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<div style="direction: ltr;font-family: Tahoma;color: #000000;font-size: 10pt;"><font size="2">Dear
<span style="background-color:white;" lang="en-US"><font face="Times New Roman,serif"><span style="font-size:12pt;"><font color="black">Acting ONDCP Director Michael Botticelli & DEA Administrators,<br>
<br>
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<p class="MsoNormal"><font size="2">Thank you for organizing today’s stakeholders conference call!
</font></p>
<font size="2"></font>
<p class="MsoNormal"><font size="2"><br>
I have additional questions and comments below, including information regarding the applicability of the rules inner liner specifications that I mentioned during the call.<br>
</font><font size="2"><br>
1. In the Media conference call, were you able to stress that the public must know that it will be some time before pharmacies will be able take their medications, and some pharmacies may not take advantage of this opportunity at all? For those living near
a pharmacy that applies to participate, they may have a long wait. </font></p>
<font size="2"></font>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;
margin-left:45.0pt;text-indent:-9.0pt">
<font size="2">A. The law does not take effect until Oct 9. </font></p>
<font size="2"></font>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;
margin-left:45.0pt;text-indent:-9.0pt">
<font size="2">B. The DEA application process to accept controlled substances will take time (more or less depending on the speed of the application process)
</font></p>
<font size="2"></font>
<p class="MsoNormal" style="mso-margin-top-alt:auto;margin-bottom:12.0pt;
margin-left:45.0pt;text-indent:-9.0pt">
<font size="2">C. Implementing a pharmacy program (purchasing/installing boxes & training staff) will also take time. Though it is possible pharmacies have been privately preparing programs, it is likely they have been waiting to read the final rule so they
don't need to redo anything that doesn't meet the requirements of the final Rule.</font></p>
<font size="2"></font>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="2">If this, possibly multi-month, delay is not stressed at every opportunity, I fear a
<b>flood</b> of medications will go into the trash and down a toilet when people, excited by news reports of the new rule, finally bring their unwanted medications in, only to be turned away by their pharmacy. I think a significant number of these frustrated
people will get rid of their medications that day rather than store them, waiting for a local program to start.
<br>
</font><font size="2"><br>
2. The DEA's <span class="st">National Prescription Drug Take-Back Initiative is a tremendously successful program. At the end of today’s call, I heard a speaker reminding us to participate in the “last” DEA Take Back event.
</span></font></p>
<font size="2"></font>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="2"><span class="st">I think it would be a terrible mistake to discontinue the Take-Back program so soon.<span style="mso-spacerun:yes">
</span>Until it is shown that pharmacies, in all areas covered by the DEA Take Back, are acting on this unfunded opportunity, many communities will see a decrease in safe disposal options, possible to none.
<br>
</span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="2"><span class="st"><br>
</span></font></p>
<font size="2"></font>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="2"><span class="st">Many local law enforcement agencies are only able to accept controlled substances because of the Take-Back Initiative. Without it, some would not
have room to securely store the collected medications until they can be properly destroyed. Many have no funds to properly dispose of what they collect, other than the DEA pick-up following Take Back events.</span><br>
</font><font size="2"><br>
</font><font size="2"><span class="st">3. Your efforts to increase the number of convenient, safe disposal options for unwanted household medications are very appreciated!</span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="2"><span class="st"><br>
</span></font></p>
<font size="2"></font>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="2"><span class="st"><span style="mso-bidi-font-weight:normal">4. Inner Liner</span><b>
</b><span style="mso-spacerun:yes"> </span></span></font></p>
<font size="2"></font>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="st"><font size="2">Here are photos (w URL's or attachments in case they don't show up in the body of the email) of the t</font>wo drop-box models law enforcement in
