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<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>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<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<div>
<p class=MsoNormal><strong><b><font size=2 color=navy face=Arial><span
style='font-size:10.0pt;font-family:Arial;color:navy'>Cheri Grasso </span></font></b></strong><font
color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=1 color=navy face=Arial><span style='font-size:
7.5pt;font-family:Arial;color:navy'>Pharmaceuticals Project </span></font><font
color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=1 color=navy face=Arial><span style='font-size:
7.5pt;font-family:Arial;color:navy'>Local Hazardous Waste Management Program in
<st1:place w:st="on"><st1:PlaceName w:st="on">King</st1:PlaceName> <st1:PlaceType
w:st="on">County</st1:PlaceType></st1:place></span></font><font color=navy><span
style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><st1:Street w:st="on"><st1:address w:st="on"><font size=1
color=navy face=Arial><span style='font-size:7.5pt;font-family:Arial;
color:navy'>130 Nickerson Street, Suite 100</span></font></st1:address></st1:Street><font
size=1 color=navy face=Arial><span style='font-size:7.5pt;font-family:Arial;
color:navy'> | <st1:place w:st="on"><st1:City w:st="on">Seattle</st1:City>, <st1:State
w:st="on">WA</st1:State> <st1:PostalCode w:st="on">98109</st1:PostalCode></st1:place>
| 206-263-3089</span></font><font color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=1 color=navy face=Arial><span style='font-size:
7.5pt;font-family:Arial;color:navy'>www.lhwmp.org</span></font><o:p></o:p></p>
</div>
<div>
<div class=MsoNormal align=center style='text-align:center'><font size=3
face="Times New Roman"><span style='font-size:12.0pt'>
<hr size=2 width="100%" align=center tabindex=-1>
</span></font></div>
<p class=MsoNormal><b><font size=2 face=Tahoma><span style='font-size:10.0pt;
font-family:Tahoma;font-weight:bold'>From:</span></font></b><font size=2
face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma'> 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><o:p></o:p></p>
</div>
<p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size:
12.0pt'><o:p> </o:p></span></font></p>
<div>
<div>
<p class=MsoNormal><font size=2 color=black face=Tahoma><span style='font-size:
10.0pt;font-family:Tahoma;color:black'>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:<o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><font size=2 color=black face=Tahoma><span style='font-size:
10.0pt;font-family:Tahoma;color:black'> <o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><strong><b><font size=2 color=black face=Tahoma><span
style='font-size:10.0pt;font-family:Tahoma;color:black'>DEA</span></font></b></strong><font
size=2 color=black face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma;
color:black'>: 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.<o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><strong><b><font size=2 color=black face=Tahoma><span
style='font-size:10.0pt;font-family:Tahoma;color:black'>EPA/DEQ or state
equivalent for RCRA</span></font></b></strong><font size=2 color=black
face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma;color:black'>:
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.<o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><strong><b><font size=2 color=black face=Tahoma><span
style='font-size:10.0pt;font-family:Tahoma;color:black'>Boards of Pharmacy</span></font></b></strong><font
size=2 color=black face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma;
color:black'>: 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.<o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><strong><b><font size=2 color=black face=Tahoma><span
style='font-size:10.0pt;font-family:Tahoma;color:black'>DOT</span></font></b></strong><font
size=2 color=black face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma;
color:black'>: regulates shipping of HW pharms or Haz Mat pharms. Don't
regulate non-haz mat pharms.<o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><strong><b><font size=2 color=black face=Tahoma><span
style='font-size:10.0pt;font-family:Tahoma;color:black'>City or Regional
Sewering authority</span></font></b></strong><font size=2 color=black
face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma;color:black'>: may
have limitations on the types or quantities of pharms that can be sewered.<o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><font size=2 color=black face=Tahoma><span style='font-size:
10.0pt;font-family:Tahoma;color:black'> <o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><strong><b><font size=2 color=black face=Tahoma><span
style='font-size:10.0pt;font-family:Tahoma;color:black'>Post Office</span></font></b></strong><font
size=2 color=black face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma;
color:black'>: 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.<o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><strong><b><font size=2 color=black face=Tahoma><span
style='font-size:10.0pt;font-family:Tahoma;color:black'>Board of Vet or Nursing</span></font></b></strong><font
size=2 color=black face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma;
color:black'>: no pie for them, they defer to the Board of Pharmacy. I am
only 99% sure of that.<o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><strong><b><font size=2 color=black face=Tahoma><span
style='font-size:10.0pt;font-family:Tahoma;color:black'>JCAHO</span></font></b></strong><font
size=2 color=black face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma;
color:black'>: 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.<o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><strong><b><font size=2 color=black face=Tahoma><span
style='font-size:10.0pt;font-family:Tahoma;color:black'>Rules governing
hospitals....:</span></font></b></strong><font size=2 color=black face=Tahoma><span
style='font-size:10.0pt;font-family:Tahoma;color:black'> covered above, I
believe, between RCRA/Board of Pharm/DOT/DEA<o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><strong><b><font size=2 color=black face=Tahoma><span
style='font-size:10.0pt;font-family:Tahoma;color:black'>State Survey...</span></font></b></strong><font
size=2 color=black face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma;
color:black'>: no idea what that's about, maybe a subpart of one of the
regulatory agencies above?<o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><strong><b><font size=2 color=black face=Tahoma><span
style='font-size:10.0pt;font-family:Tahoma;color:black'>State Pharmacy
Associations</span></font></b></strong><font size=2 color=black face=Tahoma><span
style='font-size:10.0pt;font-family:Tahoma;color:black'>: MN's is very
supportive of collection, but don't have a regulatory role. <o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><font size=2 color=black face=Tahoma><span style='font-size:
10.0pt;font-family:Tahoma;color:black'> <o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><font size=2 color=black face=Tahoma><span style='font-size:
10.0pt;font-family:Tahoma;color:black'>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. <o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><font size=2 color=black face=Tahoma><span style='font-size:
10.0pt;font-family:Tahoma;color:black'> <o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><font size=2 color=black face=Tahoma><span style='font-size:
10.0pt;font-family:Tahoma;color:black'>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">http://www.pca.state.mn.us/index.php/waste/waste-and-cleanup/waste-management/industry-specific-waste/health-care-industry.html</a><o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><font size=2 color=black face=Tahoma><span style='font-size:
10.0pt;font-family:Tahoma;color:black'> <o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><font size=2 color=black face=Tahoma><span style='font-size:
10.0pt;font-family:Tahoma;color:black'>Hopefully that helps for starters.
