Okla. Admin. Code § 535:15-10-5

Current through Vol. 42, No. 4, November 1, 2024

Section 535:15-10-5 - Compounding equipment

(a) Equipment used in the compounding of drug preparations shall be of appropriate design and capacity as well as suitably located to facilitate operations for its intended use, cleaning and maintenance.

(b) Compounding equipment shall be of suitable composition so the surfaces that contact components shall neither be reactive, additive nor absorptive therefore not affecting or altering the purity of the compounded preparation.

(c) Equipment and utensils used for compounding shall be thoroughly cleaned promptly after every use to prevent contamination and must be stored in a manner to protect them from contamination. A cleaning log is recommended.

(d) Defective equipment shall be clearly labeled as such.

(e) Automated, mechanical, electronic, limited commercial scale manufacturing or testing equipment, and other types of equipment may be used in the compounding of drug products. If such equipment is used, it shall be routinely inspected, calibrated as necessary or checked to ensure proper performance. An equipment calibration log must be maintained.

(f) When drug products with special precautions (antibiotics and hazardous materials) are involved appropriate measures must be utilized in order to prevent cross-contamination and proper disposal procedures must be followed. These measures include either the dedication of equipment for such operations or the meticulous cleaning of equipment prior to its use for the preparation of other drugs. A cleaning log must be maintained. Equipment dedicated for specific use (i.e. penicillin) shall be clearly designated as such.

Okla. Admin. Code § 535:15-10-5

Added at 17 Ok Reg 2633, eff 7-1-00; Amended at 26 Ok Reg 2276, eff 7-1-09

Amended by Oklahoma Register, Volume 32, Issue 23, August 17, 2015, eff. 8/27/2015.