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
Universal Citation: GA Rules and Regs r 480-11-.05
Current through Rules and Regulations filed through March 20, 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.
(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.
O.C.G.A. Secs. 26-4-5, 26-4-27, 26-4-28, 26-4-86.
Disclaimer: These regulations may not be the most recent version. Georgia may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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