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<div><font size="+0"><span><b>FOR IMMEDIATE RELEASE</b><b><br>
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<div style="TEXT-ALIGN: center; MARGIN: 0px 0px 5px" align="center"><font size="5" face="Helvetica Neue,Arial,Helvetica,sans-serif"><span style="FONT-SIZE: 30px"><b>Press Release</b></span></font></div>
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<div style="TEXT-ALIGN: center; MARGIN: 0px 0px 5px" align="center"><font color="#0e37a0" size="2" face="Arial,Helvetica,sans-serif"><span style="FONT-SIZE: 16px"><b>DEA proposes reduction to amount of controlled substances to be manufactured in 2018</b></span></font></div>
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<div style="TEXT-ALIGN: justify; MARGIN: 0px" align="left"><font size="+0"><span>AUG 4 - (WASHINGTON) – The U.S. Drug Enforcement Administration is proposing a reduction for controlled substances that may be manufactured in the U.S. next year by 20 percent
as compared to 2017, per the proposed notice being published in the Federal Register on August 7, 2017 and available for public inspection today.</span></font></div>
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<div style="TEXT-ALIGN: justify; MARGIN: 12px 0px" align="left"><font size="+0"><span> The DEA has proposed to reduce more commonly prescribed schedule II opioid painkillers, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, codeine, meperidine
and fentanyl. Demand for these opioid medicines has dropped, according to sales data obtained by DEA from IMS Health, a company that provides insurance companies with data on prescriptions written and prescription medications sold in America.</span></font></div>
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<div style="TEXT-ALIGN: justify; MARGIN: 12px 0px" align="left"><font size="+0"><span>“Physicians, pharmacists, and patients must recognize the inherent risks of these powerful medications, especially for long-term use,” said Acting Administrator Chuck Rosenberg.
“More states are mandating use of prescription drug monitoring programs, which is good, and that has prompted a decrease in opioid prescriptions.”</span></font></div>
<div style="TEXT-ALIGN: justify; MARGIN: 12px 0px" align="left"><font size="+0"><span>The Proposed Aggregate Production Quotas (APQ) for Schedule I and II controlled substances that is being published in the Federal Register reflects the total amount of controlled
substances needed to meet the country’s legitimate medical, scientific, research, industrial, and export needs for the year and for the maintenance of reserve stocks. </span></font></div>
<div style="TEXT-ALIGN: justify; MARGIN: 12px 0px" align="left"><font size="+0"><span>In 2016, the Centers for Disease Control and Prevention issued guidelines to practitioners recommending a reduction in prescribing opioid medications for chronic pain. DEA
and its federal partners have increased efforts in the last several years to educate practitioners, pharmacists, manufacturers, and the public about the dangers associated with the misuse of opioid medications and the importance of properly prescribing.</span></font></div>
<div style="TEXT-ALIGN: justify; MARGIN: 12px 0px" align="left"><font size="+0"><span> When Congress passed the Controlled Substances Act, the quota system was intended to reduce or eliminate diversion from “legitimate channels of trade” by controlling the
quantities of the basic ingredients needed for the manufacture of controlled substances. The purpose of quotas is to provide for an adequate and uninterrupted supply for legitimate medical need of schedule I and schedule II controlled substances, which have
a high potential for abuse, while limiting the amounts available to prevent diversion.</span></font></div>
<div style="TEXT-ALIGN: justify; MARGIN: 12px 0px" align="left"><font size="+0"><span>DEA must balance the production of what is needed for legitimate use against the production of an excessive amount of these potentially harmful substances. DEA establishes
an APQ for more than 250 schedule I and II controlled substances annually.</span></font></div>
<div style="TEXT-ALIGN: justify; MARGIN: 12px 0px" align="left"><font size="+0"><span>In setting the APQ, DEA considers data from many sources, including estimates of the legitimate medical need from the Food and Drug Administration; estimates of retail consumption
based on prescriptions dispensed; manufacturers’ disposition history and forecasts; data from DEA’s own internal system for tracking controlled substance transactions; and past quota histories.</span></font></div>
<div style="TEXT-ALIGN: justify; MARGIN: 12px 0px" align="left"><font size="+0"><span>Once the aggregate quota is set, DEA allocates individual manufacturing and procurement quotas to those manufacturers that apply for them. DEA may revise a company’s quota
at any time during the year if change is warranted due to increased sales or exports; new manufacturers entering the market; new product development; or product recalls. </span></font></div>
<div style="TEXT-ALIGN: justify; MARGIN: 12px 0px" align="left"><font size="+0"><span> The Federal Register notice is available here:<a href="http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTcwODA0Ljc2NjY1MTMxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE3MDgwNC43NjY2NTEzMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MTQ5OTEyJmVtYWlsaWQ9ZWdvdHRsaWViQGNpdHlvZml0aGFjYS5vcmcmdXNlcmlkPWVnb3R0bGllYkBjaXR5b2ZpdGhhY2Eub3JnJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&100&&&https://www.federalregister.gov/documents/2017/08/07/2017-16439/established-aggregate-production-quotas-for-schedule-i-and-ii-controlled-substances-assessment-of" target="_blank"><font color="#1d5782" face="Helvetica Neue,Arial,Helvetica,sans-serif">https://www.federalregister.gov/documents/2017/08/07/2017-16439/established-aggregate-production-quotas-for-schedule-i-and-ii-controlled-substances-assessment-of</font></a>.</span></font></div>
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<div style="FONT-SIZE: 13px; FONT-FAMILY: Tahoma"><font size="+0"><span lang="en-US">
<div><font size="2">Ed Gottlieb<br>
Chair, Coalition for Safe Medication Disposal<br>
Board Member, New York Product Stewardship Council<br>
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<div><font size="2">Industrial Pretreatment Coordinator</font></div>
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<div><font size="2">Ithaca Area Wastewater Treatment Facility</font><br>
<font size="2">525 3</font><sup>rd</sup><font size="2"> Street</font></div>
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<div><font size="2">Ithaca, NY 14850</font></div>
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<div><font size="2">(607) 273-8381</font></div>
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<div><font size="2">fax: (607) 273-8433</font></div>
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