[Pharmwaste] RE: Pharmwaste digest, Vol 1 #152 - 1 msg
Richard Verch
Richard@StrongServices.com
Fri, 7 Oct 2005 08:17:45 -0400
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Tammy and Jennifer:
Regarding the Thu, 6 Oct 2005 e-mail about local pharmacy take-backs:
Some clarification and amplification of the statement: "If they [the =20
pharmacy] are accepting controlled substances..." needs to be made.
Pharmacies cannot accept controlled substances from citizens =20
legally. DEA will not allow it, as the CSA only allows for transfer =20
of controlled substances with in a closed-loop framework: from one =20
DEA Registrant to another. Once dispensed to a citizen, it is =20
outside of the DEA's closed-system of distribution. A citizen is not =20=
a Registrant of the DEA, and therefore it is not legal to transfer =20
the controlled substances to the pharmacy.
However, the DEA, in 21 CFR 1301.24 waives the registration =20
requirement for local law enforcement acting in official duty. **The =20=
police department you mention would be accepting controlled =20
substances (versus the pharmacy.)** This little distinction is =20
important for all to know.
Additionally, there has been some correspondence from the DEA that =20
indicates "..controlled substances cannot be commingled with the non-=20
controlled substances..." during these unwanted medication disposal =20
projects.
We call this issue "the DEA obstacle", and we brought this matter up =20
two weeks ago with the DEA. While on an invited panel discussion =20
with the headquarter DEA folks, Strong characterized the current laws =20=
as a regulatory roadblock, not allowing for an efficient means of =20
recapturing unwanted controlled substances - thus hindering the =20
entire pharmaceutical collection effort.
DEA's response was well received, and we believe that DEA recognizes =20
more each year that this as an issue that must be addressed. DEA is =20
hand-tied because the law simply doesn't allow for distribution/=20
transaction between the consumer (non-registrant) and any other =20
entity (except law enforcement as we have seen).
DEA, understandably, has reason to be wary of this sort of 'reverse-=20
distribution; however, they also clearly see the net benefit.
So, a change must be made to the law that restricts the transactions =20
from consumers. Specifically, we are suggesting 21 CFR part 1307.21, =20
and related affected sections, be modified to achieve the goal. =20
Strong will work with DEA to suggest and implement a regulatory =20
mechanism that achieves the mutual goals of properly governed disposal.
Regards,
Richard Verch, CHMM
President
770.409.1500 x111
770.409.1449 fax
www.StrongServices.com
---
Supported by:
Beth Batelaan
770.409.1500 x142
Beth@StrongServices.com
Founded over a decade ago, Strong Environmental, Inc. is the =20
recognized industry leader in providing treatment and disposal =20
services for a broad spectrum of industrial, non-hazardous, EPA =20
hazardous, DEA controlled substances and special waste materials. We =20
offer our clients the industry=92s most comprehensive network of waste =20=
disposal and treatment facilities and a management team of =20
experienced service-focused professionals.
This message is sent in confidence for the addressee only. It may =20
contain confidential or sensitive information. The contents are not =20
to be disclosed to anyone other than the addressee. Unauthorized =20
recipients are requested to preserve this confidentiality and to =20
advise us of any errors in transmission. Thank you
--Apple-Mail-5-56409802
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<HTML><BODY style=3D"word-wrap: break-word; -khtml-nbsp-mode: space; =
-khtml-line-break: after-white-space; "><DIV style=3D"margin-top: 0px; =
margin-right: 0px; margin-bottom: 0px; margin-left: 0px; ">Tammy and =
Jennifer:</DIV><DIV style=3D"margin-top: 0px; margin-right: 0px; =
margin-bottom: 0px; margin-left: 0px; "><BR =
class=3D"khtml-block-placeholder"></DIV><DIV style=3D"margin-top: 0px; =
margin-right: 0px; margin-bottom: 0px; margin-left: 0px; ">Regarding =
the=A0Thu, 6 Oct 2005 e-mail about local pharmacy take-backs:</DIV><DIV =
