1. (a) The quality assurance program shall comply with section 1711 and the standards contained in USP Chapter 1163, Quality Assurance in Pharmaceutical Compounding. In addition, the program shall include a written procedure for any action(s) taken, in the event any radiopharmaceutical is discovered to be outside the expected standards for integrity, quality, and purity, such as a recall.
2. (b) The Board shall be notified in writing within 96 hours of the facility's receipt of a complaint, excluding delivery delays, involving a radiopharmaceutical. Recalls and adverse drug experiences as defined in 21 CFR section 310.305(b) shall be reported to the Board and other agencies in compliance with relevant provisions of law.
3. (c) In addition to subsection (b), the pharmacist-in-charge shall initiate a review of any complaints made to the facility related to a potential quality problem with a radiopharmaceutical and any reported adverse drug experiences within 72 hours of receipt of the complaint or occurrence. Such review shall be documented and dated as defined in the SOPs. In the event the PIC is not available within 72 hours, the PIC shall define in the SOPs the pharmacist who will be required to review.
4. (d) The SOPs shall specify the 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. This subsection shall also include actions to be taken if the compounding area or equipment is rendered unusable or in downtime situations.
5. (e) The SOPs shall be reviewed on an annual basis by the pharmacist-in-charge. Such review shall be documented by the pharmacist-in-charge consistent with the SOPs. The SOPs shall be updated to reflect changes to processes, facility changes, or other changes that impact the radiopharmaceutical. Such SOP changes shall be disseminated to the affected staff prior to implementation. Documentation of compliance with the subsection shall be maintained for three years.
6. (f) Failure to follow written SOPs constitutes a basis for enforcement action.

In addition to the standards established in USP Chapter 825, the processing of radiopharmaceuticals shall meet the requirements of this section. The facility shall have SOPs that cover and are specific to each location and manufacturer.

Note: Authority cited: Sections 4005 and 4126.8, Business and Professions Code. Reference: Sections 4005, 4126.8, 4126.9, 4127.1, 4301 and 4306.5, Business and Professions Code.

History

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