[Pharmwaste] Pharmaceutical Waste
Stevan Gressitt
gressitt@uninets.net
Mon, 24 Jan 2005 13:22:05 -0500
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Such a database or rather a cross-walk is what the next step is for the
Unused Registry. NDC I believe is covered by the Orange Book available at
the FDA for downloading. It is not bedtime reading though. Or rather maybe
that is what it should be. The problem we are running into is the disposal
listing. I suspect it is already in existence in the Reverse Distributor's
computers but all proprietary. Given the number of different molecules in
most pharmaceuticals including things such as coatings, binders, etc, the
question is how many of those other compounds need to be considered beyond
the so called "active ingredient." Vaccines certainly are an example of
that, but beyond that I suspect it is actually quite a small number. If
anyone does come up with information for cross-walking NDC to RCRA, we would
be quite interested in hearing about it. Stevan Gressitt
_____
From: pharmwaste-admin@lists.dep.state.fl.us
[mailto:pharmwaste-admin@lists.dep.state.fl.us] On Behalf Of Grasso, Cheri
Sent: Monday, January 24, 2005 11:30 AM
To: 'Proffitt, Leah'; Johnson, Emma (ECY); pharmwaste@lists.dep.state.fl.us
Subject: RE: [Pharmwaste] Pharmaceutical Waste
The FDA decided not to require the bar code to have RCRA information because
they thought it could be linked with the National Drug Code (NDC) in the
database that hospitals will use to get the drug information. The good news
is that enough of us made comments that the FDA mentioned them in the rule.
See Federal Register, Vol. 69, No. 38 page 9135.
After this ruling, I spoke with Philip Chao, the FDA rep on this rule. He
said the FDA's role is to make make the NDC available to those that will
build the database. He didn't know who would build the database or what form
it would take -- that would have to be worked out privately. FDA's vision
was whoever built the database with the NDC info into it could add the RCRA
info that would be linked to the NDC information. He guessed the key players
may be the UCC (Uniform Commercial Code) & manufacturers. I followed up on
the contact he gave me who knew about this database, Allen Goldhammer of
PhRMA. Allen said PhRMA was not developing this theoretical database for
other manufacturers and didn't know who was.
To date I have not yet been able to locate anyone who knows about this
database. If anyone out there has any information or ideas on this national
database, please let me know. I would be happy to follow up on them.
Cheri B. Grasso
Environmental & Health Investigator, II
Local Hazardous Waste Management Program
130 Nickerson Street, Suite 100
Seattle, WA 98109
(206) 263-3089
cheri.grasso@metrokc.gov
-----Original Message-----
From: Proffitt, Leah [mailto:Leah.Proffitt@dep.state.fl.us]
Sent: Wednesday, January 19, 2005 8:26 AM
To: Johnson, Emma (ECY); pharmwaste@lists.dep.state.fl.us
Subject: RE: [Pharmwaste] Pharmaceutical Waste
Hi everyone,
On a completely different note, has anyone heard what happened to a proposal
to amend barcoding on drugs to include RCRA disposal requirements (see
attachment)? I believe our Office of General Counsel commented on this on
behalf of Florida DEP (at least I know I forwarded it to them!), but I never
heard what, if anything, became of it.
Leah D. Proffitt
Environmental Specialist
FDEP Central District
Hazardous Waste
(407) 893-3323
S/C 325-2283
-----Original Message-----
From: pharmwaste-admin@lists.dep.state.fl.us
[mailto:pharmwaste-admin@lists.dep.state.fl.us]On Behalf Of Johnson, Emma
(ECY)
Sent: Wednesday, January 19, 2005 10:55 AM
To: pharmwaste@lists.dep.state.fl.us
Subject: RE: [Pharmwaste] Pharmaceutical Waste
Others have tried this approach, I believe. The way that the Controlled
Substances Act works basically exempts the end user from the closed loop
accounting system that DEA mandates. However, as soon as you return those
substances to a pharmacy (for instance) the DEA is going to care, and you
would need to make sure that the regulators are on board for what
'unrecoverable' means.
