Refer to Sections 9.1, 9.1.1, 9.2.1, 9.2.2 and 9.3 of the NAPRA Guidance Document for Pharmacy Compounding of Non-sterile Preparations.
It is preferable to have separate areas for compounding hazardous and non-hazardous non-sterile preparations, however, if this is impossible and the same area is used, compounding and/or cleaning personnel must, at minimum, be assured that the area and any reusable equipment has been meticulously deactivated, decontaminated and cleaned to prevent any risk of cross-contamination from the hazardous materials before other preparations are compounded.
Because of the difficulty of removing hazardous product contamination, the surfaces of ceilings, walls, floors, fixtures, shelving, counters and cabinets in the non-sterile compounding area should be smooth, impermeable, free from cracks and crevices, and made of non-shedding material. It is strongly recommended that equipment be dedicated for compounding each of hazardous and non-hazardous drugs. Alternatively, disposable equipment should be used, if possible, to reduce the chances of cross-contamination.
The Designated Manager/department head and/or non-sterile compounding supervisor must have policies and procedure in place for the deactivation, decontamination and cleaning required after compounding hazardous non-sterile preparations. As part of the pharmacy’s quality assurance program, personnel must be trained and their work routinely assessed to ensure compliance with procedures.