1. (a) The individual responsible for preparing a nonsterile radiopharmaceutical shall:

   1. (1) Follow manufacturer preparation instructions, unless minor deviations are made pursuant to subsection (c).
   2. (2) Only use an area that is suitably cleaned and is uncluttered.
   3. (3) Have documented processes in its SOPs for activities (e.g., cleaning) between the preparation cycles of different nonsterile products.

2. (b) The individual responsible for preparing a sterile radiopharmaceutical (including intravascular devices) shall:

   1. (1) Follow manufacturer preparation instructions, unless minor deviations are made pursuant to subsection (c).
   2. (2) Use at least the minimum environmental standards from section 7 of USP Chapter 825.
3. (c) When preparing radiopharmaceuticals with minor deviations (“preparation with minor deviations” as defined in USP Chapter 825) the SOPs shall at least define the circumstances that necessitate a deviation and all quality control testing requirements and limits.
4. (d) Equipment and supplies initially used for processing of blood components (including red blood cells) shall be solely dedicated for processing of blood components. Equipment and supplies shall be thoroughly cleaned and disinfected, in accordance with section 1738.7, prior to initiation of the next radiolabeling procedure.
5. (e) When processing blood components, all garb must be removed and replaced prior to initiation of the next radiolabeling procedure.

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).