059-13 Wyo. Code R. §§ 13-5 - Drug Compounding Facilities

(a) Pharmacies engaging in compounding shall have a specifically designated and adequate area (space) for the orderly compounding of prescriptions that is maintained in a good state of repair and for the placement of materials and equipment. Sterile compounding shall be performed in a separate area in compliance with Chapter 17.

(b) To maintain stability, bulk medications and other chemicals or materials used in the compounding of medications must be stored in adequately labeled containers in a clean, dry, and temperature-controlled area or, if required, under proper refrigeration. The refrigerator shall provide a storage temperature of 36 to 46 degrees Fahrenheit (2 to 8 degrees Centigrade). If a freezer compartment is utilized, it must maintain a temperature of -13 to +14 degrees Fahrenheit (-25 to -10 degrees Centigrade).

(c) Adequate lighting and ventilation shall be provided in all drug compounding areas. Potable water for drinking and washing shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any compounded drug product. Adequate washing facilities, easily accessible to the compounding area(s) of the pharmacy, shall be provided. These facilities shall include, but not be limited to, hot and cold water, soap or detergent, and air-driers or single-use towels.

(d) The area(s) used for compounding shall be maintained in a clean and sanitary condition.

(e) If sterile products are being compounded, the pharmacist shall follow Chapter 17 of this regulation.

(f) If drug products with special precautions to prevent contamination, such as penicillin, are involved in a compounding procedure, appropriate measures, including either the dedication of equipment or meticulous cleaning of contaminated equipment prior to its use for the preparation of other drugs, must be utilized in order to prevent cross-contamination.

Notes

059-13 Wyo. Code R. §§ 13-5