1. (a) SOPs shall specify steps to be taken for processing radiopharmaceuticals when the microbiological air and surface monitoring action levels are exceeded, including the investigative and corrective actions, allowable activities, and resampling procedures.
2. (b) The designated person shall review and identify data trends for all sampling results. The designated person shall evaluate trends to determine if corrective action is needed. The results of the review shall be documented in the facility's SOPs and readily retrievable during inspection in accordance with the requirements in section 1738.9.
3. (c) Environmental sampling shall be done in compliance with the Controlled Environment Testing Association's (CETA's) Certification Application Guide USP <797> Viable Environmental Monitoring for Sterile Compounding Facilities (CAG-009, Revised September 2020), which is hereby incorporated by reference.
4. (d) Incubators shall be cleaned, maintained, calibrated and operated in accordance with the manufacturer's specifications. Temperatures must be monitored either manually or by a continuous recording device during incubation, and the results must be reviewed and documented as described in the facility's SOPs. For incubators without specific manufacturers' specifications, cleaning shall take place at least every 30 days and calibration shall take place at least every 12 months.

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, 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).