Ga. Comp. R. & Regs. 480-25-.09

Current through Rules and Regulations filed through October 29, 2024

Rule 480-25-.09 - Labeling

All radiopharmaceuticals dispensed from a nuclear pharmacy shall be dispensed in appropriate containers and labeled in accordance with the following:

(a) The immediate inner container shall be labeled with:

1. the identifying prescription number; and

2. the name of the radioactive drug.

(b) In addition to any labeling standards established by law the immediate outer container shall be labeled with:

1. the name of the radionuclide;

2. the chemical form;

3. the amount of radioactive material contained, in millicuries (mCi) or microcuries (uCi);

4. if a liquid, the volume expressed in cubiccentimeters (cc) or milliliters (ml);

5. the requested calibration time and date;

6. the words "For Physician Use Only" in the absence of the name of the patient;

7. the name and address of the institution where the radiopharmaceutical will be administered;

8. the expiration date and time of the radioactive drug;

9. auxillary instructions for use, if applicable;

10. name of the procedure for which drug is intended;

11. name of prescribing practitioner;

12. The standard radiation symbol; and

13. The words "Caution - Radioactive Material".

Ga. Comp. R. & Regs. R. 480-25-.09

O.C.G.A. Secs. 16-13-73, 26-3-7, 26-3-8, 26-3-17, 26-4-87, 26-4-130, 26-4-138, 26-4-174, 26-4-178.

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

Repealed: New Rule of same title adopted.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