[Pharmwaste] Pharmaceutical Waste
Grasso, Cheri
Cheri.Grasso@METROKC.GOV
Mon, 24 Jan 2005 08:30:09 -0800
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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/ <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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link=3Dblue>
<DIV><SPAN class=3D843254215-24012005><FONT face=3DArial size=3D2><FONT =
color=3D#0000ff>The FDA decided not to require the bar code to have =
RCRA=20
information because they thought it could be linked with the National =
Drug Code=20
(NDC) in the database that hospitals will use to get the drug =
information. The good news is that enough of us made =
comments that=20
the FDA mentioned them in the rule. See Federal =
Register, Vol.=20
69, No. 38 page 9135. </FONT></FONT></SPAN></DIV>
<DIV><SPAN class=3D843254215-24012005><FONT face=3DArial=20
size=3D2></FONT></SPAN> </DIV>
<DIV><SPAN class=3D843254215-24012005><FONT face=3DArial size=3D2><FONT =
size=3D2><FONT=20
color=3D#0000ff><SPAN class=3D843254215-24012005>After this ruling, I =
spoke with=20
Philip Chao, the FDA rep on this rule. </SPAN>He said the FDA's =
role is to=20
make make the NDC available to those that will build the database. He =
didn't=20
know who would build the database or what form it would take -- that =
would have=20
to be worked out privately. FDA's vision was whoever built the database =
with the=20
NDC info into it could add the RCRA info that would be linked to the =
NDC=20
information. He guessed the key players may be the UCC (Uniform =
Commercial Code)=20
& manufacturers. <SPAN class=3D843254215-24012005>I followed =
up on the=20
contact he gave me who knew about this database, Allen Goldhammer of=20
PhRMA. Allen said PhRMA was not developing this theoretical =
database for=20
other manufacturers and didn't know who=20
was. </SPAN></FONT></FONT></FONT></SPAN></DIV>
<DIV><SPAN class=3D843254215-24012005><FONT face=3DArial size=3D2><FONT =
size=3D2><FONT=20
color=3D#0000ff><SPAN=20
class=3D843254215-24012005></SPAN></FONT></FONT></FONT></SPAN> </DI=
V>
<DIV><SPAN class=3D843254215-24012005><FONT face=3DArial size=3D2><FONT =
size=3D2><FONT=20
color=3D#0000ff><SPAN class=3D843254215-24012005>To date I have not =
yet been=20
able to locate anyone who knows about this database. If =
anyone out=20
there has any information or ideas on this national database, please =
let me=20
know. I would be happy to follow up on=20
them.</SPAN></FONT></FONT></FONT></SPAN></DIV>
<DIV><SPAN class=3D843254215-24012005><FONT face=3DArial size=3D2><FONT =
size=3D2><FONT=20
color=3D#0000ff><SPAN=20
class=3D843254215-24012005></SPAN></FONT></FONT></FONT></SPAN> </DI=
V>
<DIV><SPAN class=3D843254215-24012005><FONT face=3DArial size=3D2><FONT =
size=3D2><FONT=20
color=3D#0000ff><SPAN class=3D843254215-24012005>
<P><FONT face=3DArial size=3D2>Cheri B. Grasso</FONT> <BR><FONT =
face=3DArial=20
size=3D2>Environmental & Health Investigator, II</FONT> <BR><FONT =
face=3DArial=20
size=3D2>Local Hazardous Waste Management Program</FONT> <BR><FONT =
face=3DArial=20
size=3D2>130 Nickerson Street, Suite 100</FONT> <BR><FONT face=3DArial=20
size=3D2>Seattle, WA 98109</FONT> <BR><FONT face=3DArial =
size=3D2>(206)=20
263-3089</FONT> <BR><FONT face=3DArial =
size=3D2>cheri.grasso@metrokc.gov</FONT>=20
</P> </SPAN></FONT></FONT></FONT></SPAN></DIV>
<BLOCKQUOTE dir=3Dltr style=3D"MARGIN-RIGHT: 0px">
<DIV class=3DOutlookMessageHeader dir=3Dltr align=3Dleft><FONT =
face=3DTahoma=20
