1. (a) The inner container of a repackaged radiopharmaceutical shall be labeled with the following:

   1. (1) Standard radiation symbol.
   2. (2) The words “Caution -- Radioactive Material.”
   3. (3) The radionuclide and chemical form (generic name).
   4. (4) Radioactivity with units at the time of calibration and the calibration time.

2. (b) The outer shielding of a repackaged radiopharmaceutical shall be labeled with the following:

   1. (1) Standard radiation symbol.
   2. (2) The words “Caution -- Radioactive Material.”
   3. (3) The radionuclide and chemical form (generic name).
   4. (4) Radioactivity with units at the time of calibration and the calibration time.
   5. (5) Volume, or number of units (e.g., capsules), as applicable.
   6. (6) Product expiration or BUD (consistent with Table 7 of USP Chapter 825), as applicable.
   7. (7) Special storage and handling instructions.

In addition to the standards in USP Chapter 825, the processing of radiopharmaceuticals shall meet the requirements of this section.

Note: Authority cited: Sections 4005 and 4126.8, Business and Professions Code. Reference: Sections 4005, 4126.8, 4301 and 4306.5, Business and Professions Code.

History

1. New section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).