Storage and Control - Controlled Substances

Controlled substances must be stored in substantially constructed, double-locking boxes that have been mounted on a wall or bolted into a laboratory bench drawer.   Locked drawers alone do not provide adequate security for storage of controlled substances.

Records Overview
Receipt of Controlled Substance
Use of Controlled Substances
Managing Expired Controlled Substances
Biennial Inventory of Controlled Substances

Records Overview

  • Principal Investigators must maintain complete and accurate inventory records for all controlled substances.
  • CDS records must be kept according to the following:
    • Stored separate from other non-DEA records
    • Recorded in English without the use of symbols, codes, etc.
    • Retained a minimum of two years from the date of last purchase, transfer, usage, etc.
    • Use only pre-printed forms supplied by EHS to record CDS transactions

Receipt of Controlled Substance

  • A document, known as the Controlled Substances Receipt Record, must be maintained readily available by the laboratory (Controlled Substances Receipt Record) documenting the receipt of controlled substances.
  • This receipt record, or 'chain of custody', is used to document the movement of CDS from arrival to EHS receipt & inventory to final delivery to the authorized lab.
  • The Controlled Substances Receipt Record must contain the following information:
    • Authorized Principal Investigator
    • Building/room number
    • Date received
    • Vendor name
    • Vendor address
    • Vendor DEA number
    • Compound name
    • Strength or concentration
    • Number of vials
  • Each record must be signed by the laboratory representative receiving the controlled substance.

Use of Controlled Substances

  • A separate record (Controlled Substance Use Log - example) must be maintained for the storage and use of each container/vial of controlled substance (use meaning to administer, dispense, professionally use, or otherwise dispose).
  • The multi-page document consists of a primary record and any number of continuation pages.
    • Blank copies of continuation pages are available for download under 'Resources' section on the right hand side of this page.
  • The Controlled Substance Use Log includes the following information:
    • Principal Investigator
    • Receipt date
    • Location of storage/use
    • Unique identification number (assigned)
    • CDS type, strength/concentration and quantity (ml, mg)
  • Laboratory staff record starting volume/mass and each subsequent use, calculating mass balance to track the quantity remaining.
  • Each entry, or record of use, must be initialed by the individual making the withdrawal.
    • ATTENTION: Dilutions mixed from the original stock container must be tracked on a separate Usage Log.
    • Most labs use a copy of the usage log from the original container - CONTACT EHS FOR CLEAN COPIES OF USAGE LOGS.
  • When a container is empty, a copy of the usage log indicating '0.0' (or some volume less than a full dose) remaining is emailed to EHS.

Managing Expired Controlled Substances

  • Laboratory groups are responsible for notifying EHS of expired controlled substances. 
  • EHS periodically schedules CDS destructions, to be witnessed by a commissioned police officer from the Department of Public Safety (DPS).
    • NOTE: Schedule II controlled substance destructions require NJ Dept. of Community Affairs approval - this could take weeks.
  • Storage of 'expired' CDS
    • Place expired CDS into a zip-top plastic bag labeled  “Expired – Do Not Use” and date.
      • Each CDS vial shall be marked by the researcher as follows:
        • Expired – Do Not Use
        • Date that drug was labeled as expired
        • Initials of person labeling drug as expired.
    • Labeled, sealed bag must be placed into the laboratory’s locked controlled substance box.
  • Upon destruction of expired drug, researcher documents date of destruction on the original Controlled Substance Usage Log.
  • EHS then removes the drug from the electronic inventory.

Biennial Inventory of Controlled Substances

  • A complete and accurate inventory (Biennial Inventory Form) of the stock of controlled substances within each authorized laboratory must be recorded when he/she first engages in research with controlled substances and then biennially thereafter.
  • The Office of Environmental Health and Safety will issue reminder notices to complete the biennial inventory form.
  • Separate Biennial Inventory Forms must be submitted for Schedule II Controlled Substances.
  • This biennial inventory must be retained on the laboratory premises for two years, separate from other business records and be readily available for potential regulatory review as described above.