Standard Operating Procedures

Drug Returns/Destruction

  • Expired Drugs: When drug supplies expire, IDS personnel mark "EXPIRED-DO NOT USE" on the inventory and set it aside for processing by the study monitor if the study is company-sponsored. The study monitor instructs IDS personnel to either return expired drugs to the sponsor or destroy them on site. For investigator-initiated studies, the expired inventory is set aside to be written up for destruction.
  • Drug Returns: To return expired, used or unused drug supplies to the sponsor, IDS personnel use the sponsor's selected carrier, usually Federal Express or UPS. For return shipments, the sponsor must supply an account number with the carrier. IDS personnel document all returns of expired, used or unused study drug using a return form supplied by the sponsor and/or on the IDAR.

Local Destruction

  • Non-controlled, bulk waste: Non-controlled, bulk pharmaceutical waste can be destroyed rather than returned to the sponsor. If the sponsor requests that the drug be destroyed on site, IDS personnel place the substance in the designated pharmaceutical waste bin, fill out the "Environmental Health and Safety Office Chemical Inventory" form and deliver the bins to the Emory University Chemical Disposal facility each Thursday afternoon, after 12:00 PM. The Chemical Disposal Facility turns waste over to an outside contractor (MKC Enterprises) for incineration. IDS personnel maintain a copy of the chemical inventory form in the protocol file.
  • Chemotherapy: Unused chemotherapeutic agents can be destroyed according to the above procedure, but must be placed in a separate bin and the bin should be marked to indicate that it contains chemotherapy.
  • Controlled Substances: Controlled substances can be destroyed rather than returned to the sponsor. Emory Healthcare Pharmacy contracts with Easy Returns Worldwide, Inc. for disposal of controlled drugs. Easy Return personnel visit the pharmacy every quarter and account for all controlled drugs to be destroyed. Using a DEA 222, they transfer the drugs to their facility for destruction via incineration.
  • Empty/used vials: For drug-company sponsored studies, empty vials are saved (as required by sponsor) for study monitors to inspect at routine monitoring visits. Once checked, the monitor can authorize local destruction of empty/used vials. A notation should be made in the accountability log and the vials can be placed in the IV waste bin available in the IDS.
  • Empty vials from chemotherapeutic and biologic agents will not be retained for monitor inspection, but are destroyed following dose preparation. They are placed in the ChemoSafety bucket. Full buckets are picked up in IDS by Emory Healthcare Facilities Management who contracts with Stericycle, Inc. to destroy via incineration.  For NCI studies, empty vials of all drugs are destroyed following dose preparation also via Stericycle, Inc.