The major elements of the controlled substance program include centralized research registrations for animal research, established policies and standardized operating procedures for storage, security, inventory, usage and disposal of unused and expired waste containing controlled substances. The objectives of the program are to assist university personnel with adherence to Federal and State regulations, enforce internal standards, provide training and monitor compliance and regulatory developments.

Controlled substances are pharmaceutical drugs or chemical substances with or without currently acceptable medical therapeutic value, having a potential for abuse, and likelihood of causing dependence when abused. The acquisition, possession and use of these substances is strictly regulated by the DEA under the authority of the Controlled Substance Act enacted in 1970. A current list of controlled substances can be found in section 1308 of the most recent issue of Title 21 Code of Federal Regulations (CFR), PART 1300-END: https://www.ecfr.gov/current/title-21/chapter-II 

The DEA assigns each controlled substance a schedule number (I through V) according to its medicinal value, harmfulness, and potential for abuse or addiction. A higher schedule number indicates the substance has more medicinal value and less potential for abuse or addiction. The controlled substance manufacturer container label will have a symbol indicating its schedule (CII or C-II, CIII or C-III etc.)

An animal use protocol justifying the use of controlled substance(s) must be submitted to the IACUC and approved. CS training is mandatory. Enrollment can be initiated by submitting CS approval forms and completing training requirements.  Information and forms can be found on the CS program website. Once approval forms are processed an evaluation of laboratory level security will be scheduled.

A PI holding an IACUC-approved animal use protocol which includes the use of specific CS or senior laboratory personnel identified and authorized by the PI who require access to a safe or storage cabinet and/or obtains or uses CS in the absence of others are examples of authorized users. To be considered an authorized user the submission of CS Approved Personnel (CSAP) and CS Authorization Release (CSAR) forms is required. Comparative Medicine Resources (CMR) staff involved in clinical veterinary care are also considered authorized CS users.

Initial and refresher training is mandatory for any lab personnel with access to CS. Initial in-person orientation training sessions will be scheduled periodically by unit. Hands on laboratory training to review best practices in recordkeeping and storage will be provided as needed. Online yearly refresher training is accessible through eIACUC and links can be found under the training tab on the CS webpage.

Authorized CS Users request CS by submitting a completed Controlled Substance Request Form (CSRF) to the CS program coordinator assigned to the physical location where the CS is to be stored. 

When not in use, CS must be stored in an Approved Storage Safe or Cabinet in an Authorized Storage Location. All laboratory storage locations must be inspected by the CS program before use of CS is authorized. Storage approval is granted dependent on multiple factors including the type of CS used, general accessibility to the laboratory and surrounding area and the presence of a double lock system.

Safes that weigh less than 750 pounds must be permanently securely anchored to the floor or wall.  A bolted safe or double lock narcotics cabinet is the recommended storage of Schedules I and II. 

A substantially constructed cabinet must be affixed to the floor or the wall (e.g. a stationary lab bench or narcotics cabinet) and a double lock system must be in place. Where a lab bench is utilized a secondary lock box in a locked drawer is required. Dependent on specific area security, cabinet and type of CS required for use, additional security measures may be needed.

Additionally, key or code access must be limited to an absolute minimum number of laboratory members.

Any suspicion that a CS has been misplaced or stolen must be reported to the CS program coordinators immediately upon discovery. Significant loss or theft must be reported by the University Registrant Designee to The NJ Drug Control Administration (DEA), Diversion Control Office, the NJ Drug Control Unit (DCU) and Rutgers University Police Department RUPD.

Loss of CS must be reported to the campus CS coordinator within 24 hours and immediately justified within the CS usage log and documented with two signatures. Any loss of CS from broken vials or spillage, that can be recovered must be reviewed by the registration and/or unit coordinator.

Laboratory staff who do not handle or have direct access to controlled substances themselves (e.g., they work on other experiments, they perform custodial duties in the laboratory, etc.) should not be listed as personnel approved by the PI to work with CS. Only those laboratory members listed on the CSAP form may handle CS.

Contact the unit coordinator in your area to arrange return of unused or expired CS.

No. Each PI requiring use of controlled substances in animal research must be enrolled in the controlled substance program, secure CS from the centralized program and accept responsibility for the storage, security, appropriate usage and return of any unused or expired CS to the CS program unit coordinator.

Dilutions of CS are allowable for administration in the course of the approved research, where adherence to all applicable IACUC policies andCS storage, disposal and recordkeeping policies are maintained. CS cocktails and dilutions must be assigned the earliest expiration date allowable following IACUC policy expiration dates or actual CS expiration dates. Dilutions of primary CS stock should be administered immediately following preparation or a separate CSUF listing the relationship to the primary CS container and dilution ratio must be assigned.

Rutgers University IACUC Policy prohibits the use of expired drugs and reagents for euthanasia, anesthesia and analgesia agents. Drugs cannot be used beyond their expiration date even if a procedure is terminal. All expired CS must be returned to the local CS program unit coordinator for disposal.

All opioid analgesics used for pain relief are currently classified as controlled substances. Commonly used opioid analgesics include Morphine, Hydromorphone, Fentanyl and Buprenorphine. Morphine, Hydromorphone and Fentanyl are examples of Schedule II substances, whereas Buprenorphine is an example of a Schedule III substance.

Sodium Pentobarbital is an example of an injectable anesthetic agent commonly used for euthanasia purposes in research. Formulations containing only Sodium Pentobarbital are Schedule II CS. Formulations that include phenytoin such as Euthasol and Somnasol are Schedule III CS. Phenytoin is a potent central nervous and cardiovascular system suppressant that aids in the euthanasia process.  Sodium Pentobarbital products specifically labeled for use as primary agents of euthanasia have very concentrated formulations. These products are prohibited for use in any other manner other than for euthanasia.

Ketamine and pentobarbital (Nembutal®) are examples of commonly used injectable anesthetic agents in research. Pentobarbital (Nembutal®) is a schedule II CS and Ketamine is a schedule III CS.  Sedative agents commonly used in conjunction with ketamine include midazolam and diazepam. Midazolam and diazepam are schedule IV CS.

Acepromazine, Xylazine and Isoflurane are not controlled substances.  Acepromazine, Xylazine and Isoflurane are marketed as prescription veterinary drugs, therefore vendors will require a clinical practioner’s license for procurement. Contact your local CMR if you need assistance obtaining veterinary drugs.