,,ii #aafth ,,congress #ast ,session ,s4 #bfhf ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,october #bc1 #bjai,mr4 ,gardner 7for himself and ,mr4 ,coons7 introduced the following bill2 which was read twice and referred to the ,committee on the ,judiciary ,a ,,bill ,to improve reporting of the distribution of controlled substances1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,suspicious ,order ,identification ,act of #bjai4 #b4 ,strengthening ,,arcos ,section #cjg7;d7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbg7;d77 is amended to read as follows3 7#a7 7,a7 ,every registrant under section #cjc shall and in such form as the ,attorney ,general may require1 make reports in electronic format to the ,attorney ,general of every sale1 delivery1 or other disposal 7other than by dispensing by a practitioner7 by the registrant of any controlled substance1 identifying by the registration number assigned under this title the person or establishment 7unless exempt from registration under section #cjb7;d77 to whom such sale1 delivery1 or other disposal was made4 7,b7 ,every registrant shall make each report required under subparagraph 7,a7-- 7i7 not later than #cj days after the sale1 delivery1 or other disposal2 or 7ii7 after the date on which the real-time reporting system is established under section #c7;e77#c7 of the ,suspicious ,order ,identification ,act of #bjai is implemented1 in real time4 4 #c4 ,suspicious ,orders ,task ,force 7a7 ,definitions ,in this section3 7#a7 ,administrator ,the term ,administrator means the ,administrator of the ,drug ,enforcement ,administration4 7#b7 ,controlled substance2 distributor2 manufacturer ,the terms controlled substance1 distributor1 and manufacturer have the meanings given those terms in section #ajb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb74 7#c7 ,real time ,the term real time means with as little delay as technically and economically feasible1 as determined by the ,attorney ,general following the program designed under subsection 7e77#a71 but not to exceed #bd hours4 7#d7 ,registrant ,the term registrant-- 7,a7 means a person registered under section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc72 and 7,b7 does not include a practitioner4 7b7 ,establishment ,the ,attorney ,general1 in consultation with the ,director of the ,office of ,national ,drug ,control ,policy and the ,secretary of ,health and ,human ,services1 shall establish a ,suspicious ,order ,monitoring ,task ,force 7referred to in this section as the ,task ,force74 7c7 ,composition 7#a7 ,in general ,the ,task ,force shall be composed of appropriate personnel from-- 7,a7 the ,department of ,justice2 7,b7 the ,drug ,enforcement ,administration2 7,c7 the ,office of ,national ,drug ,control ,policy2 7,d7 the ,national ,institute of ,standards and ,technology2 and 7,e7 other appropriate ,federal1 ,state1 and local law enforcement and regulatory agencies with experience in investigating and prosecuting illegal transactions of controlled substances as determined by the ,attorney ,general1 in consultation with the ,secretary of ,health and ,human ,services4 7#b7 ,consultants ,the ,task ,force shall consult with-- 7,a7 industry members1 including-- 7i7 data analytic professionals2 7ii7 community pharmacies that dispense controlled substances2 7iii7 chain pharmacies that dispense controlled substances2 7iv7 distributors of controlled substances2 7v7 manufacturers of controlled substances2 7vi7 ,state and local public health officials2 and 7vii7 other relevant industry professionals2 and 7,b7 relevant industry regulators and entities that utilize real-time reporting of transactions1 orders1 or other activities with the goal of identifying suspicious activity1 such as appropriate personnel from the ,financial ,crimes ,enforcement ,network and money transfer industry professionals4 7d7 ,meetings 7#a7 ,in general ,the ,task ,force shall meet not less frequently than #d times per year and at such other times as may be determined necessary by the ,task ,force4 7#b7 ,initial meeting ,not later than #fj days after the date of enactment of this ,act1 the ,task ,force shall hold the initial meeting of the ,task ,force4 7e7 ,preliminary order evaluation program 7#a7 ,in general 7,a7 ,design ,not later than #fj days after the date on which the ,task ,force holds the initial meeting required under subsection 7d77#b71 the ,task ,force shall begin to design a program in accordance with paragraph 7#b74 7,b7 ,purpose ,the program described in subparagraph 7,a7 shall be designed to share necessary data1 in a limited capacity1 with registrants in order to provide