Ga. Comp. R. & Regs. 480-25-.08

Current through Rules and Regulations filed through November 21, 2024

Rule 480-25-.08 - Equipment

(1) In addition to other articles and equipment required by the Board for all pharmacies in the State, the nuclear pharmacy shall have:

(a) dose calibrator;

(b) vertical laminar flow hood;

(c) single or multiple channel scintillation analyzer;

(d) microscope and hemocytometer;

(e) adequate glassware, utensils, and gloves;

(f) calculator;

(g) laboratory incubator;

(h) water or oil bath;

(i) aluminum ion test kit; and

(j) adequate apparatus and supplies for performing chromatography.

(2) Nuclear pharmacies shall also have equipment required for the safe handling and storage of radioactive materials, as required by the Department's Rules and Regulations for radioactive materials.

(3) Each nuclear pharmacy shall utilize unit dose transport containers, a/k/a lead pigs,

(a) Unit dose transport containers, a/k/a lead pigs, for radioactive doses shall include:

1.an effective tamper-evident seal;

2.an effective mechanism to avoid radioactive contamination; and

3.an effective system to prevent contamination of the transport container with blood, bodily fluids, or other biohazardous substances.

(b) No nuclear pharmacist or nuclear pharmacy shall re-use a unit dose transport container or lead pig that has been contaminated with blood, bodily fluids, or other hazardous substances.

(c) Any unit dose transport container or lead pig returned to a nuclear pharmacy with the tamper-evident seal broken and containing an exposed unit dose syringe shall be considered contaminated.

(d) Section 3 of this Rule shall not apply to:

1.an individual prescriber preparing radiopharmaceuticals for administration to his or her own patients;

2.transfer of radioactive material, not intended for use as a drug, to other legally authorized persons; and

3.the occasional transfer of bulk radiopharmaceuticals to other authorized entities or persons to meet shortages.

(e) Biohazardous prevention systems containing a barrier that if used properly eliminates or substantially reduces the potential for contamination of the unit dose transport container, or lead pig, would meet the requirements of these regulations. Improper use of such system resulting in ineffective sanitation of the unit dose transport container, or lead pig, would require that such containers be effectively sanitized prior to subsequent use or discarding of that container.

Ga. Comp. R. & Regs. R. 480-25-.08

O.C.G.A. §§ 26-3-7, 26-3-17, 26-4-27, 26-4-28, 26-4-110, 26-4-130, 26-4-170, 26-4-172, 26-4-174, 26-4-178.

Original Rule entitled "Equipment" adopted. F. Mar. 9, 1984; eff. Mar. 29, 1984.

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

Repealed: New Rule of same title adopted. F. June 13, 2002; eff. July 3, 2002.

Amended: F. Apr. 20, 2015; eff. May 10, 2015.