Suspicious Order Identification Act of 2019

II 116TH CONGRESS 1ST SESSION S. 2686 To improve reporting of the distribution of controlled substances, and for other purposes. IN THE SENATE OF THE UNITED STATES OCTOBER 23, 2019 Mr. GARDNER (for himself and Mr. COONS) introduced the following bill; which was read twice and referred to the Committee on the Judiciary A BILL To improve reporting of the distribution of controlled substances, and for other purposes. 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 ‘‘Suspicious Order Iden- 4 tification Act of 2019’’. 5 SEC. 2. STRENGTHENING ARCOS. 6 Section 307(d) of the Controlled Substances Act (21 7 U.S.C. 827(d)) is amended to read as follows: 8 ‘‘(1)(A) Every registrant under section 303 shall and 9 in such form as the Attorney General may require, make 10 VerDate Sep 11 2014 03:18 Oct 26, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2686.IS S2686 kjohnson on DSK79L0C42 with BILLS 2 •S 2686 IS reports in electronic format to the Attorney General of 1 every sale, delivery, or other disposal (other than by dis- 2 pensing by a practitioner) by the registrant of any con- 3 trolled substance, identifying by the registration number 4 assigned under this title the person or establishment (un- 5 less exempt from registration under section 302(d)) to 6 whom such sale, delivery, or other disposal was made. 7 ‘‘(B) Every registrant shall make each report re- 8 quired under subparagraph (A)— 9 ‘‘(i) not later than 30 days after the sale, deliv- 10 ery, or other disposal; or 11 ‘‘(ii) after the date on which the real-time re- 12 porting system is established under section 3(e)(3) 13 of the Suspicious Order Identification Act of 2019 14 is implemented, in real time.’’. 15 SEC. 3. SUSPICIOUS ORDERS TASK FORCE. 16 (a) DEFINITIONS.—In this section: 17 (1) ADMINISTRATOR.—The term ‘‘Adminis- 18 trator’’ means the Administrator of the Drug En- 19 forcement Administration. 20 (2) CONTROLLED SUBSTANCE; DISTRIBUTOR; 21 MANUFACTURER.—The terms ‘‘controlled sub- 22 stance’’, ‘‘distributor’’, and ‘‘manufacturer’’ have the 23 meanings given those terms in section 102 of the 24 Controlled Substances Act (21 U.S.C. 802). 25 VerDate Sep 11 2014 03:18 Oct 26, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2686.IS S2686 kjohnson on DSK79L0C42 with BILLS 3 •S 2686 IS (3) REAL TIME.—The term ‘‘real time’’ means 1 with as little delay as technically and economically 2 feasible, as determined by the Attorney General fol- 3 lowing the program designed under subsection 4 (e)(1), but not to exceed 24 hours. 5 (4) REGISTRANT.—The term ‘‘registrant’’— 6 (A) means a person registered under sec- 7 tion 303 of the Controlled Substances Act (21 8 U.S.C. 823); and 9 (B) does not include a practitioner. 10 (b) ESTABLISHMENT.—The Attorney General, in 11 consultation with the Director of the Office of National 12 Drug Control Policy and the Secretary of Health and 13 Human Services, shall establish a Suspicious Order Moni- 14 toring Task Force (referred to in this section as the ‘‘Task 15 Force’’). 16 (c) COMPOSITION.— 17 (1) IN GENERAL.—The Task Force shall be 18 composed of appropriate personnel from— 19 (A) the Department of Justice; 20 (B) the Drug Enforcement Administration; 21 (C) the Office of National Drug Control 22 Policy; 23 (D) the National Institute of Standards 24 and Technology; and 25 VerDate Sep 11 2014 03:18 Oct 26, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2686.IS S2686 kjohnson on DSK79L0C42 with BILLS 4 •S 2686 IS (E) other appropriate Federal, State, and 1 local law enforcement and regulatory agencies 2 with experience in investigating and prosecuting 3 illegal transactions of controlled substances as 4 determined by the Attorney General, in con- 5 sultation with the Secretary of Health and 6 Human Services. 7 (2) CONSULTANTS.