```

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2838 Reported in Senate (RS)]

<DOC>

                                                       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.

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

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Using Data to Prevent 
Opioid Diversion Act of 2018''.</DELETED>

<DELETED>SEC. 2. FINDINGS.</DELETED>

<DELETED>    Congress finds the following:</DELETED>
        <DELETED>    (1) In 2016, there were nearly 64,000 drug 
        overdose deaths in the United States. More than 42,000 of these 
        deaths were opioid-related.</DELETED>
        <DELETED>    (2) The regulations promulgated under the 
        Controlled Substances Act (21 U.S.C. 801 et seq.) require drug 
        manufacturers and distributors to--</DELETED>
                <DELETED>    (A) provide effective controls against the 
                diversion of controlled substances;</DELETED>
                <DELETED>    (B) detect and disclose suspicious orders 
                to the Drug Enforcement Administration; and</DELETED>
                <DELETED>    (C) keep complete and accurate records 
                relating to the manufacture or distribution of 
                controlled substances.</DELETED>
        <DELETED>    (3) Despite the requirements described in 
        paragraph (2), it has been publicly reported that between 2006 
        and 2016, nearly 21,000,000 opioids were distributed to 2 
        pharmacies in Williamson, West Virginia, which has a population 
        of approximately 3,000. It has been further reported that 
        between 2007 and 2008, nearly 9,000,000 pills were distributed 
        to a single pharmacy in Kermit, West Virginia, which has a 
        population of 392.</DELETED>
        <DELETED>    (4) Similarly, it has been publicly reported that 
        780,000,000 oxycodone and hydrocodone pills were distributed to 
        pharmacies throughout West Virginia between 2007 and 2012. In 
        the same period, more than 1,700 people in the State died from 
        overdoses of these 2 substances.</DELETED>
        <DELETED>    (5) Drug manufacturers and distributors are 
        required to report the sale, delivery or other disposal of 
        narcotics to the Drug Enforcement Administration through the 
        Automated Reports and Consolidated Ordering System.</DELETED>
        <DELETED>    (6) Notwithstanding the reporting requirement 
        described in paragraph (5), the Drug Enforcement Administration 
        does not disclose the total quantity and type of opioids 
        distributed to a single pharmacy or practitioner with those 
        manufacturers and distributors who are required to input 
        information into the Automated Reports and Consolidated 
        Ordering System. This creates a barrier to identifying and 
        stopping potentially suspicious orders.</DELETED>
        <DELETED>    (7) Although manufacturers and distributors are 
        already required to provide effective controls against the 
        diversion of controlled substances, this lack of data sharing 
        may create a barrier to better identifying and stopping 
        potentially suspicious orders.</DELETED>
        <DELETED>    (8) On an annual basis, the Attorney General of 
        the United States is statutorily required to share the 
        controlled substance or substances in schedule II that have the 
        highest rates of abuse and to prepare and make available 
        reports on the distribution patterns of such substances, with 
        State regulatory, licensing, and law enforcement agencies. The 
        Attorney General of the United States has entered into data 
        sharing agreements with the attorneys general of the vast 
        majority of States, Puerto Rico, and the District of Colombia 
        to share, pursuant to State law and policy, data obtained from 
        State prescription drug monitoring programs and other 
        sources.</DELETED>
        <DELETED>    (9) To further reduce barriers associated with 
        identifying suspicious patterns and stopping the diversion of 
        opioids, the remaining States and territories of the United 
        States should enter into similar agreements with, and to the 
        greatest extent practical share data obtained from State 
        prescription drug monitoring programs with, the Attorney 
        General of the United States.</DELETED>

<DELETED>SEC. 3. PURPOSE.</DELETED>

<DELETED>    (a) In General.--The purpose of this Act is to provide 
