[Pharmwaste] Pharmaceutical Waste
Charlotte A. Smith
csmith@pharmecology.com
Mon, 24 Jan 2005 10:47:35 -0600
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Hi Cheri,
=20
Just a reminder that PharmEcology Associates has this database available
as the PharmE Waste Wizard on subscription. We have over 128,000 drug
items listed and add on average 1,000 products per month. The cost to
hospitals is minimal given the complexity of the information. We
indicate which drugs are RCRA hazardous waste and also provide risk
manaement category for drugs which are not listed and should be, such
over 100 chemotherapy agents. We estimated it would require a pharmacist
six months to review all the drugs in their formulary for hazardous
waste designation. We can run that for them in two weeks. Sometimes the
private sector is the most efficient way to manage these issues. We'd be
pleased to provide additional information to anyone who is interested.=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: Grasso, Cheri [mailto:Cheri.Grasso@METROKC.GOV]=20
Sent: Monday, January 24, 2005 10:30 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. =20
=20
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.=20
=20
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.
=20
Cheri B. Grasso=20
Environmental & Health Investigator, II=20
Local Hazardous Waste Management Program=20
130 Nickerson Street, Suite 100=20
Seattle, WA 98109=20
(206) 263-3089=20
cheri.grasso@metrokc.gov=20
=20
-----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,
=20
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.=20
Leah D. Proffitt=20
Environmental Specialist=20
FDEP Central District=20
Hazardous Waste=20
(407) 893-3323=20
S/C 325-2283=20
=20
-----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.
=20
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. =20
=20
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...=20
=20
Emma Johnson
Washington State Department of Ecology
=20
-----Original Message-----
From: Ann Heil [mailto:aheil@lacsd.org]=20
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
=20
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.
=20
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.=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
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=3D749374216-24012005><FONT face=3DArial color=3D#0000ff =
size=3D2>Hi=20
Cheri,</FONT></SPAN></DIV>
<DIV><SPAN class=3D749374216-24012005><FONT face=3DArial color=3D#0000ff =
size=3D2></FONT></SPAN> </DIV>
<DIV><SPAN class=3D749374216-24012005><FONT face=3DArial color=3D#0000ff =
size=3D2>Just a=20
reminder that PharmEcology Associates has this database available as the =
PharmE=20
Waste Wizard on subscription. We have over 128,000 drug items =
listed and=20
add on average 1,000 products per month. The cost to hospitals is =
minimal given=20
the complexity of the information. We indicate which drugs are RCRA =
hazardous=20
waste and also provide risk manaement category for drugs which are not =
listed=20
and should be, such over 100 chemotherapy agents. We estimated it would =
require=20
a pharmacist six months to review all the drugs in their formulary for =
hazardous=20
waste designation. We can run that for them in two weeks. Sometimes the =
private=20
sector is the most efficient way to manage these issues. We'd be pleased =
to=20
provide additional information to anyone who is interested. =
</FONT></SPAN></DIV>
<DIV><FONT face=3DArial color=3D#0000ff size=3D2></FONT> </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<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> =
Grasso, Cheri=20
[mailto:Cheri.Grasso@METROKC.GOV] <BR><B>Sent:</B> Monday, January 24, =
2005=20
10:30 AM<BR><B>To:</B> 'Proffitt, Leah'; 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=3D843254215-24012005><FONT face=3DArial =
size=3D2><FONT=20
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=20
Code (NDC) in the database that hospitals will use to get =
the drug=20
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=20
to make make the NDC available to those that will build the database. =
He=20
didn't know who would build the database or what form it would take -- =
that=20
would have to be worked out privately. FDA's vision was whoever built =
the=20
database with the NDC info into it could add the RCRA info that would =
be=20
linked to the NDC information. He guessed the key players may be the =
UCC=20
(Uniform Commercial Code) & manufacturers. <SPAN=20
class=3D843254215-24012005>I followed up on the contact he gave me who =
knew=20
about this database, Allen Goldhammer of PhRMA. Allen said PhRMA =
was not=20
developing this theoretical database for other manufacturers and =
didn't know=20
who 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> </DIV=
>
<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> </DIV=
>
<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 =
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=20
19, 2005 8:26 AM<BR><B>To:</B> Johnson, Emma (ECY);=20
pharmwaste@lists.dep.state.fl.us<BR><B>Subject:</B> RE: [Pharmwaste] =
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 =
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=20
to 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=20
</B>Johnson, 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=20
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=20
