Does OCP or NAPRA have examples or lists of Level A, B and C preparations?
No, the NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations (elsewhere referred to as “the standards”), adopted by the College, do 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.
For instance, risk assessments of similar formulations may yield different results across pharmacies because of the following:
- Numerous factors involved in assessing risk (e.g., quantity of ingredients being handled, frequency of compounding high-risk or low-risk preparations)
- Differences in pharmacy size, layout, personnel, number and volume of preparations compounded in the pharmacy, etc.
- Customized nature of compounded preparations, which may be altered to suit a specific patient’s needs
- Various ways risk may be mitigated (e.g., consider the NIOSH “hierarchy of controls”)
How a pharmacy chooses to conduct and document the rationale for their risk assessments so that it is reflective of their pharmacy is up to the discretion of the non-sterile compounding supervisor. For further support, the College has developed an optional risk assessment template, companion guide and examples for ensuring a risk assessment is performed for each compounded preparation.
Refer to Section 4.1 of the NAPRA Guidance Document for Pharmacy Compounding of Non-Sterile Preparations for additional factors to consider that can have an impact on the outcome of your risk assessment. Note that where the guidance document uses the language of “should,” it may be acceptable to meet the required standard using other technologies, techniques, materials and procedures than those suggested only if they have been proven to be equivalent or superior to those described in the guidance document.