[Pharmwaste] Pharmaceutical Waste

[Ann Heil]

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What if we had a handy way to render controlled substances nonrecoverable?
Let's speculate that we had some sort of small kit, containing a bitter
liquid into which liquid drugs could be poured, and a quick setting cement
into which solid drugs could be placed. Could we get around controlled
substance regs by having the person dropping them off apply this kit prior
to dropping them off? The group that is collecting the pharmaceuticals would
then not be subject to controlled substances regs, because the controlled
substances would have already been rendered nonrecoverable.
 
Ann Heil
LACSD

-----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: Tuesday, January 18, 2005 4:49 PM
To: Chapman, Alice; Bill Lewry; pharmwaste@lists.dep.state.fl.us
Subject: RE: [Pharmwaste] Pharmaceutical Waste


Thanks, Alice, that issue about the licensee being a person is correct when
it has to do with dispensed controlled substances. That what makes take back
to problematic. 
 
 

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 

H2E Champion for Change Award

-----Original Message-----
From: Chapman, Alice [mailto:Alice.Chapman@METROKC.GOV] 
Sent: Tuesday, January 18, 2005 6:27 PM
To: Bill Lewry; pharmwaste@lists.dep.state.fl.us
Subject: RE: [Pharmwaste] Pharmaceutical Waste


Just to clarify a side issue mentioned in your question...
 
Neither the FDA nor the DEA approves or permits incinerators for disposal of
drugs.  The DEA regulations require that controlled substances be destroyed
"beyond reclamation".  We're accustomed in the world of hazardous waste to
having particular sites permitted and approved by EPA.  The DEA looks at it
differently.  As long as the drugs are in the custody of an approved
"licensee" (often a person), and "destroyed beyond reclamation",
everything's fine.  Incineration is a handy way of making drugs
non-reclamable!  Every incinerator I've talked to (I called as many as I
could find in the US a couple of years ago) has burned controlled
substances.  Usually the licensee witnesses the drugs as they go into the
system.  The drugs can't sit around in storage on-site before burning, that
would require facility changes to meet security requirements.  
 
The loop you're attributing to FDA, is actually managed by DEA and state
Boards of Pharmacy.
 
Pharmaceuticals can be found in every category of hazardous waste.  Your
proposal would work for many, but drugs packaged as inhalers (compressed
gases) or as injections (dose of drug in syringe attached to needle & ready
to go) would need to be handled differently.  
 
The major drawback I see in your proposal is that disposal costs are paid
for by local governments, and the relatively low collection rate of
hazardous stuff out there that actually makes it's way to government-run
collection sites.  I'd like to see what can happen when there are as many
collection points for drugs as there are pharmacies.
 
:)  ac

Alice Chapman, PE
Local Hazardous Waste Management Program in King County
130 Nickerson St, #100
Seattle, WA  98109
http://www.govlink.org/hazwaste/ <http://www.govlink.org/hazwaste/> 
 
206-263-3058 phone
206-263-3070 fax
 
 
  _____  

From: Bill Lewry [mailto:Bill_Lewry@kcmo.org] 
Sent: Saturday, January 15, 2005 12:53 PM
To: pharmwaste@lists.dep.state.fl.us
Subject: [Pharmwaste] Pharmaceutical Waste



Dear Listserve:

I would appreciate if someone could provide answer to the following
question.

Simply out of curiosity, I understand the (potential / possible) need to
create a system to deal with this issue, but unlike latex paint, electronics
and carpet, amongst others, it would appear to this uninitiated person that
there is little reclaimable asset to be gained from spent / out of date
pharmaceuticals.

Allowing that there is little benefit, then we have the issue of these not
falling into inappropriate hands. At least in the narcotics area.

Pharmaceuticals once issued to the end user are "out of the loop" of the FDA
and would then at end of life become "HHW", and it appears should then be
treated as any other HHW.

It would appear that these items would simply be best placed amongst other
"toxics", drummed without external indicative labelling (Eg. NOS, Toxic, 6
(6.1)) and shipped for incineration. They would not then require to go to an
FDA approved incinerator.

An alternative would be to place in an A fuel drum (all parties in
agreement) and ship in that fashion.

For the amounts and quantities involved in most programs, this would seem
the easy solution, for programs specifically chasing these wastestreams as a
revenue source, they could arrange contracts as appropriate under auspices
of the FDA if they themselves saw a need to regulate material which was
regulatorily in the vast majority of cases "de-regulated" by age or
condition.

I look forward to the discussion thread this question line may provoke.

Sincerely.

Bill Lewry / KCMO.


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