style=3D"margin-top: 0px; margin-right: 0px; margin-bottom: 0px; =
margin-left: 0px; "><BR class=3D"khtml-block-placeholder"></DIV><DIV =
style=3D"margin-top: 0px; margin-right: 0px; margin-bottom: 0px; =
margin-left: 0px; ">Some clarification and amplification of the =
statement: "If they [the pharmacy] are accepting controlled =
substances..." needs to be made.=A0=A0</DIV><DIV style=3D"margin-top: =
0px; margin-right: 0px; margin-bottom: 0px; margin-left: 0px; "><BR =
class=3D"khtml-block-placeholder"></DIV><DIV style=3D"margin-top: 0px; =
margin-right: 0px; margin-bottom: 0px; margin-left: 0px; ">Pharmacies =
cannot accept controlled substances from citizens legally.=A0 DEA will =
not allow it, as the CSA only allows for transfer of controlled =
substances with in a closed-loop framework: from one DEA Registrant to =
another.=A0 Once dispensed to a citizen, it is outside of the DEA's =
closed-system of distribution.=A0=A0A citizen is not a Registrant of the =
DEA, and therefore it is not legal to transfer the controlled substances =
to the pharmacy.=A0</DIV><DIV style=3D"margin-top: 0px; margin-right: =
0px; margin-bottom: 0px; margin-left: 0px; "><BR =
class=3D"khtml-block-placeholder"></DIV><DIV style=3D"margin-top: 0px; =
margin-right: 0px; margin-bottom: 0px; margin-left: 0px; ">However, the =
DEA, in 21 CFR 1301.24 waives the registration requirement for local law =
enforcement acting in official duty.=A0 **The police department you =
mention would be accepting controlled substances (versus the =
pharmacy.)**=A0 This little distinction is important for all to =
know.</DIV><DIV style=3D"margin-top: 0px; margin-right: 0px; =
margin-bottom: 0px; margin-left: 0px; "><BR =
class=3D"khtml-block-placeholder"></DIV><DIV style=3D"margin-top: 0px; =
margin-right: 0px; margin-bottom: 0px; margin-left: 0px; ">Additionally, =
there has been some correspondence from the DEA that indicates =
"..controlled substances cannot be commingled with the non-controlled =
substances..." during these unwanted medication disposal =
projects.</DIV><DIV style=3D"margin-top: 0px; margin-right: 0px; =
margin-bottom: 0px; margin-left: 0px; "><BR =
class=3D"khtml-block-placeholder"></DIV><DIV style=3D"margin-top: 0px; =
margin-right: 0px; margin-bottom: 0px; margin-left: 0px; "><BR =
class=3D"khtml-block-placeholder"></DIV><DIV style=3D"margin-top: 0px; =
margin-right: 0px; margin-bottom: 0px; margin-left: 0px; ">We call this =
issue "the DEA obstacle", and we brought this matter up two weeks ago =
with the DEA.=A0 While on an invited panel discussion with the =
headquarter DEA folks, Strong characterized the current laws as a =
regulatory roadblock, not allowing for an efficient means of recapturing =
unwanted controlled substances - thus hindering the entire =
pharmaceutical collection effort.</DIV><DIV style=3D"margin-top: 0px; =
margin-right: 0px; margin-bottom: 0px; margin-left: 0px; font: normal =
normal normal 12px/normal Helvetica; min-height: 14px; "><BR></DIV><DIV =
style=3D"margin-top: 0px; margin-right: 0px; margin-bottom: 0px; =
margin-left: 0px; ">DEA's response was well received, and we believe =
that DEA recognizes more each year that this as an issue that must be =
addressed. DEA is hand-tied because the law simply doesn't allow for =
distribution/transaction between the consumer (non-registrant) and any =
other entity (except law enforcement as we have seen).=A0=A0</DIV><DIV =
style=3D"margin-top: 0px; margin-right: 0px; margin-bottom: 0px; =
margin-left: 0px; font: normal normal normal 12px/normal Helvetica; =
min-height: 14px; "><BR></DIV><DIV style=3D"margin-top: 0px; =
margin-right: 0px; margin-bottom: 0px; margin-left: 0px; ">DEA, =
understandably, has reason to be wary of this sort of =
'reverse-distribution; however, they also clearly see the net =
benefit.=A0=A0</DIV><DIV style=3D"margin-top: 0px; margin-right: 0px; =
margin-bottom: 0px; margin-left: 0px; font: normal normal normal =
12px/normal Helvetica; min-height: 14px; "><BR></DIV><DIV =
style=3D"margin-top: 0px; margin-right: 0px; margin-bottom: 0px; =
margin-left: 0px; ">So, a change must be made to the law that restricts =
