Controlled Drug Exemptions & Biosafety Permits

Any Principal Investigator (PI) planning to use controlled drugs as part of an animal research or teaching project must obtain an exemption from Health Canada. Health Canada requires a copy of the approved Animal Use Protocol(s) (AUPs) detailing their use at the time of application. Processing of applications takes on average 4-6 weeks, and exemptions are valid for one year. PIs are responsible for ensuring that they annually renew their exemptions prior to expiry, as needed, in order to continue to legally possess them. Please refer to Standard Operating Procedures (SOP) #1.11.0 Process for Controlled Substances in Animal Studies for more information.

Some controlled drugs are classified as restricted (see section J of Food and Drug Regulations). Researchers using restricted drugs must also complete the following steps.

1. Submit a letter signed by the applicable campus or division representative (i.e. Principal/Vice-Principal Research or Dean/Vice-Dean Research) with their exemption application (refer to Appendix 3 of SOP #1.11.0 – Template letter to Health Canada for an example of the required letter).
2. Submit a copy of the above letter and the completed exemption application form to the Animal Ethics & Compliance Unit (AECU).
3. Once the exemption application is approved, submit a copy of the Health Canada permit to the Animal Ethics & Compliance Unit (AECU) .

PIs who wish to use biohazardous agents (i.e. Risk Group 1, 2, or 3) in their animal studies must ensure that they have applied for a U of T Biosafety Permit through Environmental Health and Safety (EHS). Additional animal handler training for projects involving Risk Group (RG) 2 or RG3 agents in animals is required. See Mandatory Animal Handler Training for details.

• SOP #1.11.0 Process for Controlled Substances in Animal Studies
• Animal Handler Training Guide
• Animal Handler Training Matrix
• Biosafety (CL2) and Chemical Hazard Training Request Form

• Maintain records of all Schedule J drug exemptions relating to animal use
• Provide assistance in obtaining exemptions and in seeking approval to destroy drugs when they have expired or are no longer required for studies