[Pharmwaste] Letter to Pharmacies

Wed Feb 26 16:30:17 EST 2014

Hi Burke,

Thanks for questioning my interpretation of the draft rules to mean that disposal via trash or flushing is banned.  Reviewing the draft rules I continued to read in “ban” until I got to the section, “Environmental Considerations.   I will take out the reference to a ban from my letter.  See below for details.

With luck, the actual rule will be clear on this, and all, points!  Thanks again for the feedback!

Hi Catherine,  

Thanks for tweaks to the letter!

Ed

This is what led me to the conclusion that disposal via trash or flushing would be banned.  I added bold to highlight some text.
 [pg 75790 Federal Register / Vol. 77, No. 246/ Friday, Dec 21, 2012]   

"Proposed Disposal Act Implementing Regulations" 
"Disposal of Controlled Substances by Ultimate Users—Authorized Persons"... 
"DEA proposes three options for ultimate users to dispose of controlled substances: (1) Take-back events; (2) mail-back programs; and (3) collection receptacle locations."... 

And, further down that page:

"Possession for Disposal" 
"Once a controlled substance is lawfully dispensed to an ultimate user, the ultimate user is in possession of that substance. Only the ultimate user or other authorized persons (i.e., persons lawfully entitled to dispose of an ultimate user decedent’s property and, in some cases, the LTCF where the ultimate user resides or has resided) may dispose of such controlled substances in accordance with DEA’s proposed ultimate user disposal regulations."

On page 75794 the three proposed disposal options are repeated under the heading:
"Disposal of Controlled Substances by Ultimate Users—Authorized Methods" 

As you note, the rule discusses:  
"Methods of Destruction 
DEA is proposing a standard of destruction—non-retrievable—for persons that destroy or cause the destruction of controlled substances." and defines “non-retrievable”. [pg. 75803]. 

Finally, supporting the interpretation that this is not a ban, from pg. 75804:

"Environmental Considerations 
In passing the Disposal Act to provide those individuals seeking to dispose of unwanted or unused controlled substances in their household with more disposal options beyond discarding or flushing the substances, Congress expected that there would be fewer such substances introduced into the environment, particularly into the water.43  DEA also recognizes that the establishment of alternative, lawful means for disposing of unused or expired pharmaceutical controlled substances may alleviate some existing environmental concerns. For example, recent studies have reported on the presence of pharmaceutical chemicals in varying concentrations in water supplies. DEA is hopeful that the increased availability of methods for citizens to safely and securely dispose of unwanted prescription drugs will have a positive impact on reducing the introduction of chemical contaminants into the water supply. However, collection and destruction of unwanted and unused pharmaceuticals cannot and will not address water contamination that occurs from other means such as bodily elimination or excretion of such substances. 

Ed

Thanks for all your efforts to put this letter together Ed.  
Re: “Another expected key measure is a ban on the disposal of medications via trash or flushing.”  
The proposed regulations require any voluntary collection program to render controlled substances non-retrievable and trash and flushing would not meet the non-retrievable standard.  However, I don’t see anything saying medications would be banned from trash or flushing.  That sounds like it would be outside the DEA’s purview over the Controlled Substances Act. 
Can you reference any language in the proposed regs that suggests a ban?  
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
916.341.6592

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From: pharmwaste-bounces at lists.dep.state.fl.us [mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Ed Gottlieb
Sent: Wednesday, February 26, 2014 11:15 AM
To: pharmwaste at lists.dep.state.fl.us
Subject: [Pharmwaste] Letter to Pharmacies

Hi All,

Below is a draft of a letter my group wants to send (probably this Friday) to all of our local pharmacies and their corporate HQ's (one of our local pharmacies is not part of a chain.)  We may offer a free drop-box to one pharmacy if we think it will get them to participate when they otherwise wouldn't have.  
Please send me any corrections, or other suggestions, you have for the letter.  Thanks!

Ed

February 28, 2014

Dear Pharmacist,

As you are probably aware, the DEA announced that they will publish, in March, a new rule regarding the collection and disposal of unwanted medications.  Creating the new rule was required by the Secure and Responsible Drug Disposal Act, signed into law in 2010.  

There are several key provisions anticipated to be included in the rule, most notably allowing pharmacies to take-back all unwanted and/or unused medications, including controlled substances.  It is also expected that pharmacies will be allowed to set-up collection stations in Long-term Care Facilities. Participation will be a voluntary public service; there will be no federal funding available to implement take-back programs. The rule should include requirements governing collection procedures, storage containers, and disposal requirements.

Another expected key measure is a ban on the disposal of medications via trash or flushing.  Once the rule is published, our organization is planning a public education effort.  We would like to publicize all of the local take-back options that are available.  

We are happy that a more convenient option, compared to the drop-boxes we placed in law enforcement buildings, could soon be available.  Considering the extensive publicity that CVS recently received for no longer selling tobacco, we think any pharmacy that takes advantage of this new opportunity will benefit.  Clearly, the first pharmacy in the area to offer this service will get the most media attention.    

Does your pharmacy have plans to host a drop-box at your location?  If so, when is it expected to be open to the public?  We would be happy to help promote your program.  

We are available for consultation if you have any questions regarding the new DEA rule or about how to set up a take-back program.  Please don’t hesitate to contact us.

Sincerely,

Ed Gottlieb
Chair, Coalition for Safe Medication Disposal *
Industrial Pretreatment Coordinator 
Ithaca Area Wastewater Treatment Facility
525 3rd Street
Ithaca, NY 14850

* The Coalition for Safe Medication Disposal includes representatives of:  
Tompkins County (TC) Health Dept., TC Administration, TC Sheriff, Lifelong (a senior’s group), Community Coalition for Healthy Youth, Ithaca Area Wastewater Treatment Facility, and an RN “at large” member.  More information can be found at:  http://www.healthyyouth.org/medication-disposal.php

Cc: Corporate HQ

Ed Gottlieb
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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