Cal. Code Regs. tit. 16, § 1738.5 – Facilities and Engineering Controls.

(a) A sink used for compounding or hand hygiene shall not be part of a restroom or water closet.
(b) The temperature shall be monitored either manually or by a continuous recording device in the SRPA and classified areas each day that processing is performed.
(c) Storage and elution of non-direct infusion radionuclide generators shall take place in an ISO Class 8 or better area.
(d) If an SRPA is used:
1. (1) Except for walls, the SRPA's visible perimeter shall be at least 1 meter from all sides of the PEC or in a separate room.
2. (2) Surfaces within the SRPA shall be smooth, impervious, free from cracks and crevices, and non-shedding, so they can be easily cleaned and disinfected and to minimize spaces in which microorganisms and other contaminants can accumulate.
  (e)(1) Testing and certification of all classified areas shall be completed by a competent individual. A competent individual is a technician who possesses a current accreditation issued by The Controlled Environment Testing Association (CETA), or who is under the direct supervision of an individual who possesses a current accreditation issued by CETA. The facility shall review and maintain a copy of the accreditation documentation in accordance with requirements in section 1738.9.
3. (2) Certification shall be completed consistent with the provisions established in USP Chapter 797, titled “Pharmaceutical Compounding -- Sterile Preparations” (USP <797>). CETA standard(s) used to perform certification testing in all classified areas shall be recorded on the certification report as specified in USP Chapter 797.
(f) SOPs shall specify steps to be taken if any classified area fails to meet the specified ISO classification, including the investigative and corrective actions, allowable activities, and retesting procedures.
(g) All classified spaces and equipment must be recertified when there is any change in the Primary Engineering Control (PEC), or the compounding environment. For purposes of this subsection, a change includes when the PEC is moved, repaired, or replaced, when the facility is modified in a manner that affects airflow or traffic patterns, or when improper aseptic techniques are observed. SOPs must address the conditions under which recertification must also be completed when temporarily moving or permanently relocating a PEC.
(h) Activities and tasks carried out within the SRPA and classified areas shall be limited to only those necessary for processing a radiopharmaceutical.
(i) Food, drinks, and materials exposed in patient care and treatment areas must not enter SRPA or classified areas.

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, 4081, 4105, 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).