Ga. Comp. R. & Regs. 480-21-.04

Current through Rules and Regulations filed through November 21, 2024

Rule 480-21-.04 - Physical Requirements

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.

(b) Equipment.

1. Laminar Airflow Hood; or Class 100 Clean Room;

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. Equipment for light/dark field examination;

5. Appropriate 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.

(c) Supplies.

1. Disposable needles, syringes and other supplies needed for aseptic admixture;

2. Disinfectant cleaning solutions;

3. Handwashing agent with bactericidal action;

4. Disposable, lint free paper towels;

5. Appropriate filters and filtration equipment;

6. Disposable masks and sterile, disposable gloves;

7. Gowns, if chemotherapy agents are routinely prepared;

8. An oncology drug spill kit, if chemotherapy agents are routinely prepared.

(d) 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 ADMIXTURES.

(e) Variances.

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. R. 480-21-.04

O.C.G.A. Secs. 26-4-27, 26-4-28, 26-4-110, 26-4-111.

Original Rule entitled "Physical Requirements" was filed on August 30, 1985; effective September 19, 1985.

Amended: F. Sept. 29, 1998; eff. Oct. 19, 1998.

Repealed: New Rule of same title adopted. F. Feb. 20, 2002; eff. Mar. 12, 2002.