Preventing Drug Diversion Act of 2018

To improve the systems for identifying the diversion of controlled substances. 1. Short title This Act may be cited as the Preventing Drug Diversion Act of 2018 2. Improvements to prevent drug diversion (a) Definition (1) In general Section 102 of the Controlled Substances Act ( 21 U.S.C. 802 (57) The term suspicious order (A) an order of a controlled substance of unusual size; (B) an order of a controlled substance deviating substantially from a normal pattern; (C) orders of controlled substances of unusual frequency; and (D) an order or pattern of orders of a controlled substance that meet such other criteria as are established by the Attorney General by regulation. . (2) Regulations Not later than 1 year after the date of enactment of this Act, the Attorney General shall promulgate regulations under paragraph (57)(D) of section 102 of the Controlled Substances Act, as added by paragraph (1) of this subsection. (b) Suspicious orders Part C of the Controlled Substances Act ( 21 U.S.C. 821 312. Suspicious orders (a) Reporting Each registrant shall— (1) design and operate a system to identify suspicious orders for the registrant; (2) ensure that the system designed and operated under paragraph (1) by the registrant complies with applicable Federal and State privacy laws; and (3) upon discovering a suspicious order or series of orders, notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business. (b) Suspicious order database Not later than 1 year after the date of enactment of this section, the Attorney General shall establish a centralized database for collecting reports of suspicious orders. (c) Sharing information with the States (1) In general The Attorney General shall make available to the point of contact for criminal and civil enforcement efforts designated by the Governor or chief executive officer of a State— (A) information regarding suspicious orders in the State, including information in the database established under subsection (b); and (B) information relating to the State in the Automation of Reports and Consolidated Orders System, or any subsequent automated system developed by the Drug Enforcement Administration to monitor selected controlled substances. (2) Timing The Attorney General shall provide information in accordance with paragraph (1) within a reasonable period of time after obtaining the information. (3) Coordination In establishing the process for the provision of information under this subsection, the Attorney General shall coordinate with States to ensure that the Attorney General has access to information, as permitted under State law, possessed by the States relating to prescriptions for controlled substances that will assist in enforcing Federal law. . (c) Increased civil penalties Section 402(c) of the Controlled Substances Act ( 21 U.S.C. 842(c) (1) in paragraph (1)(B), by striking shall not exceed $10,000. (i) except as provided in clause (ii), $10,000; and (ii) if the violation relates to the reporting of suspicious orders or failing to maintain effective controls against diversion, $100,000. ; and (2) in paragraph (2)— (A) in subparagraph (A), by inserting or (D) subparagraph (B) (B) by adding at the end the following: (D) In the case of a violation referred to in subparagraph (A) that was a violation of paragraph (5) or (10) of subsection (a) that relates to the reporting of suspicious orders or failing to maintain effective controls against diversion, the criminal fine shall not exceed $500,000. . (d) Reports to Congress (1) Definition In this subsection, the term suspicious orders (2) One time report Not later than 1 year after the date of enactment of this Act, the Attorney General shall submit to Congress a report on the reporting of suspicious orders, which shall include— (A) a description of the centralized database established under section 312 of the Controlled Substances Act, as added by this section, to collect reports of suspicious orders; (B) a description of the system established under section 312 of the Controlled Substances Act, as added by this section, to share information with States; (C) information regarding how the Attorney General used reports of suspicious orders before the date of enactment of this Act and after the date of enactment of this Act, including how the Attorney General received the reports and what actions were taken in response to the reports; and (D) descriptions of the data analyses conducted on reports of suspicious orders and information in the Automation of Reports and Consolidated Orders System of the Drug Enforcement Administration to identify suspicious activity. (3) Additional reports Not later than 1 year after the date of enactment of this Act, and annually thereafter until the date that is 5 years after the date of enactment of this Act, the Attorney General shall submit to Congress a report providing, for the previous year— (A) the number of reports of suspicious orders; (B) a description of actions taken in response to reports of suspicious orders; and (C) a description of the information shared with States based on reports of suspicious orders and information in the Automation of Reports and Consolidated Orders System of the Drug Enforcement Administration.

Summary: Preventing Drug Diversion Act of 2018 This bill establishes a new requirement intended to help drug manufacturers and distributors identify and prevent suspicious orders of opioids and reduce rates of diversion. Specifically, the Drug Enforcement Administration must use its automated data system&#8212;the Automated Reports and Consolidated Ordering System&#8212;to inform drug manufacturers and distributors about the quantity and type of opioids that are distributed to pharmacies and practitioners. Additionally, the bill establishes new requirements for reporting, collecting, and sharing information about suspicious orders.