Topic

Controlled Drug Exemptions & Biosafety Permits

Who is this for?

Anyone using controlled drugs or biohazardous agents as part of their animal research or teaching at the University of Toronto (U of T), including those in the following roles.

  • Professor, Faculty Member
  • Teaching Stream Faculty
  • Principal Investigator (PI) Assistant with My Research Animal Protocol (MRAP) privileges

What do I need before I can begin?

You plan to submit or have submitted an Animal Use Protocol (AUP) that involves the use of controlled drugs or biohazardous agents.

Use of Controlled Drugs in Animal Studies

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) .

Use of Biohazardous Agents in Animal Studies

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.

Forms & Downloads

VPRI Role

  • 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

VPRI Contact

Staff

General Inquiries: Animal Ethics & Compliance Unit

Research Oversight & Compliance Office (ROCO)
(416) 978-1134

Other Resources

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