[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2686 Introduced in Senate (IS)]

<DOC>






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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Suspicious Order Identification Act 
of 2019''.

SEC. 2. STRENGTHENING ARCOS.

    Section 307(d) of the Controlled Substances Act (21 U.S.C. 827(d)) 
is amended to read as follows:
    ``(1)(A) Every registrant under section 303 shall and in such form 
as the Attorney General may require, make reports in electronic format 
to the Attorney General of every sale, delivery, or other disposal 
(other than by dispensing by a practitioner) by the registrant of any 
controlled substance, identifying by the registration number assigned 
under this title the person or establishment (unless exempt from 
registration under section 302(d)) to whom such sale, delivery, or 
other disposal was made.
    ``(B) Every registrant shall make each report required under 
subparagraph (A)--
            ``(i) not later than 30 days after the sale, delivery, or 
        other disposal; or
            ``(ii) after the date on which the real-time reporting 
        system is established under section 3(e)(3) of the Suspicious 
        Order Identification Act of 2019 is implemented, in real 
        time.''.

SEC. 3. SUSPICIOUS ORDERS TASK FORCE.

    (a) Definitions.--In this section:
            (1) Administrator.--The term ``Administrator'' means the 
        Administrator of the Drug Enforcement Administration.
            (2) Controlled substance; distributor; manufacturer.--The 
        terms ``controlled substance'', ``distributor'', and 
        ``manufacturer'' have the meanings given those terms in section 
        102 of the Controlled Substances Act (21 U.S.C. 802).
            (3) Real time.--The term ``real time'' means with as little 
        delay as technically and economically feasible, as determined 
        by the Attorney General following the program designed under 
        subsection (e)(1), but not to exceed 24 hours.
            (4) Registrant.--The term ``registrant''--
                    (A) means a person registered under section 303 of 
                the Controlled Substances Act (21 U.S.C. 823); and
                    (B) does not include a practitioner.
    (b) Establishment.--The Attorney General, in consultation with the 
Director of the Office of National Drug Control Policy and the 
Secretary of Health and Human Services, shall establish a Suspicious 
Order Monitoring Task Force (referred to in this section as the ``Task 
Force'').
    (c) Composition.--
            (1) In general.--The Task Force shall be composed of 
        appropriate personnel from--
                    (A) the Department of Justice;
                    (B) the Drug Enforcement Administration;
                    (C) the Office of National Drug Control Policy;
                    (D) the National Institute of Standards and 
                Technology; and
                    (E) other appropriate Federal, State, and local law 
                enforcement and regulatory agencies with experience in 
                investigating and prosecuting illegal transactions of 
                controlled substances as determined by the Attorney 
                General, in consultation with the Secretary of Health 
                and Human Services.
            (2) Consultants.--The Task Force shall consult with--
                    (A) industry members, including--
                            (i) data analytic professionals;
                            (ii) community pharmacies that dispense 
                        controlled substances;
                            (iii) chain pharmacies that dispense 
                        controlled substances;
                            (iv) distributors of controlled substances;
                            (v) manufacturers of controlled substances;
                            (vi) State and local public health 
                        officials; and
                            (vii) other relevant industry 
                        professionals; and
                    (B) relevant industry regulators and entities that 
                utilize real-time reporting of transactions, orders, or 
                other activities with the goal of identifying 
                suspicious activity, such as appropriate personnel from 
                the Financial Crimes Enforcement Network and money 
                transfer industry professionals.
    (d) Meetings.--
            (1) In general.--The Task Force shall meet not less 
        frequently than 4 times per year and at such other times as may 
        be determined necessary by the Task Force.
            (2) Initial meeting.--Not later than 60 days after the date 
        of enactment of this Act, the Task Force shall hold the initial 
        meeting of the Task Force.
    (e) Preliminary Order Evaluation Program.--
            (1) In general.--
                    (A) Design.--Not later than 60 days after the date 
                on which the Task Force holds the initial meeting 
                required under subsection (d)(2), the Task Force shall 
                begin to design a program in accordance with paragraph 
                (2).
                    (B) Purpose.--The program described in subparagraph 
                (A) shall be designed to share necessary data, in a 
                limited capacity, with registrants in order to provide 
                registrants with information to identify suspicious 
                ordering in real time.
                    (C) Deadline for completion.--Not later than 8 
                months after the date of enactment of this Act, the 
                Task Force shall complete the design required under 
                subparagraph (A).
            (2) Requirements.--
                    (A) In general.--The program required under 
                paragraph (1) shall establish a process for--
                            (i) transitioning to a requirement to 
                        report in real time to the Attorney General 
                        under section 307(d) of the Controlled 
