Suspicious Order Identification Act of 2019
This bill requires the Drug Enforcement Administration to implement a program that requires real-time reporting of every sale, delivery, or disposal of any controlled substance (i.e., substances regulated under federal law because of their potential for dependence and addiction).The bill also establishes a Suspicious Order Monitoring Task Force to make recommendations regarding the program. Until the program is operational, the bill also increases the frequency of current reporting requirements.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2686 Introduced in Senate (IS)]
<DOC>
116th CONGRESS
1st Session
S. 2686
To improve reporting of the distribution of controlled substances, and
for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
October 23, 2019
Mr. Gardner (for himself and Mr. Coons) introduced the following bill;
which was read twice and referred to the Committee on the Judiciary
_______________________________________________________________________
A BILL
To improve reporting of the distribution of controlled substances, and
for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Suspicious Order Identification Act
of 2019''.
SEC. 2. STRENGTHENING ARCOS.
Section 307(d) of the Controlled Substances Act (21 U.S.C. 827(d))
is amended to read as follows:
``(1)(A) Every registrant under section 303 shall and in such form
as the Attorney General may require, make reports in electronic format
to the Attorney General of every sale, delivery, or other disposal
(other than by dispensing by a practitioner) by the registrant of any
controlled substance, identifying by the registration number assigned
under this title the person or establishment (unless exempt from
registration under section 302(d)) to whom such sale, delivery, or
other disposal was made.
``(B) Every registrant shall make each report required under
subparagraph (A)--
``(i) not later than 30 days after the sale, delivery, or
other disposal; or
``(ii) after the date on which the real-time reporting
system is established under section 3(e)(3) of the Suspicious
Order Identification Act of 2019 is implemented, in real
time.''.
SEC. 3. SUSPICIOUS ORDERS TASK FORCE.
(a) Definitions.--In this section:
(1) Administrator.--The term ``Administrator'' means the
Administrator of the Drug Enforcement Administration.
(2) Controlled substance; distributor; manufacturer.--The
terms ``controlled substance'', ``distributor'', and
``manufacturer'' have the meanings given those terms in section
102 of the Controlled Substances Act (21 U.S.C. 802).
(3) Real time.--The term ``real time'' means with as little
delay as technically and economically feasible, as determined
by the Attorney General following the program designed under
subsection (e)(1), but not to exceed 24 hours.
(4) Registrant.--The term ``registrant''--
(A) means a person registered under section 303 of
the Controlled Substances Act (21 U.S.C. 823); and
(B) does not include a practitioner.
(b) Establishment.--The Attorney General, in consultation with the
Director of the Office of National Drug Control Policy and the
Secretary of Health and Human Services, shall establish a Suspicious
Order Monitoring Task Force (referred to in this section as the ``Task
Force'').
(c) Composition.--
(1) In general.--The Task Force shall be composed of
appropriate personnel from--
(A) the Department of Justice;
(B) the Drug Enforcement Administration;
(C) the Office of National Drug Control Policy;
(D) the National Institute of Standards and
Technology; and
(E) other appropriate Federal, State, and local law
enforcement and regulatory agencies with experience in
investigating and prosecuting illegal transactions of
controlled substances as determined by the Attorney
General, in consultation with the Secretary of Health
and Human Services.
(2) Consultants.--The Task Force shall consult with--
(A) industry members, including--
(i) data analytic professionals;
(ii) community pharmacies that dispense
controlled substances;
(iii) chain pharmacies that dispense
controlled substances;
(iv) distributors of controlled substances;
(v) manufacturers of controlled substances;
(vi) State and local public health
officials; and
(vii) other relevant industry
professionals; and
(B) relevant industry regulators and entities that
utilize real-time reporting of transactions, orders, or
other activities with the goal of identifying
suspicious activity, such as appropriate personnel from
the Financial Crimes Enforcement Network and money
transfer industry professionals.
(d) Meetings.--
(1) In general.--The Task Force shall meet not less
frequently than 4 times per year and at such other times as may
be determined necessary by the Task Force.
(2) Initial meeting.--Not later than 60 days after the date
of enactment of this Act, the Task Force shall hold the initial
meeting of the Task Force.
(e) Preliminary Order Evaluation Program.--
(1) In general.--
(A) Design.--Not later than 60 days after the date
on which the Task Force holds the initial meeting
required under subsection (d)(2), the Task Force shall
begin to design a program in accordance with paragraph
(2).
