[Pharmwaste] RE: DEA regulatory change: some real traction?

Tue Jan 31 09:51:46 EST 2006

Hi John,

At the Maine conference hosted by Dr. Gressitt I presented a model for
consumer take-back using reverse distributors. During the discussion
period, several of us asked the DEA representative specifically if they
would consider a modification in the regulations to enable that process
to take place. Andy McFaul from DEA said that a well drafted letter from
representatives of RDs to DEA describing the process and supported by
other regulatory bodies, such as state boards of pharmacy and controlled
substances boards, would be considered. He encouraged actual draft
language. I believe that process has begun although I am not involved
with it at this time. I suspect the willingness to consider such a
proposal is being driven by the incessant questions being received by
DEA as to how best to bring unused controlled substances back out of the
market. 

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

H2E Champion for Change Award 2004

  _____  

From: Price, John L. [mailto:John.L.Price at dep.state.fl.us] 
Sent: Tuesday, January 31, 2006 8:18 AM
To: pharmwaste at lists.dep.state.fl.us
Cc: Charlotte A. Smith; Lucy Doroshko; Andria Ventura;
Scott at ProductStewardship.US
Subject: DEA regulatory change: some real traction?

Charlotte: Does "a movement afoot" mean that there is finally some
traction at or within DEA for a regulatory change in response to ongoing
requests from collection programs? Or are you referring to the ongoing
clatter from community programs continuing to request a regulatory
change? From the email traffic that I've seen on this issue, so far it
seems that everybody except DEA has the stomach for a regulatory change
regarding take back of controlled substances.  If DEA is getting on
board, that's progress.

Thanks, 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: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Charlotte
A. Smith
Sent: Monday, January 30, 2006 4:50 PM
To: Lucy Doroshko; Andria Ventura; pharmwaste at lists.dep.state.fl.us
Subject: RE: [Pharmwaste] RE: Pharmwaste Digest, Vol 3, Issue 12

Hello! There is a movement afoot to get DEA to change the regulations to
enable reverse distributors to be able to accept controlled substances
from consumer via the mail. This already happens to some extent with
product recalls. Some of the reverse distributors, such as Capital
Returns, are researching this approach. Consumers could receive mailback
instructions when they pick up their prescriptions at the pharmacy. Once
the DEA hurdle is overcome, funding is the next challenge. Product
stewardship would seem a logical choice, since reverse distributors
could document which drug company manufactured the drug if it was in the
original container and a chargeback could be issued. Original
containment will not always be the case but could account for a majority
of the returns. Otherwise we still haven't solved the issue of
controlled substances being diverted, involved in poisonings, and
entering the ecosystem. 

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

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 Lucy
Doroshko
Sent: Monday, January 30, 2006 3:44 PM
To: Andria Ventura; pharmwaste at lists.dep.state.fl.us
Subject: [Pharmwaste] RE: Pharmwaste Digest, Vol 3, Issue 12

I know that DEA is becoming more aware of this problem and the fact that
so many community programs are being asked by residents to manage their
waste pharmaceuticals.  I like your idea, Andria.  What about different
colored containers (dayglo purple or some such) so that patients would
remember that the drug is a controlled substance?  I already know the
negative part of that idea ... then the criminal element would more
easily be able to identify discarded medication in the trash.  But, has
the idea of different colored containers for controlled substances been
put forth?

Lucy Doroshko, Recycling Specialist
Pollution Prevention and Compliance Assistance Section
MDEQ Environmental Science and Services Division
525 W. Allegan, One North
PO Box 30457
Lansing, MI  48909-7957
517/373-1322
FAX:  517/241-0858
doroshkl at michigan.gov

Check the DEQ Recycling Website at www.michigan.gov/deqrecycling

>>> "Andria Ventura" <aventura at cleanwater.org> 1/30/2006 4:40 PM >>>

Regarding the issue of controlled substances, would it be possible to
institute a policy requiring pharmacists to inform patients that a
prescription is controlled, and therefore, not acceptable for drop off
later
on when they dispense the drug?

Andria Ventura
Clean Water Action

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