[Pharmwaste] Flushing Reference Correction
Ed Gottlieb
EGottlieb at cityofithaca.org
Thu Nov 12 09:48:50 EST 2015
Hi All,
I was asked to provide the reference for my statement that the DEA, "mandate an non-recoverable standard, mentioning that incineration and chemical digestion meet the standard and flushing and trash disposal do not." When I went back to that reference, I realize it is in the draft rule. It did not make it to the final rule. Also, I overstated the case. The draft said incineration and chemical digestion "may achieve the non-retrievable standard". [My emphasis.]
http://www.deadiversion.usdoj.gov/fed_regs/rules/2012/fr1221_8.htm
Methods of Destruction
DEA is proposing a standard of destruction--non-retrievable--for persons that destroy or cause the destruction of controlled substances. Some examples of current technology that may achieve the non- retrievable standard are incineration and chemical digestion. Flushing and mixing controlled substances with coffee grounds or kitty litter are examples of existing methods of destruction that do not meet the non-retrievable standard. These examples are not exhaustive and DEA is not requiring, endorsing, authorizing, or recommending any particular method of destruction so long as the desired result is achieved and the method is compliant with all applicable federal, state, tribal, and local laws and regulations. This standard is intended to allow public and private entities to develop a variety of destruction methods that are secure, convenient, and responsible, consistent with preventing the diversion of such substances. DEA is proposing a standard of destruction that provides communities the flexibility to tailor disposal options to meet their resources and needs and allows for advances in technology.
The question was asked in reference to a hospital flushing syringe waste. The DEA final rule says that is not allowed:
https://www.federalregister.gov/articles/2014/09/09/2014-20926/disposal-of-controlled-substances#h-8
DEA Registrant Disposal
...As stated in the NPRM, a controlled substance dispensed for immediate administration pursuant to an order for medication in an institutional setting remains under the custody and control of that registered institution even if the substance is not fully exhausted (e.g., some of the substance remains in a vial, tube, transdermal patch, or syringe after administration but cannot or may not be further utilized, commonly referred to as “drug wastage” and “pharmaceutical wastage”). Such remaining substance must be properly recorded, stored, and destroyed in accordance with DEA regulations (e.g.,§ 1304.22(c)), and all applicable Federal, State, tribal, and local laws and regulations, although the destruction need not be recorded on a DEA Form 41.
Additional disposal references from the final rule:
Methods of Destruction (Executive Summary)
Existing DEA regulations do not specify a standard to which controlled substances must be destroyed. With this final rule, the DEA is implementing a standard of destruction—non-retrievable—for registrants that destroy controlled substances, and procedures for the destruction of controlled substances. 21 CFR 1300.05<https://www.federalregister.gov/select-citation/2014/09/09/21-CFR-1300.05> (“non-retrievable”), 1317.90, and 1317.95. The DEA is not requiring a particular method of destruction, so long as the desired result is achieved. This standard is intended to allow public and private entities to develop a variety of destruction methods that are secure, convenient, and responsible, consistent with preventing the diversion of such substances. Destruction of controlled substances must also meet all other applicable Federal, State, tribal, and local laws and regulations. Once a controlled substance is rendered “non-retrievable,” it is no longer subject to the requirements of the DEA regulations.
§ 1317.90 Methods of destruction.
(a) All controlled substances to be destroyed by a registrant, or caused to be destroyed by a registrant pursuant to § 1317.95(c), shall be destroyed in compliance with applicable Federal, State, tribal, and local laws and regulations and shall be rendered non-retrievable.
(b) Where multiple controlled substances are comingled, the method of destruction shall be sufficient to render all such controlled substances non-retrievable. When the actual substances collected for destruction are unknown but may reasonably include controlled substances, the method of destruction shall be sufficient to render non-retrievable any controlled substance likely to be present.
(c) The method of destruction shall be consistent with the purpose of rendering all controlled substances to a non-retrievable state in order to prevent diversion of any such substance to illicit purposes and to protect the public health and safety.
Additional disposal references from other DEA sources:
Letter to Registrants (Sept 9, 2014)
http://www.deadiversion.usdoj.gov/drug_disposal/dear_registrant_disposal.pdf
Destruction of Controlled Substances:
The final rule implements a standard of destruction: non-retrievable.
The process utilized to render a substance "non-retrievable" shall permanently alter the substance's physical or chemical condition or state through irreversible means and thereby render the substance unavailable and unusable for all practical purposes. A substance is considered "non-retrievable" when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue.
