II 

Calendar No. 476 

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, Mr. DURBIN, and 

Mr. MANCHIN) introduced the following bill; which was read twice and 

referred to the Committee on the Judiciary 

JUNE 19, 2018 

Reported by Mr. GRASSLEY, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

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’’. 


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1 SEC. 2. FINDINGS. 

2 Congress finds the following: 

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

4 overdose deaths in the United States. More than 

5 42,000 of these deaths were opioid-related. 

6 (2) The regulations promulgated under the 

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

8 require drug manufacturers and distributors to— 

9 (A) provide effective controls against the 

10 diversion of controlled substances; 

11 (B) detect and disclose suspicious orders to 

12 the Drug Enforcement Administration; and 

13 (C) keep complete and accurate records re14 lating to the manufacture or distribution of 

15 controlled substances. 

16 (3) Despite the requirements described in para17 graph (2), it has been publicly reported that between 

18 2006 and 2016, nearly 21,000,000 opioids were dis19 tributed to 2 pharmacies in Williamson, West Vir20 ginia, which has a population of approximately 

21 3,000. It has been further reported that between 

22 2007 and 2008, nearly 9,000,000 pills were distrib23 uted to a single pharmacy in Kermit, West Virginia, 

24 which has a population of 392. 

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

26 780,000,000 oxycodone and hydrocodone pills were 


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1 distributed to pharmacies throughout West Virginia 

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

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

4 of these 2 substances. 

5 (5) Drug manufacturers and distributors are 

6 required to report the sale, delivery or other disposal 

7 of narcotics to the Drug Enforcement Administra8 tion through the Automated Reports and Consoli9 dated Ordering System. 

10 (6) Notwithstanding the reporting requirement 

11 described in paragraph (5), the Drug Enforcement 

12 Administration does not disclose the total quantity 

13 and type of opioids distributed to a single pharmacy 

14 or practitioner with those manufacturers and dis15 tributors who are required to input information into 

16 the Automated Reports and Consolidated Ordering 

17 System. This creates a barrier to identifying and 

18 stopping potentially suspicious orders. 

19 (7) Although manufacturers and distributors 

20 are already required to provide effective controls 

21 against the diversion of controlled substances, this 

22 lack of data sharing may create a barrier to better 

23 identifying and stopping potentially suspicious or24 ders. 


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

2 of the United States is statutorily required to share 

3 the controlled substance or substances in schedule II 

4 that have the highest rates of abuse and to prepare 

5 and make available reports on the distribution pat6 terns of such substances, with State regulatory, li7 censing, and law enforcement agencies. The Attor8 ney General of the United States has entered into 

9 data sharing agreements with the attorneys general 

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

11 District of Colombia to share, pursuant to State law 

12 and policy, data obtained from State prescription 

13 drug monitoring programs and other sources. 

14 (9) To further reduce barriers associated with 

15 identifying suspicious patterns and stopping the di16 version of opioids, the remaining States and terri17 tories of the United States should enter into similar 

18 agreements with, and to the greatest extent practical 

19 share data obtained from State prescription drug 

20 monitoring programs with, the Attorney General of 

21 the United States. 

22 SEC. 3. PURPOSE. 

23 (a) IN GENERAL.—The purpose of this Act is to pro24 vide drug manufacturers and distributors with access to 

25 anonymized information through the Automated Reports 


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1 and Consolidated Ordering System to help drug manufac2 turers and distributors identify, report, and stop sus3 picious orders of opioids and reduce diversion rates. 

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

5 should be construed to absolve a drug manufacturer, drug 

6 distributor, or other Drug Enforcement Administration 

7 registrant from the responsibility of the manufacturer, dis8 tributor, or other registrant to— 

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

10 or 

11 (2) use all available sources of information to 

12 determine— 

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

14 and 

15 (B) whether or not an order described in 

16 subparagraph (A) is suspicious. 

17 SEC. 4. AMENDMENTS. 

18 (a) RECORDS AND REPORTS OF REGISTRANTS.—Sec19 tion 307 of the Controlled Substances Act (21 U.S.C. 827) 

20 is amended— 

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

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

23 (2) by inserting after subsection (e) the fol24 lowing: 


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1 ‘‘(f)(1) The Attorney General shall, not less fre2 quently than quarterly, make the following information 

3 available to manufacturer and distributor registrants 

4 through the Automated Reports and Consolidated Order5 ing System, or any subsequent automated system devel6 oped by the Drug Enforcement Administration to monitor 

7 selected controlled substances: 

8 ‘‘(A) The total number of distributor reg9 istrants that distribute controlled substances to a 

10 pharmacy or practitioner registrant, aggregated by 

11 the name and address of each pharmacy and practi12 tioner registrant. 

