Policy Respecting the Distribution of Medication Samples

POLICY

Approved: March 2005; Updated June 2006

Legislative references:

College Contact: Pharmacy Practice


Definition

A medication sample is defined as a trial package of medication distributed to the pharmacist without cost. It is the responsibility of the pharmacy manager to ensure that there is clear documentation regarding the origin and distribution trail (provenance) of the sample so that he/she is able to fulfill the obligation to ensure the integrity of the medication dispensed, and that it is of acceptable standard and quality.

Schedule I samples

Schedule I drugs require a prescription for sale and are provided to the public by the pharmacist following the diagnosis and professional intervention of a practitioner. As such, any samples of Schedule I drugs can only be provided pursuant to a prescription.Where a drug sample is dispensed, a pharmacist:

  • may not charge the patient for the sample.
  • may charge a professional fee.
  • must communicate to the patient that a medication sample was used in dispensing.
  • will label as per s. 156 of the Drug and Pharmacies Regulation Act. In addition, record documentation to reflect that a sample was dispensed.

Schedule II samples

Schedule II narcotic substances may not be provided as drug samples.
[Reference: Narcotic Control Regulations, Section 70]. Schedule II drug samples (non-narcotic) may be provided to the public at no charge. The distribution must be done however, in compliance with the conditions for sale for Schedule II items as set out in “Canada’s National Drug Scheduling System” and with the labelling requirements under the Regulations to the Food and Drugs Act without further packaging or labelling.


Schedule III samples

The Schedule III sample can only be provided to the public within a pharmacy when a pharmacist is present. The Schedule III sample may be provided at no charge and with the labelling requirements under the Regulations to the Food and Drugs Act without further packaging or labelling.


Unscheduled drug samples

Unscheduled drugs can be sold without professional supervision and are available from any retail outlet. Accordingly, sampling of these products does not fall under the purview of the Ontario College of Pharmacists.