I'm not sure if the gains of using these kits would pay off either,
especially if you were having a person sort the drugs based on their
'controlled' status (asking the consumer to hand over their medication to
you, identifying the pharmaceutical, unscrewing the top, pouring it in,
etc.) You may also be adding significant weight to your shipment of
hazardous waste, which would cost more.
However, I agree the way out of the DEA Controlled Substances Act is to come
up with a take-back scenario that is secure and ensures final disposal, with
approval from your state board of pharmacy and the DEA (not particularly
easy). This is something we're working on in Washington...
Emma Johnson
Washington State Department of Ecology
-----Original Message-----
From: Ann Heil [mailto:aheil@lacsd.org]
Sent: Wednesday, January 19, 2005 7:33 AM
To: 'Charlotte A. Smith'; 'Chapman, Alice'; 'Bill Lewry';
pharmwaste@lists.dep.state.fl.us
Subject: RE: [Pharmwaste] Pharmaceutical Waste
What if we had a handy way to render controlled substances nonrecoverable?
Let's speculate that we had some sort of small kit, containing a bitter
liquid into which liquid drugs could be poured, and a quick setting cement
into which solid drugs could be placed. Could we get around controlled
substance regs by having the person dropping them off apply this kit prior
to dropping them off? The group that is collecting the pharmaceuticals would
then not be subject to controlled substances regs, because the controlled
substances would have already been rendered nonrecoverable.
Ann Heil
LACSD
-----Original Message-----
From: pharmwaste-admin@lists.dep.state.fl.us
[mailto:pharmwaste-admin@lists.dep.state.fl.us]On Behalf Of Charlotte A.
Smith
Sent: Tuesday, January 18, 2005 4:49 PM
To: Chapman, Alice; Bill Lewry; pharmwaste@lists.dep.state.fl.us
Subject: RE: [Pharmwaste] Pharmaceutical Waste
Thanks, Alice, that issue about the licensee being a person is correct when
it has to do with dispensed controlled substances. That what makes take back
to problematic.
Charlotte A. Smith, R. Ph., M.S., HEM
President
PharmEcology Associates, LLC
200 S. Executive Drive, Suite 101
Brookfield, WI 53005
262-814-2635
Fax 414-479-9941
H2E Champion for Change Award
-----Original Message-----
From: Chapman, Alice [mailto:Alice.Chapman@METROKC.GOV]
Sent: Tuesday, January 18, 2005 6:27 PM
To: Bill Lewry; pharmwaste@lists.dep.state.fl.us
Subject: RE: [Pharmwaste] Pharmaceutical Waste
Just to clarify a side issue mentioned in your question...
Neither the FDA nor the DEA approves or permits incinerators for disposal of
drugs. The DEA regulations require that controlled substances be destroyed
"beyond reclamation". We're accustomed in the world of hazardous waste to
having particular sites permitted and approved by EPA. The DEA looks at it
differently. As long as the drugs are in the custody of an approved
"licensee" (often a person), and "destroyed beyond reclamation",
everything's fine. Incineration is a handy way of making drugs
non-reclamable! Every incinerator I've talked to (I called as many as I
could find in the US a couple of years ago) has burned controlled
substances. Usually the licensee witnesses the drugs as they go into the
system. The drugs can't sit around in storage on-site before burning, that
would require facility changes to meet security requirements.
The loop you're attributing to FDA, is actually managed by DEA and state
Boards of Pharmacy.
Pharmaceuticals can be found in every category of hazardous waste. Your
proposal would work for many, but drugs packaged as inhalers (compressed
gases) or as injections (dose of drug in syringe attached to needle & ready
to go) would need to be handled differently.
The major drawback I see in your proposal is that disposal costs are paid
for by local governments, and the relatively low collection rate of
hazardous stuff out there that actually makes it's way to government-run
collection sites. I'd like to see what can happen when there are as many
collection points for drugs as there are pharmacies.