our program are using.</span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><img src="file:///C:\DOCUME~1\EGOTTL~1\LOCALS~1\Temp\msohtml1\01\clip_image002.jpg" alt="Front Access Locking Drop Box with Removable Tote" height="384" width="215"></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><img src="file:///C:\DOCUME~1\EGOTTL~1\LOCALS~1\Temp\msohtml1\01\clip_image004.jpg" height="383" width="288"></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="st">The inner tote (used w/out lid) for the green, narrow-profile box can be seen at:</span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="st"><br>
</span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="st"><a href="http://www.buschsystems.com/wp-content/uploads/2014/02/product-specs-waste-watcher-series-20-gallon-busch-systems.pdf" target="_blank">http://www.buschsystems.com/wp-content/uploads/2014/02/product-specs-waste-watcher-series-20-gallon-busch-systems.pdf</a></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="st"><a href="http://www.buschsystems.com/wp-content/uploads/2014/02/product-specs-waste-watcher-series-20-gallon-busch-systems.pdf" target="_blank"><br>
</a></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="st">Note: The inner totes for these [and other models of collection boxes] are heavy duty, reusable plastic.<span style="mso-spacerun:yes">
</span>They are lined with heavy duty plastic bags, which are sealed before the bag is pulled out of the tote.</span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="st">The bag is immediately put into a hinged lid transport container, pictured here:</span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="st"><span style="mso-spacerun:yes"><br>
</span></span></p>
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<p class="MsoNormal">http://www.globalindustrial.com/p/storage/bins-totes-containers/shipping-security/distribution-container-with-hinged-lid-22x15-1-4x17-1-4-blue</p>
</span></span>
<p></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><a><span style="text-decoration:
none;text-underline:none"><img src="file:///C:\DOCUME~1\EGOTTL~1\LOCALS~1\Temp\msohtml1\01\clip_image005.jpg" alt="Distribution Container With Hinged Lid 21-7/8x15-1/4x17-1/4 Blue" border="0" height="264" width="264"></span></a></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto">This container is sealed with a tamper evident, numbered tag and the weight logged.<span style="mso-spacerun:yes">
</span>The tag is only removed when the contents are delivered for witnessed destruction or custody of the contents is transferred to the DEA.</p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><br>
</p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="st">My understanding, after reading the rule, is the tote, or possibly the plastic bag, needs to be labeled (with a unique number and the volume of the contents) and
be disposed of with the medications.<span style="mso-spacerun:yes"> </span>I don’t see how either of those options are practical.<span style="mso-spacerun:yes">
</span>The rule seems to assume a disposable cardboard box is being used inside the secure box.<span style="mso-spacerun:yes"> None of the many models of commercial boxes I have seen are designed to hold a cardboard box.
<br>
</span></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="st"><span style="mso-spacerun:yes"><br>
</span></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="st">Even if a cardboard box is found that fits inside, that opens the possibility of a glass bottle breaking, puncturing the bag, soaking the box, and causing a spill
and exposure risk.</span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="st"><span style="mso-spacerun:yes"> </span><span style="mso-spacerun:yes">
<br>
</span></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="st">Excerpt from our programs SOP (full SOP attached):</span></p>
<p class="Level2" style="margin-left:.5in;text-align:left;text-indent:
0in;mso-list:l0 level2 lfo1;tab-stops:list .75in" align="left">
<span style="font-size:11.5pt;font-family:"Times New Roman""><span style="mso-list:
Ignore">A.<span style="font:7.0pt "Times New Roman"">
</span></span></span><span style="font-size:11.5pt;font-family:"Times New Roman"">Officers emptying the box must have had blood borne pathogen training.<span style="mso-spacerun:yes">
</span>Officers should request any necessary assistance to isolate and properly dispose of any hazardous material.
