Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-11 - PHARMACEUTICAL COMPOUNDING › Rule 480-11-.05 - Drug Compounding Controls

Current through Rules and Regulations filed through June 27, 2024
(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:
1. Component name; and
2. Weight or measure.
(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; and
4. The pharmacy's lot or identification
			 number and expiration date for the compounded drug/ preparation if
			 applicable.