size=3D2>-----Original Message-----<BR><B>From:</B> Proffitt, Leah=20
[mailto:Leah.Proffitt@dep.state.fl.us]<BR><B>Sent:</B> Wednesday, =
January 19,=20
2005 8:26 AM<BR><B>To:</B> Johnson, Emma (ECY);=20
pharmwaste@lists.dep.state.fl.us<BR><B>Subject:</B> RE: [Pharmwaste]=20
Pharmaceutical Waste<BR><BR></FONT></DIV>
<DIV><SPAN class=3D355221116-19012005><FONT face=3D"Comic Sans MS" =
color=3D#0000ff=20
size=3D2>Hi everyone,</FONT></SPAN></DIV>
<DIV><SPAN class=3D355221116-19012005><FONT face=3D"Comic Sans MS" =
color=3D#0000ff=20
size=3D2></FONT></SPAN> </DIV>
<DIV><SPAN class=3D355221116-19012005><FONT face=3D"Comic Sans MS" =
color=3D#0000ff=20
size=3D2>On a completely different note, has anyone heard what =
happened to=20
a proposal to amend barcoding on drugs to include RCRA disposal=20
requirements (see attachment)? I believe our Office of General =
Counsel=20
commented on this on behalf of Florida DEP (at least I know I =
forwarded it to=20
them!), but I never heard what, if anything, became of it.=20
</FONT></SPAN></DIV>
<DIV><SPAN class=3D355221116-19012005>
<P><FONT face=3D"Comic Sans MS" color=3D#0000ff size=3D2>Leah D. =
Proffitt</FONT>=20
<BR><FONT face=3D"Comic Sans MS" color=3D#0000ff =
size=3D2>Environmental=20
Specialist</FONT> <BR><FONT face=3D"Comic Sans MS" color=3D#0000ff =
size=3D2>FDEP=20
Central District</FONT> <BR><FONT face=3D"Comic Sans MS" =
color=3D#0000ff=20
size=3D2>Hazardous Waste</FONT> <BR><FONT face=3D"Comic Sans MS" =
color=3D#0000ff=20
size=3D2>(407) 893-3323</FONT> <BR><FONT face=3D"Comic Sans MS" =
color=3D#0000ff=20
size=3D2>S/C 325-2283</FONT> </P></SPAN></DIV>
<DIV><SPAN class=3D355221116-19012005><FONT face=3D"Comic Sans MS" =
color=3D#0000ff=20
size=3D2></FONT></SPAN> </DIV>
<BLOCKQUOTE dir=3Dltr style=3D"MARGIN-RIGHT: 0px">
<DIV class=3DOutlookMessageHeader dir=3Dltr align=3Dleft><FONT =
face=3DTahoma=20
size=3D2>-----Original Message-----<BR><B>From:</B>=20
pharmwaste-admin@lists.dep.state.fl.us=20
[mailto:pharmwaste-admin@lists.dep.state.fl.us]<B>On Behalf Of =
</B>Johnson,=20
Emma (ECY)<BR><B>Sent:</B> Wednesday, January 19, 2005 10:55=20
AM<BR><B>To:</B> =
pharmwaste@lists.dep.state.fl.us<BR><B>Subject:</B> RE:=20
[Pharmwaste] Pharmaceutical Waste<BR><BR></FONT></DIV>
<DIV class=3DSection1>
<P class=3DMsoNormal><FONT face=3DArial color=3Dnavy size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt; COLOR: navy; FONT-FAMILY: Arial">Others =
have tried=20
this approach, I believe.<SPAN style=3D"mso-spacerun: yes"> =
</SPAN>The=20
way that the Controlled Substances Act works basically exempts the =
end user=20
from the closed loop accounting system that DEA mandates. <SPAN=20
style=3D"mso-spacerun: yes"> </SPAN>However, as soon as you =
return those=20
substances to a pharmacy (for instance) the DEA is going to care, =
and you=20
would need to make sure that the regulators are on board for what=20
'unrecoverable' means.<o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dnavy size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt; COLOR: navy; FONT-FAMILY: =
Arial"><o:p> </o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dnavy size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt; COLOR: navy; FONT-FAMILY: Arial">I'm not =
sure if the=20
gains of using these kits would pay off either, especially if you =
were=20
having a person sort the drugs based on their 'controlled' status =
(asking=20
the consumer to hand over their medication to you, identifying the=20
pharmaceutical, unscrewing the top, pouring it in, etc.) <SPAN=20
