Frequently Asked Questions > How do I know if my pharmacy is engaged in compounding?
FAQ

How do I know if my pharmacy is engaged in compounding?

Health Canada considers compounding to be the following:

“The combining or mixing together of two or more ingredients (of which at least one is a drug or pharmacologically active component) to create a final product in an appropriate form for dosing. It can involve raw materials or the alteration of the form and strength of commercially available products. It can include reformulation to allow for a novel drug delivery. Compounding does not include mixing, reconstituting, or any other manipulation that is performed in accordance with the directions for use on an approved drug’s labelling material.”

Before compounding a non-sterile preparation, the need for the compounded product should be confirmed by checking for commercially available preparations in the Health Canada’s Drug Product Database and contacting manufacturers.  To comply with the Health Canada policy on compounding, this confirmation is required in order to validate the lack of product availability and avoid duplicating an approved drug.

Non-sterile preparations can be categorized as simple, moderate or complex (as outlined in United States Pharmacopeia (USP) Chapter <795> Pharmaceutical Compounding – Nonsterile Preparations). A number of factors go into determining the type of preparation and level of risk when compounding preparations. Pharmacists and pharmacy technicians who compound non-sterile preparations should evaluate their practice, develop service-related procedures and implement appropriate quality controls for both patients and compounding personnel, with a view to guaranteeing the overall quality and safety of non-sterile preparations.