Health Canada’s position on the unauthorized manufacturing of products sold as compounded glucagon like peptide 1 (GLP-1) receptor agonists

Health Canada’s position on the unauthorized manufacturing of  products sold as compounded glucagon like peptide 1 (GLP-1)  receptor agonists 

CPBC is sharing Health Canada's position statement below to ensure all registrants are aware of Health Canada's directive regarding GLP-1 compounding activities.

Health Canada has expressed ongoing concerns about compounding of GLP-1 agonists, particularly, but not limited to, semaglutide. Health Canada considers these activities to be a form of manufacturing rather than compounding, as most involve the use of unauthorized active pharmaceutical ingredients and duplication of currently available authorized manufactured products without unmet therapeutic need.

Health Canada has noted that this activity appears to be happening in licensed pharmacies across the country, and indicated they will be proceeding with enforcement and compliance actions.

CPBC’s Compliance Officers will also be operating in alignment with this directive during inspections. Pharmacy professionals are expected to familiarize themselves with Health Canada’s directive and ensure compliance with all provincial and federal requirements.

For addtional questions, please contact Health Canada at: [email protected]