What equipment is needed if we are compounding both hazardous and non-hazardous non-sterile preparations?

It is strongly recommended that the pharmacy has one set of dedicated equipment (including personal protective equipment) for compounding hazardous drugs and another set for non-hazardous drugs. Alternatively, disposable equipment should be used, if possible, to reduce the risk of cross-contamination.

If it is not possible to have dedicated equipment for hazardous compounding, at an absolute minimum there should be policies and procedures in place to ensure that equipment is meticulously deactivated, decontaminated and cleaned immediately after compounding preparations with hazardous materials, before being used for non-hazardous preparations. The pharmacy should review section 9 of the guidance document, which further outlines the requirements for hazardous preparations.

For occasional non-sterile hazardous compounding, a C-PEC* used for sterile hazardous compounding (e.g., Class II BSC or CACI†) may be used, provided it is decontaminated, cleaned and disinfected before compounding the non-sterile preparation and again before resuming sterile compounding in that C-PEC due to the higher risk posed to patients.

*C-PEC (containment primary engineering control): a ventilated device designed to minimize exposure of personnel and the environment to hazardous products when such products are being handled directly (guidance document, section 9.2). Refer to question below regarding facilities.

†BSC – biological safety cabinet; CACI – compounding aseptic containment isolator.

Refer to Sections 9.2.1, 9.2.2, 9.2.3 and 9.3 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.