The regulatory landscape for peptide therapies in Canada has evolved significantly over the past several years. For practitioners considering the integration of peptide-based treatments into their practice, understanding the current Health Canada framework is essential.
Drug Identification Numbers (DINs)
Peptide compounds that meet the definition of a "drug" under the Food and Drugs Act require a Drug Identification Number (DIN) before they can be sold in Canada. Practitioners should verify DIN registration for any peptide product they are considering prescribing.
Compounding Regulations
Many therapeutic peptides are available through licensed compounding pharmacies under provincial pharmacy regulations. These preparations are made to specific patient prescriptions and are exempt from the standard drug approval pathway, provided they meet provincial standards for compounded preparations.
The Special Access Program
Health Canada's Special Access Program (SAP) provides a pathway for practitioners to access drugs not yet approved in Canada for patients with serious or life-threatening conditions. This program has been used for several advanced peptide therapies that are commercially available in other jurisdictions.