[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 3282 Introduced in Senate (IS)]

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115th CONGRESS
  2d Session
                                S. 3282

 To amend the Controlled Substances Act to require that orders subject 
to review be submitted through a clearinghouse, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 26, 2018

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 amend the Controlled Substances Act to require that orders subject 
to review be submitted through a clearinghouse, 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 ``DEA Order Clearinghouse Act of 
2018''.

SEC. 2. REQUIRED CLEARINGHOUSE FOR REGISTRANT ORDERS.

    (a) In General.--The Controlled Substances Act (21 U.S.C. 801 et 
seq.) is amended--
            (1) in section 303(f), in the matter preceding paragraph 
        (1), by striking ``The Attorney General'' and inserting 
        ``Subject to section 303A, the Attorney General''; and
            (2) by inserting after section 303 the following:

``SEC. 303A. REQUIRED CLEARINGHOUSE FOR REGISTRANT ORDERS.

    ``(a) In General.--Not later than 2 years after the date of 
enactment of this section, the Attorney General shall--
            ``(1) establish a clearinghouse that would subject all 
        orders of controlled substances and listed chemicals to the 
        clearinghouse for recording and review, prior to final review 
        by the registrant;
            ``(2) amend the regulations relative to controlled 
        substances in schedule II ordering requirements that would 
        allow for uniform electronic ordering of controlled substances 
        in schedule II, III, IV and V electronically to the 
        clearinghouse; and
            ``(3) may deny, suspend, or revoke a registration issued 
        under section 303(f), or the registration of a distributor 
        under section 303(b) or 303(e), if the practitioner or 
        distributor, as applicable, is not substantially in compliance 
        with the requirements of this section.
    ``(b) Clearinghouse.--
            ``(1) In general.--An order for a controlled substance may 
        not be filled by the registrant unless--
                    ``(A) the order is first transmitted electronically 
                to the Attorney General, acting through the 
                Administrator of the Drug Enforcement Administration 
                (referred to in this section as the `Administrator');
                    ``(B) the Administrator uses the algorithm 
                described in paragraph (2) to determine if the order is 
                an outlier and is potentially suspicious;
                    ``(C) the Administrator relays the order to the 
                registrant with whom the order is placed, regardless of 
                whether the algorithm was exceeded, for further 
                analysis of the order under section 1301.74(b) of title 
                21, Code of Federal Regulations; and
                    ``(D) the registrant has received a waiver from the 
                Administrator exempting the registrant from this 
                section.
            ``(2) Algorithm.--
                    ``(A) In general.--The clearinghouse established 
                under this section shall use an input-based algorithm, 
                including techniques such as artificial intelligence, 
                machine learning, and other methods of analyzing large 
                data, that--
                            ``(i) automatically identifies orders that 
                        exceed the metrics of the algorithm;
                            ``(ii) notifies the registrant if the order 
                        is an outlier and is potentially suspicious;
                            ``(iii) is informed by all data available 
                        to the Administrator and uses pharmacy best 
                        practices;
                            ``(iv) takes into consideration existing 
                        State and Federal law; and
                            ``(v) establishes different parameters for 
                        different registrants using relevant 
                        information based on pharmacy type, location, 
                        and size.
                    ``(B) Refinement.--The Administrator of the Drug 
                Enforcement Administration (referred to in this section 
                as the `Administrator') shall review, update, and 
                revise the algorithm biannually based on feedback from 
                industry and relevant stakeholders to ensure 
                functionality.
            ``(3) Consultation.--The Administrator shall consult with 
        the Director of the National Institute of Standards and 
        Technology for technical assistance in establishing the 
        clearinghouse.
    ``(c) Responsibilities of Distributors and Manufacturers Regarding 
Suspicious Orders.--This section may not be construed as relieving any 
distributor or manufacturer from the requirements established in 
section 1301.74(b) of title 21, Code of Federal Regulations, or any 
successor regulation, with respect to suspicious orders.
    ``(d) Contractor Regarding Data Analytics.--
            ``(1) In general.--The Administrator shall award a contract 
        to a public or private entity enabling the Administrator to 
        carry out the technological aspects of tracking, processing and 
        evaluating orders under this section.
            ``(2) Eligible entities.--An entity is eligible for an 
        award under paragraph (1) if the entity has significant 
        experience in data analytics and in processing the volume of 
        electronic data involved in reviewing orders under this section 
        within the timeframe required in subsection (c).
            ``(3) Capabilities.--A contract awarded under paragraph (1) 
        shall--
                    ``(A) provide a data management and configurable 
                visual analytics solution capable of ingesting and 
                managing data entities, including manufacturers, and 
                distributors, retail dispensers across relevant data 
                maintained by the Administrator;
                    ``(B) standardize the data format, with the ability 
                to flexibly model data for analyses and link data 
                across sources; and
                    ``(C) provide an environment for analysis that is 
                interoperable.
            ``(4) Commercial items.--The Administrator shall comply 
        with section 3307 of title 41, United States Code, in awarding 
        a contract under paragraph (1). The Administrator may not enter 
        into a contract for any capabilities sought under paragraph (1) 
        that are not for commercial items unless the Administrator 
        first determines in writing that no commercial items are 
        suitable to meet the needs of the Drug Enforcement 
        Administration.
            ``(5) Timeline of contract.--Any contract awarded under 
        paragraph (1) for a data management and visual analytics 
        solution shall require the public or private entity awarded 
        such contract to deliver a functioning solution sufficient to 
        fulfill the purposes of this section not later than 180 days 
        after the date on which the contract is awarded, unless the 
        Administrator grants an extension for unforeseen delays.
            ``(6) Federal acquisition regulation.--A contract awarded 
        under this subsection shall be in accordance with the Federal 
        Acquisition Regulation.
            ``(7) Access to data.--An entity that is awarded a contract 
        under this subsection shall have access to the relevant data to 
        create the system.
    ``(e) Waiver.--
            ``(1) In general.--Beginning on the date on which the 36-
        month period described in subsection (b)(1)(A)(ii) expires, a 
        pharmacy may submit to the Administrator an application for a 
        waiver from the requirements of subsection (b)(1)(A) if the 
        pharmacy is unable to transmit orders electronically.
            ``(2) Response.--The Administrator shall approve or deny an 
        application submitted under paragraph (1) not later than the 
        90-day period beginning on the date on which the application is 
        received.
            ``(3) Liability.--No waiver issued under paragraph (1) 
        shall mitigate the liability of the pharmacy for any drugs 
        diverted that did not pass through the clearinghouse.
    ``(f) Funding.--
            ``(1) Diversion control fee account.--The activities 
        performed under this section shall be considered to be elements 
        of the diversion control program for purposes of section.
            ``(2) Prohibition.--No registrant may pass on the cost of 
        the clearinghouse to its customers.''.
    (b) Technical and Conforming Amendment.--The table of contents for 
the Controlled Substances Act (21 U.S.C. 801 et seq.) is amended by 
inserting after the item relating to section 303 the following:

``Sec. 303A. Required clearinghouse for registrant orders.''.
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