[Pharmwaste] Pharmaceutical Waste
Charlotte A. Smith
csmith@pharmecology.com
Sat, 15 Jan 2005 20:53:24 -0600
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In response to Bill Lewry's questions regarding disposing of outdated
pharmaceuticals, RCRA hazardous waste disposal is certainly the option
of choice at this time. The greatest regulatory problem comes not from
FDA, which really doesn't have much jurisdiction except for minimal
oversight of reverse distributors, but rather from the Drug Enforcement
Administration. Even though dispensed controlled substances are out of
the formal DEA regulatory loop, it is illegal for any entity other than
the person for whom the drugs were prescribed to have possession of
them, other than law enforcement officers in the line of duty. Lynn
Rubenstein of the Northeast Recycling Council, also a member of this
listserve, has successfully completed one pilot for a take back program
involving law enforcement. Ann Heil's HHW program in Los Angeles cannot
take back controlled substances at this time. Perhaps they and others,
such as Dr. Steve Gressit in Maine, can continue the dialog on this
particular issue.=20
=20
A second issue is whether or not the household status is maintained
relative to the entity taking back the drugs, such as a pharmacy.
Federally, Kristina Meson of OSWR, EPA, confirmed that the commercial
entity would not need to manage the drugs as hazardous waste unless they
were commingled with hazardous waste generated in the course of doing
business. Some states, however, have stricter regulations. MInnesota,
for example, recently determined that a pharmacy involved in accepting
consumer drugs containing hazardous waste would need to register as a
HHW facility, a burdensome process. They are looking at options to that
requirement.=20
=20
So the four primary areas to be addressed would seem to be security in
general, given the high street value of even non-controlled drugs, DEA
issues, EPA haz waste issues, and the cost of collection, documentation
and disposal. I hope this is helpful.=20
=20
Best regards,=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: Bill Lewry [mailto:Bill_Lewry@kcmo.org]=20
Sent: Saturday, January 15, 2005 2:53 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=3D790254302-16012005><FONT face=3DArial color=3D#0000ff =
size=3D2>In=20
response to Bill Lewry's questions regarding disposing of outdated=20
pharmaceuticals, RCRA hazardous waste disposal is certainly the option =
of choice=20
at this time. The greatest regulatory problem comes not from FDA, which =
really=20
doesn't have much jurisdiction except for minimal oversight of reverse=20
distributors, but rather from the Drug Enforcement Administration. Even =
though=20
dispensed controlled substances are out of the formal DEA regulatory =
loop, it is=20
illegal for any entity other than the person for whom the drugs were =
prescribed=20
to have possession of them, other than law enforcement officers in the =
line of=20
duty. Lynn Rubenstein of the Northeast Recycling Council, also a member =
of this=20
listserve, has successfully completed one pilot for a take back program=20
involving law enforcement. Ann Heil's HHW program in Los Angeles cannot =
take=20
back controlled substances at this time. Perhaps they and others, such =
as Dr.=20
Steve Gressit in Maine, can continue the dialog on this particular =
issue.=20
</FONT></SPAN></DIV>
<DIV><SPAN class=3D790254302-16012005><FONT face=3DArial color=3D#0000ff =
size=3D2></FONT></SPAN> </DIV>
<DIV><SPAN class=3D790254302-16012005><FONT face=3DArial color=3D#0000ff =
size=3D2>A=20
second issue is whether or not the household status is maintained =
relative to=20
the entity taking back the drugs, such as a pharmacy. Federally, =
Kristina Meson=20
of OSWR, EPA, confirmed that the commercial entity would not need to =
manage the=20
drugs as hazardous waste unless they were commingled with hazardous =
waste=20
generated in the course of doing business. Some states, however, have =
stricter=20
regulations. MInnesota, for example, recently determined that a pharmacy =
involved in accepting consumer drugs containing hazardous waste would =
need to=20
register as a HHW facility, a burdensome process. They are looking at =
options to=20
that requirement. </FONT></SPAN></DIV>
<DIV><SPAN class=3D790254302-16012005><FONT face=3DArial color=3D#0000ff =
size=3D2></FONT></SPAN> </DIV>
<DIV><SPAN class=3D790254302-16012005><FONT face=3DArial color=3D#0000ff =
size=3D2>So the=20
four primary areas to be addressed would seem to be security in general, =
given=20
the high street value of even non-controlled drugs, DEA issues, EPA haz =
waste=20
issues, and the cost of collection, documentation and disposal. I =
hope=20
this is helpful. </FONT></SPAN></DIV>
<DIV><SPAN class=3D790254302-16012005><FONT face=3DArial color=3D#0000ff =
size=3D2></FONT></SPAN> </DIV>
<DIV><SPAN class=3D790254302-16012005><FONT face=3DArial color=3D#0000ff =
size=3D2>Best=20
regards, </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> Bill =
Lewry=20
[mailto:Bill_Lewry@kcmo.org] <BR><B>Sent:</B> Saturday, January 15, =
2005 2:53=20
PM<BR><B>To:</B> pharmwaste@lists.dep.state.fl.us<BR><B>Subject:</B>=20
[Pharmwaste] Pharmaceutical Waste<BR><BR></FONT></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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