

12 the date of enactment of this Act; 

13 (ii) a mechanism to ensure that the 

14 costs of running the program are not 

15 passed through to customers of registrants, 

16 unless the registrants are customers of 

17 other registrants; 

18 (iii) technical requirements for ensur19 ing that registrants may access all relevant 

20 de-identified data, with output provided in 

21 a standard database file format; and 

22 (iv) a mechanism to ensure that the 

23 program required to be designed under 

24 subparagraph (A) is updated based on 


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1 feedback from industry members and other 

2 relevant entities. 

3 (3) IMPLEMENTATION.—Not later than 1 year 

4 after the date of enactment of this Act, the Attorney 

5 General shall— 

6 (A) implement the program designed under 

7 paragraph (1) to collect and share in real time 

8 data for registrants to evaluate the orders of 

9 controlled substances from distributors to man10 ufacturers and from pharmacies to distributors; 

11 or 

12 (B) otherwise implement a program to col13 lect and share in real time data for drug manu14 facturers and distributors, by providing access 

15 to anonymized information to help drug manu16 facturers and distributors identify, report, and 

17 stop suspicious orders of controlled substances 

18 and reduce diversion rates. 

19 (4) RECOMMENDED STATUTORY AND REGU20 LATORY CHANGES.—In designing the program re21 quired under paragraph (1), the Task Force— 

22 (A) shall submit to the Attorney General 

23 any recommendations for necessary amend24 ments to regulations of the Department of Jus25 tice relating to the requirements for ordering 


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1 schedule II controlled substances, so as to allow 

2 uniform electronic ordering of controlled sub3 stances in schedules II, III, IV, and V electroni4 cally through the program; and 

5 (B) may submit to Congress any rec6 ommendations for necessary legislative changes 

7 so that a real-time data analytics solution can 

8 be used across the United States. 

9 (5) RESPONSIBILITY OF REGISTRANTS.—All 

10 registered drug manufacturers and distributors shall 

11 be responsible for reviewing any information made 

12 available by the Attorney General and complying 

13 with any regulations regarding the program designed 

14 under paragraph (1) and implemented under para15 graph (3). 

16 (f) FUNDING.— 

17 (1) IN GENERAL.—The Attorney General, act18 ing through the Administrator, shall use amounts 

19 collected as fees for distributors and registrants 

20 under section 303 of the Controlled Substances Act 

21 (21 U.S.C. 823) and section 1007 of the Controlled 

22 Substances Import and Export Act (21 U.S.C. 957) 

23 to carry out this section. 

24 (2) OFFSET.— 


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1 (A) IN GENERAL.—The Administrator 

2 may, on an equal basis and in accordance with 

3 subparagraph (B), increase the fees described 

4 in paragraph (1) for distributors and reg5 istrants to the extent necessary to defray the 

6 costs of this section. 

7 (B) TIERED FEE.—The Administrator 

8 shall establish a tiered user fee for distributors 

9 and registrants in proportion to the volume of 

10 sales and purchases. 

11 (g) APPLICABILITY OF FACA.— 

12 (1) IN GENERAL.—Except as provided in para13 graph (2), the Federal Advisory Committee Act (5 

14 U.S.C. App.) shall apply to the Task Force. 

15 (2) TERMINATION.—The Task Force shall ter16 minate on the date on which the program is fully 

17 implemented under subsection (e)(3). 

18 (h) RULES OF CONSTRUCTION.—Nothing in this Act 

19 shall be construed as relieving any manufacturer, dis20 tributor, or other registrant from the responsibilities of 

21 the manufacturer, distributor, or other registrant, as the 

22 case may be, to— 

23 (1) identify, stop, and report suspicious orders; 


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1 (2) maintain effective controls against diversion 

2 in accordance with section 303 of the Controlled 

3 Substances Act (21 U.S.C. 823); and 

4 (3) comply with the requirements established in 

5 section 1301.74(b) of title 21, Code of Federal Reg6 ulations, or any successor regulation thereto, with 

7 respect to suspicious orders. 

Æ 


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