Office of Research

Pharmaceutical Disposal

 

Currently there are 2 methods for disposal of off specification and out of date Controlled Drugs/Substances that are regulated by DEA. These methods include Reverse Distribution or disposal through the Hazardous Waste Disposal Contract managed by the Office of Research Safety.

 

*Please note that Controlled drug and Controlled Substance are one and the same and are used interchangeable in this document.

 

Do not wait until you are in need of immediate disposal of a DEA Controlled Substance. Because of the paperwork involved, notifications and scheduling required, this is a lengthy disposal procedure. Notification should start at least 2 months prior to the actual time/date these substances need to be removed from your inventory.

 

Under Reverse Distribution:

The licensee must file the DEA form 41 with their local DEA office and also request a copy of the Companies currently approved by DEA to receive these controlled drugs. Then the licensee will follow the proper procedures provided by one of those companies in order to complete the transfer. The licensee must package and mail the materials to the reverse distribution company and keep all related records. The Office of Research Safety’s Hazardous Waste Management Facility cannot provide this service or be in possession of controlled substances. Any controlled substances that inadvertently come into the Office of Research Safety’s Hazardous Waste Management Facility possession will be returned to the licensee immediately.

 

Under the Hazardous Waste Disposal Contract:

The licensee notifies the Hazardous Waste Officer that they have controlled drugs ready for disposal. The licensee will also supply a list of these controlled drugs to include name, DEA classification, amount and lot number. The Hazardous Waste Officer will then arrange disposal with the Hazardous Waste Disposal Contractor. The Hazardous Waste Disposal Contractor will fill out all forms needed for disposal including the DEA Form 41. They will submit this paperwork to the Hazardous Waste Officer for the appropriate signatures as needed. The Hazardous Waste Disposal Contractor will then file all paper work with the appropriate agencies. A date will be set for the Hazardous Waste Disposal Contractor’s DEA licensed representative to arrive on campus and take possession of the controlled drugs from the licensee. Note: The controlled drugs will remain with the licensee until the Hazardous Waste Disposal contractor’s representative takes physical possession of them.

 

Please take all precautions not to lose control of any Controlled Substance as this constitutes a serious violation of your license. DEA Controlled Substances include all those containers labeled with a large "C" and respective Roman numerals as to their classification by DEA.

 

Sanitary Sewer Disposal of Controlled Substances and Pharmaceuticals is forbidden at Clemson University main campus. Our treatment plant has no industrial discharge permit for such materials. And many of them can be harmful to the environment. The Office of Research Safety Hazardous Waste Management Facility can and will provide services for the other Pharmaceuticals that are NOT Controlled Drugs under DEA. These can be declared as Hazardous Wastes and we will pick them up and properly destroy them.

 

If you are unsure of whether your Pharmaceuticals are Controlled Substances (for example, the label is missing, the compound was made in the laboratory or the items is from very old stock before the common use of the large "C") you can consult lists from the Department of Justice, Drug Enforcement Division: http://www.deadiversion.usdoj.gov/schedules/index.html

 

There you will find two links: one to the "List of Controlled Substances" (I, II, III, IV and V), and one to "Exempted Lists". If your Pharmaceutical is NOT on the List of Controlled Substances, declare it as a chemical waste in the normal fashion.

If you find your Pharmaceutical's name on the list of controlled substances, consult the

"Exempted Lists." If your material is on the Controlled Substance list, but not the Exempted list, you have a controlled substance and will have to be disposed of via one of the two routes for Controlled Substance Disposal explained in this document. If it is on both lists, you have an exempted material. If you do find that you have an Exempt item, we ask that you expressly declare this type of waste separately from any other wastes as an "Exempt Controlled Substance" on the disposal declaration form, and the Licensee will have to co-witness the destruction and documentation of destruction when we come to pick it up. The licensee will have to place the declared material into some destructive media we will provide, and sign off on the destruction. This waste will then be further and permanently destroyed by incineration through the Hazardous Waste Disposal Contractor.