The physical requirements are:
(a) Space. Each retail pharmacy providing
home health care services shall have a designated area for preparing
compounded, sterile parenteral products. This area shall be physically separate
from other areas and should be designed to avoid unnecessary traffic and
airflow disturbances. The minimum space shall be 150 square feet. It shall be
used only for the preparation of specialty products. It shall be of sufficient
size to accommodate a laminar airflow hood and to provide for the proper
storage of drugs and supplies under appropriate conditions of temperature,
light, moisture, sanitation, ventilation, and security.
1. Laminar Airflow Hood; or Class 100 Clean
2. Infusion Pumps, if
3. Sink, in working
condition, with hot and cold running water, which is convenient to the
compounding area for the purpose of hand scrubs prior to compounding;
4. Equipment for light/dark field
disposal containers for used needles, syringes, etc., and if applicable,
cytotoxic waste from the preparation of chemotherapy agents;
6. A Class II, vertical flow biological
safety cabinet, if chemotherapy agents are routinely prepared;
7. Refrigerator/Freezer with a thermometer
and in working condition.
1. Disposable needles, syringes and other
supplies needed for aseptic admixture;
2. Disinfectant cleaning solutions;
3. Handwashing agent with bactericidal
4. Disposable, lint free
filters and filtration equipment;
6. Disposable masks and sterile, disposable
7. Gowns, if chemotherapy
agents are routinely prepared;
An oncology drug spill kit, if chemotherapy agents are routinely
References. In addition to references required of a retail pharmacy, current
edition of an established reference on IV stability and incompatibility, such
as, HANDBOOK ON INJECTABLE DRUGS, or KING'S GUIDE TO PARENTERAL
1. The pharmacist-in-charge may submit to the
Georgia State Board of Pharmacy a written request for a variance to these
provisions relating to minimum equipment requirements. Stated reasons for
application for variances must be included in the submitted request. A variance
shall be granted by the Board only when, in the judgement of the Board, there
are sound reasons for doing so that relate to the necessary or efficient
delivery of health care. After consideration by the Board, the requestor will
be notified in writing of the Board's decision.
2. If approved, said letter(s) will serve as
the proof of the Board's approval for variances indicted in the letter, and
must be posted next to the inspection report.
Ga. Comp. R. & Regs.
Original Rule entitled
"Physical Requirements" was filed on August 30,
1985; effective September 19, 1985.
F. Sept. 29, 1998; eff.
Oct. 19, 1998.
Repealed: New Rule of same title adopted. F.
Feb. 20, 2002; eff.
Mar. 12, 2002.