drug manufacturers and distributors with access to anonymized 
information through the Automated Reports and Consolidated Ordering 
System to help drug manufacturers and distributors identify, report, 
and stop suspicious orders of opioids and reduce diversion 
rates.</DELETED>
<DELETED>    (b) Rule of Construction.--Nothing in this Act should be 
construed to absolve a drug manufacturer, drug distributor, or other 
Drug Enforcement Administration registrant from the responsibility of 
the manufacturer, distributor, or other registrant to--</DELETED>
        <DELETED>    (1) identify, report, and stop suspicious orders; 
        or</DELETED>
        <DELETED>    (2) use all available sources of information to 
        determine--</DELETED>
                <DELETED>    (A) the legitimacy of a customer's order; 
                and</DELETED>
                <DELETED>    (B) whether or not an order described in 
                subparagraph (A) is suspicious.</DELETED>

<DELETED>SEC. 4. AMENDMENTS.</DELETED>

<DELETED>    (a) Records and Reports of Registrants.--Section 307 of 
the Controlled Substances Act (21 U.S.C. 827) is amended--</DELETED>
        <DELETED>    (1) by redesignating subsections (f), (g), and (h) 
        as subsections (g), (h), and (i), respectively;</DELETED>
        <DELETED>    (2) by inserting after subsection (e) the 
        following:</DELETED>
<DELETED>    ``(f)(1) The Attorney General shall, not less frequently 
than quarterly, make the following information available to 
manufacturer and distributor registrants through the Automated Reports 
and Consolidated Ordering System, or any subsequent automated system 
developed by the Drug Enforcement Administration to monitor selected 
controlled substances:</DELETED>
        <DELETED>    ``(A) The total number of distributor registrants 
        that distribute controlled substances to a pharmacy or 
        practitioner registrant, aggregated by the name and address of 
        each pharmacy and practitioner registrant.</DELETED>
        <DELETED>    ``(B) The total quantity and type of opioids 
        distributed, listed by Administration Controlled Substances 
        Code Number, to each pharmacy and practitioner registrant 
        described in subparagraph (A).</DELETED>
<DELETED>    ``(2) The information required to be made available under 
paragraph (1) shall be made available not later than the 15th day of 
the first month following the quarter to which the information 
relates.</DELETED>
<DELETED>    ``(3)(A) All registered manufacturers and distributors 
shall be responsible for reviewing the information made available by 
the Attorney General under this subsection.</DELETED>
<DELETED>    ``(B) In determining whether to initiate proceedings under 
this title against a registered manufacturer or distributor based on 
the failure of the registrant to maintain effective controls against 
diversion or otherwise comply with the requirements of this title or 
the regulations issued thereunder, the Attorney General may take into 
account that the information made available under this subsection was 
available to the registrant.''; and</DELETED>
        <DELETED>    (3) by inserting after subsection (i), as so 
        redesignated, the following:</DELETED>
<DELETED>    ``(j) All of the reports required under this section shall 
be provided in an electronic format.''.</DELETED>
<DELETED>    (b) Cooperative Arrangements.--Section 503 of the 
Controlled Substances Act (21 U.S.C. 873) is amended--</DELETED>
        <DELETED>    (1) by striking subsection (c) and inserting the 
        following:</DELETED>
<DELETED>    ``(c)(1) The Attorney General shall, once every 6 months, 
prepare and make available to regulatory, licensing, attorneys general, 
and law enforcement agencies of States a standardized report containing 
descriptive and analytic information on the actual distribution 
patterns, as gathered through the Automated Reports and Consolidated 
Ordering System, or any subsequent automated system, pursuant to 
section 307 and which include detailed amounts, outliers, and trends of 
distributor and pharmacy registrants, in such States for the controlled 
substances contained in schedule II, which, in the discretion of the 
Attorney General, are determined to have the highest abuse.</DELETED>
<DELETED>    ``(2) If the Attorney General publishes the report 
described in paragraph (1) once every 6 months as required under 
paragraph (1), nothing in this subsection shall be construed to bring 
an action in any court to challenge the sufficiency of the information 
or to compel the Attorney General to produce any documents or reports 
