Drug Sample Distribution Rules Expanded

Summary#

These final regulations, Regulations Amending the Food and Drug Regulations (Distribution of Drugs as Samples) — SOR/2020-74, change who can be given free samples of certain drugs and under what conditions. Published in the Canada Gazette on April 29, 2020, they let some low-risk non-prescription drugs and certain natural health products be handed out to the public (people 18 years or older) and update which health professionals can receive samples for patients. The rules come into force when section 57 of the Canada–United States–Mexico Agreement Implementation Act comes into force (or on registration if later).

What it does#

• Creates a new, on‑going list (called List D) of certain low‑risk non-prescription drugs that may be distributed as samples to the public without a signed order.
• Allows some low‑risk natural health products to be distributed as samples to the public (these are listed separately under the Natural Health Products Regulations).
• Limits public distribution to people aged 18 years or older.
• Stops anyone from giving a sample to the public within 30 days before a product’s expiry date (or during the month of expiry if the expiry is month/year) or after expiry.
• Keeps rules for samples given to health professionals: prescription drugs still require a signed order from a practitioner or pharmacist, and distributors must keep required records.
• Expands the class of “practitioners” who can receive samples so the federal rules line up with who provinces allow to prescribe (for example, nurse practitioners and other provincially authorized prescribers).
• Lets Health Canada update List D more quickly by publishing changes online after a 60‑day public consultation (this is an ambulatory incorporation by reference).
• Replaces a NAFTA cross‑reference with references to CUSMA Articles 20.48 and 20.49 to reflect the new trade agreement.

Who's affected#

• Consumers who might receive free samples: anyone aged 18 years or older.
• Health professionals who prescribe or dispense drugs (physicians, pharmacists, nurse practitioners and other provincially authorized prescribers).
• Manufacturers, importers, retailers and distributors of non‑prescription drugs and natural health products that might be offered as samples.
• Public health bodies and municipalities that distribute products like sunscreens at events.
• People in rural, northern and remote communities where nurse practitioners and non‑physician prescribers often provide front‑line care.

If it’s unclear whether a specific product is covered, check whether it’s on the published List D or the Natural Health Products list referenced by Health Canada.

Why it matters#

• It makes it legally easier for people to get free samples of some low‑risk over‑the‑counter drugs and natural health products. That can help people try a product before buying it and can improve access for people with limited money or access to pharmacies.
• Expanding who can receive samples (for example, nurse practitioners) can speed treatment and improve access in communities with fewer doctors or pharmacies.
• Safety limits are included: samples can’t go to minors, and distributors can’t hand out products close to or past expiry. That aims to balance access with basic safety protections.
• The ambulatory list approach means Health Canada can add or remove products faster when safety information changes, after a public 60‑day consultation.
• These changes implement a Canada‑U.S.‑Mexico trade commitment under CUSMA, so Canada’s rules are now aligned with that agreement for these products.