The decision algorithm for assessing risk for compounding non-sterile products asks you to consider whether you are compounding an “occasional small quantity” of a hazardous product. How is this defined and why is this important for determining the level of requirements?

The NAPRA Non-Sterile Compounding Standards do not assign a specific numerical value to define “small quantity” or “occasional.”

What constitutes an “occasional small quantity” for a preparation or ingredient depends on the amount handled and how frequently it is used; however, these cannot be considered in isolation.

First, amounts and frequency are not the only factors involved in assessing the overall degree of risk to pharmacy staff and patients (and subsequently the appropriate level of requirements [A, B or C] for a preparation that contains a hazardous product).

Second, the cumulative risk of exposure over time must also be considered, even if the preparations are compounded on different days. The level of requirements must be sufficient for the pharmacy’s compounding practice as a whole to minimize contamination of compounded products and to provide adequate protection for compounding personnel, other staff and patients entering the premises.

For example, if a pharmacy compounds many different products “occasionally,” it is possible for their level of requirements to be the same as that of a pharmacy that compounds a few products “routinely.” When it doubt, err on the side of caution. If there is uncertainty about which risk level to assign, go with the higher standard – quality patient care and safety for all personnel should always be the top priority.

The Designated Manager (DM), pharmacy department head or non-sterile compounding supervisor (if one has been appointed) is responsible for determining whether an amount is “small” or “large,” or a frequency is “occasional” or “routine.” Conducting a risk assessment for each compounded preparation will help you determine the most appropriate level of risk, while documenting these risk assessments can help you support your rationale during a pharmacy operational assessment.

Refer to Section 4.1 and 4.2, Section 9 of the NAPRA Guidance Document for Pharmacy Compounding of Non-Sterile Preparations. 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.