(a) Pharmacies engaging in compounding shall
have an adequate area for the orderly compounding of prescriptions, including
the placement of equipment and materials. The drug compounding area for sterile
preparations shall be separate and distinct from the area used for the
compounding of non-sterile drug preparations. The area(s) used for compounding
of drugs shall be maintained in a good state of repair.
(b) Bulk drugs and other chemicals or
materials used in the compounding of prescription drug orders must be stored in
adequately labeled containers in a clean, dry area or, if required, under
lighting and ventilation shall be provided in all drug-compounding areas.
Potable water shall be supplied under continuous positive pressure in a
plumbing system free of defects that could contribute to contamination of any
compounded drug preparation. Adequate washing facilities, easily accessible to
the compounding area(s) of the pharmacy shall be provided. These facilities
shall include, but not be limited to, hot and cold water, soap or detergent,
and air dryers or single-use towels.
(d) Sewage, trash, and other refuse in and
from the pharmacy and immediate drug compounding area(s) shall be disposed of
in a safe and sanitary manner.
(a) Equipment used in the compounding of drug
preparation shall be of appropriate design, appropriate capacity, and suitably
located to facilitate operations for its intended use and for its cleaning and
maintenance. Equipment used in the compounding of drug preparations shall be of
suitable composition so that surfaces that contact components, in-process
materials, or drug preparations shall not be reactive, additive, or absorptive
so as to alter the safety, identity, strength, quality, or purity of the drug
preparation beyond that desired.
(b) Equipment and utensils used for
compounding shall be cleaned and sanitized immediately prior to use to prevent
contamination that would alter the safety, identity, strength, quality, or
purity of the drug preparation beyond that desired. In the case of equipment,
utensils, and containers/closures used in the compounding of sterile drug
preparations, cleaning, sterilization, and maintenance procedures as set forth
in Board Rules.
(c) Equipment and
utensils used for compounding drugs must be stored in a manner to protect them
from contamination. Immediately prior to the initiation of compounding
operations, they must be inspected by the pharmacist and determined to be
suitable for use.
mechanical, electronic, or other types of equipment other than commercial scale
manufacturing or testing equipment, may be used in the compounding of drug
preparations. If such equipment is used, it shall be routinely inspected,
calibrated (if necessary), or checked to ensure proper performance.
Physical requirements for
pharmacies compounding sterile parenteral preparations.
(a) A pharmacy compounding or preparing
sterile parenteral preparations shall have a designated area for preparing
compounded, sterile parenteral preparations as defined in USP 797. This area
shall be physically separate from other areas and should be designed to avoid
unnecessary traffic and airflow disturbances. It shall be used only for the
preparation of sterile parental preparations.
Equipment and supplies for compounding
sterile parenteral preparations. A pharmacy compounding sterile parenteral
preparations shall have the following minimum equipment and supplies:
1. Laminar airflow hood (ISO 5) located
within a clean room, or barrier isolator as described in USP 797;
2. Infusion pumps, if appropriate;
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. Facility 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 or appropriate barrier isolator, if chemotherapy agents are
Refrigerator/freezer in working condition;
8. If compounding onsite using components
which must be weighed, Class A Balance with an assortment of metric weights or
a Class I or II Electronic Balance;
9. Disposable needles, syringes and other
supplies needed for aseptic admixture;
10. Disinfectant cleaning
11. Handwashing agent
with bactericidal action;
Disposable, lint free towels or an automatic hand dryer;
13. Appropriate filters and filtration
14. Disposable masks and
sterile, disposable gloves, gowns, hair and shoe covers and goggles when
15. An oncology drug
spill kit, if chemotherapy agents are routinely prepared.
16. For the purpose of emergency or immediate
patient care, compounded sterile preparations are exempted from the
requirements as outlined in USP 797.
Minimum equipment for pharmacies
compounding non-sterile preparations.
compounding pharmacy must have all equipment required of a pharmacy in Chapter
480-10 of the Board Rules.
Additionally, a compounding pharmacy must have the appropriate equipment for
use in compounding as defined in USP Chapters 795 and 797.
References. In addition to references
required of a pharmacy, pharmacies compounding sterile pharmaceuticals shall
also have a current edition of or electronic access to an established reference
on IV stability and incompatibility, such as, Handbook on Injectable Drugs or
King's Guide to Parenteral Admixtures, current Federal requirements for sterile
compounding and other reference material including but not limited to:
(a) "USP Pharmacists Pharmacopeia",
(a) The pharmacist-in-charge may submit to
the Georgia State Board of Pharmacy a typed request for a variance to the
provisions relating to minimum equipment requirements. The reasons for the
request for a variance must be included in the submitted request. A variance
shall be granted by the Board only when, in the judgment 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 of the Board's decision in writing.
(b) If approved, said letter(s) will serve as
proof of the Board's approval for the variance indicated in the letter, and
must be posted next to the inspection report.
Ga. Comp. R. & Regs.
Original Rule entitled "Facilities and Equipment" adopted. F.
Apr. 19, 2004; eff.
May 9, 2004.
Repealed: New Rule of same title adopted. F.
Nov. 22, 2006; eff.
Dec. 12, 2006.
Amended: F. Apr. 13,
2021; eff. May 3, 2021.