—The Task Force shall con- 8 sult with— 9 (A) industry members, including— 10 (i) data analytic professionals; 11 (ii) community pharmacies that dis- 12 pense controlled substances; 13 (iii) chain pharmacies that dispense 14 controlled substances; 15 (iv) distributors of controlled sub- 16 stances; 17 (v) manufacturers of controlled sub- 18 stances; 19 (vi) State and local public health offi- 20 cials; and 21 (vii) other relevant industry profes- 22 sionals; and 23 (B) relevant industry regulators and enti- 24 ties that utilize real-time reporting of trans- 25 VerDate Sep 11 2014 03:18 Oct 26, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2686.IS S2686 kjohnson on DSK79L0C42 with BILLS 5 •S 2686 IS actions, orders, or other activities with the goal 1 of identifying suspicious activity, such as appro- 2 priate personnel from the Financial Crimes En- 3 forcement Network and money transfer indus- 4 try professionals. 5 (d) MEETINGS.— 6 (1) IN GENERAL.—The Task Force shall meet 7 not less frequently than 4 times per year and at 8 such other times as may be determined necessary by 9 the Task Force. 10 (2) INITIAL MEETING.—Not later than 60 days 11 after the date of enactment of this Act, the Task 12 Force shall hold the initial meeting of the Task 13 Force. 14 (e) PRELIMINARY ORDER EVALUATION PROGRAM.— 15 (1) IN GENERAL.— 16 (A) DESIGN.—Not later than 60 days after 17 the date on which the Task Force holds the ini- 18 tial meeting required under subsection (d)(2), 19 the Task Force shall begin to design a program 20 in accordance with paragraph (2). 21 (B) PURPOSE.—The program described in 22 subparagraph (A) shall be designed to share 23 necessary data, in a limited capacity, with reg- 24 istrants in order to provide registrants with in- 25 VerDate Sep 11 2014 03:18 Oct 26, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2686.IS S2686 kjohnson on DSK79L0C42 with BILLS 6 •S 2686 IS formation to identify suspicious ordering in real 1 time. 2 (C) DEADLINE FOR COMPLETION.—Not 3 later than 8 months after the date of enactment 4 of this Act, the Task Force shall complete the 5 design required under subparagraph (A). 6 (2) REQUIREMENTS.— 7 (A) IN GENERAL.—The program required 8 under paragraph (1) shall establish a process 9 for— 10 (i) transitioning to a requirement to 11 report in real time to the Attorney General 12 under section 307(d) of the Controlled 13 Substances Act (21 U.S.C. 827(d)) every 14 sale, delivery, or other disposal by a reg- 15 istrant of any controlled substance; 16 (ii) limited sharing in real time of Au- 17 tomation of Reports and Consolidated Or- 18 ders System (commonly known as 19 ‘‘ARCOS’’) data with registrants to share 20 necessary data, in a limited capacity, with 21 registrants in order to provide registrants 22 with information to identify suspicious or- 23 dering in real time; and 24 VerDate Sep 11 2014 03:18 Oct 26, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2686.IS S2686 kjohnson on DSK79L0C42 with BILLS 7 •S 2686 IS (iii) ensuring data privacy, data de- 1 identification, protection of trade secrets 2 and purchasing history. 3 (B) OTHER CONSIDERATIONS.—In design- 4 ing the program under paragraph (1), the Task 5 Force shall take into consideration— 6 (i) the inclusion of a waiver process 7 for pharmacies and other registrants un- 8 able to transmit orders electronically on 9 the date of enactment of this Act; 10 (ii) a mechanism to ensure that the 11 costs of running the program are not 12 passed through to customers of registrants, 13 unless the registrants are customer of 14 other registrants; 15 (iii) technical requirements for ensur- 16 ing that registrants may access all relevant 17 de-identified data, with output provided in 18 a standard database file format; and 19 (iv) a mechanism to ensure that the 20 program required to be designed under 21 subparagraph (A) is updated based on 22 feedback from industry members and other 23 relevant entities. 24 VerDate Sep 11 2014 03:18 Oct 26, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2686.IS S2686 kjohnson on DSK79L0C42 with BILLS 8 •S 2686 IS (3) IMPLEMENTATION.