[Pharmwaste] Pharmaceutical Waste
Charlotte A. Smith
csmith@pharmecology.com
Tue, 18 Jan 2005 18:49:10 -0600
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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.=20
=20
=20
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=20
H2E Champion for Change Award
-----Original Message-----
From: Chapman, Alice [mailto:Alice.Chapman@METROKC.GOV]=20
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...
=20
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. =20
=20
The loop you're attributing to FDA, is actually managed by DEA and state
Boards of Pharmacy.
=20
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. =20
=20
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.
=20
:) ac
Alice Chapman, PE
Local Hazardous Waste Management Program in King County
130 Nickerson St, #100
Seattle, WA 98109
http://www.govlink.org/hazwaste/
=20
206-263-3058 phone
206-263-3070 fax
=20
=20
_____ =20
From: Bill Lewry [mailto:Bill_Lewry@kcmo.org]=20
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><SPAN class=3D608274800-19012005><FONT face=3DArial color=3D#0000ff =
size=3D2>Thanks, Alice, that issue about the licensee being a person is =
correct=20
when it has to do with dispensed controlled substances. That what makes =
take=20
back to problematic. </FONT></SPAN></DIV>
<DIV> </DIV>
<DIV> </DIV>
<P class=3DMsoAutoSig align=3Dleft>Charlotte A. Smith, R. Ph., M.S.,=20
HEM<BR>President<BR>PharmEcology Associates, LLC<BR>200 S. Executive =
Drive,=20
Suite 101<BR>Brookfield, WI 53005<BR>262-814-2635<BR>Fax=20
414-479-9941<?xml:namespace prefix =3D o ns =3D=20
"urn:schemas-microsoft-com:office:office" /><o:p> </o:p></P>
<P class=3DMsoAutoSig align=3Dleft><o:p><FONT color=3D#0000ff>H2E =
Champion for Change=20
Award</FONT></o:p></P>
<BLOCKQUOTE dir=3Dltr style=3D"MARGIN-RIGHT: 0px">
<DIV></DIV>
<DIV class=3DOutlookMessageHeader lang=3Den-us dir=3Dltr =
align=3Dleft><FONT=20
face=3DTahoma size=3D2>-----Original Message-----<BR><B>From:</B> =
Chapman, Alice=20
[mailto:Alice.Chapman@METROKC.GOV] <BR><B>Sent:</B> Tuesday, January =
18, 2005=20
6:27 PM<BR><B>To:</B> Bill Lewry;=20
pharmwaste@lists.dep.state.fl.us<BR><B>Subject:</B> RE: [Pharmwaste]=20
Pharmaceutical Waste<BR><BR></FONT></DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D708151000-19012005><FONT =
face=3DArial=20
color=3D#0000ff size=3D2>Just to clarify a side issue mentioned in =
your=20
question...</FONT></SPAN></DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D708151000-19012005><FONT =
face=3DArial=20
color=3D#0000ff size=3D2></FONT></SPAN> </DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D708151000-19012005><FONT =
face=3DArial=20
color=3D#0000ff size=3D2>Neither the FDA nor the DEA approves or =
permits=20
incinerators for disposal of drugs. The DEA regulations require =
that=20
controlled substances be destroyed "beyond reclamation". We're=20
accustomed in the world of hazardous waste to having particular sites=20
permitted and approved by EPA. The DEA looks at it =
differently. As=20
long as the drugs are in the custody of an approved "licensee" (often =
a=20
person), and "destroyed beyond reclamation", everything's fine. =20
Incineration is a handy way of making drugs non-reclamable! =
Every=20
incinerator I've talked to (I called as many as I could find in the US =
a=20
couple of years ago) has burned controlled substances. Usually =
the=20
licensee witnesses the drugs as they go into the system. The =
drugs can't=20
sit around in storage on-site before burning, that would require =
facility=20
changes to meet security requirements. </FONT></SPAN></DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D708151000-19012005><FONT =
face=3DArial=20
color=3D#0000ff size=3D2></FONT></SPAN> </DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D708151000-19012005><FONT =
face=3DArial=20
color=3D#0000ff size=3D2>The loop you're attributing to FDA, is =
actually managed=20
by DEA and state Boards of Pharmacy.</FONT></SPAN></DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D708151000-19012005><FONT =
face=3DArial=20
color=3D#0000ff size=3D2></FONT></SPAN> </DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D708151000-19012005><FONT =
face=3DArial=20
color=3D#0000ff size=3D2>Pharmaceuticals can be found in every =
category of=20
hazardous waste. Your proposal would work for many, but drugs =
packaged=20
