DEA Controlled Dangerous Substances (CDS)

Many of the narcotics, synthetic steroids, depressants, and stimulants manufactured for legitimate medical use are subject to abuse and have, therefore, been brought under legal control.

Researchers authorized to possess and administer CDS may do so under a valid DEA license and only with prior approval of EHS; authorized personnel must comply with all applicable regulatory requirements relating to drug security, control, disposal and recordkeeping.

The DEA and its state affiliates (Department of Consumer Affairs, Drug Control Unit in NJ) categorize CDS materials into or 'schedule' categories based on the likelihood of diversion, mostly due to abuse and addiction prevalence. Materials fall into one of five schedules, from highest control to least;

Campus Research Material License - Life Sciences Complex

• Princeton University research and animal care are administered under a single, campus-wide license.
• EHS is responsible for maintaining the university's CDS license
• License renewal occurs annually and is directed by EHS

Researchers may request authorization to use CDS materials by submitting the completed Application to Use DEA Controlled Dangerous Substances accessable under the Resources section on this page.

Proposed use of CDS materials on laboratory animals is reviewed and approved separately by the university’s Institutional Animal Care and Use Committee (IACUC) through the animal use protocol application process.

Related EHS Web Content:

• Animal Research (Main Page)
• Registering Animal Research

DEA Controlled Dangerous Substance (CDS) purchase requisitions are reviewed and approved by EHS.

Departmental Purchasing Agent

To ensure timely review of CDS purchases be sure to observe the following.

• Order using the university's Central Purchasing System - Princeton PRIME
  • Ensure the appropriate purchasing category is selected
    • Purchasing Category = '51000000'
    • Category Description = 'DEA Controlled Substances'
    • Click to view PRIME purchasing 'category tree'

EHS Review/Approval

EHS is notified via email upon department approval of CDS requisitions.

• EHS staff review the following prior to approving CDS orders.
  • Confirm Principal Investigator/Authorization
  • Review quantity ordered against proposed use plan
  • Provide CDS vendor with proof of license
  • Approve

Material Arrival

• Deliveries are made ONLY to the address indicated on the university’s DEA License:
  • PRINCETON UNIVERSITY
    LIFE SCIENCES COMPLEX - WASHINGTON RD
    DELIVERIES TO LEWIS THOMAS LAB
    PRINCETON, NJ, 08540-6405
  • Items are tracked during delivery and EHS notifies the Dept. Office and central receiving of delivery status

• EHS is notified by receiving staff when the items arrive
  • EHS personnel receive the material upon arrival
  • CDS is entered into the University CDS Inventory
  • Unique Vial ID No. are assigned to each vial
  • Controlled Substance Use Log (see sample log in 'Resources')
    • Use log is to be used by lab staff to track the use of CDS from initial use to container completion
      • Destructions can be requested
      • Destruction only to be conducted through EHS
    • Return a copy of the log to EHS when material is used up or destroyed (EHS)
• EHS delivers material to the campus laboratory location
  • Lab staff sign the Controlled Substance Receipt Record chain of custody to document receipt (see sample chain of custody in 'Resources')
• CDS materials are immediately secured in EHS approved lock-box

Inventory and Accounting

• Biennial physical inventory verifications are conducted in June of odd numbered years.
• DEA Regulation states, “After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years.”
  • “The biennial inventory may be taken on any date which is within two years of the previous biennial inventory date.”
• EHS will formally request that each lab conduct a semiannual review using the PeopleSoft inventory.
  • Lab personnel review the CDS inventory and report any discrepancy noted directly to EHS
  •  EHS will confirm the change and adjust the ‘working inventory.’

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.

EHS schedules CDS destructions periodially, as needed, throughout the year. Once researchers request a CDS destruction, EHS coordinates and performs the destruction arranging a Public Safety Officer to serve as witness. The destructions follow protocol approved by The State of NJ Division of Consumer Affairs Drug Control Unit.

Disposal of CDS Material

• Unwanted, expired or otherwise unusable material is destroyed via chemical oxidation and the resulting solution is managed by EHS through the university's chemical waste program.
• The destruction is documented on each CDS usage log, and is also recorded in a Destruction of Controlled Material log (see 'Resources') maintained by EHS.

Disposal of Empty Vials, Needles/Syringes

• Empty vials, bottles, and needles/syringes are disposed in regulated medical waste.
  • To qualify as empty, a vial must contain a quantity that cannot be withdrawn from the container using reasonable means, referred to as a "heal."
  • All empty containers must have their labeling destroyed in such a way that the label can no longer be read.
• Needles and syringes must be discarded via approved medical waste sharps containers. When full, sharps containers must be placed in regulated medical waste boxes for final disposal.
  • For more information about regulated sharps and/or regulated medical waste, see Biohazard Waste Disposal
• All boxes and outer packaging should be defaced in such a way that the original contents of the package cannot be discerned.  Outer packaging from CDS containers can then be recycled (e.g., paper/cardboard), or disposed of in the laboratory trash/refuse.