II 

115TH CONGRESS 

2D SESSION S. 2838 

To amend the Controlled Substances Act to require the Drug Enforcement 

Administration to report certain information on distribution of opioids, 

and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MAY 15, 2018 

Mrs. FEINSTEIN (for herself, Mr. GRASSLEY, Mrs. CAPITO, and Mr. DURBIN) 

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 the Drug 

Enforcement Administration to report certain information on distribution of opioids, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Using Data to Prevent 

5 Opioid Diversion Act of 2018’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 


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1 (1) In 2016, there were nearly 64,000 drug 

2 overdose deaths in the United States. More than 

3 42,000 of these deaths were opioid-related. 

4 (2) The regulations promulgated under the 

5 Controlled Substances Act (21 U.S.C. 801 et seq.) 

6 require drug manufacturers and distributors to— 

7 (A) provide effective controls against the 

8 diversion of controlled substances; 

9 (B) detect and disclose suspicious orders to 

10 the Drug Enforcement Administration; and 

11 (C) keep complete and accurate records re12 lating to the manufacture or distribution of 

13 controlled substances. 

14 (3) Despite the requirements described in para15 graph (2), it has been publicly reported that between 

16 2006 and 2016, nearly 21,000,000 opioids were dis17 tributed to 2 pharmacies in Williamson, West Vir18 ginia, which has a population of approximately 

19 3,000. It has been further reported that between 

20 2007 and 2008, nearly 9,000,000 pills were distrib21 uted to a single pharmacy in Kermit, West Virginia, 

22 which has a population of 392. 

23 (4) Similarly, it has been publicly reported that 

24 780,000,000 oxycodone and hydrocodone pills were 

25 distributed to pharmacies throughout West Virginia 


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1 between 2007 and 2012. In the same period, more 

2 than 1,700 people in the State died from overdoses 

3 of these 2 substances. 

4 (5) Drug manufacturers and distributors are 

5 required to report the sale, delivery or other disposal 

6 of narcotics to the Drug Enforcement Administra7 tion through the Automated Reports and Consoli8 dated Ordering System. 

9 (6) Notwithstanding the reporting requirement 

10 described in paragraph (5), the Drug Enforcement 

11 Administration does not disclose the total quantity 

12 and type of opioids distributed to a single pharmacy 

13 or practitioner with those manufacturers and dis14 tributors who are required to input information into 

15 the Automated Reports and Consolidated Ordering 

16 System. This creates a barrier to identifying and 

17 stopping potentially suspicious orders. 

18 (7) Although manufacturers and distributors 

19 are already required to provide effective controls 

20 against the diversion of controlled substances, this 

21 lack of data sharing may create a barrier to better 

22 identifying and stopping potentially suspicious or23 ders. 

24 (8) On an annual basis, the Attorney General 

25 of the United States is statutorily required to share 


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1 the controlled substance or substances in schedule II 

2 that have the highest rates of abuse and to prepare 

3 and make available reports on the distribution pat4 terns of such substances, with State regulatory, li5 censing, and law enforcement agencies. The Attor6 ney General of the United States has entered into 

7 data sharing agreements with the attorneys general 

8 of the vast majority of States, Puerto Rico, and the 

9 District of Colombia to share, pursuant to State law 

10 and policy, data obtained from State prescription 

11 drug monitoring programs and other sources. 

12 (9) To further reduce barriers associated with 

13 identifying suspicious patterns and stopping the di14 version of opioids, the remaining States and terri15 tories of the United States should enter into similar 

16 agreements with, and to the greatest extent practical 

17 share data obtained from State prescription drug 

18 monitoring programs with, the Attorney General of 

19 the United States. 

20 SEC. 3. PURPOSE. 

21 (a) IN GENERAL.—The purpose of this Act is to pro22 vide drug manufacturers and distributors with access to 

23 anonymized information through the Automated Reports 

24 and Consolidated Ordering System to help drug manufacVerDate Sep 11 2014 21:21 May 17, 2018 Jkt 079200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2838.IS S2838

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1 turers and distributors identify, report, and stop sus2 picious orders of opioids and reduce diversion rates. 

3 (b) RULE OF CONSTRUCTION.—Nothing in this Act 

4 should be construed to absolve a drug manufacturer, drug 

5 distributor, or other Drug Enforcement Administration 

6 registrant from the responsibility of the manufacturer, dis7 tributor, or other registrant to— 

8 (1) identify, report, and stop suspicious orders; 

9 or 

10 (2) use all available sources of information to 

11 determine— 

12 (A) the legitimacy of a customer’s order; 

13 and 

14 (B) whether or not an order described in 

15 subparagraph (A) is suspicious. 

16 SEC. 4. AMENDMENTS. 

17 (a) RECORDS AND REPORTS OF REGISTRANTS.—Sec18 tion 307 of the Controlled Substances Act (21 U.S.C. 827) 

19 is amended— 

20 (1) by redesignating subsections (f), (g), and 

21 (h) as subsections (g), (h), and (i), respectively; 

22 (2) by inserting after subsection (e) the fol23 lowing: 

24 ‘‘(f)(1) The Attorney General shall, not less fre25 quently than quarterly, make the following information 


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1 available to manufacturer and distributor registrants 

2 through the Automated Reports and Consolidated Order3 ing System, or any subsequent automated system devel4 oped by the Drug Enforcement Administration to monitor 

5 selected controlled substances: 

6 ‘‘(A) The total number of distributor reg7 istrants that distribute controlled substances to a 

8 pharmacy or practitioner registrant, aggregated by 

9 the name and address of each pharmacy and practi10 tioner registrant. 

