‘‘(c)(1) The Attorney General shall, once every 6 
months, prepare and make available to regulatory, licens-
ing, 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 Consoli-
dated Orders System, or any subsequent automated sys-
tem, pursuant to section 307. Such reports shall 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 discre-
tion of the Attorney General, are determined to have the 
highest abuse. 
‘‘(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 authorize an action to be brought in any 
court to challenge the sufficiency of the information in the 
report or to compel the Attorney General to produce any 
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)— 
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(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 manufacturer or distribu-
tors of opioids registered under this title, 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 accord-
ance with section 307(f).’’; and 
(2) in subsection (c)— 
(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 manufacturer or distributor of opioids reg-
istered under this title and related to the reporting of sus-
picious orders for opioids, failing to maintain effective con-
trols against diversion of opioids, or failing to review the 
most recent information made available by the Attorney 
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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 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 manufacturer or 
distributor of opioids registered under this title that re-
lates to the reporting of suspicious orders for opioids, fail-
ing 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. 4. RULE OF CONSTRUCTION. 
Nothing in this Act should be construed to absolve 
a drug manufacturer, drug distributor, or other Drug En-
forcement Administration registrant from the responsi-
bility of the manufacturer, distributor, or other registrant 
to— 
(1) identify, stop, and report suspicious orders; 
or 
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(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. 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. 
Æ 
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