[Pharmwaste] DOT Special Permit for Inner Liner Shipments

Mon Jul 11 12:28:31 EDT 2016

I'm dealing with this issue right now in Colorado as we are about to launch
our statewide medication take-back program.

Our approved collectors - law enforcement, pharmacies, and
hospitals/clinics - will be shipping inner liners to our reverse
distributor via UPS. We were told by DOT that this method of operation will
require each collector to obtain the special permit. I'm still waiting for
clarification from DOT on items in Section 10 of the permit,  specifically
whether or not the security plan, registration, and hazmat training are
required. Our RD was told by DOT that the permit could take from 14 to 30
days to obtain from the date of application.

If a reverse distributor is physically picking up inner liners at
collection sites, the reverse distributor needs the special permit, not the
collectors. This is the Stericycle scenario.

The DOT contact is Andrew Eckenrode.
andrew.eckenrode at dot.gov

On Mon, Jul 11, 2016 at 9:54 AM, <pharmwaste-request at lists.dep.state.fl.us>
wrote:

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> Today's Topics:
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>    1. Opioid Marketing Legal Decisions (Ed Gottlieb)
>    2. New DOT requirement for authorized collectors (Jaramillo, Jeanie)
>
>
> ---------- Forwarded message ----------
> From: Ed Gottlieb <EGottlieb at cityofithaca.org>
> To: "pharmwaste at lists.dep.state.fl.us" <pharmwaste at lists.dep.state.fl.us>
> Cc:
> Date: Mon, 11 Jul 2016 14:12:54 +0000
> Subject: [Pharmwaste] Opioid Marketing Legal Decisions
> News items not directly linked to pharm waste that may be of interest:
>
>
> https://www.statnews.com/pharmalot/2016/07/06/pfizer-opioids-chicago-painkiller/
> To avoid a lawsuit, drug manufacturer Pfizer has agreed to start
> disclosing, in promotional materials for its opioid painkiller Embeda, that
> narcotic drugs come with a serious risk of addiction even when used
> according to directions.  Will others follow suit?
>
>
> https://www.statnews.com/2016/05/11/oxycontin-records-sought-stat-ordered-unsealed-kentucky-judge/
> In May, a Kentucky judge ruled in a lawsuit, brought by STAT, that secret
> documents tied to the marketing of OxyContin must be released. The drug
> maker is appealing that decision which has postponed the release.
>
> 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
>
>
> ---------- Forwarded message ----------
> From: "Jaramillo, Jeanie" <Jeanie.Jaramillo at ttuhsc.edu>
> To: "pharmwaste at lists.dep.state.fl.us" <pharmwaste at lists.dep.state.fl.us>
> Cc:
> Date: Mon, 11 Jul 2016 15:54:26 +0000
> Subject: [Pharmwaste] New DOT requirement for authorized collectors
>
> Hello All,
>
>
>
> We have a permanent medication disposal receptacle at the pharmacy located
> on our University campus. I assist with its management (and finding funding
> for it!) We were recently notified that we are now required to obtain a DOT
> permit in order to ship these med-containing boxes. I’m attaching a letter
> from the DOT for your review and I’m hopeful that some of you are more
> knowledgeable on this and can help.
>
>
>
> While the DOT permit has no related fee, the underlying theme seems to be
> that the meds are considered “hazardous” and there is a statement that “Each
> "Hazmat employee", as defined in § 171.8, who performs a function subject
> to this special permit must receive training on the requirements and
> conditions of this special permit in addition to the training required by
> §§ 172.700 through 172.704”. My guess is the training won’t be free.
>
>
>
> From the DOT letter, it appears that this action has resulted from a
> request by Stericycle. Yet, household generated pharmaceutical waste is
> exempt from RCRA, so I’m at a loss. It also seems a conflict of interest
> that a medical waste vendor has pushed for this. These are the same meds
> that mail order companies are shipping to patients nationwide.
>
>
>
> This is yet another barrier to participation as “authorized collectors”.
>
>
>
> Any thoughts?
>
>
>
> Jeanie Jaramillo-Stametz, PharmD
>
> Managing Director, Texas Panhandle Poison Center
>
> Asst. Professor, Texas Tech UHSC School of Pharmacy
>
> Director, Medication Cleanout
>
> 1300 S. Coulter St., Suite 105
>
> Amarillo, TX 79106
>
> (voicemail): (806)414-9299
>
> (poison center office): (806)414-9402; 9404
>
> (mobile): (806)376-0039
>
>
>
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-- 
*Greg Fabisiak*
*Environmental Integration Coordinator*

Colorado Department of Public Health and Environment
4300 Cherry Creek Drive South, DEHS-A2
Denver, CO 80246-1530
office: 303.692.2903 | fax: 303.753.6809
e-mail: greg.fabisiak at state.co.us
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