Section 246-878-080. Equipment.

(1) Equipment used in the compounding of drug products shall be of appropriate design, appropriate capacity, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. Equipment used in the compounding of drug products shall be suitable composition so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond that desired.

(2) Equipment and utensils used for compounding shall be cleaned and sanitized immediately prior to use to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond that desired. In the case of equipment, utensils, and containers/closures used in the compounding of sterile drug products, cleaning, sterilization, and maintenance procedures as set forth in WAC 246-871-080.

(3) Equipment and utensils used for compounding drugs must be stored in a manner to protect them from contamination. Immediately prior to the initiation of compounding operations, they must be inspected by the pharmacist and determined to be suitable for use.

(4) Automatic, mechanical, electronic, or other types of equipment other than commercial scale manufacturing or testing equipment, may be used in the compounding of drug products. If such equipment is used, it shall be routinely inspected, calibrated (if necessary), or checked to ensure proper performance.

[Statutory Authority: RCW 18.64.005. WSR 94-08-101, § 246-878-080, filed 4/6/94, effective 5/7/94.]

RCW 18.64.005. WSR 94-08-101, § 246-878-080, filed 4/6/94, effective 5/7/94.

Rules

246-871-080,