[Pharmwaste] DEA needs to do outreach

Ed Gottlieb EGottlieb at cityofithaca.org
Thu Feb 26 14:58:44 EST 2015


I just sent this letter to DEA Division Director Arnold.  He supervised the writing of the new take back rule.


Dear Director Arnold,

After seeing yet another news story about a new drop box being installed outside a law enforcement building, I wrote a letter to the editor (see below), with the intention of sending it to some widely read law enforcement publications.

I realized that this sort of outreach really should come from the DEA.  Please consider how you can effectively communicate the basic requirements of the new Controlled Take Back Rule to law enforcement agencies.  If that includes the use of letters to the editor, you are welcome to copy any, or all, of my letter.

Regarding a previously submitted question, I still hope for your response regarding the acceptability of a small, frosted Plexiglas view port to detect the fill level of a drop box without unlocking it.  If personal information can't be read through the view port, is such a feature acceptable?

Thanks for your consideration of both these issues!  I look forward to your response.


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

Pharmaceutical Drop Box Programs Need Review

Providing the public with convenient ways to dispose of unwanted medications, especially controlled substances, is an important public service.  Removing unwanted pharmaceuticals from homes decreases the likelihood of illegal diversion, accidental overdose, and environmental contamination.

After the US Drug Enforcement Agency (DEA) established the Take Back Initiative in 2010, what had been a small number of existing law enforcement collection events quickly multiplied.  The ninth and final DEA event, on September 27, 2014, included 4,076 agencies collecting 309 tons of unwanted medications at 5,495 sites in just four hours!

To increase disposal convenience, a steadily growing number of law enforcement agencies (and pharmacies, mainly for non-controlled collection[JPL1] ) have installed permanent drop boxes at their locations.  Thanks to wide community support, and some limited funding from state agencies and others, new drop boxes continue to be installed.

Kudos to all of you that have taken the lead on this important issue!

But, are you aware that your drop box program may need to be modified to be compliant with recent changes to federal take back rules?  This letter was inspired by reading multiple stories of new drop boxes being installed that are in violation of a new federal rule.

Late in 2014, the DEA issued a rule regulating the take back of controlled substances.  [http://www.deadiversion.usdoj.gov/drug_disposal/fact_sheets/disposal_public.pdf]

The big change is that pharmacies can now apply to take back controlled pharmaceuticals.  Since the rule does not require participation, and provides no funding, it may be quite some time before a pharmacy near you participates.  Law enforcement programs remain the primary method for safe disposal.

I want to mention that once the new rule was in place, the DEA announced the end of the hugely successful Take Back Initiative.  That decision has left many law enforcement agencies struggling to find funding to keep their one day and/or drop box collection programs going.  It is going to be a tough transition time.

Back to my main point...the rule also specifies how law enforcement collects controlled substances.  Please take the time to make sure your program is in compliance with the new rule.  To find the references below, the full rule is located at: http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/2014-20926.pdf

Here are a few details, specific to law enforcement, which should be part of your review check list.

1. Boxes must be inside buildings.  The DEA is looking for active monitoring.

§ 1317.35 Collection by law enforcement. (3) Collection receptacles located inside law enforcement's physical address.   Also:

§ 1317.75 Collection receptacles (d) (1) Inside a collector's registered location, inside law enforcement's physical location, or at an authorized long-term care facility;

2. Signage must indicate that Schedule II-V controlled and non-controlled substances are acceptable and that Schedule I controlled is not. [§ 1317.75 (e) (4)].  (I had to add this wording to my programs signage using stickers.)

3. Collected medications must be “stored in a manner that prevents the diversion of controlled substances and is consistent with that agency's standard procedures…” [§ 1317.35 (c)]  (We wrote an SOP specifying that inventory of the contents was not necessary.  Identifying and counting so many controlled substances isn’t practical.  This also cleared to way to be in compliance with our state accreditation rules.)

4. The box must contain an opaque inner liner that, upon removal, must be labeled as specified in your departments SOP.  If custody is to be transferred to a reverse distributor, a specific list of labeling requirements must be followed. [§ 1317.35]

For those of you holding take back events, you can authorize non-law enforcement personnel to assist with required, and voluntary, activities including:  receiving, weighing, separating controlled from non-controlled, removing unacceptable items (sharps, mercury), inventorying, etc. [Executive Summary: J. Prohibition on Handling, Sorting, and Inventorying Inner Liner Contents and Mail-Back Package Contents; Response to Issues 2 & 3,]

If you have any questions about the rule, you should contact your DEA field office.  I’d also be happy to try and answer your questions.  Please let me know if your DEA field office says something in conflict with your reading of the rule.  Thank you.

Keep up the good work!

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