Section 246-878-040. Facilities.

(1) Pharmacies engaging in compounding shall have an adequate area for the orderly compounding of prescriptions, including the placement of equipment and materials. The drug compounding area for sterile products shall be separate and distinct from the area used for the compounding of nonsterile drug products. The area(s) used for compounding of drugs shall be maintained in a good state of repair.

(2) Bulk drugs and other chemicals or materials used in the compounding of drugs must be stored in adequately labeled containers in a clean, dry area or, if required, under proper refrigeration.

(3) Adequate lighting and ventilation shall be provided in all drug compounding areas. Potable water 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.

(4) The area(s) used for the compounding of drugs shall be maintained in a clean and sanitary condition. It shall be free of infestation by insects, rodents, and other vermin. Trash shall be held and disposed of in a timely and sanitary manner. Sewage and other refuse in and from the pharmacy and immediate drug compounding area(s) shall be disposed of in a safe and sanitary manner.

[Statutory Authority: RCW 18.64.005. WSR 94-08-101, § 246-878-040, filed 4/6/94, effective 5/7/94.]

RCW 18.64.005. WSR 94-08-101, § 246-878-040, filed 4/6/94, effective 5/7/94.