This article is designed to be a guide to help you understand your treatment options.
1. What Are Compounded Medications?
Compounded medications are custom-made by a pharmacist when a Health Canada–approved medication is not available, not suitable, or cannot be used for a specific patient.
Compounding may be helpful when:
– A medication needs to be made into a different form
– A patient has an allergy to an ingredient
– A specific strength or dose is not commercially available
– There is a temporary drug shortage
Compounding fills gaps in care but is not the same as receiving a Health Canada–approved medication.
Compounded vs. Branded (Health Canada–Approved) Medications
| Compounded Medication | Branded / Health Canada–Approved Medication |
|---|---|
| Custom-made by a pharmacist for an individual patient | Manufactured in large batches under strict regulatory standards |
| Used when an approved product is not available, not suitable, or cannot be used | Used when an approved product meets the patient’s needs |
| Not reviewed or approved by Health Canada | Reviewed and approved by Health Canada |
| No clinical trials or bioequivalence testing | Supported by clinical trials for safety, effectiveness, and dosing |
| Potency and stability may vary between pharmacies | Consistent potency, purity, and stability across batches |
| Quality depends on pharmacy processes and ingredients | Quality verified through regulated manufacturing requirements |
| No requirement to prove absorption or clinical effect | Predictable absorption, outcomes, and safety demonstrated |
| May use raw ingredients not assessed by Health Canada | Uses Health Canada–approved active ingredients and excipients |
| Appropriate in select situations (allergies, shortages, special dosing needs) | First-line when an approved option fits the patient’s needs |
| Not interchangeable with approved medications | Interchangeability and dosing are established and regulated |
| Cost may vary (sometimes lower, sometimes higher) | Cost varies; patient support programs or discounts may be available |
| Higher risk with sterile or injectable compounds | Strict contamination controls for sterile and injectable products |
2. How Compounded Medications Are Regulated in Canada
– Not reviewed or approved by Health Canada
– Quality depends on the individual pharmacy
– Follow provincial and National Association of Pharmacy Regulatory Authorities, compounding standards
3. Safety and Quality Considerations
– No standardized potency (You may not get the same strength and effect each time you take it) or stability testing(Special testing that confirms the medication remains stable)
– Variability between pharmacies
– Higher risks with sterile or injectable compounds
– Costs may vary
4. Questions to Ask Before Choosing a Compounded Medication
– Why am I being offered a compounded version?
– Is there an approved alternative?
– How is quality checked?
– How long is it stable?
– What outcomes can I expect?
5. Compounded GLP-1 and GLP-1/GIP Medications
– Health Canada does not approve compounded GLP-1 products
– No clinical trials or bioequivalence testing
– Not interchangeable with approved medications
– Discuss any compounded GLP-1 option with your prescriber
6. Key Takeaways
– Compounded meds are useful when approved products are not appropriate
– They are not reviewed by Health Canada
– Not substitutes for approved products when commercial options exist
– Discuss risks, benefits, and alternatives with your healthcare team
References:
Health Canada: Policy on Manufacturing and Compounding Drug Products
Health Canada: Drug Compounding FAQs
National Association of Pharmacy Regulatory Authorities Model Standards for Non-Sterile and Sterile Compounding
Provincial Pharmacy Colleges: Compounding Standards
ISMP Canada: Compounding Safety Alerts
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This article was sponsored by Novo Nordisk Canada. All content is created independently by My Weight – What To Know with no influence from Novo Nordisk.
