Model Regulatory Guideline for the Distribution of Medication Samples by Pharmacists

NAPRA Council approved the following model guideline on April 21, 2001.

A medication sample is defined as a trial package of medication distributed to the pharmacist without cost. It would not include "free or bonus goods" provided as part of a larger purchase.

A pharmacist may dispense sample medication pursuant to a prescription, labelled in compliance with the rules governing labelling in the jurisdiction and may charge a professional fee but not charge for the cost of the medication. The pharmacist must inform the patient when medication samples are being dispensed.

Where the medication sample contains a Schedule I drug (as defined in Canada's National Drug Scheduling System), a prescription is required for distribution to the patient.

Distribution to patients of sample medication containing Schedule II, III or unscheduled drugs does not require a prescription. The distribution must be done however, in compliance with the conditions for sale set out in "Canada's National Drug Scheduling System" and the labelling requirements under the Regulations to the Food and Drugs Act. Without further packaging or labelling, there should be no charge for distributing the manufacturer’s packaged sample of non-prescription medication.