In case anybody wanted to read Stericycle’s application they submitted for the special permit.

 

 

 

Good afternoon all,

 

I just got off the phone after a couple of lengthy conversations with the DOT today regarding this special permit. They were kind of shocked that this is even being talked about amongst us as they said it is “very clear” as to what this special permit entails…I simply laughed at that point. J

 

Anyhow, per the DOT rep, this special permit was granted to Stericycle in order for them to begin accepting controlled substances within their pharmaceutical disposal programs. They previously did not collect them in their offered services.

 

The conflict presents with current programs that utilize a public drop-off kiosk and offer the common carrier shipping method which follows the DEA regulations that mandate no inspection of contents disposed of within a kiosk in order to prevent controlled substance diversion; however, that direct action of not inspecting materials prior to shipping is a violation of existing DOT rules. The DOT stated that Stericycle recognized the discrepancy between the DEA and DOT rules and therefore filed for the special permit. They wanted to reiterate this is an existing DOT rule and is not “new.” The fact that Stericycle found there was a loop-hole and closed it with the special permit is what is new.

 

The DOT stated that within this conflict of the DEA and DOT rules, neither rule supersedes the other.

 

As a shipper of anything, the DOT explained that everyone is responsible for identifying and correctly marking a package for commerce transport, even as a regular home-owner we ‘declare’ that the items we ship are not dangerous/ hazardous. Within a medication collection kiosk it is possible for P and/or U class medications such as Warfarin (Coumadin) or Epinephrine to be disposed of and therefore the contents are then deemed hazardous materials.

 

The DOT stated that any shipper of contents such as household deposited medications must apply for and display this permit for rule compliance.

 

The rep said that the application needed is the “party status” one, of which an example of is here:

http://phmsa.dot.gov/staticfiles/PHMSA/DownloadableFiles/Files/Hazmat/pt_app.pdf

Here is the checklist to gather the info needed to apply for the permit:

http://phmsa.dot.gov/staticfiles/PHMSA/DownloadableFiles/Hazmat/Special%20Permits/PTE%20Checklist.pdf

Their main webpage is here:

http://www.phmsa.dot.gov/hazmat/permits-approvals/special-permits

 

The DOT contact I spoke with was also named Jordan. J Their division number is 1-800-467-4922.

The Special Permits division number is 202-366-4535.

 

 

 

Thanks, Margaret!

 

I’m wondering how Walgreen’s is handling this (no pun intended!) Since they are implementing bins in 500 stores and each one would have to have someone with Hazmat training. I’ve been sharing info with our DEA diversion program manager as it relates to participation as “authorized collectors”. I believe this is going to create another barrier. I don’t believe my administrators are going to be happy about it.

 

 

 

Hi all, it’s great to have this exchange of info on the pharmwaste listserv and great that PSI has a DOT webinar lined up for later this month on this topic.

 

I hope useful to clarify different training requirements to help avoid any more “oh no!” responses than are already being generated by a new DOT requirement.

 

The DOT special permit letter references hazmat employee training required under §§ 172.700 through 172.704, which is referencing CFR Title 49 Transportation.

Here is the language of those sections:  https://www.law.cornell.edu/cfr/text/49/part-172/subpart-H

Here is link to FAQs from PHMSA on Hazmat Training:

http://www.phmsa.dot.gov/portal/site/PHMSA/menuitem.6f23687cf7b00b0f22e4c6962d9c8789/?vgnextoid=a6295f29a45b3110VgnVCM1000009ed07898RCRD&vgnextchannel=982d08ae2db83110VgnVCM1000009ed07898RCRD

Please note the first FAQ states that an employer and employee may train and test themselves.

 

The HAZWOPER training is different and is an OSHA requirement.  It requires specific formal training in a 40 hour or 24 hour course for employees working at a hazardous site.  http://www.osha.com/courses/hazwoper.html

 

Seems like we’re generating a great list of items to confirm or ask about on the PSI webinar.

 

Margaret Shield, PhD

Community Environmental Health Strategies, LLC

margaret.shield@CEHstrategies.com

mobile:  206-499-5452

 

 

 

Does Sharps Compliance have this permit?

I believe ANYONE in the process of handling hazardous pharmaceuticals, RCRA, controlled substances will need the permit as well as HAZWOPER (as it is called) training.

John F. Birrer, President/CEO

Asepsis Bio Group, Inc.

 

I am still deciphering the contents, but overall, it appears that this is targeting the carriers of the boxes. Stericycle applied for this special permit and was granted it under two different entity names: http://www.phmsa.dot.gov/hazmat/regs/sp-a/special-permits/search enter: 20255

 

Any companies who ship meds for disposal via UPS or FedEx needs to contact their representative and find out how they are addressing this ruling as this basically is saying their drivers would need to be trained to handle these boxes/ containers full of ‘hazardous’ medications.

 

This to me seems like a very effective measure at dampening the competition seen lately with companies utilizing general carriers (UPS, FedEx) for medication disposal programs. Hospitals and clinics have been switching from Stericycle to economical and effective programs like those from Heritage and Sharps Compliance. However, being that UPS and FedEx already handle hazardous material in commerce, this may not be anything more than another application process for them.

 

As for places who have employees handling the containers prepping them for shipment, I am leaning on the notion that the stipulations needed to be compliant with this special permit should already be in place with a new and existing employee training program with regularly scheduled training sessions in place for compliance; this usually comes from the vendor of the medication disposal program when the program is implemented into a facility. I have reached out to the DOT and Sharps Compliance for further clarification about this rule.

 

Jordan Fengel, B.S.

Solid Waste/ Recycling Coordinator

Chair of Texas Product Stewardship Council

TCEQ MSW Lic# SW0006104

SWANA Composting Cert #937614

USZWBC Associate

Environmental Services

300-1 Industrial Ave

Georgetown, TX 78627

Office: (512) 930-8131

Fax: (512) 931-7713

For large files: https://www.hightail.com/u/jfengel

 

From: cpsc-pharmaceuticals-listserv@googlegroups.com [mailto:cpsc-pharmaceuticals-listserv@googlegroups.com] On Behalf Of Heidi Sanborn
Sent: Monday, July 11, 2016 11:05 AM
To: Heidi Sanborn <Heidi@calpsc.org>
Subject: FW: New DOT requirement for authorized collectors

 

I’m sharing this from the national pharma listserv because this will impact anyone planning on shipping their meds from bins.   Please share any concerns about how this will impact your programs today or in the future.

 

Heidi

 

From: Pharmwaste [mailto:pharmwaste-bounces@lists.dep.state.fl.us] On Behalf Of Jaramillo, Jeanie
Sent: Monday, July 11, 2016 8:54 AM
To: pharmwaste@lists.dep.state.fl.us
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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