                        Substances Act (21 U.S.C. 827(d)) every sale, 
                        delivery, or other disposal by a registrant of 
                        any controlled substance;
                            (ii) limited sharing in real time of 
                        Automation of Reports and Consolidated Orders 
                        System (commonly known as ``ARCOS'') data with 
                        registrants to share necessary data, in a 
                        limited capacity, with registrants in order to 
                        provide registrants with information to 
                        identify suspicious ordering in real time; and
                            (iii) ensuring data privacy, data de-
                        identification, protection of trade secrets and 
                        purchasing history.
                    (B) Other considerations.--In designing the program 
                under paragraph (1), the Task Force shall take into 
                consideration--
                            (i) the inclusion of a waiver process for 
                        pharmacies and other registrants unable to 
                        transmit orders electronically on the date of 
                        enactment of this Act;
                            (ii) a mechanism to ensure that the costs 
                        of running the program are not passed through 
                        to customers of registrants, unless the 
                        registrants are customer of other registrants;
                            (iii) technical requirements for ensuring 
                        that registrants may access all relevant de-
                        identified data, with output provided in a 
                        standard database file format; and
                            (iv) a mechanism to ensure that the program 
                        required to be designed under subparagraph (A) 
                        is updated based on feedback from industry 
                        members and other relevant entities.
            (3) Implementation.--Not later than 1 year after the date 
        of enactment of this Act, the Attorney General shall--
                    (A) implement the program designed under paragraph 
                (1) to collect and share in real time data for 
                registrants to evaluate the orders of controlled 
                substances from distributors to manufacturers and from 
                pharmacies to distributors; or
                    (B) otherwise implement a program to collect and 
                share in real time data for drug manufacturers and 
                distributors, by providing access to anonymized 
                information to help drug manufacturers and distributors 
                identify, report, and stop suspicious orders of 
                controlled substances and reduce diversion rates.
            (4) Recommended statutory and regulatory changes.--In 
        designing the program required under paragraph (1), the Task 
        Force--
                    (A) shall submit to the Attorney General any 
                recommendations for necessary amendments to regulations 
                of the Department of Justice relating to the 
                requirements for ordering schedule II controlled 
                substances, so as to allow uniform electronic ordering 
                of controlled substances in schedules II, III, IV, and 
                V electronically through the program; and
                    (B) may submit to Congress any recommendations for 
                necessary legislative changes so that a real-time data 
                analytics solution can be used across the United 
                States.
            (5) Responsibility of registrants.--All registered drug 
        manufacturers and distributors shall be responsible for 
        reviewing any information made available by the Attorney 
        General and complying with any regulations regarding the 
        program designed under paragraph (1) and implemented under 
        paragraph (3).
    (f) Funding.--
            (1) In general.--The Attorney General, acting through the 
        Administrator, shall use amounts collected as fees for 
        distributors and registrants under section 303 of the 
        Controlled Substances Act (21 U.S.C. 823) and section 1007 of 
        the Controlled Substances Import and Export Act (21 U.S.C. 957) 
        to carry out this section.
            (2) Offset.--
                    (A) In general.--The Administrator may, on an equal 
                basis and in accordance with subparagraph (B), increase 
                the fees described in paragraph (1) for distributors 
                and registrants to the extent necessary to defray the 
                costs of this section.
                    (B) Tiered fee.--The Administrator shall establish 
                a tiered user fee for distributors and registrants in 
                proportion to the volume of sales and purchases.
    (g) Applicability of FACA.--
            (1) In general.--Except as provided in paragraph (2), the 
        Federal Advisory Committee Act (5 U.S.C. App.) shall apply to 
        the Task Force.
            (2) Termination.--The Task Force shall terminate on the 
        date on which the program is fully implemented under subsection 
        (e)(3).
    (h) Rules of Construction.--Nothing in this Act shall be construed 
as relieving any manufacturer, distributor, or other registrant from 
the responsibilities of the manufacturer, distributor, or other 
registrant, as the case may be, to--
            (1) identify, stop, and report suspicious orders;
            (2) maintain effective controls against diversion in 
        accordance with section 303 of the Controlled Substances Act 
        (21 U.S.C. 823); and
            (3) comply with the requirements established in section 
        1301.74(b) of title 21, Code of Federal Regulations, or any 
        successor regulation thereto, with respect to suspicious 
        orders.
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