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(1) The pharmacy must have a designated area with entry restricted to designated personnel for preparing sterile products. This area must be:

(a) a separate room with a closed door, isolated from other areas with restricted entry or access, and designed to avoid unnecessary traffic and airflow disturbances from activity within the controlled facility;

(b) used only for the preparation of sterile pharmaceuticals;

(c) of sufficient size to accommodate a laminar airflow hood and to provide for the proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation, and security; and

(d) one with cleanable work surfaces, walls and floors.

(2) The pharmacy preparing the sterile products must have:

(a) appropriate environmental control devices capable of

maintaining at least a class 100 environment in the workplace where critical activities are performed. The devices must be capable of maintaining class 100 conditions during normal activity. Examples of appropriate devices include laminar airflow hoods and zonal laminar flow of high efficiency particulate air filtered air;

(b) appropriate disposal containers for used needles, syringes, etc., and if applicable, for antineoplastic waste from the preparation of antineoplastic agents and infectious wastes from patients' homes;

(c) appropriate biohazard cabinetry when antineoplastic drug products are prepared;

(d) temperature controlled delivery containers, when appropriate;

(e) infusion devices, when appropriate;

(f) a sink with hot and cold running water which is convenient to compounding area for the purpose of hand scrubs prior to compounding; and

(g) a refrigerator/freezer with a thermometer.

(3) The pharmacy shall maintain supplies and provide attire adequate to maintain an environment suitable for the aseptic preparation of sterile products.

(4) The pharmacy shall maintain sufficient current reference materials relating to sterile products to meet the needs of the pharmacy personnel. Reference materials must contain information on stability, incompatibilities, mixing guidelines, and the handling of antineoplastic products.

History: Sec. 50-5-103, MCA; IMP, Sec. 50-5-103 and 50-5-213, MCA; NEW, 1996 MAR p. 2587, Eff. 10/4/96; TRANS, from DHES, 2002 MAR p. 185.

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