Peptides: Regulations and enforcement
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Classification
Product classification is the first step in any regulatory process at Health Canada.
A peptide product could be classified as either:
- a drug regulated under the Food and Drug Regulations
- a natural health product regulated under the Natural Health Products Regulations
The classification depends on:
- what it's used for
- what it's made of
- how it's administered (for example, orally or by injection)
Both drugs and natural health products come in a wide variety of forms, like:
- drops
- tablets
- creams
- capsules
- tinctures
- solutions
- ointments
Injectable peptides are always classified as drugs. They're regulated under the Food and Drug Regulations because of the increased potential risks associated with their use. They require stricter controls to help ensure they are sterile, safe and of high quality.
Health Canada makes classification decisions based on available evidence at a point-in-time. These decisions may change based on new scientific evidence or other pertinent information.
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Regulations
Before a drug can be authorized for sale in Canada, Health Canada reviews the information submitted by the manufacturer to assess the product's safety, efficacy and quality. Health Canada authorizes a drug only when:
- the evidence supports its intended use
- its benefits outweigh its risks
- identified risks and uncertainties can be appropriately managed
Natural health products must also undergo a Health Canada review before they can be sold in Canada.
Authorized peptide products sold in Canada have either:
- an 8-digit drug identification number (DIN) or
- an 8-digit natural product number (NPN)
Unauthorized peptide products don't have a DIN or NPN, and haven't:
- been assessed by Health Canada for safety, efficacy and quality
- shown, through scientific evidence reviewed by Health Canada, to provide their claimed health benefits
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Compounding peptides
Compounding is the process of combining, mixing or altering ingredients to prepare a medication for a patient's specific medical needs. It's made by pharmacists and other licensed health care practitioners. For example, if a child can't swallow tablets, a pharmacist may compound their medicine as a liquid.
In Canada, compounding is a recognized health care practice that generally falls under provincial and territorial rules and regulations. However, some activities that are described as "compounding" may be considered drug manufacturing. These activities fall under the federal:
- Food and Drugs Act
- Food and Drug Regulations
- Natural Health Product Regulations
Compounding must be a legitimate part of the practice of regulated healthcare professionals and must not be used as a means to circumvent the federal drug review and approval process.
Compounded products should be:
- recommended by a health care practitioner, in the context of an individual patient-health care practitioner relationship
- prepared for a patient to meet a specific medical need (when an authorized product isn't available)
Pharmacists and health care practitioners who compound products:
- are responsible for the safety, efficacy and quality of their products
- must not advertise specific compounded products to the general public
Compounding drugs
Our Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051) explains what may make an activity compounding or manufacturing. It looks at factors like:
- where the drug's ingredients come from
- if the drug is already commercially available
- if the drug is prepared and sold outside a patient-health care practitioner relationship
We consider all factors in the policy together to decide if the activity is compounding or manufacturing.
A compounded drug is different from a commercially manufactured drug. It is not subject to the same Health Canada assessment and authorization process.
Health Canada expects compounded drugs to be prepared from:
- an authorized drug
- an ingredient used in a drug authorized for sale in Canada
- an ingredient listed in a recognized pharmacopoeia, such as the:
- British Pharmacopoeia (BP)
- United States Pharmacopeia (USP)
- European Pharmacopoeia (Ph. Eur.)
Compounding natural health products
In Canada, compounding natural health products follows different factors than compounding drugs. However, compounded natural health products must still be prepared according to professional and provincial or territorial requirements.
Injectable products cannot be natural health products in Canada. They're regulated as drugs because they're administered directly into the body, and need stricter controls to keep them sterile, safe and of high quality.
Learn more:
- Natural Health Product Compounding Policy: Policy statement
- Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051)
Compliance and enforcement
Health Canada conducts compliance and enforcement activities to identify and address products that do not meet Canadian regulatory requirements. Unauthorized health products have not been assessed by Health Canada for safety, efficacy and quality. It is illegal to sell or promote unauthorized health products in Canada.
Unauthorized peptides are increasingly being advertised and sold online for a wide range of purposes despite not being authorized for sale in Canada. We've seen an increase in complaints about the sale and promotion of unauthorized peptides, especially online. In response, we're strengthening our compliance and enforcement activities to address their growing availability and to help protect Canadians from potential health risks.
We're also aware of peptides being compounded in Canada and we are working closely with provincial and territorial regulators to address these concerns and protect people in Canada. Activities involving unauthorized peptide ingredients, or those that extend beyond the accepted scope of compounding, may be considered manufacturing rather than compounding. In these cases, Health Canada will take action under the Food and Drugs Act and its regulations.
Health Canada monitors the marketplace and takes enforcement action when individuals or businesses sell, advertise/promote or distribute unauthorized peptides. Our goal is to help protect the health and safety of people in Canada by:
- addressing misleading or illegal activities
- reducing the availability of unauthorized health products
We take appropriate action against individuals and businesses that do not comply with the law. This includes those who sell, advertise, promote or distribute unauthorized peptides. We determine the most appropriate response based on the nature of the non-compliance and the potential risk to health and safety. We take stronger actions when non-compliance continues or more serious risks to health and safety are identified.
These actions include:
- recalls
- product seizures
- requests to stop sales
- court-issued entry warrants
- permanent court injunctions to cease non-compliant activity
- ministerial orders to cease the advertising and sale of unauthorized health products
We expect regulated parties to:
- comply with legislative and regulatory requirements
- address any non-compliance quickly and appropriately
We also work with the Canada Border Services Agency to help prevent unauthorized peptides from entering Canada. Imported shipments that contain health products that do not meet Canadian regulatory requirements may be refused entry, detained or seized based on the level of risk they pose.
We continue to monitor emerging scientific evidence, market developments, and evolving health risks. Regulatory decisions are always based on the latest available evidence related to safety, effectiveness, and quality. We will take action when risks to people in Canada are identified.
You can report products to us if you believe they are:
- unsafe
- unauthorized
- advertised or promoted with false or misleading claims
Fill out our health product complaint form
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