[Pharmwaste] Do DEA regulations allow
municipal wastecombustortoreceive mailed back controlled
substances fromhouseholds?Wouldcombustors want to?
gressitt
gressitt at uninets.net
Sun Aug 20 17:45:26 EDT 2006
We are hoping to have enough different representatives of different states
and stages of legislative process that proposals for state and federal level
action can hopefully get molded. It looks good so far. Stevan Gressitt, M.D.
207-441-0291
From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Charlotte A.
Smith
Sent: Thursday, August 17, 2006 2:47 PM
To: Taam, Damon; Johnson, Emma (ECY); Volkman, Jennifer; Price, John L.
Cc: Hickle, Garth; pharmwaste at lists.dep.state.fl.us; Schreifels, Susan;
Countryman, Linda; Tenace, Laurie; Fran Kurk
Subject: RE: [Pharmwaste] Do DEA regulations allow municipal
wastecombustortoreceive mailed back controlled substances
fromhouseholds?Wouldcombustors want to?
I agree mailback to an incinerator is problematic. I have not given up the
concept of changing the DEA regulations to enable reverse distributors to
receive consumer drugs, including controlled substances. This has happened
with recalls. Draft language will be discussed at the Maine Unused Med
meeting on Oct 23/24. Contact Dr. Steve Gressitt for more informaiton. Once
that is approved, a pilot should be set up between a reverse distributor,
manufacturer, and major chain solely for that manufacturer's drugs. Once the
bugs are worked out, a campaign to enlist more manufacturers and retailers
could evolve. A fee would need to be determined to be charged to the
manufacturer for all costs. The data that would be gathered, not available
at this time, could be invaluable to the manufacturer as well as to 3rd
party payers. I look forward to living long enough to see this happen!
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
csmith at pharmecology.com
www.pharmecology.com <http://www.pharmecology.com/>
H2E Champion for Change Award 2004
_____
From: Taam, Damon [mailto:DTaam at spokanecity.org]
Sent: Thursday, August 17, 2006 1:16 PM
To: Johnson, Emma (ECY); Volkman, Jennifer; Price, John L.; Charlotte A.
Smith
Cc: Hickle, Garth; pharmwaste at lists.dep.state.fl.us; Schreifels, Susan;
Countryman, Linda; Tenace, Laurie; Fran Kurk
Subject: RE: [Pharmwaste] Do DEA regulations allow municipal
wastecombustortoreceive mailed back controlled substances
fromhouseholds?Wouldcombustors want to?
Hi all- I concur with Emma that a mail back program is a nonstarter. As a
municipal representative of the Spokane Regional Waste to Energy Facility (
local government owned) we viewed the mail back program as a nightmare
(imagine what a private profit making company would say). Step out your box
and envision all the drugs being shipped into your office. You have no
control over anything shipped to you, hazardous or otherwise, you have no
one to pay disposal fees (it does cost money to run a facility) and the DEA
is all over you because you are in illegal possesion of a controlled
substances and do not have the appropriate authority, skilled personnel and
facilities to handle the pharmaceutical waste. The System is supportive of
increased management of pharmaceutical waste and feels that Waste to Energy
is the appropriate technology (2500 F) to destroy the pharmaceutical drugs.
The Spokane facility currently combusts over 275,000 tons of MSW
annually(800 tons /day), the anticipated WA state annual quantity of
pharmaceutical waste needing combustion service is 200 - 400 tons. For us to
gear up (if we could?) and be a DEA compliant is beyond our mission and
would be tough to justify. Just my point of view.
Damon M.K. Taam
Spokane Regional Solid Waste System
808 Spokane Falls Blvd.
Spokane, WA 99201
(509) 625-6580 Office
(509) 625-6537 Fax
-----Original Message-----
From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Johnson, Emma
(ECY)
Sent: Thursday, August 17, 2006 9:32 AM
To: Volkman, Jennifer; Price, John L.; Charlotte A. Smith
Cc: Hickle, Garth; pharmwaste at lists.dep.state.fl.us; Schreifels, Susan;
Countryman, Linda; Tenace, Laurie; Fran Kurk
Subject: RE: [Pharmwaste] Do DEA regulations allow municipal
wastecombustortoreceive mailed back controlled substances
fromhouseholds?Wouldcombustors want to?
