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<div style="direction: ltr;font-family: Tahoma;color: #000000;font-size: 10pt;">FYI,
<br>
<br>
I just sent this letter to DEA Division Director Arnold. He supervised the writing of the new take back rule.<br>
<br>
Ed<br>
<br>
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<p class="MsoNormal">Dear Director Arnold,</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">After seeing yet another news story about a new drop box being installed
<u>outside</u> a law enforcement building, I wrote a letter to the editor (see below), with the intention of sending it to some widely read law enforcement publications.</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">I realized that this sort of outreach really should come from the DEA.<span style="mso-spacerun:yes">
</span>Please consider how you can effectively communicate the basic requirements of the new Controlled Take Back Rule to law enforcement agencies.<span style="mso-spacerun:yes">
</span>If that includes the use of letters to the editor, you are welcome to copy any, or all, of my letter.</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">Regarding a previously submitted question, I still hope for your response regarding the acceptability of a small, frosted Plexiglas view port to detect the fill level of a drop box without unlocking it.<span style="mso-spacerun:yes">
</span>If personal information can't be read through the view port, is such a feature acceptable?</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">Thanks for your consideration of both these issues!<span style="mso-spacerun:yes">
</span>I look forward to your response.</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">Sincerely,</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">Ed Gottlieb</p>
<p class="MsoNormal">Chair, Coalition for Safe Medication Disposal</p>
<p class="MsoNormal">Industrial Pretreatment Coordinator</p>
<p class="MsoNormal">Ithaca Area Wastewater Treatment Facility</p>
<p class="MsoNormal">525 3rd Street</p>
<p class="MsoNormal">Ithaca, NY<span style="mso-spacerun:yes"> </span>14850</p>
<p class="MsoNormal">(607) 273-8381</p>
<p class="MsoNormal">fax: (607) 273-8433</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal"><b style="mso-bidi-font-weight:normal">Pharmaceutical Drop Box Programs Need Review</b></p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">Providing the public with convenient ways to dispose of unwanted medications, especially controlled substances, is an important public service.<span style="mso-spacerun:yes">
</span>Removing unwanted pharmaceuticals from homes decreases the likelihood of illegal diversion, accidental overdose, and environmental contamination.</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">After the US Drug Enforcement Agency (DEA) established the Take Back Initiative in 2010, what had been a small number of existing law enforcement collection events quickly multiplied.<span style="mso-spacerun:yes">
</span>The ninth and final DEA event, on September 27, 2014, included 4,076 agencies collecting 309 tons of unwanted medications at 5,495 sites in just four hours!
</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">To increase disposal convenience, a steadily growing number of law enforcement agencies (and pharmacies, mainly for non-controlled collection[JPL1] ) have installed permanent drop boxes at their locations.<span style="mso-spacerun:yes">
</span>Thanks to wide community support, and some limited funding from state agencies and others, new drop boxes continue to be installed.
</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">Kudos to all of you that have taken the lead on this important issue!<span style="mso-spacerun:yes">
</span></p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">But, are you aware that your drop box program may need to be modified to be compliant with recent changes to federal take back rules?<span style="mso-spacerun:yes">
</span>This letter was inspired by reading multiple stories of new drop boxes being installed that are in violation of a new federal rule.
</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">Late in 2014, the DEA issued a rule regulating the take back of controlled substances.<span style="mso-spacerun:yes">
</span>[http://www.deadiversion.usdoj.gov/drug_disposal/fact_sheets/disposal_public.pdf]</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">The big change is that pharmacies can now apply to take back controlled pharmaceuticals.<span style="mso-spacerun:yes">
</span>Since the rule does not require participation, and provides no funding, it may be quite some time before a pharmacy near you participates.<span style="mso-spacerun:yes">
</span>Law enforcement programs remain the primary method for safe disposal.</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">I want to mention that once the new rule was in place, the DEA announced the end of the hugely successful Take Back Initiative.<span style="mso-spacerun:yes">
</span>That decision has left many law enforcement agencies struggling to find funding to keep their one day and/or drop box collection programs going.<span style="mso-spacerun:yes">
</span>It is going to be a tough transition time. </p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">Back to my main point...the rule also specifies how law enforcement collects controlled substances.<span style="mso-spacerun:yes">
</span>Please take the time to make sure your program is in compliance with the new rule.<span style="mso-spacerun:yes">
</span>To find the references below, the full rule is located at: http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/2014-20926.pdf</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">Here are a few details, specific to law enforcement, which should be part of your review check list.
</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">1. Boxes must be inside buildings.<span style="mso-spacerun:yes">
</span>The DEA is looking for active monitoring.</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">§ 1317.35 Collection by law enforcement. (3) Collection receptacles located inside law enforcement's physical address.<span style="mso-spacerun:yes">
</span>Also:</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">§ 1317.75 Collection receptacles (d) (1) Inside a collector's registered location, inside law enforcement's physical location, or at an authorized long-term care facility;</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">2. Signage must indicate that Schedule II-V controlled and non-controlled substances are acceptable and that Schedule I controlled is not. [§ 1317.75 (e) (4)].<span style="mso-spacerun:yes">
</span>(I had to add this wording to my programs signage using stickers.)</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">3. Collected medications must be “stored in a manner that prevents the diversion of controlled substances and is consistent with that agency's standard procedures…” [§ 1317.35 (c)]<span style="mso-spacerun:yes">
</span>(We wrote an SOP specifying that inventory of the contents was not necessary.<span style="mso-spacerun:yes">
</span>Identifying and counting so many controlled substances isn’t practical.<span style="mso-spacerun:yes">
</span>This also cleared to way to be in compliance with our state accreditation rules.)</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">4. The box must contain an opaque inner liner that, upon removal, must be labeled as specified in your departments SOP.<span style="mso-spacerun:yes">
</span>If custody is to be transferred to a reverse distributor, a specific list of labeling requirements must be followed. [§ 1317.35]</p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">For those of you holding take back events, you can authorize non-law enforcement personnel to assist with required, and voluntary, activities including:<span style="mso-spacerun:yes">
</span>receiving, weighing, separating controlled from non-controlled, removing unacceptable items (sharps, mercury), inventorying, etc. [Executive Summary: J. Prohibition on Handling, Sorting, and Inventorying Inner Liner Contents and Mail-Back Package Contents;
Response to Issues 2 & 3,] </p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">If you have any questions about the rule, you should contact your DEA field office.<span style="mso-spacerun:yes">
</span>I’d also be happy to try and answer your questions.<span style="mso-spacerun:yes">
</span>Please let me know if your DEA field office says something in conflict with your reading of the rule.<span style="mso-spacerun:yes">
</span>Thank you.<span style="mso-spacerun:yes"> </span></p>
<p class="MsoNormal"> </p>
<p class="MsoNormal">Keep up the good work!</p>
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