registrants with information to identify suspicious ordering in real time4 7,c7 ,deadline for completion ,not later than #h months after the date of enactment of this ,act1 the ,task ,force shall complete the design required under subparagraph 7,a74 7#b7 ,requirements 7,a7 ,in general ,the program required under paragraph 7#a7 shall establish a process for-- 7i7 transitioning to a requirement to report in real time to the ,attorney ,general under section #cjg7;d7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbg7;d77 every sale1 delivery1 or other disposal by a registrant of any controlled substance2 7ii7 limited sharing in real time of ,automation of ,reports and ,consolidated ,orders ,system 7commonly known as ,,arcos7 data with registrants to share necessary data1 in a limited capacity1 with registrants in order to provide registrants with information to identify suspicious ordering in real time2 and 7iii7 ensuring data privacy1 data de-identification1 protection of trade secrets and purchasing history4 7,b7 ,other considerations ,in designing the program under paragraph 7#a71 the ,task ,force shall take into consideration-- 7i7 the inclusion of a waiver process for pharmacies and other registrants unable to transmit orders electronically on the date of enactment of this ,act2 7ii7 a mechanism to ensure that the costs of running the program are not passed through to customers of registrants1 unless the registrants are customer of other registrants2 7iii7 technical requirements for ensuring that registrants may access all relevant de-identified data1 with output provided in a standard database file format2 and 7iv7 a mechanism to ensure that the program required to be designed under subparagraph 7,a7 is updated based on feedback from industry members and other relevant entities4 7#c7 ,implementation ,not later than #a year after the date of enactment of this ,act1 the ,attorney ,general shall-- 7,a7 implement the program designed under paragraph 7#a7 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 distributors2 or 7,b7 otherwise implement a program to collect and share in real time data for drug manufacturers and distributors1 by providing access to anonymized information to help drug manufacturers and distributors identify1 report1 and stop suspicious orders of controlled substances and reduce diversion rates4 7#d7 ,recommended statutory and regulatory changes ,in designing the program required under paragraph 7#a71 the ,task ,force-- 7,a7 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 substances1 so as to allow uniform electronic ordering of controlled substances in schedules ,,ii1 ,,iii1 ,,iv1 and ,v electronically through the program2 and 7,b7 may submit to ,congress any recommendations for necessary legislative changes so that a real-time data analytics solution can be used across the ,united ,states4 7#e7 ,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 7#a7 and implemented under paragraph 7#c74 7f7 ,funding 7#a7 ,in general ,the ,attorney ,general1 acting through the ,administrator1 shall use amounts collected as fees for distributors and registrants under section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 and section #ajjg of the ,controlled ,substances ,import and ,export ,act 7#ba ,u4,s4,c4 #ieg7 to carry out this section4 7#b7 ,offset 7,a7 ,in general ,the ,administrator may1 on an equal basis and in accordance with subparagraph 7,b71 increase the fees described in paragraph 7#a7 for distributors and registrants to the extent necessary to defray the costs of this section4 7,b7 ,tiered fee ,the ,administrator shall establish a tiered user fee for distributors and registrants in proportion to the volume of sales and purchases4 7g7 ,applicability of ,,faca 7#a7 ,in general ,except as provided in paragraph 7#b71 the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 shall apply to the ,task ,force4 7#b7 ,termination ,the ,task ,force shall terminate on the date on which the program is fully implemented under subsection 7e77#c74 7h7 ,rules of construction ,nothing in this ,act shall be construed as relieving any manufacturer1 distributor1 or other registrant from the responsibilities of the manufacturer1 distributor1 or other registrant1 as the case may be1 to-- 7#a7 identify1 stop1 and report suspicious orders2 7#b7 maintain effective controls against diversion in accordance with section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc72 and 7#c7 comply with the requirements established in section #acja4gd7;b7 of title #ba1 ,code of ,federal ,regulations1 or any successor regulation thereto1 with respect to suspicious orders4