Hi all- The Washington State PH:ARM team considered using a mail back
program for collection of household pharmaceuticals initially. Our idea was
to provide some sort of mailer to consumers and they could mail the material
directly to the Waste to Energy facility in our state. We ran into three
logistical barriers, which I wanted to share, perhaps they do or do not
apply in your situation.
1. There needs to be some authorized entity (if the mix of material
contains controlled substances, you need law enforcement) to receive the
medications. Our incinerator could not receive the medications directly, as
they had no law enforcement capabilities there, nor were they able to accept
any sort of waste by mail. We imagined some sort of secure PO box located
near the facility, and someone would have to take the material from the PO
box to the Waste to Energy facility. DEA may desire inventory control in
this system, which could be quite a barrier.
2. Volume issues. The idea of a mailer works great for the half of a
vial that is left over, but how do you deal with the large quantity of meds
from a death in the family?
3. Cost. At $1.00-$5.00 per mailer (weight, volume) in postage, that
is a lot of money. If you want 2 million people in your state to use the
program (less than half of the population in Washington) it adds up to $2 to
$10 million just in postage alone. We weren't sure if consumers would be
willing to pay postage. And we weren't envisioning manufacturers paying for
that cost at this early point in time.
Best regards
Emma Johnson
Washington State Department of Ecology
_____
From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Volkman,
Jennifer
Sent: Tuesday, August 15, 2006 4:50 PM
To: Price, John L.; Charlotte A. Smith
Cc: Hickle, Garth; pharmwaste at lists.dep.state.fl.us; Schreifels, Susan;
Countryman, Linda; Tenace, Laurie; Fran Kurk
Subject: RE: [Pharmwaste] Do DEA regulations allow municipal waste
combustortoreceive mailed back controlled substances from
households?Wouldcombustors want to?
Hello Jack and all,
I don't know if this information will be helpful, but we are also
considering applying for a grant here, so I've been thinking about what
might work. Ideas...some maybe not that well thought out...
For households located in areas where we know their waste is directed to
mixed-muni incinerators, I think we can safely educate HH's to put
old/unused pharms, including controlled substances, in their garbage (tape
up the jars, mix them with the nasties, etc first). There is no need to
collect/mail them separately and bump into all of the regulatory and
operational issues. Pharms generated in areas where waste goes to landfills
would be worth collecting separately and mailing in or redirecting to a
mixed-muni incinerator. In this case, there could be considerable
transportation cost and operational barriers to get them from the law
enforcement office to the MM incinerator and it may be simpler to render the
pharms inedible/unrecognizable at the law enforcement office and ship them
with a HW contractor as a standard HW labpack. You'd have to comply with
DOT regulations and you'd want to work with your HW contractor to see what
the options are for packaging.
Some of our HHW programs collect pharms, but not controlled substances.
I'll ask whether they ship the non-haz pharms in a separate lab pack or if
they just mix them in with their oil based paint. I believe they properly
lab pack the hazardous pharms, but I know I've heard of programs that handle
the non-haz pharms in a more economical manner. If local law enforcement
could take a bag o' pharms down to the county public works garage and dump
it in the oil paint drum, things would be greatly simplified. There is,
however, much to know about what is haz, non-haz and controlled.
Oh! another idea. They could be mailed in to a controlled mailbox at the
law enforcement office(s) closest to the MM incinerator, not every one in
the state. Manufacturers could fund the system.
We still need to ask DEA questions and work with them on practical, safe
options. We still need to work with the medical community on ways to reduce
the amount of unused pharms.
Jnifr
-----Original Message-----
From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Price, John
L.
Sent: Tuesday, August 15, 2006 10:05 AM
To: Charlotte A. Smith
Cc: Tenace, Laurie; pharmwaste at lists.dep.state.fl.us
Subject: RE: [Pharmwaste] Do DEA regulations allow municipal waste
combustorto receive mailed back controlled substances from households?Would
combustors want to?
