[Pharmwaste] DEA; "may not" = may ?

[Ed Gottlieb]

Hi All,
 
Someone from EPA suggested that I am misinterpreting one part of the
DEA draft rules.
Because of use of the word "may", he reads the following as actually
permitting inventory.
"Controlled substances collected by collectors may not be individually
counted or inventoried."
Since this may be correct, I am rewording my comment as follows:
 
      The meaning of this rule is not clear.   The use of the word
“may" leaves it open to interpretation.


If what was meant is, "Controlled substances collected by collectors do
not have to be individually counted or inventoried." we are very
supportive.
Suggestion:  Clarify the wording.
 
If this rule is intended to mean, “must not (or "shall not") be
individually counted or inventoried under any circumstances", this will
prevent data collection for existing and future research efforts.

Suggestion:  Provide an exemption to this ban on inventorying collected
materials under certain circumstances.  [We may include specific
exemptions as suggested by others.]  The ban on any non-law enforcement
person from handling controlled substances at any time would also need
to be removed to allow for inventory to occur.
 
Our groups’ inventory efforts are done under the watchful eye of law
enforcement and produce data that could prove important to setting new
prescribing guidelines designed to prevent so much waste medication from
being generated.  Medical professionals, mostly pharmacists and pharmacy
technicians do the actual counting of doses with the help of a pill
counting machine.
 
Ongoing disposal data for residential and LTC sources, obtained from
collection events and drop-boxes, would do more than provide a
scientific basis for establishing better prescribing guidelines.  This
data could also be used to verify if new prescribing guidelines are
having a measurable effect on the amount of waste produced.
 
Providing exceptions to the ban on inventorying adds a minimal risk of
diversion while offering a significant means to gather data important
for setting policies to reduce the amount of pharmaceutical waste
produced.
 
 
Ed Gottlieb

Chair Coalition for Safe Medication Disposal
Industrial Pretreatment Coordinator
Ithaca Area Wastewater Treatment Facility
525 3rd Street
Ithaca, NY  14850
(607) 273-8381
fax: (607) 273-8433
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