13 ‘‘(B) The total quantity and type of opioids dis14 tributed, listed by Administration Controlled Sub15 stances Code Number, to each pharmacy and practi16 tioner registrant described in subparagraph (A). 

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

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

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

20 which the information relates. 

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

22 shall be responsible for reviewing the information made 

23 available by the Attorney General under this subsection. 

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

25 under this title against a registered manufacturer or disVerDate Sep 11 2014 22:53 Jun 19, 2018 Jkt 079200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6401 E:\BILLS\S2838.RS S2838

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1 tributor based on the failure of the registrant to maintain 

2 effective controls against diversion or otherwise comply 

3 with the requirements of this title or the regulations issued 

4 thereunder, the Attorney General may take into account 

5 that the information made available under this subsection 

6 was available to the registrant.’’; and 

7 (3) by inserting after subsection (i), as so re8 designated, the following: 

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

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

11 (b) COOPERATIVE ARRANGEMENTS.—Section 503 of 

12 the Controlled Substances Act (21 U.S.C. 873) is amend13 ed— 

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

15 following: 

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

17 months, prepare and make available to regulatory, licens18 ing, attorneys general, and law enforcement agencies of 

19 States a standardized report containing descriptive and 

20 analytic information on the actual distribution patterns, 

21 as gathered through the Automated Reports and Consoli22 dated Ordering System, or any subsequent automated sys23 tem, pursuant to section 307 and which include detailed 

24 amounts, outliers, and trends of distributor and pharmacy 

25 registrants, in such States for the controlled substances 


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

2 Attorney General, are determined to have the highest 

3 abuse. 

4 ‘‘(2) If the Attorney General publishes the report de5 scribed in paragraph (1) once every 6 months as required 

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

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

8 sufficiency of the information or to compel the Attorney 

9 General to produce any documents or reports referred to 

10 in this subsection.’’. 

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

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

13 amended— 

14 (1) in subsection (a)— 

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

16 the end; 

17 (B) in paragraph (16), by striking the pe18 riod at the end and inserting ‘‘; or’’; and 

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

20 following: 

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

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

23 recent information made available by the Attorney 

24 General in accordance with section 307(f) before 


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1 each distribution of a controlled substance referred 

2 to in such information.’’; and 

3 (2) in subsection (c)— 

4 (A) in paragraph (1), by striking subpara5 graph (B) and inserting the following: 

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

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

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

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

10 committed by a registered manufacturer or distributor of 

11 opioids and related to the reporting of suspicious orders 

12 for opioids, failing to maintain effective controls against 

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

14 information made available by the Attorney General in ac15 cordance with section 307(f), the penalty shall not exceed 

16 $100,000.’’; and 

17 (B) in paragraph (2)— 

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

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

20 (ii) by adding at the end the fol21 lowing: 

22 ‘‘(D) In the case of a violation described in subpara23 graph (A) that was a violation of paragraph (5), (10), or 

24 (17) of subsection (a) committed by a registered manufac25 turer or distributor of opioids that relates to the reporting 


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1 of suspicious orders for opioids, failing to maintain effec2 tive controls against diversion of opioids, or failing to re3 view the most recent information made available by the 

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

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

6 exceed $500,000.’’. 

7 SEC. 5. REPORT. 

8 Not later than 1 year after the date of enactment 

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

10 a report that provides information about how the Attorney 

11 General is using data in the Automation of Reports and 

12 Consolidated Orders System to identify and stop sus13 picious activity, including whether the Attorney General 

14 is looking at aggregate orders from individual pharmacies 

15 to multiple distributors that in total are suspicious, even 

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

17 order to a given distributor. 

18 SECTION 1. SHORT TITLE. 

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

20 Opioid Diversion Act of 2018’’. 

21 SEC. 2. FINDINGS. 

22 Congress finds the following: 

23 (1) In 2016, there were nearly 64,000 drug over24 dose deaths in the United States. More than 42,000 

25 of these deaths were opioid-related. 