Clarification letter to practitioners (October 17, 2014):
http://www.deadiversion.usdoj.gov/drug_disposal/dear_practitioner_pharm_waste_101714.pdf
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
________________________________
From: Jackson, Jen (ENV) [cynthia.jackson at sfgov.org]
Sent: Tuesday, November 10, 2015 5:27 PM
To: Ed Gottlieb
Subject: RE: [Pharmwaste] Your Safer Alternative to the DEA Rule
Hi Ed,
Could you direct me to the place in the DEA rule where it states that flushing do not meet the non-recoverable standard? I was looking around for that in the regs themselves as well as the Federal Register and didn’t see anything about that, but maybe was hunting for the wrong word or in the wrong place. Thanks for your help.
We have a hospital that is flushing syringe waste due to a letter from the DEA they received last spring. If you have any suggested alternatives for syringe waste, I’d be grateful for that as well.
Thanks much!
Jen Jackson
Toxics Reduction & Healthy Ecosystems Programs Manager
San Francisco Department of the Environment
1455 Market Street, Suite 1200, San Francisco, CA 94103
jen.jackson at sfgov.org<mailto:jen.jackson at sfgov.org> T: (415) 355-3758 C: (415) 629-0446
From: Ed Gottlieb [mailto:EGottlieb at cityofithaca.org]
Sent: Tuesday, November 10, 2015 1:34 PM
To: Lawernce Kenemore Jr. <ldkjr100 at gmail.com>; pharmwaste at lists.dep.state.fl.us
Subject: [Pharmwaste] Your Safer Alternative to the DEA Rule
Hi Larry,
You protest listserv discussion of the DEA rule stating that, "there are other safer alternatives that collect and dispose or more products than anything you have done so far. Everyone seems to want to create something new when there are products and programs that work more effectively." I presume you are referring to your disposal product.
The DEA rule leaves us in an awkward position. They mandate an non-recoverable standard, mentioning that incineration and chemical digestion meet the standard and flushing and trash disposal do not. They go on to say they will not evaluate other technologies (or is it products?).
Though reading research papers may have convinced me that activated carbon, used in the proper ratio and given enough time, will meet the DEA standard, most folks will only have a companies assurance that their product does.
Looking at the FillAbox website, I didn't see a specific claim that it meets the DEA standard. Did I overlook it? If so, do you think FillAbox would consider offering a guarantee? Perhaps a promise to pay all legal fees and fines should the government take action, on the basis of improper disposal of pharmaceuticals, against any home or corporate consumer using your product? A guarantee might help close sales with potential customers.
I (somewhat cynically) venture to say that even without any consideration of your products performance, a guarantee is probably a low risk action. The DEA has already told us they won't be checking. What other agency will? The longstanding lack of government resources for environmental protection/enforcement makes a challenge unlikely, in my opinion.
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
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
________________________________
From: pharmwaste-bounces at lists.dep.state.fl.us<mailto:pharmwaste-bounces at lists.dep.state.fl.us> [pharmwaste-bounces at lists.dep.state.fl.us] on behalf of Lawernce Kenemore Jr. [ldkjr100 at gmail.com]
Sent: Tuesday, November 10, 2015 3:36 PM
To: pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>
Subject: [Pharmwaste] Re: Pharmwaste Digest, Vol 121, Issue 8
[New Box Logo 5-1_edited-1.jpg]
FillAboxrecycling.com
Larry Kenemore Jr.
Inventor/Consultant to
Board of Directors
10092 Bianchi Way #207
Cupertino CA. 95014
(855) 873-4965
A Woman Owned/
Minority Owned Business
D&B #079463523
NAICS #562920
CAGE #079463523/7AKL
Larrykenemorejr at fillaboxrecycling.com<mailto:Larrykenemorejr at fillaboxrecycling.com>
Ed and others;
Interesting reading, however it seems that you all have missed the point (or the boat) so to speak. Why create a complete new system as the DEA has when there are other safer alternatives that collect and dispose or more products than anything you have done so far. Everyone seems to want to create something new when there are products and programs that work more effectively.
