Ga. Comp. R. & Regs. R. 480-11-.07 - Control of Components and Drug Preparation Containers and Closures

(1) Components, drug preparation containers, closures, and bagged or boxed components of drug preparation containers and closures used in the compounding of drugs shall be handled and stored in a manner to prevent contamination and to permit unhindered cleaning of the work area (e.g., floors) and inspection.

(2) Drug preparation containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the compounded drug beyond the desired result. Components, drug preparation containers, and closures for use in the compounding of drug preparations shall be rotated so that the oldest stock is used first. Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the compounded drug preparation. Drug preparation containers and closures shall be clean and, where indicated by the intended use of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.

(3) Drug preparation containers and closures intended for the compounding of sterile preparations must be handled, sterilized, processed and stored to remove pyrogenic properties to assure that they are suitable for their intended purpose. Methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug preparation containers and closures used in the preparation of sterile pharmaceuticals. These processes shall be performed by pharmacists or under the pharmacist's supervision.

Notes

Ga. Comp. R. & Regs. R. 480-11-.07

O.C.G.A. Secs. 26-4-5, 26-4-27, 26-4-28, 26-4-86.

Original Rule entitled "Control of Components and Drug Product Containers and Closures" adopted. F. Apr. 19, 2004; eff. May 9, 2004. Repealed: New Rule entitled "Control of Components and Drug Preparation Containers and Closures" adopted. F. Nov. 22, 2006; eff. Dec. 12, 2006.