Compounding

“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."

Policy on manufacturing and compounding drug products in Canada (POL-0051) Ottawa, ON: Health Canada; 2009

Compounding activities are undertaken for a variety of reasons, some of which include:

  • A commercially available product is not available in a ready-to-administer form that meets the needs of the patient
  • The patient cannot swallow a drug that is supplied in solid dosage form and requires the drug to be administered in a liquid form

The provision of high quality compounded preparations does not just happen—it is the intentional outcome of structures and processes that are deliberately designed, organized, and executed. It is founded on good science and a quality management framework, drawing on how people, supplies and equipment, processes, and the physical environment influence product quality.

 

Standards of practice for pharmacists and pharmacy technicians stipulate how compounding should be done: guidelines help to achieve and exceed the expected standard. The resources provided here should answer some of your questions, prompt you to raise more questions, and reach out to the wealth of knowledge and skills within the pharmacy community. The content is updated regularly. If you have suggestions to change the content, please write to Cathy Lyder.