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1 (2) The regulations promulgated under the Con2 trolled Substances Act (21 U.S.C. 801 et seq.) require 

3 drug manufacturers and distributors to— 

4 (A) provide effective controls against the di5 version of controlled substances; 

6 (B) detect and disclose suspicious orders to 

7 the Drug Enforcement Administration; and 

8 (C) keep complete and accurate records re9 lating to the manufacture or distribution of con10 trolled substances. 

11 (3) Despite the requirements described in para12 graph (2), it has been publicly reported that between 

13 2006 and 2016, nearly 21,000,000 opioids were dis14 tributed to 2 pharmacies in Williamson, West Vir15 ginia, which has a population of approximately 

16 3,000. It has been further reported that between 2007 

17 and 2008, nearly 9,000,000 pills were distributed to 

18 a single pharmacy in Kermit, West Virginia, which 

19 has a population of 392. 

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

21 780,000,000 oxycodone and hydrocodone pills were 

22 distributed to pharmacies throughout West Virginia 

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

24 than 1,700 people in the State died from overdoses of 

25 these 2 substances. 


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1 (5) Drug manufacturers and distributors are re2 quired to report the sale, delivery or other disposal of 

3 narcotics to the Drug Enforcement Administration 

4 through the Automated Reports and Consolidated Or5 ders System. 

6 (6) Notwithstanding the reporting requirement 

7 described in paragraph (5), the Drug Enforcement 

8 Administration does not disclose the total quantity 

9 and type of opioids distributed to a single pharmacy 

10 or practitioner with those manufacturers and dis11 tributors who are required to input information into 

12 the Automated Reports and Consolidated Orders Sys13 tem. This creates a barrier to identifying and stop14 ping potentially suspicious orders. 

15 (7) Although manufacturers and distributors are 

16 already required to provide effective controls against 

17 the diversion of controlled substances, this lack of data 

18 sharing may create a barrier to better identifying and 

19 stopping potentially suspicious orders. 

20 (8) On an annual basis, the Attorney General of 

21 the United States is statutorily required to share the 

22 controlled substance or substances in schedule II that 

23 have the highest rates of abuse and to prepare and 

24 make available reports on the distribution patterns of 

25 such substances, with State regulatory, licensing, and 


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1 law enforcement agencies. The Attorney General of the 

2 United States has entered into data sharing agree3 ments with the attorneys general of the vast majority 

4 of States, Puerto Rico, and the District of Colombia 

5 to share, pursuant to State law and policy, data ob6 tained from State prescription drug monitoring pro7 grams and other sources. 

8 (9) To further reduce barriers associated with 

9 identifying suspicious patterns and stopping the di10 version of opioids, the remaining States and terri11 tories of the United States should enter into similar 

12 agreements with, and to the greatest extent practical 

13 share data obtained from State prescription drug 

14 monitoring programs with, the Attorney General of 

15 the United States. 

16 SEC. 3. PURPOSE. 

17 (a) IN GENERAL.—The purpose of this Act is to pro18 vide drug manufacturers and distributors with access to 

19 anonymized information through the Automated Reports 

20 and Consolidated Orders System to help drug manufactur21 ers and distributors identify, report, and stop suspicious 

22 orders of opioids and reduce diversion rates. 

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

24 should be construed to absolve a drug manufacturer, drug 

25 distributor, or other Drug Enforcement Administration regVerDate Sep 11 2014 22:53 Jun 19, 2018 Jkt 079200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6203 E:\BILLS\S2838.RS S2838

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1 istrant from the responsibility of the manufacturer, dis2 tributor, or other registrant to— 

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

4 or 

5 (2) maintain effective controls against diversion 

6 in accordance with section 303 of the Controlled Sub7 stances Act (21 U.S.C. 823) or any successor law or 

8 associated regulation. 

9 SEC. 4. AMENDMENTS. 

10 (a) RECORDS AND REPORTS OF REGISTRANTS.—Sec11 tion 307 of the Controlled Substances Act (21 U.S.C. 827) 

12 is amended— 

13 (1) by redesignating subsections (f), (g), and (h) 

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

15 (2) by inserting after subsection (e) the following: 

16 ‘‘(f)(1) The Attorney General shall, not less frequently 

17 than quarterly, make the following information available 

18 to manufacturer and distributor registrants through the 

19 Automated Reports and Consolidated Orders System, or 

20 any subsequent automated system developed by the Drug 

21 Enforcement Administration to monitor selected controlled 

22 substances: 

23 ‘‘(A) The total number of distributor registrants 

24 that distribute controlled substances to a pharmacy or 


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1 practitioner registrant, aggregated by the name and 

2 address of each pharmacy and practitioner registrant. 