referred to in this subsection.''.</DELETED>
<DELETED>    (c) Civil and Criminal Penalties.--Section 402 of the 
Controlled Substances Act (21 U.S.C. 842) is amended--</DELETED>
        <DELETED>    (1) in subsection (a)--</DELETED>
                <DELETED>    (A) in paragraph (15), by striking ``or'' 
                at the end;</DELETED>
                <DELETED>    (B) in paragraph (16), by striking the 
                period at the end and inserting ``; or''; and</DELETED>
                <DELETED>    (C) by inserting after paragraph (16) the 
                following:</DELETED>
        <DELETED>    ``(17) in the case of a registered manufacturer or 
        distributor of opioids, to fail to review the most recent 
        information made available by the Attorney General in 
        accordance with section 307(f) before each distribution of a 
        controlled substance referred to in such information.''; 
        and</DELETED>
        <DELETED>    (2) in subsection (c)--</DELETED>
                <DELETED>    (A) in paragraph (1), by striking 
                subparagraph (B) and inserting the following:</DELETED>
<DELETED>    ``(B)(i) Except as provided in clause (ii), in the case of 
a violation of paragraph (5), (10), or (17) of subsection (a), the 
penalty shall not exceed $10,000.</DELETED>
<DELETED>    ``(ii) In the case of a violation described in clause (i) 
committed by a registered manufacturer or distributor of opioids and 
related to the reporting of suspicious orders for opioids, failing to 
maintain effective controls against diversion of opioids, or failing to 
review the most recent information made available by the Attorney 
General in accordance with section 307(f), the penalty shall not exceed 
$100,000.''; and</DELETED>
                <DELETED>    (B) in paragraph (2)--</DELETED>
                        <DELETED>    (i) in subparagraph (A), by 
                        inserting ``or (D)'' after ``subparagraph 
                        (B)''; and</DELETED>
                        <DELETED>    (ii) by adding at the end the 
                        following:</DELETED>
<DELETED>    ``(D) In the case of a violation described in subparagraph 
(A) that was a violation of paragraph (5), (10), or (17) of subsection 
(a) committed by a registered manufacturer or distributor of opioids 
that relates to the reporting of suspicious orders for opioids, failing 
to maintain effective controls against diversion of opioids, or failing 
to review the most recent information made available by the Attorney 
General in accordance with section 307(f), the criminal fine under 
title 18, United States Code, shall not exceed $500,000.''.</DELETED>

<DELETED>SEC. 5. REPORT.</DELETED>

<DELETED>    Not later than 1 year after the date of enactment of this 
Act, the Attorney General shall submit to Congress a report that 
provides information about how the Attorney General is using data in 
the Automation of Reports and Consolidated Orders System to identify 
and stop suspicious activity, including whether the Attorney General is 
looking at aggregate orders from individual pharmacies to multiple 
distributors that in total are suspicious, even if no individual order 
rises to the level of a suspicious order to a given 
distributor.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Using Data to Prevent Opioid 
Diversion Act of 2018''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) In 2016, there were nearly 64,000 drug overdose deaths 
        in the United States. More than 42,000 of these deaths were 
        opioid-related.
            (2) The regulations promulgated under the Controlled 
        Substances Act (21 U.S.C. 801 et seq.) require drug 
        manufacturers and distributors to--
                    (A) provide effective controls against the 
                diversion of controlled substances;
                    (B) detect and disclose suspicious orders to the 
                Drug Enforcement Administration; and
                    (C) keep complete and accurate records relating to 
                the manufacture or distribution of controlled 
                substances.
            (3) Despite the requirements described in paragraph (2), it 
        has been publicly reported that between 2006 and 2016, nearly 
        21,000,000 opioids were distributed to 2 pharmacies in 
        Williamson, West Virginia, which has a population of 
        approximately 3,000. It has been further reported that between 
        2007 and 2008, nearly 9,000,000 pills were distributed to a 
        single pharmacy in Kermit, West Virginia, which has a 
        population of 392.
