Compilation of Rules and Regulations of the State of Georgia
Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY
Chapter 480-25 - NUCLEAR PHARMACIES AND PHARMACISTS
Rule 480-25-.08 - Equipment
Universal Citation: GA Rules and Regs r 480-25-.08
Current through Rules and Regulations filed through March 20, 2024
(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.
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.
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