‘‘(2) If the Attorney General publishes the report de-
scribed 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 pe-
riod 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)— 
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(A) in paragraph (1), by striking subpara-
graph (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 ac-
cordance 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 fol-
lowing: 
‘‘(D) In the case of a violation described in subpara-
graph (A) that was a violation of paragraph (5), (10), or 
(17) of subsection (a) committed by a registered manufac-
turer or distributor of opioids that relates to the reporting 
of suspicious orders for opioids, failing to maintain effec-
tive controls against diversion of opioids, or failing to re-
view the most recent information made available by the 
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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 sus-
picious 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. 
SEC. 6. IMPROVEMENTS TO PREVENT DRUG DIVERSION. 
(a) DEFINITION.— 
(1) IN
GENERAL.—Section 102 of the Con-
trolled Substances Act (21 U.S.C. 802) is amended 
by adding at the end the following: 
‘‘(57) The term ‘suspicious order’ includes— 
‘‘(A) an order of a controlled substance of 
unusual size; 
‘‘(B) an order of a controlled substance de-
viating substantially from a normal pattern; 
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‘‘(C) orders of controlled substances of un-
usual frequency; and 
‘‘(D) an order or pattern of orders of a 
controlled substance that meet such other cri-
teria as are established by the Attorney General 
by regulation.’’. 
(2) REGULATIONS.—Not later than 1 year after 
the date of enactment of this Act, the Attorney Gen-
eral shall promulgate regulations under paragraph 
(57)(D) of section 102 of the Controlled Substances 
Act, as added by paragraph (1) of this subsection. 
(b) SUSPICIOUS ORDERS.—Part C of the Controlled 
Substances Act (21 U.S.C. 821 et seq.) is amended by 
adding at the end the following: 
‘‘SEC. 312. SUSPICIOUS ORDERS. 
‘‘(a) REPORTING.—Each registrant shall— 
‘‘(1) design and operate a system to identify 
suspicious orders for the registrant; 
‘‘(2) ensure that the system designed and oper-
ated under paragraph (1) by the registrant complies 
with applicable Federal and State privacy laws; and 
‘‘(3) upon discovering a suspicious order or se-
ries of orders, notify the Administrator of the Drug 
Enforcement Administration and the Special Agent 
in Charge of the Division Office of the Drug En-
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forcement Administration for the area in which the 
registrant is located or conducts business. 
‘‘(b) SUSPICIOUS ORDER DATABASE.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this section, the Attorney 
General shall establish a centralized database for 
collecting reports of suspicious orders. 
‘‘(2) SATISFACTION OF REPORTING REQUIRE-
MENTS.—If a registrant reports a suspicious order 
to the centralized database established under para-
graph (1), the registrant shall be considered to have 
complied with the requirement under subsection 
(a)(3) to notify the Administrator of the Drug En-
forcement Administration and the Special Agent in 
Charge of the Division Office of the Drug Enforce-
ment Administration for the area in which the reg-
istrant is located or conducts business. 
‘‘(c) SHARING INFORMATION WITH THE STATES.— 
‘‘(1) IN GENERAL.—The Attorney General shall 
prepare and make available information regarding 
suspicious orders in a State, including information 
in the database established under subsection (b)(1), 
to the point of contact for purposes of administra-
tive, civil, and criminal oversight relating to the di-
version of controlled substances for the State, as 
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designated by the Governor or chief executive officer 
of the State. 
‘‘(2) TIMING.—The Attorney General shall pro-
vide information in accordance with paragraph (1) 
within a reasonable period of time after obtaining 
the information. 
‘‘(3) COORDINATION.—In establishing the proc-
ess for the provision of information under this sub-
section, the Attorney General shall coordinate with 
States to ensure that the Attorney General has ac-
cess to information, as permitted under State law, 
possessed by the States relating to prescriptions for 
controlled substances that will assist in enforcing 
Federal law.’’. 
(c) REPORTS TO CONGRESS.— 
(1) DEFINITION.—In this subsection, the term 
‘‘suspicious order’’ has the meaning given that term 
in section 102 of the Controlled Substances Act, as 
amended by this Act. 
(2) ONE TIME REPORT.—Not later than 1 year 
after the date of enactment of this Act, the Attorney 
General shall submit to Congress a report on the re-
porting of suspicious orders, which shall include— 
(A) a description of the centralized data-
base established under section 312 of the Con-
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(B) a summary of actions taken in re-
sponse to reports, in the aggregate, of sus-
picious orders; and 
(C) a description of the information shared 
with States based on reports of suspicious or-
ders. 
Æ 
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