NAPRA Standards for Non-Sterile Compounding

The Ontario College of Pharmacists (OCP) adopted the National Association of Pharmacy Regulatory Authorities (NAPRA) Model Standards for Pharmacy Compounding of Non-Sterile Preparations in January 2022. The standards apply to all pharmacy professionals across practice settings and are intended to support safe compounding practices and minimize risks to both patients and pharmacy personnel.

Pharmacists are expected to evaluate whether a non-sterile preparation is appropriate for the patient or whether a commercially available alternative would be more suitable.[i] Where compounding is deemed necessary, the Designated Manager/department head must ensure that the pharmacy has the resources necessary to safely and accurately prepare a quality preparation.[ii]

Compounding requirements are structured according to the level of risk associated with the preparation process and the substances involved. These are generally categorized into three levels reflecting increasing complexity and hazard: Levels A, B and C:

• Level A consists of simple and moderate compounds;
• Level B consists of complex compounds or small quantities of ingredients or preparations that require ventilation and are compounded occasionally;
• Level C includes drugs or materials identified as hazardous by the National Institute for Occupational Safety and Health (NIOSH) and/or Workplace Hazardous Materials Information System (WHMIS).[iii]

NAPRA does not assign specific drugs, ingredients or formulations to each level of requirement (A, B or C). This is because compounding, like other aspects of pharmacy practice, is highly varied and dynamic. The approach to documenting and justifying risk assessments may vary by site and is up to the discretion of the non-sterile compounding supervisor, but should reflect the nature and complexity of the compounding activities performed.ⁱ

In February 2026, OCP developed resources to assist pharmacy personnel in implementing the NAPRA Model Standards. The Non-Sterile Compounding Supervisor Training Course is mandatory for registrants who are new to the role of non-sterile compounding supervisor or current non-sterile compounding supervisors in pharmacies where standards for non-sterile compounding are not being met. The training course is free of charge and also available to anyone (e.g., registrants wishing to refresh, strengthen, or supplement their knowledge). Additional tools have been developed to support risk assessment and documentation, including templates and guidance materials outlining appropriate mitigation strategies.  While the use of these tools is not mandatory, they provide a structured approach to documenting risk assessments in alignment with the NAPRA model standards.

For more information about the NAPRA Model Standards for Non-Sterile Compounding and  their application in practice, please refer to the resources listed below.