            (4) Similarly, it has been publicly reported that 
        780,000,000 oxycodone and hydrocodone pills were distributed to 
        pharmacies throughout West Virginia between 2007 and 2012. In 
        the same period, more than 1,700 people in the State died from 
        overdoses of these 2 substances.
            (5) Drug manufacturers and distributors are required to 
        report the sale, delivery or other disposal of narcotics to the 
        Drug Enforcement Administration through the Automated Reports 
        and Consolidated Orders System.
            (6) Notwithstanding the reporting requirement described in 
        paragraph (5), the Drug Enforcement Administration does not 
        disclose the total quantity and type of opioids distributed to 
        a single pharmacy or practitioner with those manufacturers and 
        distributors who are required to input information into the 
        Automated Reports and Consolidated Orders System. This creates 
        a barrier to identifying and stopping potentially suspicious 
        orders.
            (7) Although manufacturers and distributors are already 
        required to provide effective controls against the diversion of 
        controlled substances, this lack of data sharing may create a 
        barrier to better identifying and stopping potentially 
        suspicious orders.
            (8) On an annual basis, the Attorney General of the United 
        States is statutorily required to share the controlled 
        substance or substances in schedule II that have the highest 
        rates of abuse and to prepare and make available reports on the 
        distribution patterns of such substances, with State 
        regulatory, licensing, and law enforcement agencies. The 
        Attorney General of the United States has entered into data 
        sharing agreements with the attorneys general of the vast 
        majority of States, Puerto Rico, and the District of Colombia 
        to share, pursuant to State law and policy, data obtained from 
        State prescription drug monitoring programs and other sources.
            (9) To further reduce barriers associated with identifying 
        suspicious patterns and stopping the diversion of opioids, the 
        remaining States and territories of the United States should 
        enter into similar agreements with, and to the greatest extent 
        practical share data obtained from State prescription drug 
        monitoring programs with, the Attorney General of the United 
        States.

SEC. 3. PURPOSE.

    (a) In General.--The purpose of this Act is to provide drug 
manufacturers and distributors with access to anonymized information 
through the Automated Reports and Consolidated Orders System to help 
drug manufacturers and distributors identify, report, and stop 
suspicious orders of opioids and reduce diversion rates.
    (b) Rule of Construction.--Nothing in this Act should be construed 
to absolve a drug manufacturer, drug distributor, or other Drug 
Enforcement Administration registrant from the responsibility of the 
manufacturer, distributor, or other registrant to--
            (1) identify, stop, and report suspicious orders; or
            (2) maintain effective controls against diversion in 
        accordance with section 303 of the Controlled Substances Act 
        (21 U.S.C. 823) or any successor law or associated regulation.

SEC. 4. AMENDMENTS.

    (a) Records and Reports of Registrants.--Section 307 of the 
Controlled Substances Act (21 U.S.C. 827) is amended--
            (1) by redesignating subsections (f), (g), and (h) as 
        subsections (g), (h), and (i), respectively;
            (2) by inserting after subsection (e) the following:
    ``(f)(1) The Attorney General shall, not less frequently than 
quarterly, make the following information available to manufacturer and 
distributor registrants through the Automated Reports and Consolidated 
Orders System, or any subsequent automated system developed by the Drug 
Enforcement Administration to monitor selected controlled substances:
            ``(A) The total number of distributor registrants that 
        distribute controlled substances to a pharmacy or practitioner 
        registrant, aggregated by the name and address of each pharmacy 
        and practitioner registrant.
            ``(B) The total quantity and type of opioids distributed, 
        listed by Administration Controlled Substances Code Number, to 
        each pharmacy and practitioner registrant described in 
        subparagraph (A).
    ``(2) The information required to be made available under paragraph 
(1) shall be made available not later than the 15th day of the first 
month following the quarter to which the information relates.
    ``(3)(A) All registered manufacturers and distributors shall be 
responsible for reviewing the information made available by the 
Attorney General under this subsection.