11 ‘‘(B) The total quantity and type of opioids dis12 tributed, listed by Administration Controlled Sub13 stances Code Number, to each pharmacy and practi14 tioner registrant described in subparagraph (A). 

15 ‘‘(2) The information required to be made available 

16 under paragraph (1) shall be made available not later than 

17 the 15th day of the first month following the quarter to 

18 which the information relates. 

19 ‘‘(3)(A) All registered manufacturers and distributors 

20 shall be responsible for reviewing the information made 

21 available by the Attorney General under this subsection. 

22 ‘‘(B) In determining whether to initiate proceedings 

23 under this title against a registered manufacturer or dis24 tributor based on the failure of the registrant to maintain 

25 effective controls against diversion or otherwise comply 


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1 with the requirements of this title or the regulations issued 

2 thereunder, the Attorney General may take into account 

3 that the information made available under this subsection 

4 was available to the registrant.’’; and 

5 (3) by inserting after subsection (i), as so re6 designated, the following: 

7 ‘‘(j) All of the reports required under this section 

8 shall be provided in an electronic format.’’. 

9 (b) COOPERATIVE ARRANGEMENTS.—Section 503 of 

10 the Controlled Substances Act (21 U.S.C. 873) is amend11 ed— 

12 (1) by striking subsection (c) and inserting the 

13 following: 

14 ‘‘(c)(1) The Attorney General shall, once every 6 

15 months, prepare and make available to regulatory, licens16 ing, attorneys general, and law enforcement agencies of 

17 States a standardized report containing descriptive and 

18 analytic information on the actual distribution patterns, 

19 as gathered through the Automated Reports and Consoli20 dated Ordering System, or any subsequent automated sys21 tem, pursuant to section 307 and which include detailed 

22 amounts, outliers, and trends of distributor and pharmacy 

23 registrants, in such States for the controlled substances 

24 contained in schedule II, which, in the discretion of the 


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1 Attorney General, are determined to have the highest 

2 abuse. 

3 ‘‘(2) If the Attorney General publishes the report de4 scribed in paragraph (1) once every 6 months as required 

5 under paragraph (1), nothing in this subsection shall be 

6 construed to bring an action in any court to challenge the 

7 sufficiency of the information or to compel the Attorney 

8 General to produce any documents or reports referred to 

9 in this subsection.’’. 

10 (c) CIVIL AND CRIMINAL PENALTIES.—Section 402 

11 of the Controlled Substances Act (21 U.S.C. 842) is 

12 amended— 

13 (1) in subsection (a)— 

14 (A) in paragraph (15), by striking ‘‘or’’ at 

15 the end; 

16 (B) in paragraph (16), by striking the pe17 riod at the end and inserting ‘‘; or’’; and 

18 (C) by inserting after paragraph (16) the 

19 following: 

20 ‘‘(17) in the case of a registered manufacturer 

21 or distributor of opioids, to fail to review the most 

22 recent information made available by the Attorney 

23 General in accordance with section 307(f) before 

24 each distribution of a controlled substance referred 

25 to in such information.’’; and 


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1 (2) in subsection (c)— 

2 (A) in paragraph (1), by striking subpara3 graph (B) and inserting the following: 

4 ‘‘(B)(i) Except as provided in clause (ii), in the case 

5 of a violation of paragraph (5), (10), or (17) of subsection 

6 (a), the penalty shall not exceed $10,000. 

7 ‘‘(ii) In the case of a violation described in clause (i) 

8 committed by a registered manufacturer or distributor of 

9 opioids and related to the reporting of suspicious orders 

10 for opioids, failing to maintain effective controls against 

11 diversion of opioids, or failing to review the most recent 

12 information made available by the Attorney General in ac13 cordance with section 307(f), the penalty shall not exceed 

14 $100,000.’’; and 

15 (B) in paragraph (2)— 

16 (i) in subparagraph (A), by inserting 

17 ‘‘or (D)’’ after ‘‘subparagraph (B)’’; and 

18 (ii) by adding at the end the fol19 lowing: 

20 ‘‘(D) In the case of a violation described in subpara21 graph (A) that was a violation of paragraph (5), (10), or 

22 (17) of subsection (a) committed by a registered manufac23 turer or distributor of opioids that relates to the reporting 

24 of suspicious orders for opioids, failing to maintain effec25 tive controls against diversion of opioids, or failing to reVerDate Sep 11 2014 21:21 May 17, 2018 Jkt 079200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2838.IS S2838

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1 view the most recent information made available by the 

2 Attorney General in accordance with section 307(f), the 

3 criminal fine under title 18, United States Code, shall not 

4 exceed $500,000.’’. 

5 SEC. 5. REPORT. 

6 Not later than 1 year after the date of enactment 

7 of this Act, the Attorney General shall submit to Congress 

8 a report that provides information about how the Attorney 

9 General is using data in the Automation of Reports and 

10 Consolidated Orders System to identify and stop sus11 picious activity, including whether the Attorney General 

12 is looking at aggregate orders from individual pharmacies 

13 to multiple distributors that in total are suspicious, even 

14 if no individual order rises to the level of a suspicious 

15 order to a given distributor. 

Æ 


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