Rule 480-11-.05 - Drug Compounding Controls(1) For compounding of drugs in anticipation of prescription drug orders: (a) There shall be written procedures for the compounding of drug preparations to assure that the finished preparations have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include a listing of the components (ingredients), their amounts (in weight or volume), the order of component mixing, and a description of the compounding process. All equipment and utensils and the container/closure system, relevant to the sterility and stability of the intended use of the drug, shall be listed. These written procedures shall be followed in the execution of the drug compounding procedure. Nothing in these rules shall prohibit or exclude the use of electronic or computer equipment to meet these requirements.(b) Components for drug preparation compounding shall be accurately weighed, measured, or subdivided as appropriate. These operations should be checked and rechecked by the compounding pharmacist at each stage of the process to ensure that each weight or measure is correct as stated in the written compounding procedures. If a component is transferred from the original container to another (e.g., a powder is taken from the original container, weighed, placed/stored in an appropriate container), the new container shall be appropriate and shall be identified with the: (c) To assure the reasonable uniformity and integrity of compounded drug preparations, written procedures shall be established and followed that describe the tests or examinations to be conducted on the preparation compounded (e.g., degree of weight variation among capsules.) Such control procedures shall be established to monitor the output and to validate the performance of those compounding processes that may be responsible for causing variability in the final drug preparation. Such control procedures shall include, but are not limited to, the following (where appropriate): 1. Capsule weight variation;2. Adequacy of mixing to assure uniformity and homogeneity;3. Clarity, completeness, or pH of solutions.(d) Appropriate written procedures designed to prevent microbiological contamination of compounded drug preparations purporting to be sterile shall be established and followed. Such procedures shall include validation of any sterilization process.(e) All personnel involved in any step of the compounding process shall be clearly identified in the compounding record. The compounding record must document the following: 1. The ingredients and amounts or volumes used including the source, lot numbers and expiration dates;2. The order of the mixing or preparation of the preparation including the date mixed;3. The identity of the pharmacist and any staff member involved in each step of the procedure; and4. The pharmacy's lot or identification number and expiration date for the compounded drug/ preparation if applicable.(2) Compounding of drugs for an individual prescription drug order. The pharmacist must document in a readily retrievable manner, the following information: (a) The ingredients and lot numbers used in the compounding;(b) The amounts (weights or volumes) of each ingredient;(c) The order of component mixing;(d) A description of the compounding process;(e) The name of the responsible pharmacist and all other personnel involved in each step of the compounding; and(f) Appropriate written procedures designed to prevent microbiological contamination if the compounded prescription is purported to be sterile.Ga. Comp. R. & Regs. R. 480-11-.05
O.C.G.A. Secs. 26-4-5, 26-4-27, 26-4-28, 26-4-86.
Original Rule entitled "Drug Compounding Controls" adopted. F. Apr. 19, 2004; eff. May 9, 2004.Repealed: New Rule of same title adopted. F. Nov. 22, 2006; eff. Dec. 12, 2006.