:) ac
Alice Chapman, PE
Local Hazardous Waste Management Program in King County
130 Nickerson St, #100
Seattle, WA 98109
http://www.govlink.org/hazwaste/
206-263-3058 phone
206-263-3070 fax
_____
From: Bill Lewry [mailto:Bill_Lewry@kcmo.org]
Sent: Saturday, January 15, 2005 12:53 PM
To: pharmwaste@lists.dep.state.fl.us
Subject: [Pharmwaste] Pharmaceutical Waste
Dear Listserve:
I would appreciate if someone could provide answer to the following
question.
Simply out of curiosity, I understand the (potential / possible) need to
create a system to deal with this issue, but unlike latex paint, electronics
and carpet, amongst others, it would appear to this uninitiated person that
there is little reclaimable asset to be gained from spent / out of date
pharmaceuticals.
Allowing that there is little benefit, then we have the issue of these not
falling into inappropriate hands. At least in the narcotics area.
Pharmaceuticals once issued to the end user are "out of the loop" of the FDA
and would then at end of life become "HHW", and it appears should then be
treated as any other HHW.
It would appear that these items would simply be best placed amongst other
"toxics", drummed without external indicative labelling (Eg. NOS, Toxic, 6
(6.1)) and shipped for incineration. They would not then require to go to an
FDA approved incinerator.
An alternative would be to place in an A fuel drum (all parties in
agreement) and ship in that fashion.
For the amounts and quantities involved in most programs, this would seem
the easy solution, for programs specifically chasing these wastestreams as a
revenue source, they could arrange contracts as appropriate under auspices
of the FDA if they themselves saw a need to regulate material which was
regulatorily in the vast majority of cases "de-regulated" by age or
condition.
I look forward to the discussion thread this question line may provoke.
Sincerely.
Bill Lewry / KCMO.
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<p class=3DMsoNormal><font size=3D2 color=3Dnavy face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:navy'>Such a database or rather a =
cross-walk is
what the next step is for the Unused Registry. NDC I believe is covered =
by the
Orange Book available at the FDA for downloading. It is not bedtime =
reading
though. Or rather maybe that is what it should be. The problem we are =
running
into is the disposal listing. I suspect it is already in existence in =
the
Reverse Distributor’s computers but all proprietary. Given the =
number of
different molecules in most pharmaceuticals including things such as =
coatings,
binders, etc, the question is how many of those other compounds need to =
be
considered beyond the so called “active ingredient.” =
Vaccines
certainly are an example of that, but beyond that I suspect it is =
actually
quite a small number. If anyone does come up with information for =
cross-walking
NDC to RCRA, we would be quite interested in hearing about it. Stevan =
Gressitt<o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dnavy face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<div>
<div class=3DMsoNormal align=3Dcenter style=3D'text-align:center'><font =
size=3D3
face=3D"Times New Roman"><span style=3D'font-size:12.0pt'>
<hr size=3D2 width=3D"100%" align=3Dcenter tabindex=3D-1>
</span></font></div>
<p class=3DMsoNormal><b><font size=3D2 face=3DTahoma><span =
style=3D'font-size:10.0pt;
font-family:Tahoma;font-weight:bold'>From:</span></font></b><font =
size=3D2
face=3DTahoma><span style=3D'font-size:10.0pt;font-family:Tahoma'>
pharmwaste-admin@lists.dep.state.fl.us
[mailto:pharmwaste-admin@lists.dep.state.fl.us] <b><span =
style=3D'font-weight:
bold'>On Behalf Of </span></b>Grasso, Cheri<br>
<b><span style=3D'font-weight:bold'>Sent:</span></b> Monday, January 24, =
2005
11:30 AM<br>
<b><span style=3D'font-weight:bold'>To:</span></b> 'Proffitt, Leah'; =
Johnson,
Emma (ECY); pharmwaste@lists.dep.state.fl.us<br>
<b><span style=3D'font-weight:bold'>Subject:</span></b> RE: [Pharmwaste]
Pharmaceutical Waste</span></font><o:p></o:p></p>
</div>
<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'><o:p> </o:p></span></font></p>
