Policies, Procedures and Guidelines

Guidance for Disposal of Drugs Used in Clinical Research

Created 2011

Expectation

Any used or unused investigational medications are to be destroyed in accordance with Federal Resource Conservation and Recovery Act (RCRA) guidelines and with standards set up by industry sponsors.

Used refers to study medications used in clincal research dispensed to research participants and returned to research team.

Unused refers to study medications never dispensed to research participants but that remain in stock at study conclusion.

Why is this important?

To ensure the safety of our patients, visitors, and staff in the Medical Center and the environment.

What do you need?

Procedure for destruction of used and unused investigational medications (empty or partially empty bottles or vials).

Contact Washington University Environmental Health and Safety (WU EHS) to determine if medication is considered a hazardous waste per Resource Conservation and Recovery Act (RCRA) guidelines.

http://ehs.wustl.edu/hmm/Pages/default.aspx
Livi Isringhausen 314-362-6735 or Jason Allen 314-747-1533
ehs@wustl.edu

Steps

  1. Empty oral medication bottles that do not contain protected patient information (PPI) will be discarded in the regular trash.
  2. Medications that are deemed DEA regulated MUST be disposed of by contacting EHS. Do NOT send these through normal chemical waste procedures. These drugs require special handling and documentation. EHS will help set up disposal through an approved vendor.
    http://ehs.wustl.edu/hmm/Pages/default.aspx
    Livi Isringhausen 314-362-3735 or 314-362-6870
    ehs@wustl.edu
  3. Agents that are deemed as non-hazardous can be placed in red biohazard-chemotoxic containers and transported by BJC Housekeeping to Steri-cycle for incineration.
    Stericycle
    6240 McKissock Ave
    St. Louis, MO 63147
    800-264-5353
    The following agents will be forwarded to Steri-cycle:

    1. Empty oral medication bottles labeled with PHI
    2. Partial oral medication bottles containing non-hazardous material
    3. Empty or partially used vials/ampules containing non-hazardous material
  4. Medications (oral or injectable), that are deemed as hazardous (per U-List or P-List), will be collected by Washington University Environmental Health and Safety for transport to an approved environmental management vendor for incineration.
      • Complete an On-Line Chemical Request for Pick-up form at http://ehs.wustl.edu/
      • Within 3 working days, an Environmental Professional will pick up the agent and place it in a Department of Transportation (DOT) approved container and transport the agent to the 90-day storage facility.  The agent will be logged into the chemical tracking system and packed for DOT shipping standards.
      • The agent will be transferred to one of two approved environmental management vendors for incineration.
      • A return manifest with a destruction code and a certificate of destruction will be returned to Washington University within 45 days of being shipped off-site.
      • Destruction records will be kept for a minimum of three (3) years.

    Provide location, type and quantity of the agent to be destroyed.
    Storage facility is located at 4500 Parkview Place, St. Louis, MO 63110
    Veolia Environmental Services
    7 Mobile St.
    Sauget, IL 62201
    618-271-2804