as inhalers (compressed gases) or as injections (dose of drug in =
syringe=20
attached to needle & ready to go) would need to be handled=20
differently. </FONT></SPAN></DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D708151000-19012005><FONT =
face=3DArial=20
color=3D#0000ff size=3D2></FONT></SPAN> </DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D708151000-19012005><FONT =
face=3DArial=20
color=3D#0000ff size=3D2>The major drawback I see in your proposal is =
that=20
disposal costs are paid for by local governments, and the relatively =
low=20
collection rate of hazardous stuff out there that actually makes it's =
way to=20
government-run collection sites. I'd like to see what can happen =
when=20
there are as many collection points for drugs as there are=20
pharmacies.</FONT></SPAN></DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D708151000-19012005><FONT =
face=3DArial=20
color=3D#0000ff size=3D2></FONT></SPAN> </DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D708151000-19012005><FONT =
face=3DArial=20
color=3D#0000ff size=3D2>:) ac</FONT></SPAN></DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D708151000-19012005><FONT =
face=3DArial=20
color=3D#0000ff size=3D2>
<DIV align=3Dleft><FONT face=3DArial size=3D2>Alice Chapman, =
PE</FONT></DIV>
<DIV align=3Dleft><FONT face=3DArial size=3D2>Local Hazardous Waste =
Management=20
Program in King County</FONT></DIV>
<DIV align=3Dleft><FONT face=3DArial size=3D2>130 Nickerson St, =
#100</FONT></DIV>
<DIV align=3Dleft><FONT face=3DArial size=3D2>Seattle, WA =
98109</FONT></DIV>
<DIV align=3Dleft><FONT face=3DArial size=3D2><A=20
=
href=3D"http://www.govlink.org/hazwaste/">http://www.govlink.org/hazwaste=
/</A></FONT></DIV>
<DIV align=3Dleft><FONT face=3DArial size=3D2></FONT> </DIV>
<DIV align=3Dleft><FONT face=3DArial size=3D2>206-263-3058 =
phone</FONT></DIV>
<DIV align=3Dleft><FONT face=3DArial size=3D2>206-263-3070=20
fax</FONT></DIV></FONT></SPAN></DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D708151000-19012005><FONT =
face=3DArial=20
color=3D#0000ff size=3D2></FONT></SPAN> </DIV>
<DIV dir=3Dltr align=3Dleft><SPAN class=3D708151000-19012005><FONT =
face=3DArial=20
color=3D#0000ff size=3D2></FONT></SPAN> </DIV>
<DIV dir=3Dltr align=3Dleft>
<HR tabIndex=3D-1>
</DIV>
<DIV dir=3Dltr align=3Dleft><FONT face=3DTahoma size=3D2><B>From:</B> =
Bill Lewry=20
[mailto:Bill_Lewry@kcmo.org] <BR><B>Sent:</B> Saturday, January 15, =
2005 12:53=20
PM<BR><B>To:</B> pharmwaste@lists.dep.state.fl.us<BR><B>Subject:</B>=20
[Pharmwaste] Pharmaceutical Waste<BR></FONT><BR></DIV>
<DIV></DIV>
<P>Dear Listserve:<BR><BR>I would appreciate if someone could provide =
answer=20
to the following question.<BR><BR><B>Simply out of curiosity,</B> I =
understand=20
the (potential / possible) need to create a system to deal with this =
issue,=20
but unlike latex paint, electronics and carpet, amongst others, it =
would=20
appear to this uninitiated person that there is little reclaimable =
asset to be=20
gained from spent / out of date pharmaceuticals.<BR><BR>Allowing that =
there is=20
little benefit, then we have the issue of these not falling into =
inappropriate=20
hands. At least in the narcotics area.<BR><BR>Pharmaceuticals once =
issued to=20
the end user are "out of the loop" of the FDA and would then at end of =
life=20
become "HHW", and it appears should then be treated as any other=20
HHW.<BR><BR>It would appear that these items would simply be best =
placed=20
amongst other "toxics", drummed without external indicative labelling =
(Eg.=20
NOS, Toxic, 6 (6.1)) and shipped for incineration. They would not then =
require=20
to go to an FDA approved incinerator.<BR><BR>An alternative would be =
to place=20
in an A fuel drum (all parties in agreement) and ship in that=20
fashion.<BR><BR>For the amounts and quantities involved in most =
programs, this=20
would seem the easy solution, for programs specifically chasing these=20
wastestreams as a revenue source, they could arrange contracts as =
appropriate=20
under auspices of the FDA if they themselves saw a need to regulate =
material=20
which was regulatorily in the vast majority of cases "de-regulated" by =
age or=20
condition.<BR><BR>I look forward to the discussion thread this =
question line=20
may provoke.<BR><BR>Sincerely.<BR><BR>Bill Lewry /=20
KCMO.</P></BLOCKQUOTE></BODY></HTML>
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