[https://app.mixmax.com/api/track/v2/tNDhA4OAbkUXJTGPb/ISbvNmLslWYtdGQwATMyp2akxmI/gIzVnLsZmLlRXY0NnLwVGZuMHdzlGbAVGdzF2dtJXYoBnI/gIzVnLsZmLlRXY0NnLwVGZuMHdzlGbAVGdzF2dtJXYoBnI]
On Tue, Nov 10, 2015 at 11:00 AM, <pharmwaste-request at lists.dep.state.fl.us<mailto:pharmwaste-request at lists.dep.state.fl.us>> wrote:
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Today's Topics:
1. RE: any good data on diversion? (Ed Gottlieb)
2. Re: RE: any good data on diversion?
(Yellow Jug Old Drugs Account Support)
---------- Forwarded message ----------
From: Ed Gottlieb <EGottlieb at cityofithaca.org<mailto:EGottlieb at cityofithaca.org>>
To: "Deborah.Hauser at epa.ohio.gov<mailto:Deborah.Hauser at epa.ohio.gov>" <Deborah.Hauser at epa.ohio.gov<mailto:Deborah.Hauser at epa.ohio.gov>>, "pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>" <pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>>
Cc:
Date: Tue, 10 Nov 2015 15:44:57 +0000
Subject: [Pharmwaste] RE: any good data on diversion?
Debbie,
Illegal diversion will always be an issue, at pharmacies, police stations, and in homes.
For awhile, I collected news reports about such occurrences. These stories are powerful reminders of the temptation of easy money and the desperation of addicts.
They are also anecdotal accounts. However many of them are collected, I suspect they will be of limited use in determining what percent of controlled substances received in take back programs are illegally diverted. I'd be surprised if there is any real data on this. The DEA probably has data on diversion from pharmacies stock of controlled substances.
I'd suggest that pharmacies who have concerns should to be reminded that the detailed procedures for take back were written by the DEA, an agency that is completely committed to the prevention of illegal diversion. They need to understand and follow the DEA procedures.
What are the specific concerns that you are hearing? If it is robbery, a double locked take back box has more security than their stock of controlled substances, which are more concentrated and easier to access. If the concern is an employee stealing from the un-inventoried contents in a return box, DEA procedure is that no single employee have both keys to access collected medications. The odds of collusion to commit a felony between two employees is small.
I'm interested to see what others have to say on this.
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<tel:%28607%29%20273-8381>
fax: (607) 273-8433<tel:%28607%29%20273-8433>
________________________________
From: pharmwaste-bounces at lists.dep.state.fl.us<mailto:pharmwaste-bounces at lists.dep.state.fl.us> [pharmwaste-bounces at lists.dep.state.fl.us<mailto:pharmwaste-bounces at lists.dep.state.fl.us>] on behalf of Deborah.Hauser at epa.ohio.gov<mailto:Deborah.Hauser at epa.ohio.gov> [Deborah.Hauser at epa.ohio.gov<mailto:Deborah.Hauser at epa.ohio.gov>]
Sent: Tuesday, November 10, 2015 9:39 AM
To: pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>
Subject: [Pharmwaste] any good data on diversion?
Good morning,
One of the biggest arguments I’ve heard against participating in the collection of unwanted pharms at pharmacies is the possibility of diversion. It seems like a valid argument, so I’d like to see if there is any anecdotal evidence to that effect.
I’ve contacted Iowa to find out what they have experienced since they’ve had the TakeAway program in place for a number of years. They still do not collect controlled substances, so I understand any diversion (or lack thereof) they experience could be attributed to that.
I’d like to hear from other states, especially ones that are collecting at pharmacies, to see if there is any data on diversion.
Thank you,
Debbie
[http://epaintra.epa.ohio.gov/portals/11/Documents/Templates/standard_logo_color_email.gif]
Deborah Hauser
Environmental Specialist
Division of Materials and Waste Management
614.728.5353<tel:614.728.5353>
---------- Forwarded message ----------
From: Yellow Jug Old Drugs Account Support <info at greatlakescleanwater.org<mailto:info at greatlakescleanwater.org>>
To: Ed Gottlieb <EGottlieb at cityofithaca.org<mailto:EGottlieb at cityofithaca.org>>
Cc: "Deborah.Hauser at epa.ohio.gov<mailto:Deborah.Hauser at epa.ohio.gov>" <deborah.hauser at epa.ohio.gov<mailto:deborah.hauser at epa.ohio.gov>>, "pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>" <pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>>
Date: Tue, 10 Nov 2015 11:49:05 -0500
Subject: Re: [Pharmwaste] RE: any good data on diversion?
To all,
While diversion may be an issue cited by some pharmacies as a reason not to participate in an Rx-Waste Collection program its likely more misinformation about the DEA regs in place to limit diversion and specific methods of collection that further reduce the potential for diversion.
