Non-Sterile Compounding Risk Assessment Resources

The College has developed the following suite of resources to help registrants conduct risk assessments for the non-sterile preparations they compound, or intend to compound, at their pharmacy: 

• A risk assessment template that outlines important details to document, reference, and consider
• A companion guide to support your understanding of what to include in the template and where to find it
• Risk assessment example 1: 1% hydrocortisone powder in 1% clotrimazole cream
• Risk assessment example 2: Progesterone 400 mg suppositories 

Use of this template is optional. How a pharmacy chooses to document risk assessments is at the discretion of the non-sterile compounding supervisor. 

Important Information About Risk Assessments 

Every pharmacy that offers non-sterile compounding services must meet or exceed the minimum requirements set out in the NAPRA’s Model Standards for Pharmacy Compounding of Non-Sterile Preparations. 

A risk assessment must be completed for each compounded preparation. Every ingredient used (e.g., drug, active pharmaceutical ingredient) should be considered. A risk assessment helps determine what level of requirements the pharmacy must have in place in order to compound the preparation. Cumulative risk (of all compounded preparations) must be taken into account. 

A risk assessment should also be conducted with appropriate resources. Safety data sheets and other applicable references should be consulted. The rationale for compounding and any risk mitigation strategies should be documented. Both risk to the preparation and risk to personnel must be considered and mitigated by adequate protection measures. 

Policies and procedures that ensure safety for personnel must be in place. 

If there is uncertainty on the risk level to assign, go with the higher standard. Quality patient care and safety of all personnel should always be the top priority.