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<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Ed,<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">The text you quoted is from the part of the proposed regulations that show the DEA’s intent. I think the key language is in the actual proposed regs under
Subpart B, § 1317.70 (f) and § 1317.75 (g) where it says the mail back package or inner liner respectively “…shall not be opened, x-rayed, analyzed, or otherwise penetrated.”
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Burke<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Mr. Burke Lucy<o:p></o:p></span></p>
<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Integrated Waste Management Specialist<o:p></o:p></span></p>
<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Department of Resources Recycling and Recovery (CalRecycle)<o:p></o:p></span></p>
<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">1001 I Street, PO Box 4025<o:p></o:p></span></p>
<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Sacramento, CA 95812<o:p></o:p></span></p>
<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"><a href="mailto:Burke.Lucy@CalRecycle.ca.gov"><span style="color:blue">Burke.Lucy@CalRecycle.ca.gov</span></a><o:p></o:p></span></p>
<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">916.341.6592<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"><o:p> </o:p></span></p>
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<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><b><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif"">From:</span></b><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif""> pharmwaste-bounces@lists.dep.state.fl.us [mailto:pharmwaste-bounces@lists.dep.state.fl.us]
<b>On Behalf Of </b>Ed Gottlieb<br>
<b>Sent:</b> Monday, February 11, 2013 8:53 AM<br>
<b>To:</b> pharmwaste@lists.dep.state.fl.us<br>
<b>Subject:</b> [Pharmwaste] DEA; "may not" = may ?<o:p></o:p></span></p>
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<p class="MsoNormal"><o:p> </o:p></p>
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<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif"">Hi All,<o:p></o:p></span></p>
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<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif""> <o:p></o:p></span></p>
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<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif"">Someone from EPA suggested that I am misinterpreting one part of the DEA draft rules.
<o:p></o:p></span></p>
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<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif"">Because of use of the word "may", he reads the following as actually permitting inventory.<o:p></o:p></span></p>
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<span style="font-size:10.0pt;font-family:"Arial","sans-serif"">"Controlled substances collected by collectors may not be individually counted or inventoried."
</span><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif""><o:p></o:p></span></li></ul>
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<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">Since this may be correct, I am rewording my comment as follows:</span><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black"><o:p></o:p></span></p>
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<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif";color:black"> <o:p></o:p></span></p>
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<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black"> The meaning of this rule is not clear. The use of the word “may" leaves it open to interpretation.
<o:p></o:p></span></p>
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<span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black"><o:p> </o:p></span></p>
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<span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">If what was meant is, "Controlled substances collected by collectors do not have to be individually counted or inventoried." we are very supportive.<o:p></o:p></span></p>
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<span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">Suggestion: Clarify the wording.
<o:p></o:p></span></p>
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<span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black"><o:p> </o:p></span></p>
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<span style="font-size:10.0pt;font-family:"Arial","sans-serif";color:black">If this rule is intended to mean, “must not (or "shall not") be individually counted or inventoried under any circumstances", this will prevent data collection for existing and future
research efforts. <br>
<br>
Suggestion: Provide an exemption to</span><span style="font-size:10.0pt;font-family:"Arial","sans-serif""> this ban on inventorying collected materials under certain circumstances. [We may include specific exemptions as suggested by others.] T<span style="color:black">he
ban on any non-law enforcement person from handling controlled substances at any time would also need to be removed to allow for inventory to occur.<o:p></o:p></span></span></p>
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<span style="font-size:10.0pt;font-family:"Arial","sans-serif""><o:p> </o:p></span></p>
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<span style="font-size:10.0pt;font-family:"Arial","sans-serif"">Our groups’ inventory efforts are done under the watchful eye of law enforcement and produce data that could prove important to setting new prescribing guidelines designed to prevent so much waste
medication from being generated. Medical professionals, mostly pharmacists and pharmacy technicians do the actual counting of doses with the help of a pill counting machine.
<o:p></o:p></span></p>
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<span style="font-size:10.0pt;font-family:"Arial","sans-serif""><o:p> </o:p></span></p>
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<span style="font-size:10.0pt;font-family:"Arial","sans-serif"">Ongoing disposal data for residential and LTC sources, obtained from collection events and drop-boxes, would do more than provide a scientific basis for establishing better prescribing guidelines.
This data could also be used to verify if new prescribing guidelines are having a measurable effect on the amount of waste produced.
<o:p></o:p></span></p>
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<span style="font-size:10.0pt;font-family:"Arial","sans-serif""> <o:p></o:p></span></p>
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<span style="font-size:10.0pt;font-family:"Arial","sans-serif"">Providing exceptions to the ban on inventorying adds a minimal risk of diversion while offering a significant means to gather data important for setting policies to reduce the amount of pharmaceutical
waste produced.</span><o:p></o:p></p>
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<o:p></o:p></p>
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<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:10.0pt;font-family:"Arial","sans-serif"">Ed Gottlieb<o:p></o:p></span></p>
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<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:10.0pt;font-family:"Arial","sans-serif"">Chair Coalition for Safe Medication Disposal<o:p></o:p></span></p>
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<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:10.0pt;font-family:"Arial","sans-serif"">Industrial Pretreatment Coordinator<o:p></o:p></span></p>
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<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:10.0pt;font-family:"Arial","sans-serif"">Ithaca Area Wastewater Treatment Facility<br>
525 3</span><sup>rd</sup><span style="font-size:10.0pt;font-family:"Arial","sans-serif""> Street</span><sup><o:p></o:p></sup></p>
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<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:10.0pt;font-family:"Arial","sans-serif"">Ithaca, NY 14850<o:p></o:p></span></p>
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<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:10.0pt;font-family:"Arial","sans-serif"">(607) 273-8381<o:p></o:p></span></p>
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<p class="MsoNormal" style="margin:0in;margin-bottom:.0001pt"><span style="font-size:10.0pt;font-family:"Arial","sans-serif"">fax: (607) 273-8433<o:p></o:p></span></p>
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