style=3D"mso-spacerun: yes"> </SPAN>You may also be adding =
significant=20
weight to your shipment of hazardous waste, which would cost =
more.<SPAN=20
style=3D"mso-spacerun: yes"> =
</SPAN><o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dnavy size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt; COLOR: navy; FONT-FAMILY: =
Arial"><o:p> </o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dnavy size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt; COLOR: navy; FONT-FAMILY: Arial">However, =
I agree=20
the way out of the DEA Controlled Substances Act is to come up with =
a=20
take-back scenario that is secure and ensures final disposal, with =
approval=20
from your state board of pharmacy and the DEA (not particularly =
easy).<SPAN=20
style=3D"mso-spacerun: yes"> </SPAN><SPAN=20
style=3D"mso-spacerun: yes"> </SPAN>This is something we're =
working on in=20
Washington... <o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dnavy size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt; COLOR: navy; FONT-FAMILY: =
Arial"><o:p> </o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dnavy size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt; COLOR: navy; FONT-FAMILY: Arial">Emma=20
Johnson<o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dnavy size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt; COLOR: navy; FONT-FAMILY: =
Arial">Washington State=20
Department of Ecology<o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dnavy size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt; COLOR: navy; FONT-FAMILY: =
Arial"><o:p> </o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DTahoma size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; FONT-FAMILY: Tahoma">-----Original=20
Message-----<BR><B><SPAN style=3D"FONT-WEIGHT: =
bold">From:</SPAN></B> Ann Heil=20
[mailto:aheil@lacsd.org<SPAN class=3DGramE>] <BR><B><SPAN=20
style=3D"FONT-WEIGHT: bold">Sent</SPAN></B></SPAN><B><SPAN=20
style=3D"FONT-WEIGHT: bold">:</SPAN></B> </SPAN></FONT><st1:date =
Month=3D"1"=20
Day=3D"19" Year=3D"2005"><FONT face=3DTahoma size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; FONT-FAMILY: Tahoma">Wednesday, January =
19,=20
2005</SPAN></FONT></st1:date><FONT face=3DTahoma size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; FONT-FAMILY: Tahoma"> =
</SPAN></FONT><st1:time=20
Hour=3D"7" Minute=3D"33"><FONT face=3DTahoma size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; FONT-FAMILY: Tahoma">7:33=20
AM</SPAN></FONT></st1:time><FONT face=3DTahoma size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; FONT-FAMILY: Tahoma"><BR><B><SPAN=20
style=3D"FONT-WEIGHT: bold">To:</SPAN></B> 'Charlotte A. Smith'; =
'Chapman,=20
Alice'; 'Bill Lewry'; pharmwaste@lists.dep.state.fl.us<BR><B><SPAN=20
style=3D"FONT-WEIGHT: bold">Subject:</SPAN></B> RE: [Pharmwaste]=20
Pharmaceutical Waste</SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3D"Times New Roman" size=3D3><SPAN=20
style=3D"FONT-SIZE: 12pt"><o:p> </o:p></SPAN></FONT></P>
<DIV>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: Arial">What if =
we had a=20
handy way to render controlled substances nonrecoverable? =
Let's=20
speculate that we had some sort of small kit, containing a bitter =
liquid=20
into which liquid drugs could be poured, and a quick setting cement =
into=20
which solid drugs could be placed. Could we get around controlled =
substance=20
regs by having the person dropping them off apply this kit prior to =
dropping=20
them off? The group that is collecting the pharmaceuticals would =
