1. (a) A radiopharmaceutical's beyond-use date (BUD) shall not exceed the shortest BUD of any of its components.
2. (b) No radiopharmaceutical CSP shall be administered after the labeled BUD. A dose shall not be sent for a scheduled administration that would occur after the labeled BUD.
3. (c) Extension of a suggested use-by time of a conventionally manufactured kit shall not exceed the BUDs in Table 7 of USP Chapter 825, for the sterility of the preparation or product.

4. (d) Prior to the extension of a suggested use-by time for a conventionally manufactured kit, the pharmacy must maintain documentation of at least the following:

   1. (1) Factors that necessitate its extension, including a full assessment of patient need for the extension.

   2. (2) Evidence that supports that the extension maintains the appropriate quality and purity (radiochemical purity and radionuclidic purity) as specified in individual monographs, and other applicable parameters as clinically appropriate.

      For the purposes of this section, the facility shall have SOPs that cover and are specific to each facility's location and kit.

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).