What should I do if I am uncertain about the risk level of a compound?

If there is uncertainty regarding the risk level to assign a compounded preparation after completing your risk assessment, defer to the higher standard in the interest of safety. The Designated Manager/non-sterile compounding supervisor’s rationale to support the pharmacy’s decision must be well-researched and documented in the risk assessment, with supporting references. 

Refer to Section 4 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.