then not be=20
subject to controlled substances regs, because the controlled =
substances=20
would have already been rendered=20
nonrecoverable.</SPAN></FONT><o:p></o:p></P></DIV>
<DIV>
<P class=3DMsoNormal><FONT face=3D"Times New Roman" size=3D3><SPAN=20
style=3D"FONT-SIZE: 12pt"> <o:p></o:p></SPAN></FONT></P></DIV>
<DIV>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: Arial">Ann=20
Heil</SPAN></FONT><o:p></o:p></P></DIV>
<DIV>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue size=3D2><SPAN =
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: =
Arial">LACSD</SPAN></FONT><o:p></o:p></P></DIV>
<BLOCKQUOTE=20
style=3D"MARGIN-TOP: 5pt; MARGIN-BOTTOM: 5pt; MARGIN-RIGHT: =
0in"><P=20
class=3DMsoNormal style=3D"MARGIN-BOTTOM: 12pt"><FONT =
face=3DTahoma size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; FONT-FAMILY: Tahoma">-----Original=20
Message-----<BR><B><SPAN style=3D"FONT-WEIGHT: =
bold">From:</SPAN></B>=20
pharmwaste-admin@lists.dep.state.fl.us=20
[mailto:pharmwaste-admin@lists.dep.state.fl.us]<B><SPAN=20
style=3D"FONT-WEIGHT: bold">On Behalf Of </SPAN></B>Charlotte A.=20
Smith<BR><B><SPAN style=3D"FONT-WEIGHT: bold">Sent:</SPAN></B> =
Tuesday,=20
January 18, 2005 4:49 PM<BR><B><SPAN=20
style=3D"FONT-WEIGHT: bold">To:</SPAN></B> Chapman, Alice; Bill =
Lewry;=20
pharmwaste@lists.dep.state.fl.us<BR><B><SPAN=20
style=3D"FONT-WEIGHT: bold">Subject:</SPAN></B> RE: [Pharmwaste]=20
Pharmaceutical Waste</SPAN></FONT><o:p></o:p></P>
<DIV>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue =
size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: =
Arial">Thanks, Alice,=20
that issue about the licensee being a person is correct when it =
has to do=20
with dispensed controlled substances. That what makes take back =
to=20
problematic. </SPAN></FONT><o:p></o:p></P></DIV>
<DIV>
<P class=3DMsoNormal><FONT face=3D"Times New Roman" =
size=3D3><SPAN=20
style=3D"FONT-SIZE: =
12pt"> <o:p></o:p></SPAN></FONT></P></DIV>
<DIV>
<P class=3DMsoNormal><FONT face=3D"Times New Roman" =
size=3D3><SPAN=20
style=3D"FONT-SIZE: =
12pt"> <o:p></o:p></SPAN></FONT></P></DIV>
<P class=3DMsoAutoSig><FONT face=3D"Times New Roman" =
size=3D3><SPAN=20
style=3D"FONT-SIZE: 12pt">Charlotte A. Smith, R. Ph., M.S.,=20
HEM<BR>President<BR>PharmEcology Associates, LLC<BR>200 S. =
Executive=20
Drive, Suite 101<BR>Brookfield, WI 53005<BR>262-814-2635<BR>Fax=20
414-479-9941<o:p></o:p></SPAN></FONT></P>
<P class=3DMsoAutoSig><FONT face=3D"Times New Roman" color=3Dblue =
size=3D3><SPAN=20
style=3D"FONT-SIZE: 12pt; COLOR: blue">H2E Champion for Change=20
Award</SPAN></FONT><o:p></o:p></P>
<BLOCKQUOTE=20
style=3D"MARGIN-TOP: 5pt; MARGIN-BOTTOM: 5pt; MARGIN-RIGHT: 0in">
<P class=3DMsoNormal style=3D"MARGIN-BOTTOM: 12pt"><FONT =
face=3DTahoma=20
size=3D2><SPAN style=3D"FONT-SIZE: 10pt; FONT-FAMILY: =
Tahoma">-----Original=20
Message-----<BR><B><SPAN style=3D"FONT-WEIGHT: =
bold">From:</SPAN></B>=20
Chapman, Alice [mailto:Alice.Chapman@METROKC.GOV] <BR><B><SPAN=20
style=3D"FONT-WEIGHT: bold">Sent:</SPAN></B> Tuesday, January =
18, 2005=20
6:27 PM<BR><B><SPAN style=3D"FONT-WEIGHT: bold">To:</SPAN></B> =
Bill Lewry;=20
pharmwaste@lists.dep.state.fl.us<BR><B><SPAN=20
style=3D"FONT-WEIGHT: bold">Subject:</SPAN></B> RE: =
[Pharmwaste]=20
Pharmaceutical Waste</SPAN></FONT><o:p></o:p></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue =
size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: Arial">Just =
to clarify=20
a side issue mentioned in your =