(B) Purpose.--The program described in subparagraph
(A) shall be designed to share necessary data, in a
limited capacity, with registrants in order to provide
registrants with information to identify suspicious
ordering in real time.
(C) Deadline for completion.--Not later than 8
months after the date of enactment of this Act, the
Task Force shall complete the design required under
subparagraph (A).
(2) Requirements.--
(A) In general.--The program required under
paragraph (1) shall establish a process for--
(i) transitioning to a requirement to
report in real time to the Attorney General
under section 307(d) of the Controlled
Substances Act (21 U.S.C. 827(d)) every sale,
delivery, or other disposal by a registrant of
any controlled substance;
(ii) limited sharing in real time of
Automation of Reports and Consolidated Orders
System (commonly known as ``ARCOS'') data with
registrants to share necessary data, in a
limited capacity, with registrants in order to
provide registrants with information to
identify suspicious ordering in real time; and
(iii) ensuring data privacy, data de-
identification, protection of trade secrets and
purchasing history.
(B) Other considerations.--In designing the program
under paragraph (1), the Task Force shall take into
consideration--
(i) the inclusion of a waiver process for
pharmacies and other registrants unable to
transmit orders electronically on the date of
enactment of this Act;
(ii) a mechanism to ensure that the costs
of running the program are not passed through
to customers of registrants, unless the
registrants are customer of other registrants;
(iii) technical requirements for ensuring
that registrants may access all relevant de-
identified data, with output provided in a
standard database file format; and
(iv) a mechanism to ensure that the program
required to be designed under subparagraph (A)
is updated based on feedback from industry
members and other relevant entities.
(3) Implementation.--Not later than 1 year after the date
of enactment of this Act, the Attorney General shall--
(A) implement the program designed under paragraph
(1) to collect and share in real time data for
registrants to evaluate the orders of controlled
substances from distributors to manufacturers and from
pharmacies to distributors; or
(B) otherwise implement a program to collect and
share in real time data for drug manufacturers and
distributors, by providing access to anonymized
information to help drug manufacturers and distributors
identify, report, and stop suspicious orders of
controlled substances and reduce diversion rates.
(4) Recommended statutory and regulatory changes.--In
designing the program required under paragraph (1), the Task
Force--
(A) shall submit to the Attorney General any
recommendations for necessary amendments to regulations
of the Department of Justice relating to the
requirements for ordering schedule II controlled
substances, so as to allow uniform electronic ordering
of controlled substances in schedules II, III, IV, and
V electronically through the program; and
(B) may submit to Congress any recommendations for
necessary legislative changes so that a real-time data
analytics solution can be used across the United
States.
(5) Responsibility of registrants.--All registered drug
manufacturers and distributors shall be responsible for
reviewing any information made available by the Attorney
General and complying with any regulations regarding the
program designed under paragraph (1) and implemented under
paragraph (3).
(f) Funding.--
(1) In general.--The Attorney General, acting through the
Administrator, shall use amounts collected as fees for
distributors and registrants under section 303 of the
Controlled Substances Act (21 U.S.C. 823) and section 1007 of
the Controlled Substances Import and Export Act (21 U.S.C. 957)
to carry out this section.
(2) Offset.--
(A) In general.--The Administrator may, on an equal
basis and in accordance with subparagraph (B), increase
the fees described in paragraph (1) for distributors
and registrants to the extent necessary to defray the
costs of this section.
(B) Tiered fee.--The Administrator shall establish
a tiered user fee for distributors and registrants in
proportion to the volume of sales and purchases.
(g) Applicability of FACA.--
(1) In general.--Except as provided in paragraph (2), the
Federal Advisory Committee Act (5 U.S.C. App.) shall apply to
the Task Force.
(2) Termination.--The Task Force shall terminate on the
date on which the program is fully implemented under subsection
(e)(3).
(h) Rules of Construction.--Nothing in this Act shall be construed
as relieving any manufacturer, distributor, or other registrant from
the responsibilities of the manufacturer, distributor, or other
registrant, as the case may be, to--
(1) identify, stop, and report suspicious orders;
(2) maintain effective controls against diversion in
accordance with section 303 of the Controlled Substances Act
(21 U.S.C. 823); and
(3) comply with the requirements established in section
1301.74(b) of title 21, Code of Federal Regulations, or any
successor regulation thereto, with respect to suspicious
orders.
<all>
Introduced in Senate
Read twice and referred to the Committee on the Judiciary.
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