Thanks, Charlotte. While the request worms its way through DEA, I'm
thinking we'll need a "Plan B" in case DEA says "no." We're on a pretty
short time line. Even if DEA says "yes," it still may be something that a
combustor could or would not want to do. These plants are built and operated
to receive municipal solid waste by the truckload. They may not have (or
want to have) the operational expertise or mindset to receive waste by the
envelope-load, particularly if it has to go to a secure location pretty
quickly. On the other hand, it would be no different than their office
staff receiving and processing mail to the appropriate location, so maybe I
am worrying about a non-problem. We'll see . . . that's what pilots are
for . . . and now I'll end my ramblings on this topic.
Jack.
John L. (Jack) Price
Environmental Manager
Hazardous Waste Management MS 4555
Florida Department of Environmental Protection
2600 Blair Stone Road
Tallahassee, FL 32399-2400
Phone:850.245.8751
Fax: 850.245.8811
john.l.price at dep.state.fl.us
www.dep.state.fl.us/waste
Please Note: Florida has a very broad public records law. Most written
communications to or from state officials regarding state business are
public records available to the public and media upon request. Your e-mail
is communications and may therefore be subject to public disclosure.
_____
From: Charlotte A. Smith [mailto:csmith at pharmecology.com]
Sent: Monday, August 14, 2006 10:29 PM
To: Price, John L.; pharmwaste at lists.dep.state.fl.us
Cc: Tenace, Laurie; Clarke, Raoul
Subject: RE: [Pharmwaste] Do DEA regulations allow municipal waste combustor
to receive mailed back controlled substances from households?
Hi Jack,
That is definitely a question for DEA in Wash DC and your regional DEA
office. It certainly is not an accepted procedure at this time. Unless the
incinerator itself is a DEA registrant, and I don't know of any municipal
incinerators that are, the returned controlled substances need to be
received by a law enforcement officer. I suggest you write a letter to your
regional DEA and they can pass it up the chain of command for a response.
You can contact them by visiting the Diversion Office directory at
http://www.deadiversion.usdoj.gov/drugreg/offices/index.html. Please keep us
posted as to their response! Hope this helps.
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
csmith at pharmecology.com
www.pharmecology.com <http://www.pharmecology.com/>
H2E Champion for Change Award 2004
_____
From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Price, John
L.
Sent: Monday, August 14, 2006 9:51 AM
To: pharmwaste at lists.dep.state.fl.us
Cc: Tenace, Laurie; Clarke, Raoul
Subject: [Pharmwaste] Do DEA regulations allow municipal waste combustor to
receive mailed back controlled substances from households?
Our agency is submitting a grant proposal under an EPA aging initiative for,
among other things, a pilot mail back program for household pharmaceuticals.
[You may want to submit a proposal as well, proposal deadline in 9/29/06.
See attached for details.]
One issue with our proposal is whether DEA regulations would permit a
municipal waste combustor to receive household unused pharmaceuticals,
including controlled substances, into a secure area of the facility. This
would be much more efficient than having the pharms returned to a law
enforcement controlled mailbox, then transshipping to the combustor that
will do the destruction, witnessed for controlled substances, regular burn
for non-controlled.
As I understand the Maine mailback pilot under development, "As long as the
postal box that accepts the returned pharmaceuticals is in law-enforcement
control, there is a specific exemption in DEA regs for possession of
controlled drugs by law-enforcement in the line of duty (community policing
for instance, or substance abuse prevention.)" [email post to list serve
4/11/06 by Gressitt].
Are there exemptions or flexibilities in the DEA controlled substances
regulations that could be interpreted to allow direct return of mailed back
unused pharms from household users to the combustor that will do the
destruction? Could a secure location at the combustor be "controlled by law
enforcement" as that is defined in the controlled substances regulations? Or
is that scenario, even as a pilot program, definitely not doable under said
controlled substances regulations?
Any information will be appreciated.
Jack.
John L. (Jack) Price
Environmental Manager
Hazardous Waste Management MS 4555
Florida Department of Environmental Protection
2600 Blair Stone Road
Tallahassee, FL 32399-2400
Phone:850.245.8751
Fax: 850.245.8811
john.l.price at dep.state.fl.us
www.dep.state.fl.us/waste
Please Note: Florida has a very broad public records law. Most written
communications to or from state officials regarding state business are
public records available to the public and media upon request. Your e-mail
is communications and may therefore be subject to public disclosure.
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