question...</SPAN></FONT><o:p></o:p></P>
<P class=3DMsoNormal><FONT face=3D"Times New Roman" =
size=3D3><SPAN=20
style=3D"FONT-SIZE: 12pt"> <o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue =
size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: =
Arial">Neither the FDA=20
nor the DEA approves or permits incinerators for disposal of=20
drugs. The DEA regulations require that controlled =
substances be=20
destroyed "beyond reclamation". We're accustomed in the =
world of=20
hazardous waste to having particular sites permitted and =
approved by=20
EPA. The DEA looks at it differently. As long as =
the drugs=20
are in the custody of an approved "licensee" (often a person), =
and=20
"destroyed beyond reclamation", everything's fine. =
Incineration is=20
a handy way of making drugs non-reclamable! Every =
incinerator I've=20
talked to (I called as many as I could find in the US a couple =
of years=20
ago) has burned controlled substances. Usually the =
licensee=20
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=20
facility changes to meet security requirements. =20
</SPAN></FONT><o:p></o:p></P>
<P class=3DMsoNormal><FONT face=3D"Times New Roman" =
size=3D3><SPAN=20
style=3D"FONT-SIZE: 12pt"> <o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue =
size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: Arial">The =
loop you're=20
attributing to FDA, is actually managed by DEA and state Boards =
of=20
Pharmacy.</SPAN></FONT><o:p></o:p></P>
<P class=3DMsoNormal><FONT face=3D"Times New Roman" =
size=3D3><SPAN=20
style=3D"FONT-SIZE: 12pt"> <o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue =
size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: =
Arial">Pharmaceuticals=20
can be found in every category of hazardous waste. Your =
proposal=20
would work for many, but drugs packaged as inhalers (compressed =
gases)=20
or as injections (dose of drug in syringe attached to needle =
& ready=20
to go) would need to be handled differently. =20
</SPAN></FONT><o:p></o:p></P>
<P class=3DMsoNormal><FONT face=3D"Times New Roman" =
size=3D3><SPAN=20
style=3D"FONT-SIZE: 12pt"> <o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue =
size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: Arial">The =
major=20
drawback I see in your proposal is that disposal costs are paid =
for by=20
local governments, and the relatively low collection rate of =
hazardous=20
stuff out there that actually makes it's way to government-run=20
collection sites. I'd like to see what can happen when =
there are=20
as many collection points for drugs as there are=20
pharmacies.</SPAN></FONT><o:p></o:p></P>
<P class=3DMsoNormal><FONT face=3D"Times New Roman" =
size=3D3><SPAN=20
style=3D"FONT-SIZE: 12pt"> <o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue =
size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: =
Arial">:) =20
ac</SPAN></FONT><o:p></o:p></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue =
size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: =
Arial">Alice Chapman,=20
PE<o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue =
size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: =
Arial">Local Hazardous=20
Waste Management Program in King =
County<o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue =
size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: Arial">130 =
Nickerson=20
St, #100<o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue =
size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: =
Arial">Seattle,=20
