Section 15.04. Physical requirements.

 

(1)  A pharmacy shall have a designated area for preparing sterile pharmaceuticals. This area shall be a room structurally isolated from other areas, with entry and access restricted to designated personnel and shall be designed to avoid unnecessary traffic and airflow disturbances. The designated area shall only be used for preparation and documentation of sterile pharmaceuticals. The designated area shall be of sufficient size to accommodate a laminar airflow hood and to provide for proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation and security. Additional drug inventory and bulk supplies shall be stored in an area separate from the designated area for preparing sterile pharmaceuticals.

(2)  A pharmacy shall maintain an environment in the designated area suitable for aseptic preparation of sterile pharmaceuticals and shall have all of the following:

(a) Appropriate environment control devices that are capable of maintaining at least a class 100 environment during normal activity in the workplace where critical objects are exposed and critical activities are performed.

(b) Appropriate disposal containers as required by OSHA in 29 CFR PART 1910 for used needles and syringes, and for disposal of other items in compounding and, if applicable, for cytotoxic waste from the preparation of chemotherapy agents and infectious wastes. This should be disposed of in a timely manner.

(c) Appropriate environmental controls including class II biological safety cabinetry in pharmacies where cytotoxic drug products are prepared.

(d) Temperature-controlled delivery containers as necessary.

(e) For hand washing, a sink with hot and cold running water in close proximity.

(f) Administration devices as necessary.

(3)  A pharmacy shall have sufficient reference materials related to sterile pharmaceuticals to meet the needs of the pharmacy staff.

(4)  The designated area shall be closed and disinfected at regular intervals with appropriate agents.

History: Cr. Register, March, 2000, No. 531 , eff. 4-1-00.