<div>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'>The FDA decided not to require the =
bar
code to have RCRA information because they thought it could be linked =
with the
National Drug Code (NDC) in the database that hospitals will =
use to
get the drug information. The good news is that enough of us =
made
comments that the FDA mentioned them in the rule. =
See Federal
Register, Vol. 69, No. 38 page 9135. </span></font><o:p></o:p></p>
</div>
<div>
<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'> <o:p></o:p></span></font></p>
</div>
<div>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'>After this ruling, I spoke with =
Philip
Chao, the FDA rep on this rule. He said the FDA's role is to make =
make
the NDC available to those that will build the database. He didn't know =
who
would build the database or what form it would take -- that would have =
to be
worked out privately. FDA's vision was whoever built the database with =
the NDC
info into it could add the RCRA info that would be linked to the NDC
information. He guessed the key players may be the UCC (Uniform =
Commercial
Code) & manufacturers. I followed up on the contact he gave me =
who
knew about this database, Allen Goldhammer of PhRMA. Allen said =
PhRMA was
not developing this theoretical database for other manufacturers and =
didn't
know who was. </span></font><o:p></o:p></p>
</div>
<div>
<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'> <o:p></o:p></span></font></p>
</div>
<div>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'>To date I have not yet been =
able to
locate anyone who knows about this database. If anyone out =
there has
any information or ideas on this national database, please let me =
know. I
would be happy to follow up on them.</span></font><o:p></o:p></p>
</div>
<div>
<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'> <o:p></o:p></span></font></p>
</div>
<div>
<p><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:10.0pt;font-family:
Arial;color:blue'>Cheri B. Grasso</span></font><font color=3Dblue><span
style=3D'color:blue'> <br>
</span></font><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:10.0pt;
font-family:Arial;color:blue'>Environmental & Health Investigator, =
II</span></font><font
color=3Dblue><span style=3D'color:blue'> <br>
</span></font><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:10.0pt;
font-family:Arial;color:blue'>Local Hazardous Waste Management =
Program</span></font><font
color=3Dblue><span style=3D'color:blue'> <br>
</span></font><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:10.0pt;
font-family:Arial;color:blue'>130 Nickerson Street, Suite =
100</span></font><font
color=3Dblue><span style=3D'color:blue'> <br>
</span></font><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:10.0pt;
font-family:Arial;color:blue'>Seattle, WA 98109</span></font><font
color=3Dblue><span style=3D'color:blue'> <br>
</span></font><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:10.0pt;
font-family:Arial;color:blue'>(206) 263-3089</span></font><font =
color=3Dblue><span
style=3D'color:blue'> <br>
</span></font><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:10.0pt;
font-family:Arial;color:blue'>cheri.grasso@metrokc.gov</span></font><font=
color=3Dblue><span style=3D'color:blue'> <o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'> </span></font><o:p></o:p></p>
</div>
<blockquote =
style=3D'margin-top:5.0pt;margin-right:0in;margin-bottom:5.0pt'>
<p class=3DMsoNormal style=3D'margin-bottom:12.0pt'><font size=3D2 =
face=3DTahoma><span
style=3D'font-size:10.0pt;font-family:Tahoma'>-----Original =
Message-----<br>
<b><span style=3D'font-weight:bold'>From:</span></b> Proffitt, Leah
[mailto:Leah.Proffitt@dep.state.fl.us]<br>
<b><span style=3D'font-weight:bold'>Sent:</span></b> Wednesday, January =
19, 2005
8:26 AM<br>
<b><span style=3D'font-weight:bold'>To:</span></b> Johnson, Emma (ECY);
pharmwaste@lists.dep.state.fl.us<br>
<b><span style=3D'font-weight:bold'>Subject:</span></b> RE: [Pharmwaste]
Pharmaceutical Waste</span></font><o:p></o:p></p>
<div>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3D"Comic Sans =
MS"><span
style=3D'font-size:10.0pt;font-family:"Comic Sans MS";color:blue'>Hi =
