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<div>To also clarify, I tried to answer the Q from the HH pharms collection and disposal perspective since that is more of the focus of the list serve, but the link at the bottom of my message is all about business pharm waste generated by the health care industry.</div>
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<font color="#000000" size="2" face="Tahoma"><b>From:</b> Grasso, Cheri [Cheri.Grasso@kingcounty.gov]<br>
<b>Sent:</b> Wednesday, June 09, 2010 10:00 AM<br>
<b>To:</b> Volkman, Jennifer (MPCA); Gayle Gray; pharmwaste@lists.dep.state.fl.us<br>
<b>Subject:</b> RE: [Pharmwaste] Question<br>
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<p class="MsoNormal"><font color="navy" size="2" face="Arial"><span style="FONT-FAMILY: Arial; COLOR: navy; FONT-SIZE: 10pt">Sherri/Gayle, is your question about regulations pertaining to pharmaceuticals generated from a business facility or from a medicine
return / take-back program for households? -Cheri</span></font></p>
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<p class="MsoNormal"><strong><b><font color="navy" size="2" face="Arial"><span style="FONT-FAMILY: Arial; COLOR: navy; FONT-SIZE: 10pt">Cheri Grasso
</span></font></b></strong><font color="navy"><span style="COLOR: navy"></span></font></p>
<p class="MsoNormal"><font color="navy" size="1" face="Arial"><span style="FONT-FAMILY: Arial; COLOR: navy; FONT-SIZE: 7.5pt">Pharmaceuticals Project
</span></font><font color="navy"><span style="COLOR: navy"></span></font></p>
<p class="MsoNormal"><font color="navy" size="1" face="Arial"><span style="FONT-FAMILY: Arial; COLOR: navy; FONT-SIZE: 7.5pt">Local Hazardous Waste Management Program in King County</span></font><font color="navy"><span style="COLOR: navy"></span></font></p>
<p class="MsoNormal"><font color="navy" size="1" face="Arial"><span style="FONT-FAMILY: Arial; COLOR: navy; FONT-SIZE: 7.5pt">130 Nickerson Street, Suite 100</span></font><font color="navy" size="1" face="Arial"><span style="FONT-FAMILY: Arial; COLOR: navy; FONT-SIZE: 7.5pt">
| Seattle, WA 98109 | 206-263-3089</span></font><font color="navy"><span style="COLOR: navy"></span></font></p>
<p class="MsoNormal"><font color="navy" size="1" face="Arial"><span style="FONT-FAMILY: Arial; COLOR: navy; FONT-SIZE: 7.5pt">www.lhwmp.org</span></font></p>
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<p class="MsoNormal"><b><font size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; FONT-SIZE: 10pt; FONT-WEIGHT: bold">From:</span></font></b><font size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; FONT-SIZE: 10pt"> Volkman, Jennifer (MPCA) [mailto:Jennifer.Volkman@state.mn.us]
<br>
<b><span style="FONT-WEIGHT: bold">Sent:</span></b> Tuesday, June 08, 2010 6:24 PM<br>
<b><span style="FONT-WEIGHT: bold">To:</span></b> Gayle Gray; pharmwaste@lists.dep.state.fl.us<br>
<b><span style="FONT-WEIGHT: bold">Subject:</span></b> RE: [Pharmwaste] Question</span></font></p>
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<p class="MsoNormal"><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">The answer depends on a lot of factors from the type of collection facility; event vs. permanent; the type of disposal and the state
you are in, among others. I don't think FDA has their finger in the pie if the drugs are not going to be recycled or reused by manufacturers. Each agency has it's own set of regulations and there is not overlap between them. Agencies don't have time to double
regulate or argue over who has precedence, so the roles are defined accordingly and you are stuck working with at least five of them. There are state and federal levels of DEA, EPA and DOT and state and local govt. can be more restrictive than the feds.
