La. Admin. Code tit. 46 § LIII-1909

Current through Register Vol. 50, No. 8, August 20, 2024

Section LIII-1909 - Labeling

A. Immediate Container. The immediate container that comes into direct contact with the radiopharmaceutical shall be labeled with:

1. the standard radiation symbol;

2. the words "Caution-Radioactive Material";

3. the prescription control number;

4. the name of the radionuclide; and

5. the amount of radioactive material contained, in the appropriate unit of measure.

B. Outer Container. In addition to any labeling requirements of the board for non-radiopharmaceuticals, the outer container of a radiopharmaceutical to be dispensed shall also be labeled with:

1. the standard radiation symbol;

2. the words "Caution-Radioactive Material";

3. the name of the radionuclide;

4. the chemical form;

5. the amount of material contained, in the appropriate unit of measure;

6. the liquid volume expressed in cubic centimeters or milliliters, where applicable; and

7. the calibration time and date for the amount of radioactivity contained.

C. The labeling requirements in this Section shall not apply to transport containers.

D. Practitioner Administered Compounds Labeling. All practitioner administered compounds, as defined in Chapter 25 of these regulations, shall be dispensed or delivered in a suitable container with a label containing the following information:

1. pharmacist's name or initials;

2. pharmacy's name, address, and telephone number;

3. preparation name;

4. prescription number or pharmacy-assigned identification number;

5. lot number;

6. beyond-use date;

7. strength and concentration;

8. practitioner's name; and

9. special storage requirements, if applicable.

La. Admin. Code tit. 46, § LIII-1909

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2098 (October 2003), effective January 1, 2004.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.