everyone,</span></font><o:p></o:p></p>
</div>
<div>
<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'> <o:p></o:p></span></font></p>
</div>
<div>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3D"Comic Sans =
MS"><span
style=3D'font-size:10.0pt;font-family:"Comic Sans MS";color:blue'>On a =
completely
different note, has anyone heard what happened to a proposal to =
amend
barcoding on drugs to include RCRA disposal requirements (see =
attachment)? I
believe our Office of General Counsel commented on this on behalf of =
Florida
DEP (at least I know I forwarded it to them!), but I never heard what, =
if
anything, became of it. </span></font><o:p></o:p></p>
</div>
<div>
<p><font size=3D2 color=3Dblue face=3D"Comic Sans MS"><span =
style=3D'font-size:10.0pt;
font-family:"Comic Sans MS";color:blue'>Leah D. Proffitt</span></font> =
<br>
<font size=3D2 color=3Dblue face=3D"Comic Sans MS"><span =
style=3D'font-size:10.0pt;
font-family:"Comic Sans MS";color:blue'>Environmental =
Specialist</span></font> <br>
<font size=3D2 color=3Dblue face=3D"Comic Sans MS"><span =
style=3D'font-size:10.0pt;
font-family:"Comic Sans MS";color:blue'>FDEP Central =
District</span></font> <br>
<font size=3D2 color=3Dblue face=3D"Comic Sans MS"><span =
style=3D'font-size:10.0pt;
font-family:"Comic Sans MS";color:blue'>Hazardous Waste</span></font> =
<br>
<font size=3D2 color=3Dblue face=3D"Comic Sans MS"><span =
style=3D'font-size:10.0pt;
font-family:"Comic Sans MS";color:blue'>(407) 893-3323</span></font> =
<br>
<font size=3D2 color=3Dblue face=3D"Comic Sans MS"><span =
style=3D'font-size:10.0pt;
font-family:"Comic Sans MS";color:blue'>S/C 325-2283</span></font> =
<o:p></o:p></p>
</div>
<div>
<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'> <o:p></o:p></span></font></p>
</div>
<blockquote =
style=3D'margin-top:5.0pt;margin-right:0in;margin-bottom:5.0pt'>
<p class=3DMsoNormal style=3D'margin-bottom:12.0pt'><font size=3D2 =
face=3DTahoma><span
style=3D'font-size:10.0pt;font-family:Tahoma'>-----Original =
Message-----<br>
<b><span style=3D'font-weight:bold'>From:</span></b> =
pharmwaste-admin@lists.dep.state.fl.us
[mailto:pharmwaste-admin@lists.dep.state.fl.us]<b><span =
style=3D'font-weight:
bold'>On Behalf Of </span></b>Johnson, Emma (ECY)<br>
<b><span style=3D'font-weight:bold'>Sent:</span></b> Wednesday, January =
19, 2005
10:55 AM<br>
<b><span style=3D'font-weight:bold'>To:</span></b>
pharmwaste@lists.dep.state.fl.us<br>
<b><span style=3D'font-weight:bold'>Subject:</span></b> RE: [Pharmwaste]
Pharmaceutical Waste</span></font><o:p></o:p></p>
<p class=3DMsoNormal><font size=3D2 color=3Dnavy face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:navy'>Others have tried this approach, I
believe. The way that the Controlled Substances Act works =
basically
exempts the end user from the closed loop accounting system that DEA
mandates. However, as soon as you return those substances to a =
pharmacy
(for instance) the DEA is going to care, and you would need to make sure =
that
the regulators are on board for what 'unrecoverable' =
means.<o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dnavy face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dnavy face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:navy'>I'm not sure if the gains of using =
these
kits would pay off either, especially if you were having a person sort =
the
drugs based on their 'controlled' status (asking the consumer to hand =
over
their medication to you, identifying the pharmaceutical, unscrewing the =
top,
pouring it in, etc.) You may also be adding significant weight to =
your
shipment of hazardous waste, which would cost more. =
<o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dnavy face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dnavy face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:navy'>However, I agree the way out of the =
DEA
Controlled Substances Act is to come up with a take-back scenario that =
is
secure and ensures final disposal, with approval from your state board =
of
pharmacy and the DEA (not particularly easy). This is =
something we're
working on in <st1:State w:st=3D"on"><st1:place =
w:st=3D"on">Washington</st1:place></st1:State>...
