- (a) Testing and certification of all ISO classified areas shall be completed by a qualified technician knowledgeable with certification methods and procedures outlined in the Controlled Environment Testing Association's (CETA) Certification Guide for Sterile Compounding Facilities as specified in this section. Testing shall be performed in accordance with CETA's Certification Guide for Sterile Compounding Facilities (CAG-003, Revised October 2022), which is hereby incorporated by reference.
- (b) CETA standard(s) used to perform certification testing in all ISO classified areas shall be recorded on the report issued by the certifying technician in accordance with the Certification Guide for Sterile Compounding Facilities.
In addition to the requirements in USP Chapter 797, the following requirements apply to sterile compounding.
Note: Authority cited: Sections 4005, 4126.8 and 4127, Business and Professions Code. Reference: Sections 4005 and 4126.8, Business and Professions Code.
History
1. New section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).