1. (a) Processing personnel experiencing any of the following: rashes, recent tattoos or oozing sores, conjunctivitis, active respiratory infection, or other conditions that could contaminate a sterile radiopharmaceutical or the environment shall not be allowed to enter the compounding area unless approved by the designated person. Any approvals provided by the designated person shall be documented and the record shall include the name of the individual granted approval, the approval date and time, the reason for granting approval, and the identification of the designated person making the decision.
2. (b) The pharmacist with direct supervision and control of personnel performing radiopharmaceutical processing shall, as defined in the facility's SOPs, demonstrate proficiency in the skills necessary to ensure the integrity, strength, quality, and labeled strength of radiopharmaceuticals.

3. (c) Aseptic manipulation competency initial training and competency and ongoing training and competency documentation shall include the Primary Engineering Control (PEC's) type and PEC unique identifier used during the evaluation. Aseptic manipulation competency evaluation and requalification shall be performed using the same procedures, type of equipment, and materials used in aseptic compounding. Aseptic qualifications from one premises may be used for another premises if all of the following conditions are met:

   1. (1) The SOPs related to compounding are identical.
   2. (2) The Secondary Engineering Control (SEC) facility designs are sufficiently similar to accommodate the use of the same SOPs.
   3. (3) The PECs are of the same type and sufficiently similar to accommodate the use of the same SOPs describing use and cleaning.
4. (d) SOPs must clearly define the acceptable use and cleaning for reusable gowns in order to prevent possible contamination of the sterile radiopharmaceuticals and designated compounding area. The facility's SOPs must describe the process to be followed should the facility allow for the reuse of garb.
5. (e) Eyeglasses shall be cleaned as part of hand hygiene and garbing, consistent with the standards specified in the SOPs.
6. (f) Garb shall be donned and removed in an ante-area or immediately outside the segregated radiopharmaceutical processing area (SRPA). Donning and doffing garb shall not occur in the anteroom at the same time unless the SOPs define specific processes that must be followed to prevent contamination.
7. (g) Any person assigned to provide the training specified in this article shall have demonstrated competency in the skills in which the person will provide training or observe and measure competency described in the facility's SOPs as referenced in section 1738.14. Documentation must be maintained demonstrating compliance with training requirements and demonstrating competency must be maintained.
8. (h) All personnel working with radiopharmaceuticals who fail any aspect of ongoing evaluation and training in personnel qualifications shall not work with radiopharmaceuticals until after successfully passing reevaluations in the deficient area(s), as detailed in the facility's SOPs.

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).