<o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dnavy face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dnavy face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:navy'>Emma =
Johnson<o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dnavy face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:navy'>Washington State Department of =
Ecology<o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dnavy face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 face=3DTahoma><span =
style=3D'font-size:10.0pt;
font-family:Tahoma'>-----Original Message-----<br>
<b><span style=3D'font-weight:bold'>From:</span></b> Ann Heil
[mailto:aheil@lacsd.org] <br>
<b><span style=3D'font-weight:bold'>Sent:</span></b> <st1:date =
Month=3D"1" Day=3D"19"
Year=3D"2005" w:st=3D"on">Wednesday, January 19, 2005</st1:date> =
<st1:time Hour=3D"7"
Minute=3D"33" w:st=3D"on">7:33 AM</st1:time><br>
<b><span style=3D'font-weight:bold'>To:</span></b> 'Charlotte A. Smith';
'Chapman, Alice'; 'Bill Lewry'; pharmwaste@lists.dep.state.fl.us<br>
<b><span style=3D'font-weight:bold'>Subject:</span></b> RE: [Pharmwaste]
Pharmaceutical Waste</span></font><o:p></o:p></p>
<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'><o:p> </o:p></span></font></p>
<div>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'>What if we had a handy way to =
render
controlled substances nonrecoverable? Let's speculate that we had =
some
sort of small kit, containing a bitter liquid into which liquid drugs =
could be
poured, and a quick setting cement into which solid drugs could be =
placed.
Could we get around controlled substance regs by having the person =
dropping
them off apply this kit prior to dropping them off? The group that is
collecting the pharmaceuticals would then not be subject to controlled
substances regs, because the controlled substances would have already =
been
rendered nonrecoverable.</span></font><o:p></o:p></p>
</div>
<div>
<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'> <o:p></o:p></span></font></p>
</div>
<div>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'>Ann =
Heil</span></font><o:p></o:p></p>
</div>
<div>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'>LACSD</span></font><o:p></o:p></p>
</div>
<blockquote =
style=3D'margin-top:5.0pt;margin-right:0in;margin-bottom:5.0pt'>
<p class=3DMsoNormal style=3D'margin-bottom:12.0pt'><font size=3D2 =
face=3DTahoma><span
style=3D'font-size:10.0pt;font-family:Tahoma'>-----Original =
Message-----<br>
<b><span style=3D'font-weight:bold'>From:</span></b>
pharmwaste-admin@lists.dep.state.fl.us =
[mailto:pharmwaste-admin@lists.dep.state.fl.us]<b><span
style=3D'font-weight:bold'>On Behalf Of </span></b>Charlotte A. =
Smith<br>
<b><span style=3D'font-weight:bold'>Sent:</span></b> Tuesday, January =
18, 2005
4:49 PM<br>
<b><span style=3D'font-weight:bold'>To:</span></b> Chapman, Alice; Bill =
Lewry;
pharmwaste@lists.dep.state.fl.us<br>
<b><span style=3D'font-weight:bold'>Subject:</span></b> RE: [Pharmwaste]
Pharmaceutical Waste</span></font><o:p></o:p></p>
<div>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'>Thanks, <st1:City =
w:st=3D"on"><st1:place
w:st=3D"on">Alice</st1:place></st1:City>, that issue about the licensee =
being a
person is correct when it has to do with dispensed controlled =
substances. That
what makes take back to problematic. </span></font><o:p></o:p></p>
</div>
<div>
<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'> <o:p></o:p></span></font></p>
</div>
<div>
<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'> <o:p></o:p></span></font></p>
</div>
<p class=3DMsoAutoSig><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'>Charlotte A. Smith, R. Ph., M.S., HEM<br>
President<br>
PharmEcology Associates, LLC<br>
<st1:Street w:st=3D"on"><st1:address w:st=3D"on">200 S. Executive Drive, =
Suite 101</st1:address></st1:Street><br>
<st1:place w:st=3D"on"><st1:City w:st=3D"on">Brookfield</st1:City>, =
<st1:State
w:st=3D"on">WI</st1:State> <st1:PostalCode =
w:st=3D"on">53005</st1:PostalCode></st1:place><br>
