[Pharmwaste] Do DEA regulations allow municipal
wastecombustortoreceive mailed back controlled substances
fromhouseholds?Wouldcombustors want to?
Charlotte A. Smith
csmith at pharmecology.com
Thu Aug 17 14:47:11 EDT 2006
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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