user from the closed loop accounting system that DEA mandates. =
<SPAN=20
style=3D"mso-spacerun: yes"> </SPAN>However, as soon as you =
return=20
those substances to a pharmacy (for instance) the DEA is going to =
care,=20
and you 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=20
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=20
style=3D"FONT-SIZE: 10pt; COLOR: navy; FONT-FAMILY: Arial">I'm not =
sure if=20
the 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 =
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=20
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=20
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 from your state board of pharmacy and the DEA (not =
particularly=20
easy).<SPAN style=3D"mso-spacerun: yes"> </SPAN><SPAN=20
style=3D"mso-spacerun: yes"> </SPAN>This is something we're =
working on=20
in Washington... <o:p></o:p></SPAN></FONT></P>
<P class=3DMsoNormal><FONT face=3DArial color=3Dnavy =
size=3D2><SPAN=20
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=20
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=20
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=20
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=20
Heil [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 =
Year=3D"2005"=20
Day=3D"19" Month=3D"1"><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
Minute=3D"33" Hour=3D"7"><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 =
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 =
style=3D"FONT-SIZE: 12pt"><o:p> </o:p></SPAN></FONT></P>
<DIV>
<P class=3DMsoNormal><FONT face=3DArial color=3Dblue =
size=3D2><SPAN=20
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=20
substance regs by having the person dropping them off apply this =
kit prior=20
to dropping them off? The group that is collecting the =
pharmaceuticals=20
would then not be subject to controlled substances regs, because =
the=20
controlled substances 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 =
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=20
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=20
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 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
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. =
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] =
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=20
do 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=20
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 =
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=20
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><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=20
clarify a side issue mentioned in your=20
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=20
FDA 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=20
is a handy way of making drugs non-reclamable! Every =
incinerator=20
I've talked to (I called as many as I could find in the US a =
couple of=20
years ago) has burned controlled substances. Usually the =
licensee witnesses the drugs as they go into the system. =
The=20
drugs can't sit around in storage on-site before burning, that =
would=20
require 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=20
you're attributing to FDA, is actually managed by DEA and =
state Boards=20
of 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 =
&=20
ready 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 =
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=20
Chapman, 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=20
Hazardous Waste Management Program in King=20
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/hazwaste=
/</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>=20
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=20
question.<BR><BR><B><SPAN style=3D"FONT-WEIGHT: bold">Simply =
out of=20
curiosity,</SPAN></B> I understand the (potential / possible) =
need to=20
create a system to deal with this issue, but unlike latex =
paint,=20
electronics and carpet, amongst others, it would appear to =
this=20
uninitiated person that there is little reclaimable asset to =
be gained=20
from spent / out of date pharmaceuticals.<BR><BR>Allowing that =
there=20
is little benefit, then we have the issue of these not falling =
into=20
inappropriate hands. At least in the narcotics=20
area.<BR><BR>Pharmaceuticals once issued to the end user are =
"out of=20
the loop" of the FDA and would then at end of life become =
"HHW", and=20
it appears should then be treated as any other HHW.<BR><BR>It =
would=20
appear that these items would simply be best placed amongst =
other=20
"toxics", drummed without external indicative labelling (Eg. =
NOS,=20
Toxic, 6 (6.1)) and shipped for incineration. They would not =
then=20
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=20
ship in that fashion.<BR><BR>For the amounts and quantities =
involved=20
in most programs, this would seem the easy solution, for =
programs=20
specifically chasing these wastestreams as a revenue source, =
they=20
could arrange contracts as appropriate under auspices of the =
FDA if=20
they themselves saw a need to regulate material which was =
regulatorily=20
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 may provoke.<BR><BR>Sincerely.<BR><BR>Bill Lewry =
/=20
=
KCMO.<o:p></o:p></SPAN></FONT></P></BLOCKQUOTE></BLOCKQUOTE></DIV></BLOCK=
QUOTE></BLOCKQUOTE></BLOCKQUOTE></BODY></HTML>
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