262-814-2635<br>
Fax 414-479-9941<o:p></o:p></span></font></p>
<p class=3DMsoAutoSig><font size=3D3 color=3Dblue face=3D"Times New =
Roman"><span
style=3D'font-size:12.0pt;color:blue'>H2E Champion for Change =
Award</span></font><o:p></o:p></p>
<blockquote =
style=3D'margin-top:5.0pt;margin-right:0in;margin-bottom:5.0pt'>
<p class=3DMsoNormal style=3D'margin-bottom:12.0pt'><font size=3D2 =
face=3DTahoma><span
style=3D'font-size:10.0pt;font-family:Tahoma'>-----Original =
Message-----<br>
<b><span style=3D'font-weight:bold'>From:</span></b> Chapman, Alice
[mailto:Alice.Chapman@METROKC.GOV] <br>
<b><span style=3D'font-weight:bold'>Sent:</span></b> Tuesday, January =
18, 2005
6:27 PM<br>
<b><span style=3D'font-weight:bold'>To:</span></b> Bill Lewry;
pharmwaste@lists.dep.state.fl.us<br>
<b><span style=3D'font-weight:bold'>Subject:</span></b> RE: [Pharmwaste]
Pharmaceutical Waste</span></font><o:p></o:p></p>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'>Just to clarify a side issue =
mentioned in
your question...</span></font><o:p></o:p></p>
<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'> <o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'>Neither the FDA nor the DEA =
approves or
permits incinerators for disposal of drugs. The DEA regulations =
require
that controlled substances be destroyed "beyond =
reclamation".
We're accustomed in the world of hazardous waste to having particular =
sites
permitted and approved by EPA. The DEA looks at it =
differently. As
long as the drugs are in the custody of an approved "licensee" =
(often
a person), and "destroyed beyond reclamation", everything's
fine. Incineration is a handy way of making drugs =
non-reclamable!
Every incinerator I've talked to (I called as many as I could find in =
the <st1:country-region
w:st=3D"on"><st1:place w:st=3D"on">US</st1:place></st1:country-region> a =
couple of
years ago) has burned controlled substances. Usually the licensee
witnesses the drugs as they go into the system. The drugs can't =
sit
around in storage on-site before burning, that would require facility =
changes
to meet security requirements. </span></font><o:p></o:p></p>
<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'> <o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'>The loop you're attributing to FDA, =
is
actually managed by DEA and state Boards of =
Pharmacy.</span></font><o:p></o:p></p>
<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'> <o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'>Pharmaceuticals can be found in =
every
category of hazardous waste. Your proposal would work for many, =
but drugs
packaged as inhalers (compressed gases) or as injections (dose of drug =
in
syringe attached to needle & ready to go) would need to be handled
differently. </span></font><o:p></o:p></p>
<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'> <o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'>The major drawback I see in your =
proposal
is that disposal costs are paid for by local governments, and the =
relatively
low collection rate of hazardous stuff out there that actually makes =
it's way
to government-run collection sites. I'd like to see what can =
happen when
there are as many collection points for drugs as there are =
pharmacies.</span></font><o:p></o:p></p>
<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'> <o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'>:) =
ac</span></font><o:p></o:p></p>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'>Alice Chapman, =
PE<o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'>Local Hazardous Waste Management =
Program
in <st1:place w:st=3D"on"><st1:PlaceName =
w:st=3D"on">King</st1:PlaceName> <st1:PlaceType
=
w:st=3D"on">County</st1:PlaceType></st1:place><o:p></o:p></span></font></=
p>
<p class=3DMsoNormal><st1:Street w:st=3D"on"><st1:address =
w:st=3D"on"><font size=3D2
color=3Dblue face=3DArial><span =
style=3D'font-size:10.0pt;font-family:Arial;
color:blue'>130 Nickerson St, =
#100</span></font></st1:address></st1:Street><font