WA 98109<o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue =
size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: Arial"><A=20
=
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 face=3DArial color=3Dblue =
size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: =
Arial"> <o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue =
size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: =
Arial">206-263-3058=20
phone<o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue =
size=3D2><SPAN=20
style=3D"FONT-SIZE: 10pt; COLOR: blue; FONT-FAMILY: =
Arial">206-263-3070=20
fax<o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3D"Times New Roman" =
size=3D3><SPAN=20
style=3D"FONT-SIZE: 12pt"> <o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3D"Times New Roman" =
size=3D3><SPAN=20
style=3D"FONT-SIZE: 12pt"> <o:p></o:p></SPAN></FONT></P>
<DIV class=3DMsoNormal style=3D"TEXT-ALIGN: center" =
align=3Dcenter><FONT=20
face=3D"Times New Roman" size=3D3><SPAN style=3D"FONT-SIZE: =
12pt">
<HR align=3Dcenter width=3D"100%" SIZE=3D2>
</SPAN></FONT></DIV>
<P class=3DMsoNormal style=3D"MARGIN-BOTTOM: 12pt"><B><FONT =
face=3DTahoma=20
size=3D2><SPAN=20
style=3D"FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: =
Tahoma">From:</SPAN></FONT></B><FONT=20
face=3DTahoma size=3D2><SPAN style=3D"FONT-SIZE: 10pt; =
FONT-FAMILY: Tahoma">=20
Bill Lewry [mailto:Bill_Lewry@kcmo.org] <BR><B><SPAN=20
style=3D"FONT-WEIGHT: bold">Sent:</SPAN></B> Saturday, January =
15, 2005=20
12:53 PM<BR><B><SPAN style=3D"FONT-WEIGHT: bold">To:</SPAN></B> =
pharmwaste@lists.dep.state.fl.us<BR><B><SPAN=20
style=3D"FONT-WEIGHT: bold">Subject:</SPAN></B> [Pharmwaste]=20
Pharmaceutical Waste</SPAN></FONT><o:p></o:p></P>
<P><FONT face=3D"Times New Roman" size=3D3><SPAN=20
style=3D"FONT-SIZE: 12pt">Dear Listserve:<BR><BR>I would =
appreciate if=20
someone could provide answer to the following =
question.<BR><BR><B><SPAN=20
style=3D"FONT-WEIGHT: bold">Simply out of curiosity,</SPAN></B> =
I=20
understand the (potential / possible) need to create a system =
to deal=20
with this issue, but unlike latex paint, electronics and =
carpet, amongst=20
others, it would appear to this uninitiated person that there =
is little=20
reclaimable asset to be gained from spent / out of date=20
pharmaceuticals.<BR><BR>Allowing that there is little benefit, =
then we=20
have the issue of these not falling into inappropriate hands. =
At least=20
in the narcotics area.<BR><BR>Pharmaceuticals once issued to =
the end=20
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=20
(Eg. NOS, Toxic, 6 (6.1)) and shipped for incineration. They =
would not=20
then require to go to an FDA approved incinerator.<BR><BR>An =
alternative=20
would be to place in an A fuel drum (all parties in agreement) =
and ship=20
in that fashion.<BR><BR>For the amounts and quantities involved =
in most=20
programs, this would seem the easy solution, for programs =
specifically=20
chasing these wastestreams as a revenue source, they could =
arrange=20
contracts as appropriate under auspices of the FDA if they =
themselves=20
saw a need to regulate material which was regulatorily in the =
vast=20
majority of cases "de-regulated" by age or condition.<BR><BR>I =
look=20
forward to the discussion thread this question line may=20
provoke.<BR><BR>Sincerely.<BR><BR>Bill Lewry /=20
=
KCMO.<o:p></o:p></SPAN></FONT></P></BLOCKQUOTE></BLOCKQUOTE></DIV></BLOC=
KQUOTE></BLOCKQUOTE></BODY></HTML>
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