Use of CS must be covered under an IACUC protocol prior to the submission and approval of any CS request

Initial and annual online refresher training is required for all personnel handling CS under an IACUC protocol. Information on how to register for these training can be found under Mandatory Training section.

PIs must designate in writing those individuals authorized to work with CS in each authorized location under the PI’s supervision.

A list of authorized personnel must be kept up-to-date by the PI and provided to the Registrant Designee/RC promptly as changes occur. The list must include anyone who uses a CS, has access to a safe combination or key where CS is stored or has unsupervised access to areas where CS are used or stored. The Controlled Substance Authorized Personnel (CSAP) form must be completed and certified by each Principal Investigator requesting use of CS for animal research.

Authorized CS users are required to sign a statement that he or she has not been convicted of a drug-related felony. The Controlled Substance Authorization Release (CSAR) is an attestation that must be completed by all personnel conducting research before being authorized to handle CS.

Individual "Researcher Registrations" will not be used to order CS for animal research. The campus Registration Coordinator, Unit Coordinator, or their designee orders and procures all CS for authorized CS users under this program. Investigators conducting animal research with CS may not place orders directly with vendors. Authorized CS users submit a request through an electronic Controlled Substance Request Form (CSRF) Do not use this form to request any associated non-controlled substances.

To ensure compliance with Title 21 1301.72 Code of Federal Regulations, when not in use CS must be stored in an approved storage safe or cabinet in an authorized storage location.

• All CS storage locations must be approved by the Registration Coordinator 
• CI & CII should be separated from schedules III-V 
• CIII & CV can be stored with CI & CII provided security measures are met

Authorized CS users must document use on the same calendar day of CS use or administration on a CS usage form (CSUF). 

• A list of authorized CS users must be kept up-to-date by the PI and provided to the CS Coordinator promptly as changes occur
• CS usage logs must be in a secure location
• Each stored vial or container must have a corresponding CSUF, including dilutions

Only Controlled Substance Program Authorized Personnel may dispose of unused or expired CS.  All CS must be kept in an approved safe or storage cabinet until they are disposed. CS is destroyed in a method approved by the DEA, the State of NJ DCU, and in consultation with the Rutgers University Police Department (RUPD) and Rutgers Environmental Health & Safety (REHS).

• Non-recoverable waste
  • Empty containers with residual amount of CS waste which cannot be removed from the container may be discarded in a biohazard sharps container.  Loss of residual amounts must be properly documented on the usage log. 
• Recoverable waste
  • Recoverable CS waste that may result from unused doses in vial or container must be returned to the Unit Coordinator for destruction.
• Expired and unused controlled substances
  • Must be returned to local Unit Coordinator along with the usage form.
  • Unit Coordinator will audit usage forms along with the returned CS and documents usage before issuing additional CS. 
  • Unit Coordinator will arrange for CS disposal as per approved methods
• Theft or misplaced Controlled Substances
  • Loss or theft of CS must be reported to Registrant Designee and the campus Registration Coordinator immediately and no later than 24 hours from such discovery. 
  • Campus RC will contact Rutgers Police Department and REHS to start investigation
  • RC will then submit a DEA Form 106 to the NJ DEA Diversion Control Office and Public Safety.  Form DDC-52 will be submitted to the DCU office.   
• Spillage
  • Any spillage or other loss of CS must be reported within 24 hours to the campus Registration Coordinator or  Unit Coordinator.

Registration and laboratory audits will be performed periodically to determine whether CS activities are in compliance with state and federal regulations as well as internal Rutgers CS policies.  Unannounced PI lab audits may include CS activities similar to scheduled audits.

• Registration Coordinator(RC)/Unit Coordinator (UC) will contact the PI to schedule an announced audit
• Be prepared to provide the most recent CS Usage Form (CSUF)
• Audits may include:
  • Verification that the research conducted coincides with both the registration protocol and the IACUC protocol on file
  • Review of CS storage, inventories, record keeping, and expired CS
• Upon completion of the lab visits, regulatory findings and internal standards observations are reviewed with the PI and approved lab personnel.
• Recommendations and best practices for corrective actions are presented.