Factors to be considered when assessing whether an activity is compounding:

• Healthcare professionals who provide compounding related services and products to patients/clients must be able to demonstrate that a patient-healthcare professional relationship exists.
• Activity is regulated and facility may be inspected by provincial/territorial regulatory authorities.
• It is expected that healthcare professionals who compound products will have appropriate risk management processes in place to manage risks associated with the compounded product and the workplace (facilities, safety etc.), in line with the standards set by their provincial/territorial regulatory bodies (for example but not limited to the toxicology, pharmacology, therapeutic value, stability, adverse reactions, labelling requirements etc. of the compounded product).
• A pharmacy may prepare drugs in very limited quantities, in anticipation of a prescription. For the purpose of this Policy, preparation involves compounding or repackaging of multiple units, not for immediate use, in a single process, by the same operator in accordance with a standardized batch preparation procedure.
• Compounding should only be done if there is a therapeutic need or lack of product availability and should not be done solely for economic reasons for the healthcare professionals.
• The compounded product must provide a customized therapeutic solution to improve patient care without duplicating an approved drug product.
• When there is a shortage or no supply of a commercially available product and the healthcare professional has determined a medical need for this product, the product may be compounded during the period of shortage or no supply only.
• Drugs should not be compounded in order to be sold to third parties who will in turn sell/deliver to patients outside of their defined patient-healthcare professional relationship (see definition of "sell"). Pharmacists that do not provide specific compounding services may contract this activity to another pharmacist who provides this type of specific compounding service.
• Compounding of clinical trial drugs is only permitted if this activity is authorized in the clinical trial application or experimental or investigational authorization.

• Product should be produced from an authorized drug or Active Pharmaceutical Ingredient (API) used in an authorized drug for use in Canada or listed in a recognized Pharmacopoeia (USP, PhEur, PhF, PhI, BP, CF, NF, Codex - Schedule B Food and Drugs Act.)
• Those engaged in sterile compounding should be knowledgeable and obtain specialized technical training in this area (The Canadian Society of Hospital Pharmacists as well as United States Pharmacopoeia (USP) have developed guidelines for the preparation of sterile preparations). Compounding of sterile products is only permitted in hospitals or other practice settings where carefully established standards for the operation of clean rooms and the preparation of sterile products are in place and documented, in accordance with a recognized source. The products are dispensed directly to patients or to those who administer to patients, and are operating within a demonstrated patient-healthcare professional relationship. Pharmacists may delegate some of the compounding responsibilities to pharmacy technicians if they are adequately trained in compounding sterile products or if the provincial/territorial laws authorize it.
• Pharmacists in hospitals providing compounding services to other hospitals should be within the same province, and operate under the same hospital management board (ie. inter-hospital transfer, where the hospital may be composed of several facilities at different locations).
• The compounded product must comply with all relevant sections of the Food and Drugs Act including sections 3 - Prohibited advertising; 8 - Prohibited sales of drugs; 9 - Deception regarding drugs; and 11 - Unsanitary manufacture of drug.
• The expiration date of the compounded product is based on known stability data. If stability data is not available, the expiration date should be short, usually limited to the duration of the prescription or use.

Sterility is not about the drug; it’s about risk of microbial contamination and the route of administration

Non-sterile compounding

Non-sterile preparations include:

• Topical, oral, otic (external), rectal, vaginal

In Phase 1, evaluating the pharmacy’s current practice environment is a priority, with the goal of implementing appropriate procedures and quality controls to protect patients and compounding personnel. For more information on Assessing Risks and Gaps, please refer to the Pharmacy Connection article Implementation Timeline for Non-Sterile Compounding Standards.

In Phase 2, the priority will be the training and assessment of all personnel engaged in non-sterile compounding. Quality assurance processes need to be put in place to monitor compliance with the standards and safety in the system.

In Phase 3, the focus will be on ensuring that the facility and equipment for the preparation of hazardous and non-hazardous non-sterile compounds are in compliance with the standards. A quality assurance program will need to address facilities, equipment, personnel, compounded non-sterile preparations, and documentation.

Sterile compounding

Sterile preparations include:

• Injections, parenteral nutrition, dialysis solutions
• Ophthalmic, otic (intratympanic)
• Nasal inhalation, respiratory therapy solutions
• Allergen extracts
• Topical preparations where sterility is essential to therapy (e.g., cream for burns, irrigation solutions for body cavity)