size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:10.0pt;font-family:Arial;
color:blue'><o:p></o:p></span></font></p>
<p class=3DMsoNormal><st1:place w:st=3D"on"><st1:City w:st=3D"on"><font =
size=3D2
color=3Dblue face=3DArial><span =
style=3D'font-size:10.0pt;font-family:Arial;
color:blue'>Seattle</span></font></st1:City><font size=3D2 =
color=3Dblue
face=3DArial><span =
style=3D'font-size:10.0pt;font-family:Arial;color:blue'>, <st1:State
w:st=3D"on">WA</st1:State> <st1:PostalCode =
w:st=3D"on">98109</st1:PostalCode></span></font></st1:place><font
size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:10.0pt;font-family:Arial;
color:blue'><o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'><a =
href=3D"http://www.govlink.org/hazwaste/">http://www.govlink.org/hazwaste=
/</a><o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'> <o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'>206-263-3058 =
phone<o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D2 color=3Dblue face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:blue'>206-263-3070 =
fax<o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'> <o:p></o:p></span></font></p>
<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'> <o:p></o:p></span></font></p>
<div class=3DMsoNormal align=3Dcenter style=3D'text-align:center'><font =
size=3D3
face=3D"Times New Roman"><span style=3D'font-size:12.0pt'>
<hr size=3D2 width=3D"100%" align=3Dcenter>
</span></font></div>
<p class=3DMsoNormal style=3D'margin-bottom:12.0pt'><b><font size=3D2 =
face=3DTahoma><span
style=3D'font-size:10.0pt;font-family:Tahoma;font-weight:bold'>From:</spa=
n></font></b><font
size=3D2 face=3DTahoma><span =
style=3D'font-size:10.0pt;font-family:Tahoma'> Bill
Lewry [mailto:Bill_Lewry@kcmo.org] <br>
<b><span style=3D'font-weight:bold'>Sent:</span></b> Saturday, January =
15, 2005
12:53 PM<br>
<b><span style=3D'font-weight:bold'>To:</span></b> =
pharmwaste@lists.dep.state.fl.us<br>
<b><span style=3D'font-weight:bold'>Subject:</span></b> [Pharmwaste]
Pharmaceutical Waste</span></font><o:p></o:p></p>
<p><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:12.0pt'>Dear
Listserve:<br>
<br>
I would appreciate if someone could provide answer to the following =
question.<br>
<br>
<b><span style=3D'font-weight:bold'>Simply out of curiosity,</span></b> =
I
understand the (potential / possible) need to create a system to deal =
with this
issue, but unlike latex paint, electronics and carpet, amongst others, =
it would
appear to this uninitiated person that there is little reclaimable asset =
to be
gained from spent / out of date pharmaceuticals.<br>
<br>
Allowing that there is little benefit, then we have the issue of these =
not
falling into inappropriate hands. At least in the narcotics area.<br>
<br>
Pharmaceuticals once issued to the end user are "out of the =
loop" of
the FDA and would then at end of life become "HHW", and it =
appears should
then be treated as any other HHW.<br>
<br>
It would appear that these items would simply be best placed amongst =
other
"toxics", drummed without external indicative labelling (Eg. =
NOS,
Toxic, 6 (6.1)) and shipped for incineration. They would not then =
require to go
to an FDA approved incinerator.<br>
<br>
An alternative would be to place in an A fuel drum (all parties in =
agreement)
and ship in that fashion.<br>
<br>
For the amounts and quantities involved in most programs, this would =
seem the
easy solution, for programs specifically chasing these wastestreams as a
revenue source, they could arrange contracts as appropriate under =
auspices of
the FDA if they themselves saw a need to regulate material which was
regulatorily in the vast majority of cases "de-regulated" by =
age or
condition.<br>
<br>
I look forward to the discussion thread this question line may =
provoke.<br>
<br>
Sincerely.<br>
<br>
Bill Lewry / KCMO.<o:p></o:p></span></font></p>
</blockquote>
</blockquote>
</blockquote>
</blockquote>
</div>
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