[Pharmwaste] Pharmaceutical Waste

Wed, 19 Jan 2005 07:55:06 -0800

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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/ <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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<body lang=3DEN-US link=3Dblue vlink=3Dblue =
style=3D'tab-interval:.5in'>

<div class=3DSection1>

Others have tried this approach, I
believe.&nbsp; The way that the =
Controlled
Substances Act works basically exempts the end user from the closed =
loop accounting
system that DEA mandates. &nbsp;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>

<p class=3DMsoNormal><font size=3D2 color=3Dnavy face=3DArial><span =
style=3D'font-size:
10.0pt;font-family:Arial;color:navy'><o:p>&nbsp;</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.) <span
style=3D'mso-spacerun:yes'>&nbsp;</span>You may also be adding =
significant weight
to your shipment of hazardous waste, which would cost more.<span
style=3D'mso-spacerun:yes'>&nbsp; </span><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>&nbsp;</o:p></span></font></p>=

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).&nbsp; &nbsp;This is something we're working =
on
in Washington... <o:p></o: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>&nbsp;</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>&nbsp;</o:p></span></font></p>=

-----Original Message----- 
From: Ann Heil =
[mailto:aheil@lacsd.org] 
Sent: <st1:date =
Month=3D"1" Day=3D"19"
Year=3D"2005">Wednesday, January 19, 2005</st1:date> =
<st1:time
Hour=3D"7" Minute=3D"33">7:33 AM</st1:time> 
To: 'Charlotte A. =
Smith';
'Chapman, Alice'; 'Bill Lewry'; pharmwaste@lists.dep.state.fl.us 
Subject: RE: =
[Pharmwaste]
Pharmaceutical Waste

<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'><o:p>&nbsp;</o:p></span></font></p>

<div>

What if we had a handy way to =
render
controlled substances nonrecoverable?&nbsp; 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.<o:p></o:p>

</div>

<div>

<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'>&nbsp;<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'>

-----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<o:p></o:p>

<div>

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. =
<o:p></o:p>

</div>

<div>

<p class=3DMsoNormal><font size=3D3 face=3D"Times New Roman"><span =
style=3D'font-size:
12.0pt'>&nbsp;<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'>&nbsp;<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>
200 S. Executive Drive, Suite 101<br>
Brookfield, WI 53005<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'>&nbsp;<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.&nbsp; The DEA regulations =
require
that controlled substances be destroyed &quot;beyond =
reclamation&quot;.&nbsp;
We're accustomed in the world of hazardous waste to having particular =
sites
permitted and approved by EPA.&nbsp; The DEA looks at it =
differently.&nbsp; As
long as the drugs are in the custody of an approved =
&quot;licensee&quot; (often
a person), and &quot;destroyed beyond reclamation&quot;, everything's
fine.&nbsp; Incineration is a handy way of making drugs =
non-reclamable!&nbsp;
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.&nbsp; Usually =
the
licensee witnesses the drugs as they go into the system.&nbsp; The =
drugs can't
sit around in storage on-site before burning, that would require =
facility
changes to meet security requirements.&nbsp; =
</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'>&nbsp;<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'>&nbsp;<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.&nbsp; Your proposal would work for many, =
but drugs
packaged as inhalers (compressed gases) or as injections (dose of drug =
in
syringe attached to needle &amp; ready to go) would need to be handled
differently.&nbsp; </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'>&nbsp;<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.&nbsp; 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'>&nbsp;<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'>:)&nbsp; =
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 King County<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'>130 Nickerson St, =
#100<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'>Seattle, WA&nbsp; =
98109<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/hazwast=
e/</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'>&nbsp;<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>

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style=3D'font-size:
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style=3D'font-size:
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<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:</sp=
an></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>

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 &quot;out of the =
loop&quot; of
the FDA and would then at end of life become &quot;HHW&quot;, and it =
appears
should then be treated as any other HHW. 
 
It would appear that these items would simply be best placed amongst =
other
&quot;toxics&quot;, 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 &quot;de-regulated&quot; by =
age or
condition. 
 
I look forward to the discussion thread this question line may =
provoke. 
 
Sincerely. 
 
Bill Lewry / KCMO.<o:p></o:p>

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