I like the question, I saw some things mentioned (JCAHO for one) that I hadn't
thought about.<o:p></o:p></span></font></p>
</div>
<div id=divRpF700035>
<div class=MsoNormal align=center style='text-align:center'><font size=2
color=black face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma;
color:black'>
<hr size=2 width="100%" align=center tabindex=-1>
</span></font></div>
<p class=MsoNormal style='margin-bottom:12.0pt'><b><font size=2 color=black
face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma;color:black;
font-weight:bold'>From:</span></font></b><font size=2 color=black face=Tahoma><span
style='font-size:10.0pt;font-family:Tahoma;color:black'>
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<o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><font size=2 color=black face=Tahoma><span style='font-size:
10.0pt;font-family:Tahoma;color:black'>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. <o:p></o:p></span></font></p>
<div>
<p class=MsoNormal><font size=2 color=black face=Tahoma><span style='font-size:
10.0pt;font-family:Tahoma;color:black'><o:p> </o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><font size=2 color=black face=Tahoma><span style='font-size:
10.0pt;font-family:Tahoma;color:black'>Thanks<o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><font size=2 color=black face=Tahoma><span style='font-size:
10.0pt;font-family:Tahoma;color:black'><o:p> </o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>Help!</span></font></span><font
color=black><span style='color:black'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'> <o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>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'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'><o:p> </o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>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'><o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>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'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'><o:p> </o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>DEA</span></font></span><font
color=black><span style='color:black'><o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>RCRA</span></font></span><font
color=black><span style='color:black'><o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>DEQ</span></font></span><font
color=black><span style='color:black'><o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>EPA</span></font></span><font
color=black><span style='color:black'><o:p></o:p></span></font></p>
<div>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>FDA</span></font></span><font
color="#500050"><span style='color:#500050'><o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>DOT</span></font></span><font
color="#500050"><span style='color:#500050'><o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>Hazardous
Waste</span></font></span><font color="#500050"><span style='color:#500050'><o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>US
Post Office</span></font></span><font color="#500050"><span style='color:#500050'><o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>Boards
of Pharmacy/Medicine/Nursing</span></font></span><font color="#500050"><span
style='color:#500050'><o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>Boards
of Veterinarian Medicine and anything surrounding Veterinarian medicine.</span></font></span><font
color="#500050"><span style='color:#500050'><o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>JCAHO</span></font></span><font
color="#500050"><span style='color:#500050'><o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>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'><o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>Rules
governing Hospitals, Nursing Homes, <st1:place w:st="on"><st1:PlaceName w:st="on">Assisted</st1:PlaceName>
<st1:PlaceName w:st="on">Living</st1:PlaceName> <st1:PlaceType w:st="on">Centers</st1:PlaceType></st1:place>,
Home Health, Hospice that state how medication must be disposed of.</span></font></span><font
color="#500050"><span style='color:#500050'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=3 color="#500050" face="Times New Roman"><span
style='font-size:12.0pt;color:#500050'> <o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>Thanks
for the assistance</span></font></span><font color="#500050"><span
style='color:#500050'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=3 color="#500050" face="Times New Roman"><span
style='font-size:12.0pt;color:#500050'> <o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>Sherri
Harward</span></font></span><font color="#500050"><span style='color:#500050'><o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>Vice
President of Research</span></font></span><font color="#500050"><span
style='color:#500050'><o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>Rx
Rescue LLC</span></font></span><font color="#500050"><span style='color:#500050'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=3 color="#1f497d" face="Times New Roman"><span
style='font-size:12.0pt;color:#1F497D'><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'><o:p></o:p></span></font></p>
<p class=MsoNormal><st1:address w:st="on"><st1:Street w:st="on"><span
class=apple-style-span><font size=3 color="#1f497d" face=Tahoma><span
style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>P.O. Box</span></font></span></st1:Street><span
class=apple-style-span><font color="#1f497d" face=Tahoma><span
style='font-family:Tahoma;color:#1F497D'> 190197</span></font></span></st1:address><font
color="#500050"><span style='color:#500050'><o:p></o:p></span></font></p>
<p class=MsoNormal><st1:place w:st="on"><st1:City w:st="on"><span
class=apple-style-span><font size=3 color="#1f497d" face=Tahoma><span
style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>Boise</span></font></span></st1:City><span
class=apple-style-span><font color="#1f497d" face=Tahoma><span
style='font-family:Tahoma;color:#1F497D'>, <st1:State w:st="on">ID</st1:State>
<st1:PostalCode w:st="on">86719-0197</st1:PostalCode></span></font></span></st1:place><font
color="#500050"><span style='color:#500050'><o:p></o:p></span></font></p>
<p class=MsoNormal><span class=apple-style-span><font size=3 color="#1f497d"
face=Tahoma><span style='font-size:12.0pt;font-family:Tahoma;color:#1F497D'>877-408-5777</span></font></span><font
color="#500050"><span style='color:#500050'><o:p></o:p></span></font></p>
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