The DEA regs for the collection of controlled substances do minimize the potential for diversion. Primarily the regs. require customers place Rx-waste in lockable container and not pass to a pharmacy employee. The two pharmacy staff signature requirement also limits diversion potential.
The regulation that speaks to Rx-Waste not being handled by pharmacy staff should be clearly indicated on the collection container in addition to other pertinent info.
The Yellow Jug Old Drugs Program utilizes a system of gel in the collection containers that render the medications irretrievable according to DEA standards. This very much minimizes the potential for diversion
We believe that the biggest barrier to pharmacies is the potential cost for a pharmacy to participate in an Rx-Waste Collection Program. Great Lake Clean Water/US Clean Water is committed to keeping costs low to encourage more pharmacies to participate resulting in more communities keeping their
water clean and their communities safe through proper collection and disposal of Rx-Waste.
Chris Angel, President
www.GreatLakesCleanWater.org<http://www.GreatLakesCleanWater.org> www.USCleanWater.org<http://www.USCleanWater.org>
---------------------------- Original Message ----------------------------
Subject: [Pharmwaste] RE: any good data on diversion?
From: "Ed Gottlieb" <EGottlieb at cityofithaca.org<mailto:EGottlieb at cityofithaca.org>>
Date: Tue, November 10, 2015 10:44 am
To: "Deborah.Hauser at epa.ohio.gov<mailto:Deborah.Hauser at epa.ohio.gov>" <Deborah.Hauser at epa.ohio.gov<mailto:Deborah.Hauser at epa.ohio.gov>>
"pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>" <pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>>
--------------------------------------------------------------------------
> Debbie,
>
> Illegal diversion will always be an issue, at pharmacies, police stations, and in homes.
>
> For awhile, I collected news reports about such occurrences. These stories are powerful reminders of the temptation of easy money and the desperation of addicts.
>
> They are also anecdotal accounts. However many of them are collected, I suspect they will be of limited use in determining what percent of controlled substances received in take back programs are illegally diverted. I'd be surprised if there is any real data on this. The DEA probably has data
on diversion from pharmacies stock of controlled substances.>
> I'd suggest that pharmacies who have concerns should to be reminded that the detailed procedures for take back were written by the DEA, an agency that is completely committed to the prevention of illegal diversion. They need to understand and follow the DEA procedures.
>
> What are the specific concerns that you are hearing? If it is robbery, a double locked take back box has more security than their stock of controlled substances, which are more concentrated and easier to access. If the concern is an employee stealing from the un-inventoried contents in a return
box, DEA procedure is that no single employee have both keys to access collected medications. The odds of collusion to commit a felony between two employees is small.>
> I'm interested to see what others have to say on this.
>
> 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<tel:%28607%29%20273-8381>
> fax: (607) 273-8433<tel:%28607%29%20273-8433>
> ________________________________
> From: pharmwaste-bounces at lists.dep.state.fl.us<mailto:pharmwaste-bounces at lists.dep.state.fl.us> [pharmwaste-bounces at lists.dep.state.fl.us<mailto:pharmwaste-bounces at lists.dep.state.fl.us>] on behalf of Deborah.Hauser at epa.ohio.gov<mailto:Deborah.Hauser at epa.ohio.gov> [Deborah.Hauser at epa.ohio.gov<mailto:Deborah.Hauser at epa.ohio.gov>]
> Sent: Tuesday, November 10, 2015 9:39 AM
> To: pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>
> Subject: [Pharmwaste] any good data on diversion?
>
> Good morning,
>
> One of the biggest arguments I’ve heard against participating in the collection of unwanted pharms at pharmacies is the possibility of diversion. It seems like a valid argument, so I’d like to see if there is any anecdotal evidence to that effect.
>
> I’ve contacted Iowa to find out what they have experienced since they’ve had the TakeAway program in place for a number of years. They still do not collect controlled substances, so I understand any diversion (or lack thereof) they experience could be attributed to that.
>
> I’d like to hear from other states, especially ones that are collecting at pharmacies, to see if there is any data on diversion.
>
> Thank you,
> Debbie
>
>
> [http://epaintra.epa.ohio.gov/portals/11/Documents/Templates/standard_logo_color_email.gif]
>
> Deborah Hauser
> Environmental Specialist
> Division of Materials and Waste Management
> 614.728.5353<tel:614.728.5353>
>
>
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