,,ii #aaeth ,,congress #b;d ,session ,s4 #cbhb ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #bf1 #bjah ,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 amend the ,controlled ,substances ,act to require that orders subject to review be submitted through a clearinghouse1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,,dea ,order ,clearinghouse ,act of #bjah4 #b4 ,required clearinghouse for registrant orders 7a7 ,in general ,the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq47 is amended-- 7#a7 in section #cjc7;f71 in the matter preceding paragraph 7#a71 by striking ,the ,attorney ,general and inserting ,subject to section #cjc;,a1 the ,attorney ,general2 and 7#b7 by inserting after section #cjc the following3 #cjc;,a4 ,required clearinghouse for registrant orders 7a7 ,in general ,not later than #b years after the date of enactment of this section1 the ,attorney ,general shall-- 7#a7 establish a clearinghouse that would subject all orders of controlled substances and listed chemicals to the clearinghouse for recording and review1 prior to final review by the registrant2 7#b7 amend the regulations relative to controlled substances in schedule ,,ii ordering requirements that would allow for uniform electronic ordering of controlled substances in schedule ,,ii1 ,,iii1 ,,iv and ,v electronically to the clearinghouse2 and 7#c7 may deny1 suspend1 or revoke a registration issued under section #cjc7;f71 or the registration of a distributor under section #cjc7;b7 or #cjc7;e71 if the practitioner or distributor1 as applicable1 is not substantially in compliance with the requirements of this section4 7b7 ,clearinghouse 7#a7 ,in general ,an order for a controlled substance may not be filled by the registrant unless-- 7,a7 the order is first transmitted electronically to the ,attorney ,general1 acting through the ,administrator of the ,drug ,enforcement ,administration 7referred to in this section as the ,administrator72 7,b7 the ,administrator uses the algorithm described in paragraph 7#b7 to determine if the order is an outlier and is potentially suspicious2 7,c7 the ,administrator relays the order to the registrant with whom the order is placed1 regardless of whether the algorithm was exceeded1 for further analysis of the order under section #acja4gd7;b7 of title #ba1 ,code of ,federal ,regulations2 and 7,d7 the registrant has received a waiver from the ,administrator exempting the registrant from this section4 7#b7 ,algorithm 7,a7 ,in general ,the clearinghouse established under this section shall use an input-based algorithm1 including techniques such as artificial intelligence1 machine learning1 and other methods of analyzing large data1 that-- 7i7 automatically identifies orders that exceed the metrics of the algorithm2 7ii7 notifies the registrant if the order is an outlier and is potentially suspicious2 7iii7 is informed by all data available to the ,administrator and uses pharmacy best practices2 7iv7 takes into consideration existing ,state and ,federal law2 and 7v7 establishes different parameters for different registrants using relevant information based on pharmacy type1 location1 and size4 7,b7 ,refinement ,the ,administrator of the ,drug ,enforcement ,administration 7referred to in this section as the ,administrator7 shall review1 update1 and revise the algorithm biannually based on feedback from industry and relevant stakeholders to ensure functionality4 7#c7 ,consultation ,the ,administrator shall consult with the ,director of the ,national ,institute of ,standards and ,technology for technical assistance in establishing the clearinghouse4 7c7 ,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 #acja4gd7;b7 of title #ba1 ,code of ,federal ,regulations1 or any successor regulation1 with respect to suspicious orders4 7d7 ,contractor regarding data analytics 7#a7 ,in general ,the ,administrator shall award a contract to a public or private entity enabling the ,administrator to carry out the technological aspects of tracking1 processing and evaluating orders under this section4 7#b7 ,eligible entities ,an entity is eligible for an award under paragraph 7#a7 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 7c74 7#c7 ,capabilities ,a contract awarded under paragraph 7#a7 shall-- 7,a7 provide a data management and configurable visual analytics solution capable of ingesting and managing data entities1 including manufacturers1 and distributors1 retail dispensers across relevant data maintained by the ,administrator2 7,b7 standardize the data format1 with the ability to flexibly model data for analyses and link data across sources2 and 7,c7 provide an environment for analysis that is interoperable4 7#d7 ,commercial items ,the ,administrator shall comply with section #ccjg of title #da1 ,united ,states ,code1 in awarding a contract under paragraph 7#a74 ,the ,administrator may not enter into a contract for any capabilities sought under paragraph 7#a7 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 ,administration4 7#e7 ,timeline of contract ,any contract awarded under paragraph 7#a7 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 #ahj days after the date on which the contract is awarded1 unless the ,administrator grants an extension for unforeseen delays4 7#f7 ,federal ,acquisition ,regulation ,a contract awarded under this subsection shall be in accordance with the ,federal ,acquisition ,regulation4 7#g7 ,access to data ,an entity that is awarded a contract under this subsection shall have access to the relevant data to create the system4 7e7 ,waiver 7#a7 ,in general ,beginning on the date on which the #cf-month period described in subsection 7b77#a77;,a77ii7 expires1 a pharmacy may submit to the ,administrator an application for a waiver from the requirements of subsection 7b77#a77;,a7 if the pharmacy is unable to transmit orders electronically4 7#b7 ,response ,the ,administrator shall approve or deny an application submitted under paragraph 7#a7 not later than the #ij-;day period beginning on the date on which the application is received4 7#c7 ,liability ,no waiver issued under paragraph 7#a7 shall mitigate the liability of the pharmacy for any drugs diverted that did not pass through the clearinghouse4 7f7 ,funding 7#a7 ,diversion control fee account ,the activities performed under this section shall be considered to be elements of the diversion control program for purposes of section4 7#b7 ,prohibition ,no registrant may pass on the cost of the clearinghouse to its customers4 4 7b7 ,technical and conforming amendment ,the table of contents for the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq47 is amended by inserting after the item relating to section #cjc the following3 ,sec4 #cjc;,a4 ,required clearinghouse for registrant orders4 4