3 ‘‘(B) The total quantity and type of opioids dis4 tributed, listed by Administration Controlled Sub5 stances Code Number, to each pharmacy and practi6 tioner registrant described in subparagraph (A). 

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

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

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

10 which the information relates. 

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

12 shall be responsible for reviewing the information made 

13 available by the Attorney General under this subsection. 

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

15 under this title against a registered manufacturer or dis16 tributor based on the failure of the registrant to maintain 

17 effective controls against diversion or otherwise comply with 

18 the requirements of this title or the regulations issued there19 under, the Attorney General may take into account that the 

20 information made available under this subsection was 

21 available to the registrant.’’; and 

22 (3) by inserting after subsection (i), as so redes23 ignated, the following: 

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

25 be provided in an electronic format.’’. 


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1 (b) COOPERATIVE ARRANGEMENTS.—Section 503 of 

2 the Controlled Substances Act (21 U.S.C. 873) is amend3 ed— 

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

5 following: 

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

7 months, prepare and make available to regulatory, licens8 ing, attorneys general, and law enforcement agencies of 

9 States a standardized report containing descriptive and 

10 analytic information on the actual distribution patterns, 

11 as gathered through the Automated Reports and Consoli12 dated Orders System, or any subsequent automated system, 

13 pursuant to section 307 and which includes detailed 

14 amounts, outliers, and trends of distributor and pharmacy 

15 registrants, in such States for the controlled substances con16 tained in schedule II, which, in the discretion of the Attor17 ney General, are determined to have the highest abuse. 

18 ‘‘(2) If the Attorney General publishes the report de19 scribed in paragraph (1) once every 6 months as required 

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

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

22 sufficiency of the information or to compel the Attorney 

23 General to produce any documents or reports referred to 

24 in this subsection.’’. 


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1 (c) CIVIL AND CRIMINAL PENALTIES.—Section 402 of 

2 the Controlled Substances Act (21 U.S.C. 842) is amend3 ed— 

4 (1) in subsection (a)— 

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

6 the end; 

7 (B) in paragraph (16), by striking the pe8 riod at the end and inserting ‘‘; or’’; and 

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

10 following: 

11 ‘‘(17) in the case of a registered manufacturer or 

12 distributor of opioids, to fail to review the most recent 

13 information, directly related to the customers of the 

14 manufacturer or distributor, made available by the 

15 Attorney General in accordance with section 307(f).’’; 

16 and 

17 (2) in subsection (c)— 

18 (A) in paragraph (1), by striking subpara19 graph (B) and inserting the following: 

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

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

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

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

24 committed by a registered manufacturer or distributor of 

25 opioids and related to the reporting of suspicious orders for 


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1 opioids, failing to maintain effective controls against diver2 sion of opioids, or failing to review the most recent informa3 tion made available by the Attorney General in accordance 

4 with section 307(f), the penalty shall not exceed $100,000.’’; 

5 and 

6 (B) in paragraph (2)— 

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

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

9 (ii) by adding at the end the following: 

10 ‘‘(D) In the case of a violation described in subpara11 graph (A) that was a violation of paragraph (5), (10), or 

12 (17) of subsection (a) committed by a registered manufac13 turer or distributor of opioids that relates to the reporting 

14 of suspicious orders for opioids, failing to maintain effective 

15 controls against diversion of opioids, or failing to review 

16 the most recent information made available by the Attorney 

17 General in accordance with section 307(f), the criminal fine 

18 under title 18, United States Code, shall not exceed 

19 $500,000.’’. 

20 SEC. 5. REPORT. 

21 Not later than 1 year after the date of enactment of 

22 this Act, the Attorney General shall submit to Congress a 

23 report that provides information about how the Attorney 

24 General is using data in the Automation of Reports and 

25 Consolidated Orders System to identify and stop suspicious 


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1 activity, including whether the Attorney General is looking 

2 at aggregate orders from individual pharmacies to multiple 

3 distributors that in total are suspicious, even if no indi4 vidual order rises to the level of a suspicious order to a 

5 given distributor. 


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Calendar No. 476 

115TH CONGRESS 

2D SESSION S. 2838 

A BILL 

To amend the Controlled Substances Act to require 

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

JUNE 19, 2018 

Reported with an amendment 


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