Sec. 7082. Suspicious Orders Task Force
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In this section: The term Administrator means the Administrator of the Drug Enforcement Administration. 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 ). 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.
The term registrant — means a person registered under section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ); and does not include practitioner. 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 ). The Task Force shall be composed of appropriate personnel from— the Department of Justice; the Drug Enforcement Administration; the Office of National Drug Control Policy; the National Institute of Standards and Technology; and 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.
The Task Force shall consult with— industry members, including— data analytic professionals; community pharmacies that dispense controlled substances; chain pharmacies that dispense controlled substances; distributors of controlled substances; manufacturers of controlled substances; State and local public health officials; and other relevant industry professionals; and 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.
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. 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. 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). 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. Not later than 8 months after the date of enactment of this Act, the Task Force shall complete the design required under subparagraph (A). The program required under paragraph
(1)shall establish a process for— 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; 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 ensuring data privacy, data de-identification, protection of trade secrets and purchasing history. In designing the program under paragraph (1), the Task Force shall take into consideration— the inclusion of a waiver process for pharmacies and other registrants unable to transmit orders electronically on the date of enactment of this Act; a mechanism to ensure that the costs of running the program are not passed through to customers of registrants, unless the registrants are customers of other registrants; technical requirements for ensuring that registrants may access all relevant de-identified data, with output provided in a standard database file format; and 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. Not later than 1 year after the date of enactment of this Act, the Attorney General shall— 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 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. In designing the program required under paragraph (1), the Task Force— 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 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. 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). 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. 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. The Administrator shall establish a tiered user fee for distributors and registrants in proportion to the volume of sales and purchases. Except as provided in paragraph (2), the Federal Advisory Committee Act (5 U.S.C. App.) shall apply to the Task Force. The Task Force shall terminate on the date on which the program is fully implemented under subsection (e)(3). Nothing in this subtitle 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— identify, stop, and report suspicious orders; maintain effective controls against diversion in accordance with section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ); and 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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