—Not later than 1 year 1 after the date of enactment of this Act, the Attorney 2 General shall— 3 (A) implement the program designed under 4 paragraph (1) to collect and share in real time 5 data for registrants to evaluate the orders of 6 controlled substances from distributors to man- 7 ufacturers and from pharmacies to distributors; 8 or 9 (B) otherwise implement a program to col- 10 lect and share in real time data for drug manu- 11 facturers and distributors, by providing access 12 to anonymized information to help drug manu- 13 facturers and distributors identify, report, and 14 stop suspicious orders of controlled substances 15 and reduce diversion rates. 16 (4) RECOMMENDED STATUTORY AND REGU- 17 LATORY CHANGES.—In designing the program re- 18 quired under paragraph (1), the Task Force— 19 (A) shall submit to the Attorney General 20 any recommendations for necessary amend- 21 ments to regulations of the Department of Jus- 22 tice relating to the requirements for ordering 23 schedule II controlled substances, so as to allow 24 uniform electronic ordering of controlled sub- 25 VerDate Sep 11 2014 03:18 Oct 26, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S2686.IS S2686 kjohnson on DSK79L0C42 with BILLS 9 •S 2686 IS stances in schedules II, III, IV, and V electroni- 1 cally through the program; and 2 (B) may submit to Congress any rec- 3 ommendations for necessary legislative changes 4 so that a real-time data analytics solution can 5 be used across the United States. 6 (5) RESPONSIBILITY OF REGISTRANTS.—All 7 registered drug manufacturers and distributors shall 8 be responsible for reviewing any information made 9 available by the Attorney General and complying 10 with any regulations regarding the program designed 11 under paragraph (1) and implemented under para- 12 graph (3). 13 (f) FUNDING.— 14 (1) IN GENERAL.—The Attorney General, act- 15 ing through the Administrator, shall use amounts 16 collected as fees for distributors and registrants 17 under section 303 of the Controlled Substances Act 18 (21 U.S.C. 823) and section 1007 of the Controlled 19 Substances Import and Export Act (21 U.S.C. 957) 20 to carry out this section. 21 (2) OFFSET.— 22 (A) IN GENERAL.—The Administrator 23 may, on an equal basis and in accordance with 24 subparagraph (B), increase the fees described 25 VerDate Sep 11 2014 03:18 Oct 26, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2686.IS S2686 kjohnson on DSK79L0C42 with BILLS 10 •S 2686 IS in paragraph (1) for distributors and reg- 1 istrants to the extent necessary to defray the 2 costs of this section. 3 (B) TIERED FEE.—The Administrator 4 shall establish a tiered user fee for distributors 5 and registrants in proportion to the volume of 6 sales and purchases. 7 (g) APPLICABILITY OF FACA.— 8 (1) IN GENERAL.—Except as provided in para- 9 graph (2), the Federal Advisory Committee Act (5 10 U.S.C. App.) shall apply to the Task Force. 11 (2) TERMINATION.—The Task Force shall ter- 12 minate on the date on which the program is fully 13 implemented under subsection (e)(3). 14 (h) RULES OF CONSTRUCTION.—Nothing in this Act 15 shall be construed as relieving any manufacturer, dis- 16 tributor, or other registrant from the responsibilities of 17 the manufacturer, distributor, or other registrant, as the 18 case may be, to— 19 (1) identify, stop, and report suspicious orders; 20 (2) maintain effective controls against diversion 21 in accordance with section 303 of the Controlled 22 Substances Act (21 U.S.C. 823); and 23 (3) comply with the requirements established in 24 section 1301.74(b) of title 21, Code of Federal Reg- 25 VerDate Sep 11 2014 03:18 Oct 26, 2019 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S2686.IS S2686 kjohnson on DSK79L0C42 with BILLS 11 •S 2686 IS ulations, or any successor regulation thereto, with 1 respect to suspicious orders. 2 Æ VerDate Sep 11 2014 03:18 Oct 26, 2019 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6301 E:\BILLS\S2686.IS S2686 kjohnson on DSK79L0C42 with BILLS