Disposal of Controlled Substances

The disposal of controlled substances is the responsibility of the licensed registrant. Controlled substance registrants have two disposal options available for expired or waste controlled substances.

To minimize waste, DEA registrants must only purchase quantities they intend to use.  Damaged, expired, unwanted, unusable, or non-returnable controlled substances must be accounted for, retained, and disposed of in accordance with applicable state and federal regulations.  The Indiana Professional Licensing Agency and the United Stated Drug Enforcement Administration (DEA) have determined that expired controlled substances must be discarded within 30-days following the date of expiration. Failure to dispose of expired medications within this time limit may result in the issuance of a warning or citation during an on-site inspection.

 A Registrants Inventory of Drugs Surrendered, DEA Form 41, is necessary to document proper disposal.

 A copy of DEA Form 41 must be retained on file following disposal of any DEA controlled substance.  It must be retained by the registrant for at least two years.

Disposal records must contain:

• DEA number, name, and address
• The reverse distributor’s DEA number, name, and address
• The number of units (in finished forms and/or commercial containers) disposed of in any manner, including the manner of disposal

The disposal record must be dated to reflect when the products were sent for destruction and left inventory.

The following are disposal options for expired or unwanted controlled substances.  IUEHS must be contacted to help determine the correct disposal method.

Contact the Supplier:

Some suppliers will take back pharmaceuticals for credit.  If possible, this is the best means of controlled substance disposal.

Reverse Distribution:

Regional campuses or those with large quantities (greater than one pound), must contact a Reverse Distributor.  This option transfers ownership of the controlled substance to a DEA-approved Pharmaceutical Returns Processor for re-use, re-sale or destruction at a hazardous waste incinerator.  This process may involve the completion of DEA Form 222 or DEA Form 41.  Please contact IUEHS for more information on Reverse Distributors.

Indiana University Bloomington (IUB) On-Campus Witnessed Destruction:

• For quantities of controlled substances less than one pound that require disposal, contact IUB EHS to request a witnessed destruction. Note: Quantities greater than one pound may require consultation with the DEA.  Contact IUB EHS for guidance.
• IUB EHS will send the registrant a blank copy of DEA Form 41, the Registrant’s Inventory of Drugs Surrendered, along with detailed instructions for completion of sections required for DEA notification and approval of destruction. The registrant is responsible for following all instruction provided by IUB EHS to initiate destruction.
• IUB EHS will forward the partially completed Form 41 to the DEA and schedule a date for witnessed destruction of the materials approximately two weeks after the form is submitted to the DEA. If any issues arise to delay or prevent the destruction, IUB EHS can assist in resolving the issues.
• On the scheduled date of destruction, the registrant or an authorized agent must take the controlled substances being disposed to the IUB EHS waste collection room in Chemistry Hall Room A027, where IUB EHS personnel will destroy the material with the necessary witnesses. The registrant will maintain legal possession of the material throughout the destruction process.
• When the destruction is complete, witnesses will sign the DEA Form 41. IUB EHS will provide copies of the completed form to the DEA and to the registrant for recordkeeping.  IUB EHS will also retain a copy.
• Abandoned controlled substances and materials obtained prior to designation as controlled substances will be managed by IUB EHS using the above procedure, with IUB EHS acting in the registrant’s place. IUB EHS will maintain security for any controlled substances in their possession until destruction is complete.

Indiana University Purdue University Indianapolis (IUPUI) In-Lab Disposal:

Registrants on the IUPUI campus are allowed to blend waste controlled substances into an appropriate volume of a suitable flammable solvent within the confines of the lab under the following conditions:

• The controlled substance is soluble or miscible in the solvent selected (e.g. water-soluble materials are blended into acetone, ethanol, methanol, or other similar solvent depending on solubility). Contact IUPUI EHS for additional guidance on selecting an appropriate solvent for the controlled substance involved.
• The disposal is recorded and witnessed by laboratory staff on a DEA Form 41.
• The waste solvent is referred to IUPUI EHS by means of an on-line request form available at https://apps.ehs.iupui.edu/waste-manifest.asp within three (3) working days of blending.
• The signed DEA Form 41 is retained on-site by the registrant for inspection by request by regulatory authorities.
• IUPUI EHS is responsible for ensuring that the blended controlled substance/solvent is collected in a timely manner, consolidated with other waste solvents, and incinerated at a fully permitted hazardous waste treatment/disposal facility. IUPUI EHS will also maintain all associated paperwork.

IUPUI Stryker Cactus Smart Sink System

Campus Registrants may schedule a time with IUPUI EHS to dispose of waste controlled substances by means of a Cactus Smart Sink System under the following conditions:

• Additional information on the Cactus Smart Sink System can be found here.
• The disposal is scheduled in advance with IUPUI EHS by calling 4-6795,            4-4351, or emailing EHS@iupui.edu
• The registrant is responsible for transporting the materials to the location specified by IUPUI EHS at an agreed-upon date and time.  (IUPUI EHS will not take possession, transport, or store material intended for disposal.)
• The disposal is recorded on a DEA Form 41 and witnessed by the laboratory representative transporting the material and an IUPUI EHS representative.
• The signed DEA Form 41 is retained on-site by the registrant for inspection by request by regulatory authorities.
• IUPUI EHS is responsible for ensuring that the disposal cartridges in the Cactus Smart Sink unit are changed on a frequency recommended by the manufacturer and incinerated at a fully permitted hazardous waste treatment/disposal facility. IUPUI EHS maintains all associated paperwork.

IUPUI On-Campus Incineration

Registrants may schedule a time through IUPUI EHS to have controlled substances (with the exception of RCRA regulated materials such as chloral hydrate) incinerated at an incinerator owned and operated by the University under the following directions:

• The incinerator is typically operated once per month from mid to late April into late October or mid-November.
• Registrants complete a DEA Form 41 for the inventory of controlled substances to be discarded.
• The completed DEA Form 41 is submitted electronically to: https://psia360.iu.edu/sites/dashboard/?module=9
• Upon review of the DEA Form 41, the material will be scheduled for incineration at the Campus Services 4 Building, 1830 W. 16^th, Indianapolis, IN.
• The registrant is responsible for transporting the material to the Campus Services 4 Building at an agreed-upon date and time. IUPUI EHS will not take possession, transport, or store material intended for disposal.
• Following incineration the registrant, IUPUI EHS, and other witnesses will sign DEA Form 41 as a witness to the destruction.
• The signed DEA Form 41 is retained on-site by the registrant for inspection by request by regulatory authorities.
• Due to the unique circumstance of chloral hydrate being regulated as both a Controlled Substance and United States Environmental Protection Agency (EPA) hazardous waste, waste containers of chloral hydrate produced on campus will be managed on a case-by-case basis with the intent of meeting both DEA and EPA regulatory requirements.