the transactions from consumers. Specifically, we are suggesting 21 CFR =
part 1307.21, and related affected sections, be modified to achieve the =
goal.=A0 Strong=A0will work with DEA to suggest and implement a =
regulatory mechanism that achieves the mutual goals of properly governed =
disposal.=A0=A0</DIV><DIV style=3D"margin-top: 0px; margin-right: 0px; =
margin-bottom: 0px; margin-left: 0px; font: normal normal normal =
12px/normal Helvetica; min-height: 14px; "><BR></DIV><DIV =
style=3D"margin-top: 0px; margin-right: 0px; margin-bottom: 0px; =
margin-left: 0px; font: normal normal normal 12px/normal Helvetica; =
min-height: 14px; "><BR></DIV><DIV style=3D"margin-top: 0px; =
margin-right: 0px; margin-bottom: 0px; margin-left: 0px; =
">Regards,</DIV><DIV style=3D"margin-top: 0px; margin-right: 0px; =
margin-bottom: 0px; margin-left: 0px; font: normal normal normal =
12px/normal Helvetica; min-height: 14px; "><BR></DIV><DIV =
style=3D"margin-top: 0px; margin-right: 0px; margin-bottom: 0px; =
margin-left: 0px; ">Richard Verch, CHMM</DIV><DIV style=3D"margin-top: =
0px; margin-right: 0px; margin-bottom: 0px; margin-left: 0px; ">=A0 =A0 =
President</DIV><DIV style=3D"margin-top: 0px; margin-right: 0px; =
margin-bottom: 0px; margin-left: 0px; ">=A0 =A0 770.409.1500 =
x111</DIV><DIV style=3D"margin-top: 0px; margin-right: 0px; =
margin-bottom: 0px; margin-left: 0px; ">=A0 =A0 770.409.1449 =
fax</DIV><DIV style=3D"margin-top: 0px; margin-right: 0px; =
margin-bottom: 0px; margin-left: 0px; ">=A0 =A0 <A =
href=3D"http://www.StrongServices.com/"><FONT class=3D"Apple-style-span" =
color=3D"#000FED">www.StrongServices.com</FONT></A></DIV><DIV =
style=3D"margin-top: 0px; margin-right: 0px; margin-bottom: 0px; =
margin-left: 0px; font: normal normal normal 12px/normal Helvetica; =
min-height: 14px; "><BR></DIV><DIV style=3D"margin-top: 0px; =
margin-right: 0px; margin-bottom: 0px; margin-left: 0px; ">---</DIV><DIV =
style=3D"margin-top: 0px; margin-right: 0px; margin-bottom: 0px; =
margin-left: 0px; ">Supported by:</DIV><DIV style=3D"margin-top: 0px; =
margin-right: 0px; margin-bottom: 0px; margin-left: 0px; ">=A0 =A0 Beth =
Batelaan</DIV><DIV style=3D"margin-top: 0px; margin-right: 0px; =
margin-bottom: 0px; margin-left: 0px; ">=A0 =A0 770.409.1500 =
x142</DIV><DIV style=3D"margin-top: 0px; margin-right: 0px; =
margin-bottom: 0px; margin-left: 0px; ">=A0 =A0 <A =
href=3D"mailto:Beth@StrongServices.com"><FONT class=3D"Apple-style-span" =
color=3D"#000FED">Beth@StrongServices.com</FONT></A></DIV><DIV =
style=3D"margin-top: 0px; margin-right: 0px; margin-bottom: 0px; =
margin-left: 0px; font: normal normal normal 12px/normal Helvetica; =
min-height: 14px; "><BR></DIV><DIV style=3D"margin-top: 0px; =
margin-right: 0px; margin-bottom: 0px; margin-left: 0px; ">Founded over =
a decade ago, Strong Environmental, Inc. is the recognized industry =
leader in providing treatment and disposal services for a broad spectrum =
of industrial, non-hazardous, EPA hazardous, DEA controlled substances =
and special waste materials. We offer our clients the industry=92s most =
comprehensive network of waste disposal and treatment facilities and a =
management team of experienced service-focused professionals.</DIV><DIV =
style=3D"margin-top: 0px; margin-right: 0px; margin-bottom: 0px; =
margin-left: 0px; font: normal normal normal 12px/normal Helvetica; =
min-height: 14px; "><BR></DIV><DIV style=3D"margin-top: 0px; =
margin-right: 0px; margin-bottom: 0px; margin-left: 0px; font: normal =
normal normal 12px/normal Helvetica; min-height: 14px; "><BR></DIV><DIV =
style=3D"margin-top: 0px; margin-right: 0px; margin-bottom: 0px; =
margin-left: 0px; ">This message is sent in confidence for the addressee =
only. It may contain confidential or sensitive information. The contents =
are not to be disclosed to anyone other than the addressee. Unauthorized =
recipients are requested to preserve this confidentiality and to advise =
us of any errors in transmission. Thank you</DIV><DIV style=3D"margin-top:=
0px; margin-right: 0px; margin-bottom: 0px; margin-left: 0px; "><BR =
class=3D"khtml-block-placeholder"></DIV></BODY></HTML>=
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