<span style="mso-spacerun:yes"> </span></span></p>
<p class="Level2" style="margin-left:.5in;text-align:left;text-indent:
0in;mso-list:l0 level2 lfo1;tab-stops:list .75in" align="left">
<span style="font-size:11.5pt;font-family:"Times New Roman""><span style="mso-list:
Ignore">B.<span style="font:7.0pt "Times New Roman"">
</span></span></span><span style="font-size:11.5pt;font-family:"Times New Roman"">Officers must wear disposable gloves when emptying the box, preferably ones that are resistant to punctures by sharps.</span></p>
<p class="Level2" style="margin-left:.5in;text-align:left;text-indent:
0in;mso-list:l0 level2 lfo1;tab-stops:list .75in" align="left">
<span style="font-size:11.5pt;font-family:"Times New Roman""><span style="mso-list:
Ignore">C.<span style="font:7.0pt "Times New Roman"">
</span></span></span><span style="font-size:11.5pt;font-family:"Times New Roman"">Unlock the box and carefully remove the plastic collection tote.<span style="mso-spacerun:yes">
</span>Seal the liner bag (with a twist tie, tape, or a knot.<span style="mso-spacerun:yes">
</span>Holding the bag from the top and away from the body (to minimize the chance of a sharp puncturing the bag and sticking you) remove it from the tote and place it into a seal-able, hinged lid, storage bin (supplied by the Sheriff.)<span style="mso-spacerun:yes">
</span><span style="mso-spacerun:yes"> </span></span></p>
<p class="Level2" style="margin-left:.5in;text-align:left;text-indent:
0in;mso-list:l0 level2 lfo1;tab-stops:list .75in" align="left">
<span style="font-size:11.5pt;font-family:"Times New Roman""><span style="mso-list:
Ignore">D.<span style="font:7.0pt "Times New Roman"">
</span></span></span><span style="font-size:11.5pt;font-family:"Times New Roman"">Once emptied, a new liner bag (supplied by the Sheriff.) is placed in the tote, which is then returned to the collection box and the box locked.</span></p>
<p class="Level2" style="margin-left:.5in;text-align:left;text-indent:
0in;mso-list:l0 level2 lfo1;tab-stops:list .75in" align="left">
<span style="font-size:11.5pt;font-family:"Times New Roman""><span style="mso-list:
Ignore">E.<span style="font:7.0pt "Times New Roman"">
</span></span></span><span style="font-size:11.5pt;font-family:"Times New Roman"">The storage bin is then weighed (to an accuracy of at least 0.5 pounds) and sealed with a numbered security zip tie.<span style="mso-spacerun:yes">
</span>The officer shall fill out a two part chain of custody form.<span style="mso-spacerun:yes">
</span>The Sheriff will provide each participating agency with a batch of consecutively numbered security tags and chain of custody forms.</span></p>
<p class="Level2" style="margin-left:.5in;text-align:left;text-indent:
0in;mso-list:l0 level2 lfo1;tab-stops:list .75in" align="left">
<span style="font-size:11.5pt;font-family:"Times New Roman""><span style="mso-list:
Ignore">F.<span style="font:7.0pt "Times New Roman"">
</span></span></span><span style="font-size:11.5pt;font-family:"Times New Roman"">The sealed bin can either be stored in the agencies’ evidence room (handling it as if it contained controlled substances) or it can be transferred to the Sheriff (by appointment)
at the County Public Safety Building, 779 Warren Rd, Ithaca.<span style="mso-spacerun:yes">
</span></span></p>
<p class="Level2" style="margin-left:.5in;text-align:left;text-indent:
0in;mso-list:l0 level2 lfo1;tab-stops:list .75in" align="left">
<span style="font-size:11.5pt;font-family:"Times New Roman""><span style="mso-list:
Ignore">G.<span style="font:7.0pt "Times New Roman"">
</span></span></span><span style="font-size:11.5pt;font-family:"Times New Roman"">When a bin is delivered to the Sheriff, the receiving Deputy and delivering Officer will weight the bin and record the transfer on the chain custody form.<span style="mso-spacerun:yes">
</span>The Deputy will also record the delivery in a log book kept in the storage trailer.<span style="mso-spacerun:yes">
</span>Each will retain a copy of the chain of custody form.</span></p>
<p class="Level2" style="margin-left:.5in;text-align:left;text-indent:
0in;mso-list:l0 level2 lfo1;tab-stops:list .75in" align="left">
<span style="font-size:11.5pt;font-family:"Times New Roman""><br>
</span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="st">I hope there is a way that our SOP’s procedures can be approved as acceptable. Please let me know if you have any questions about these points.<br>
</span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="st">I look forward to receiving your response.<span style="mso-spacerun:yes">
</span>Thank you.</span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="st"><br>
</span></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="st"><span style="color:black">Regards,</span></span><span style="color:black"><br>
<br>
Ed Gottlieb<br>
Chair, Coalition for Safe Medication Disposal <br>
Industrial Pretreatment Coordinator <br>
Ithaca Area Wastewater Treatment Facility<br>
525 3<sup>rd</sup> Street<br>
Ithaca, NY 14850<br>
(607) 273-8381<br>
fax: (607) 273-8433</span></p>
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