Use of Controlled Dangerous Substances
The purchase, use and disposal of controlled substances in New Jersey are strictly regulated by the New Jersey Department of Consumer Affairs (NJ DCA) Drug Control Unit and the United States Department of Justice Drug Enforcement Administration (US DEA). These regulations are intended to prevent diversion of controlled substances. Environmental Health and Safety holds the responsabilty to ensure that researchers planning work with controlled substances are aware of and understand their responsibility for complying with the relevant state and federal statutes and regulations governing the use of these substances whether for veterinary care and laboratory research applications.
DEA Controlled Dangerous Substances (CDS)
Many of the narcotic CDS, certain 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 must comply with regulatory requirements relating to drug security and recordkeeping.
The DEA and its state affiliates categorized CDS materials into categories or 'schedules' based on the degree to which a particular compound is likley to be abused or cause addiction. Materials fall into one of five schedules, from highest control to least; Schedule I, II, III, IV, V.
- CDS Types/DEA Schedules (categories)
- Campus License - Life Sciences Complex
- Princeton University research and animal care utilize CDS materials under a single, campus-wide license.
- EHS is responsible for maintaining the university's DEA/NJDCA license
- License renewal occurs annually and is conducted by EHS
Approval for DEA Use at Princeton
Researchers may request authorization to use CDS materials by applying to EHS.
- CDS Application for Use
- University CDS Inventory System
- Once the CDS application is filed, reviewed and approved, EHS will add the approved principal investigator to the CDS Inventory System as an approved CDS user and indicate each substance for which the lab has been approved.
- Central Purchasing System
- All DEA regulated CDS must be purchased via PeopleSoft System o Purchasing Category = ‘51000000 - DEA Controlled Substance’
- Triggers EHS review and approval
- This process takes very little time
- Requisition becomes PO
- All DEA regulated CDS orders will be placed by a Purchasing agent
- NEVER order CDS with a credit card
- Material orders are transmitted to the vendor the same day (usually)
- Have your requisitions submitted by 12:00PM to ensure expedited processing
- Req/PO conversions occur throughout the day, on the hour
- If in stock, items are typically shipped the following day
- Description – Be ‘descriptive’ (e.g., Buprenex (buprenorphine))
- Include contact information in case of questions
- License Transmittal to Vendor
- Proof of licensure and copies of licenses are provided to veterinary supply vendors upon request by EHS
Receipt of DEA Shipments
- Material Arrival
- Deliveries are made ONLY to the address indicated on the university’s DEA License
- 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 (example)
- 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 Controled Substance Recipt Record chain of custody to document receipt (example)
- CDS materials are immediately secured in EHS approved lockbox
- Initial inventory effort was conducted June 2011
- 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 ask that each lab conduct a semiannual review using the PeopleSoft inventory
- Lab personnel will review the CDS inventory and inform EHS of any discrepancy
- EHS will verify the discrepancy 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.
- Principal Investigators must maintain complete and accurate inventory records for all controlled substances.
- These records must be kept separately from all other records and documents, in or near the primary work area, and be readily available for inspection during regular work hours.
- The use of codes, symbols, or foreign languages in identifying a controlled substance or person in the record is prohibited.
- All records must be maintained by Principal Investigators for a period of at least two years from the date of the last recorded purchase, transfer, use, or other transaction involving the controlled substance.
- Pre-Printed forms to document the receipt and use of controlled substances are provided to the Principal Investigator by EHS. The pre-printed forms Usage Forms are populated with the unique identification number assigned by EHS to each vial of controlled substances.
Recipt of Controlled Substance
- A separate must be maintained (Controlled Substances Receipt Record) of the receipt of controlled substances, indicating Principal Investigator, building/room, date received, name, address and DEA number of supplier, the type, strength or concentration, and amount of the controlled substances received. EHS generates the Receipt Record for each controlled substance order.
- Each record must be signed by the laboratory representative receiving the controlled substance.
Use of Controlled Substances
- A separate and current record (Controlled Substance Use Form) for the storage and use of each controlled substance (use meaning to administer, dispense, professionally use, or otherwise dispose of) must be kept for each separate container.
- The Controlled Substance Use Form indicates the Principal Investigator name,date, building and room, unique identification number assigned, type, strength and quantity of each controlled substance container.
- Laboratory staff must note starting volume or mass of substance in the container and each subsequent use.
- Each record of use must be initialed by the person working with the controlled substance.
- When container is empty, a copy of the usage log should be emailed to EHS.
Managing Expired Controlled Substances
- Researcher is responsible for notifying EHS of expired controlled substances. Upon receipt of this notification, EHS schedules a drug destruction, to be witnessed by a Department of Public Safety (DPS) commissioned police officer. Drug destruction is scheduled as soon as a DPS commissioned police officer is available. For Schedule II drugs, destruction is scheduled upon receipt of permission and written authorization from NJ Department of Consumer Affairs.
- Expired drugs 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.
- Expired drug shall be placed into a sealable plastic bag. Bag shall also be labeled as “Expired – Do Not Use”, with a date.
- 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 Controlled Substance Usage Log. The Usage Log and the drug vial contain the same unique number, assigned upon receipt of the controlled substance by EHS.
- A copy of the controlled substance usage log reflecting destruction date is submitted by the researcher to EHS. EHS then removes the drug from our electronic inventory.
Biennial Inventory of Controlled Substances
- A complete and accurate inventory (Biennial Inventory Form) of the stock of controlled substances within each PI’s 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.
- The inventory can be taken either as of the opening of business or the close of business on the inventory date and this should also be noted on the inventory.
- 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.
Destruction and Disposal
Environmental Health and Safety (EHS) schedules controlled dangerous substance (CDS) destructions on a regular basis. Once researchers report the need for the destruction of unwanted, unused, or expired CDS, EHS coordinates and performs the destruction utilizing a Public Safety Officer as witness. The destructions follow protocol approved by The State of New Jersey Division of Consumer Affairs Drug Control Unit. The destruction is documented on each CDS usage log, and is also recorded in a Destruction of Controlled Material log maintained by EHS.
The destructions follow protocol approved by The State of New Jersey Division of Consumer Affairs Drug Control Unit. The destruction is documented on each CDS usage log, and is also recorded in a Destruction of Controlled Material log maintained by EHS.
- Disposal of Empty Vials, Needles/Syringes
- Empty vials, bottles, and needles/syringes are disposed of via regulated medical waste. To qualify as empty, a vial must contain a quantity that cannot be withdrawn from the container using reasonable means. 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.
- All boxes and outer packaging should be crossed out in such a way that the contents of the package cannot be discerned. Outer packaging can then be recycled (e.g., paper/cardboard), or disposed of in the laboratory trash/refuse.