    ``(B) In determining whether to initiate proceedings under this 
title against a registered manufacturer or distributor based on the 
failure of the registrant to maintain effective controls against 
diversion or otherwise comply with the requirements of this title or 
the regulations issued thereunder, the Attorney General may take into 
account that the information made available under this subsection was 
available to the registrant.''; and
            (3) by inserting after subsection (i), as so redesignated, 
        the following:
    ``(j) All of the reports required under this section shall be 
provided in an electronic format.''.
    (b) Cooperative Arrangements.--Section 503 of the Controlled 
Substances Act (21 U.S.C. 873) is amended--
            (1) by striking subsection (c) and inserting the following:
    ``(c)(1) The Attorney General shall, once every 6 months, prepare 
and make available to regulatory, licensing, attorneys general, and law 
enforcement agencies of States a standardized report containing 
descriptive and analytic information on the actual distribution 
patterns, as gathered through the Automated Reports and Consolidated 
Orders System, or any subsequent automated system, pursuant to section 
307 and which includes detailed amounts, outliers, and trends of 
distributor and pharmacy registrants, in such States for the controlled 
substances contained in schedule II, which, in the discretion of the 
Attorney General, are determined to have the highest abuse.
    ``(2) If the Attorney General publishes the report described in 
paragraph (1) once every 6 months as required under paragraph (1), 
nothing in this subsection shall be construed to bring an action in any 
court to challenge the sufficiency of the information or to compel the 
Attorney General to produce any documents or reports referred to in 
this subsection.''.
    (c) Civil and Criminal Penalties.--Section 402 of the Controlled 
Substances Act (21 U.S.C. 842) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (15), by striking ``or'' at the 
                end;
                    (B) in paragraph (16), by striking the period at 
                the end and inserting ``; or''; and
                    (C) by inserting after paragraph (16) the 
                following:
            ``(17) in the case of a registered manufacturer or 
        distributor of opioids, to fail to review the most recent 
        information, directly related to the customers of the 
        manufacturer or distributor, made available by the Attorney 
        General in accordance with section 307(f).''; and
            (2) in subsection (c)--
                    (A) in paragraph (1), by striking subparagraph (B) 
                and inserting the following:
    ``(B)(i) Except as provided in clause (ii), in the case of a 
violation of paragraph (5), (10), or (17) of subsection (a), the 
penalty shall not exceed $10,000.
    ``(ii) In the case of a violation described in clause (i) committed 
by a registered manufacturer or distributor of opioids and related to 
the reporting of suspicious orders for opioids, failing to maintain 
effective controls against diversion of opioids, or failing to review 
the most recent information made available by the Attorney General in 
accordance with section 307(f), the penalty shall not exceed 
$100,000.''; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (A), by inserting ``or 
                        (D)'' after ``subparagraph (B)''; and
                            (ii) by adding at the end the following:
    ``(D) In the case of a violation described in subparagraph (A) that 
was a violation of paragraph (5), (10), or (17) of subsection (a) 
committed by a registered manufacturer or distributor of opioids that 
relates to the reporting of suspicious orders for opioids, failing to 
maintain effective controls against diversion of opioids, or failing to 
review the most recent information made available by the Attorney 
General in accordance with section 307(f), the criminal fine under 
title 18, United States Code, shall not exceed $500,000.''.

SEC. 5. REPORT.

    Not later than 1 year after the date of enactment of this Act, the 
Attorney General shall submit to Congress a report that provides 
information about how the Attorney General is using data in the 
Automation of Reports and Consolidated Orders System to identify and 
stop suspicious activity, including whether the Attorney General is 
looking at aggregate orders from individual pharmacies to multiple 
distributors that in total are suspicious, even if no individual order 
rises to the level of a suspicious order to a given distributor.
                                                       Calendar No. 476

115th CONGRESS

  2d Session

                                S. 2838

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                             June 19, 2018

                       Reported with an amendment
```