[Pharmwaste] RE: Pharmwaste digest, Vol 1 #153 - 1 msg

Stevan Gressitt gressitt@uninets.net
Tue, 11 Oct 2005 00:05:19 -0400


Actually isn't there the need for FDA regulations on prescription labeling?
I understand bar coding may not however indicate scheduling but only NDC
codes. Stevan Gressitt, M.D. 

-----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: Monday, October 10, 2005 6:07 PM
To: aventura@cleanwater.org; pharmwaste@lists.dep.state.fl.us
Subject: RE: [Pharmwaste] RE: Pharmwaste digest, Vol 1 #153 - 1 msg

Unfortunately the markings for a controlled substance are only on the
original manufacturer's package, indicating a CII, CIII, etc. There are
no specific markings on the  prescription label. That is why a
pharmacist is needed to identify which drugs can be accepted at a
collection site. A change in the Controlled Substances Act is needed and
the Drug Enforcement Administration is beginning to consider such as
change. 

Charlotte A. Smith, R. Ph., M.S., HEM
President
PharmEcology Associates, LLC
200 S. Executive Drive, Suite 101
Brookfield, WI 53005
Phone: 262-814-2635
Fax: 414-479-9941
csmith@pharmecology.com


-----Original Message-----
From: pharmwaste-admin@lists.dep.state.fl.us
[mailto:pharmwaste-admin@lists.dep.state.fl.us] On Behalf Of Andria
Ventura
Sent: Monday, October 10, 2005 4:57 PM
To: pharmwaste@lists.dep.state.fl.us
Subject: [Pharmwaste] RE: Pharmwaste digest, Vol 1 #153 - 1 msg


One question - how do people know if their prescription is controlled?
For instance, Ritalin is a controlled substance, but many
parents/patients do not know that. This adds to the problem in that it
requires public education to keep these pharmaceuticals separate.

-----Original Message-----
From: pharmwaste-admin@lists.dep.state.fl.us
[mailto:pharmwaste-admin@lists.dep.state.fl.us]On Behalf Of
pharmwaste-request@lists.dep.state.fl.us
Sent: Saturday, October 08, 2005 4:07 AM
To: pharmwaste@lists.dep.state.fl.us
Subject: Pharmwaste digest, Vol 1 #153 - 1 msg


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Today's Topics:

   1. RE: Pharmwaste digest, Vol 1 #152 - 1 msg (Richard Verch)

--__--__--

Message: 1
To: pharmwaste@lists.dep.state.fl.us
From: Richard Verch <Richard@StrongServices.com>
Date: Fri, 7 Oct 2005 08:17:45 -0400
Subject: [Pharmwaste] RE: Pharmwaste digest, Vol 1 #152 - 1 msg


--Apple-Mail-5-56409802
Content-Transfer-Encoding: quoted-printable
Content-Type: text/plain;
	charset=WINDOWS-1252;
	delsp=yes;
	format=flowed

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
Content-Transfer-Encoding: quoted-printable
Content-Type: text/html;
	charset=WINDOWS-1252

<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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