[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3070 Introduced in Senate (IS)]
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116th CONGRESS
1st Session
S. 3070
To modify reporting requirements under the Controlled Substances Act.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 17, 2019
Mrs. Feinstein (for herself, Mr. Grassley, Mr. Durbin, and Mrs. Capito)
introduced the following bill; which was read twice and referred to the
Committee on the Judiciary
_______________________________________________________________________
A BILL
To modify reporting requirements under the Controlled Substances Act.
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 ``Preventing Pill Mills Through Data
Sharing Act''.
SEC. 2. REPORTING REQUIREMENTS.
(a) Records and Reports of Registrants.--Section 307 of the
Controlled Substances Act (21 U.S.C. 827) is amended--
(1) in subsection (d), by striking ``(d)(1)'' and all that
follows through the end of paragraph (1) and inserting the
following:
``(d)(1)(A) Except as provided in subparagraph (B), every person
registered under section 303 shall, not less frequently than monthly,
make reports to the Attorney General through the Automated Reports and
Consolidated Orders System, or any subsequent automated system
developed by the Drug Enforcement Administration to monitor controlled
substances, of every sale, delivery, or other disposal by the person 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) Subparagraph (A) shall not apply to--
``(i) the retail sale or delivery of a controlled substance
by a pharmacy registered under section 303 to another pharmacy
registered under that section to fulfill a specific patient
need, as defined in section 581 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360eee); or
``(ii) the retail dispensing of a controlled substance by a
pharmacy registered under section 303.
``(C) A person registered under section 303 that does not sell,
deliver, or otherwise dispose of a controlled substance during a month
shall not be required to submit a report for that month under
subparagraph (A).''; and
(2) in subsection (f)--
(A) in paragraph (1)--
(i) in the matter preceding subparagraph
(A)--
(I) by striking ``manufacturer and
distributor registrants'' and inserting
``persons registered under section
303''; and
(II) by striking ``selected'';
(ii) in subparagraph (A)--
(I) by inserting ``or pharmacy''
after ``distributor''; and
(II) by inserting before the period
at the end the following: ``to whom
controlled substances are
distributed''; and
(iii) in subparagraph (B), by striking
``opioids'' and inserting ``controlled
substances'';
(B) in paragraph (2)--
(i) by striking ``made available not
later'' and inserting the following: ``made
available--
``(A) not later'';
(ii) by striking the period at the end and
inserting a semicolon; and
(iii) by adding at the end the following:
``(B) in a format that allows the raw data to be queried
and sorted for analytical purposes; and
``(C) in a manner such that the information may be accessed
simultaneously by more than 1 user at each registered location
of a specific manufacturer, distributor, or pharmacy.''; and
(C) in paragraph (3)--
(i) in subparagraph (A), by striking
``registered manufacturers and distributors''
and inserting ``persons registered under
section 303''; and
(ii) in subparagraph (B), by striking
``registered manufacturer or distributor'' and
inserting ``person registered under section
303''.
(b) Penalties.--
(1) In general.--Section 402 of the Controlled Substances
Act (21 U.S.C. 842) is amended--
(A) in subsection (a), by striking paragraph (17)
and inserting the following:
``(17) in the case of a person registered under section
303, to fail to review the most recent information, directly
related to the customers of the person, made available by the
Attorney General in accordance with section 307(f).''; and
(B) in subsection (c)(1)(B), by striking clause
(ii) and inserting the following:
``(ii) In the case of a violation described in clause (i) committed
by a person registered under section 303 and related to the reporting
of suspicious orders of controlled substances, failing to maintain
effective controls against diversion of such substances, 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.''.
(2) Technical and conforming amendment.--Section 402(a)(16)
of the Controlled Substances Act (21 U.S.C. 842(a)(16)) is
amended by striking ``section 825 of this title'' and inserting
``section 305''.
(c) Automated Reports and Consolidated Orders System.--Section
503(c)(1) of the Controlled Substances Act (21 U.S.C. 873(c)(1)) is
amended--
(1) by inserting after ``of States'' the following: ``, and
to the Committee on the Judiciary of the Senate, the Committee
on Health, Education, Labor, and Pensions of the Senate, the
Caucus on International Narcotics Control of the Senate, the
Committee on the Judiciary of the House of Representatives, and
the Committee on Energy and Commerce of the House of
Representatives,'';
(2) by inserting after ``registrants,'' the following:
``including unusual volumes of controlled substances that are
disposed of rather than sold, and unusual numbers of deleted
transactions of high volumes of controlled substances,''; and
(3) by striking ``contained in schedule II,''.
SEC. 3. REGULATIONS AND GUIDANCE.
Not later than 90 days after the date of enactment of this Act, the
Attorney General shall--
(1) amend part 1304 of title 21, Code of Federal
Regulations, to implement the amendments made by section 2,
including the requirements that--
(A) persons registered under section 303 of the
Controlled Substances Act (21 U.S.C. 823) make the
reports under section 307(d)(1) of that Act (21 U.S.C.
827(d)(1)) on a monthly basis; and
(B) the reports described in subparagraph (A)
include all controlled substances; and
(2) issue guidance to persons described in paragraph (1)(A)
to clarify the meaning of each of the data sets contained in
the Automated Reports and Consolidated Orders System.
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