Sec. 3273. AMENDMENTS
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/statute-compilations/comps-15290/sec-3273A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
## SEC. 3273 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 30th 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 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 civil 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.” > .
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