If you have state level programs in those areas, you want to work with them vs. federal or regional offices. To date there has not been much specific guidance or federal level regulatory changes to address collection of waste pharms. Here is a start, I think
the first 5 are the most important bases to hit:</span></font></p>
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<p class="MsoNormal"><strong><b><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">DEA</span></font></b></strong><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">:
regulate possession and end management of controlled substance pharms only. The requirements, review and approval of collection programs probably shouldn't, but do vary from state to state depending on state/regional level of support for collection of HH pharms.</span></font></p>
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<p class="MsoNormal"><strong><b><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">EPA/DEQ or state equivalent for RCRA</span></font></b></strong><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">:
specifies which pharms are haz waste and whether they are regulated federally and at the state level as business waste; or at the state or local level as household haz waste. Various management standards apply and these vary from state to state for CESQG's
and HH, with less or no variation for SQG and LQG's.</span></font></p>
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<p class="MsoNormal"><strong><b><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">Boards of Pharmacy</span></font></b></strong><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">:
regulate possession of legend pharmaceuticals and those regulations vary state to state. Our Board Statutes were modified during this past legislative session to allow for possession by certain collection entities and HW transporters and facilities for the
purpose of proper disposal. Their regulations apply to Vet related pharms too.</span></font></p>
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<p class="MsoNormal"><strong><b><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">DOT</span></font></b></strong><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">:
regulates shipping of HW pharms or Haz Mat pharms. Don't regulate non-haz mat pharms.</span></font></p>
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<p class="MsoNormal"><strong><b><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">City or Regional Sewering authority</span></font></b></strong><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">:
may have limitations on the types or quantities of pharms that can be sewered.</span></font></p>
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<p class="MsoNormal"><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt"></span></font> </p>
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<p class="MsoNormal"><strong><b><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">Post Office</span></font></b></strong><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">:
standards apply when using them for mail back programs. I think a household can mail just about anything, but a business cannot collect and mail any HW pharms with the USPS to an interim or end disposal facility.</span></font></p>
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<p class="MsoNormal"><strong><b><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">Board of Vet or Nursing</span></font></b></strong><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">:
no pie for them, they defer to the Board of Pharmacy. I am only 99% sure of that.</span></font></p>
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<p class="MsoNormal"><strong><b><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">JCAHO</span></font></b></strong><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">:
I'm not aware of anything that applies specifically to pharm collections, because they don't generally occur at hospitals, but I'm sure they cover in-house management of pharms. I have not looked that stuff up.</span></font></p>
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<p class="MsoNormal"><strong><b><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">Rules governing hospitals....:</span></font></b></strong><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">
covered above, I believe, between RCRA/Board of Pharm/DOT/DEA</span></font></p>
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<p class="MsoNormal"><strong><b><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">State Survey...</span></font></b></strong><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">:
no idea what that's about, maybe a subpart of one of the regulatory agencies above?</span></font></p>
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<p class="MsoNormal"><strong><b><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">State Pharmacy Associations</span></font></b></strong><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">:
MN's is very supportive of collection, but don't have a regulatory role. </span>
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<p class="MsoNormal"><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt"></span></font> </p>
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<p class="MsoNormal"><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">Non-haz and non-controlled substance pharms have a much lower level of regulation and they make up the majority of the volume, but
since collectors generally want to take in all pharms, they must comply with the management standards for RCRA/DOT/DEA/Board. </span></font></p>
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<p class="MsoNormal"><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt"></span></font> </p>
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<p class="MsoNormal"><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">Many states have website areas devoted to the Health Care Industry, ours is below, but we don't yet have our HH collection information
done since we are in the middle of revising guidance and end disposal options. I am hoping we have info posted by Sept or so:
<a href="http://www.pca.state.mn.us/index.php/waste/waste-and-cleanup/waste-management/industry-specific-waste/health-care-industry.html" target="_blank">
http://www.pca.state.mn.us/index.php/waste/waste-and-cleanup/waste-management/industry-specific-waste/health-care-industry.html</a></span></font></p>
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<p class="MsoNormal"><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">Hopefully that helps for starters. I like the question, I saw some things mentioned (JCAHO for one) that I hadn't thought about.</span></font></p>
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<p style="MARGIN-BOTTOM: 12pt" class="MsoNormal"><b><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt; FONT-WEIGHT: bold">From:</span></font></b><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">
pharmwaste-bounces@lists.dep.state.fl.us [pharmwaste-bounces@lists.dep.state.fl.us] On Behalf Of Gayle Gray [rxrescuepack@gmail.com]<br>
<b><span style="FONT-WEIGHT: bold">Sent:</span></b> Tuesday, June 08, 2010 4:32 PM<br>
<b><span style="FONT-WEIGHT: bold">To:</span></b> pharmwaste@lists.dep.state.fl.us<br>
<b><span style="FONT-WEIGHT: bold">Subject:</span></b> [Pharmwaste] Question</span></font></p>
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<p class="MsoNormal"><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">I don't know if you have to start a new volume for this question, but could you please list it. It would be very helpful.
