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

[Lucy, Burke]

Ed,
The text you quoted is from the part of the proposed regulations that show the DEA’s intent.  I think the key language is in the actual proposed regs under Subpart B, § 1317.70 (f) and § 1317.75 (g) where it says the mail back package or inner liner respectively “…shall not be opened, x-rayed, analyzed, or otherwise penetrated.”
Burke

Mr. Burke Lucy
Integrated Waste Management Specialist
Department of Resources Recycling and Recovery (CalRecycle)
1001 I Street, PO Box 4025
Sacramento, CA 95812
Burke.Lucy at CalRecycle.ca.gov<mailto:Burke.Lucy at CalRecycle.ca.gov>
916.341.6592

From: pharmwaste-bounces at lists.dep.state.fl.us [mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Ed Gottlieb
Sent: Monday, February 11, 2013 8:53 AM
To: pharmwaste at lists.dep.state.fl.us
Subject: [Pharmwaste] DEA; "may not" = may ?

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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