[Pharmwaste] DEA

[John Gohlke]

Wess, we have been through all of this and have received a response from =
Ms. Good that basically states drug collection at non-registered DEA =
collection facilities is illegal.  We had specifically asked if HHW =
programs could accept expired medications and were told that if any of the =
expired medications were controlled substances then the HHW program would =
not be able to accept the medication.  To quote Ms. Good, collection of =
controlled substances at HHW sites "...is not allowed since controlled =
substances may only be possessed by an entity that is either registered =
with the DEA or is specifically exempted from registration in accordance =
with Title 21 United States Code (U.S.C.) Section 822(c) or by regulation =
as set forth in 21 Code of Federal Regulations (CFR) Section 1301.22 =
through 1301.25.  Further, once a controlled substance is dispensed to the =
ultimate user, it is outside the "closed system" of distribution and =
cannot be returned to a registrant.  Therefore, even if the HHWC program =
sites were registered to possess controlled substances, they would not be =
authorized to take possession of controlled substances from non-registrants=
."

Ms. Good stated the only way an HHWC program would be able to collect =
controlled substances is if a law enforcement agency participated in the =
collection of the controlled substances and followed the rules and =
regulations established by DEA for law enforcement collection.  This would =
include the law enforcement agency disposing of the collected controlled =
substances.

This may seem like a possible alternative but we have found that it is =
difficult to operate an efficient program that would include collection of =
expired medications that may or may not include controlled substances.  =
Medications tend to be mixed when delivered so they have to be sorted and =
then you have to determine is it or is it not a controlled substance.  =
Codes and names help but it can still be difficult and time consuming to =
perform identification and then to have a law enforcement rep present to  =
certify and record makes it even more difficult.=20

Several other states have received the same letter from the DEA and have =
experience the same problems and others in trying to operate a collection =
program.

John N. Gohlke, Program Specialist
Medical Waste Regulatory Program
Radiological Protection and Medical Waste Section
Waste and Hazardous Material Division
Department of Environmental Quality
517-241-1320
fax: 517-373-4797

>>> "Damro_WW" <Damro_WW@co.brown.wi.us> 07/22/05 2:04 PM >>>
Has anyone spoken to the DEA about possible pharmaceutical collections?
I found the DEA prohibits accepting any controlled substance from
someone who is not registered to have/use that substance.  That means
individuals (some nursing homes and pharmacies too) have no choice, but
to destroy the controlled substance on their own because they are not
registered and therefore can not turn the drugs over to anyone else.
Not even a pharmacy, doctor, etc.

There is a possible loop hole/grey area that allows or exempts law
enforcement to accept abandoned drugs.  There is not language that
states this is allowed as part of a collection program, but a possible
loop hole does exist.

I was told to send a letter to Patricia Good - Chief, Liaison & Policy
Section for more clarification.  Has anyone run into this or explored
this course of action already?

Wess Damro
Recycling Manager
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