</span></font></p>
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<p class="MsoNormal"><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt"></span></font> </p>
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<p class="MsoNormal"><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt">Thanks</span></font></p>
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<p class="MsoNormal"><font color="black" size="2" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: black; FONT-SIZE: 10pt"></span></font> </p>
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<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">Help!</span></font></span><font color="black"><span style="COLOR: black"></span></font></p>
<p class="MsoNormal"><font color="black" size="3" face="Times New Roman"><span style="COLOR: black; FONT-SIZE: 12pt"></span></font> </p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">Research has lead me to the understanding of how complicated pharmaceutical disposal is. Below
is a list of the different agencies that I know of that have “their finger in the pie” of pharmaceutical waste. </span></font></span><font color="black"><span style="COLOR: black"></span></font></p>
<p class="MsoNormal"><font color="black" size="3" face="Times New Roman"><span style="COLOR: black; FONT-SIZE: 12pt"></span></font> </p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">Does anyone know which rules and regulations facilities have to assure that they are in full
compliance with more than others? In other words if they work to be in full compliance, for example, with local and Board of Pharmacy rules and regulations would they be safe from repercussion and consequences from the other governing agencies? This is considering
that the facilities hope that the rules and regulations for their local and board of pharmacy rules and regulations would be the same of more strict than the others, therefore if it complies with one it should comply with all?</span></font></span><font color="black"><span style="COLOR: black"></span></font></p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">Does anyone know of other agencies that need to be on the list? I just don’t want to miss any
of the issues that each one addresses.</span></font></span><font color="black"><span style="COLOR: black"></span></font></p>
<p class="MsoNormal"><font color="black" size="3" face="Times New Roman"><span style="COLOR: black; FONT-SIZE: 12pt"></span></font> </p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">DEA</span></font></span><font color="black"><span style="COLOR: black"></span></font></p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">RCRA</span></font></span><font color="black"><span style="COLOR: black"></span></font></p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">DEQ</span></font></span><font color="black"><span style="COLOR: black"></span></font></p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">EPA</span></font></span><font color="black"><span style="COLOR: black"></span></font></p>
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<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">FDA</span></font></span><font color="#500050"><span style="COLOR: #500050"></span></font></p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">DOT</span></font></span><font color="#500050"><span style="COLOR: #500050"></span></font></p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">Hazardous Waste</span></font></span><font color="#500050"><span style="COLOR: #500050"></span></font></p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">US Post Office</span></font></span><font color="#500050"><span style="COLOR: #500050"></span></font></p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">Boards of Pharmacy/Medicine/Nursing</span></font></span><font color="#500050"><span style="COLOR: #500050"></span></font></p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">Boards of Veterinarian Medicine and anything surrounding Veterinarian medicine.</span></font></span><font color="#500050"><span style="COLOR: #500050"></span></font></p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">JCAHO</span></font></span><font color="#500050"><span style="COLOR: #500050"></span></font></p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">State Survey for Health Care Facilities (will have tags that they will survey for pharmaceutical
waste processes and documentation)</span></font></span><font color="#500050"><span style="COLOR: #500050"></span></font></p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">Rules governing Hospitals, Nursing Homes, Assisted Living Centers, Home Health, Hospice that
state how medication must be disposed of.</span></font></span><font color="#500050"><span style="COLOR: #500050"></span></font></p>
<p class="MsoNormal"><font color="#500050" size="3" face="Times New Roman"><span style="COLOR: #500050; FONT-SIZE: 12pt"></span></font> </p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">Thanks for the assistance</span></font></span><font color="#500050"><span style="COLOR: #500050"></span></font></p>
<p class="MsoNormal"><font color="#500050" size="3" face="Times New Roman"><span style="COLOR: #500050; FONT-SIZE: 12pt"></span></font> </p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">Sherri Harward</span></font></span><font color="#500050"><span style="COLOR: #500050"></span></font></p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">Vice President of Research</span></font></span><font color="#500050"><span style="COLOR: #500050"></span></font></p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">Rx Rescue LLC</span></font></span><font color="#500050"><span style="COLOR: #500050"></span></font></p>
<p class="MsoNormal"><font color="#1f497d" size="3" face="Times New Roman"><span style="COLOR: #1f497d; FONT-SIZE: 12pt"><a href="mailto:rxrescuepack@gmail.com"><span class="apple-style-span"><font color="#147dba" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #147dba">rxrescuepack@gmail.com</span></font></span></a></span></font><font color="#500050"><span style="COLOR: #500050"></span></font></p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">P.O. Box</span></font></span><span class="apple-style-span"><font color="#1f497d" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d">
190197</span></font></span><font color="#500050"><span style="COLOR: #500050"></span></font></p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">Boise</span></font></span><span class="apple-style-span"><font color="#1f497d" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d">,
ID 86719-0197</span></font></span><font color="#500050"><span style="COLOR: #500050"></span></font></p>
<p class="MsoNormal"><span class="apple-style-span"><font color="#1f497d" size="3" face="Tahoma"><span style="FONT-FAMILY: Tahoma; COLOR: #1f497d; FONT-SIZE: 12pt">877-408-5777</span></font></span><font color="#500050"><span style="COLOR: #500050"></span></font></p>
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