[Pharmwaste] Pharmaceutical Waste
Chapman, Alice
Alice.Chapman@METROKC.GOV
Tue, 18 Jan 2005 16:26:44 -0800
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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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<DIV dir=ltr align=left><SPAN class=708151000-19012005><FONT face=Arial
color=#0000ff size=2>Just to clarify a side issue mentioned in your
question...</FONT></SPAN></DIV>
<DIV dir=ltr align=left><SPAN class=708151000-19012005><FONT face=Arial
color=#0000ff size=2></FONT></SPAN> </DIV>
<DIV dir=ltr align=left><SPAN class=708151000-19012005><FONT face=Arial
color=#0000ff size=2>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. </FONT></SPAN></DIV>
<DIV dir=ltr align=left><SPAN class=708151000-19012005><FONT face=Arial
color=#0000ff size=2></FONT></SPAN> </DIV>
<DIV dir=ltr align=left><SPAN class=708151000-19012005><FONT face=Arial
color=#0000ff size=2>The loop you're attributing to FDA, is actually managed by
DEA and state Boards of Pharmacy.</FONT></SPAN></DIV>
<DIV dir=ltr align=left><SPAN class=708151000-19012005><FONT face=Arial
color=#0000ff size=2></FONT></SPAN> </DIV>
<DIV dir=ltr align=left><SPAN class=708151000-19012005><FONT face=Arial
color=#0000ff size=2>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.
</FONT></SPAN></DIV>
<DIV dir=ltr align=left><SPAN class=708151000-19012005><FONT face=Arial
color=#0000ff size=2></FONT></SPAN> </DIV>
<DIV dir=ltr align=left><SPAN class=708151000-19012005><FONT face=Arial
color=#0000ff size=2>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.</FONT></SPAN></DIV>
<DIV dir=ltr align=left><SPAN class=708151000-19012005><FONT face=Arial
color=#0000ff size=2></FONT></SPAN> </DIV>
<DIV dir=ltr align=left><SPAN class=708151000-19012005><FONT face=Arial
color=#0000ff size=2>:) ac</FONT></SPAN></DIV>
<DIV dir=ltr align=left><SPAN class=708151000-19012005><FONT face=Arial
color=#0000ff size=2>
<DIV align=left><FONT face=Arial size=2>Alice Chapman, PE</FONT></DIV>
<DIV align=left><FONT face=Arial size=2>Local Hazardous Waste Management Program
in King County</FONT></DIV>
<DIV align=left><FONT face=Arial size=2>130 Nickerson St, #100</FONT></DIV>
<DIV align=left><FONT face=Arial size=2>Seattle, WA 98109</FONT></DIV>
<DIV align=left><FONT face=Arial size=2><A
href="http://www.govlink.org/hazwaste/">http://www.govlink.org/hazwaste/</A></FONT></DIV>
<DIV align=left><FONT face=Arial size=2></FONT> </DIV>
<DIV align=left><FONT face=Arial size=2>206-263-3058 phone</FONT></DIV>
<DIV align=left><FONT face=Arial size=2>206-263-3070
fax</FONT></DIV></FONT></SPAN></DIV>
<DIV dir=ltr align=left><SPAN class=708151000-19012005><FONT face=Arial
color=#0000ff size=2></FONT></SPAN> </DIV>
<DIV dir=ltr align=left><SPAN class=708151000-19012005><FONT face=Arial
color=#0000ff size=2></FONT></SPAN> </DIV>
<DIV dir=ltr align=left>
<HR tabIndex=-1>
</DIV>
<DIV dir=ltr align=left><FONT face=Tahoma size=2><B>From:</B> Bill Lewry
[mailto:Bill_Lewry@kcmo.org] <BR><B>Sent:</B> Saturday, January 15, 2005 12:53
PM<BR><B>To:</B> pharmwaste@lists.dep.state.fl.us<BR><B>Subject:</B>
[Pharmwaste] Pharmaceutical Waste<BR></FONT><BR></DIV>
<DIV></DIV>
<P>Dear Listserve:<BR><BR>I would appreciate if someone could provide answer to
the following question.<BR><BR><B>Simply out of curiosity,</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.</P></BODY></HTML>
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