1. (a) When containment primary engineering controls (C-PECs) used for nonsterile and sterile HDs are placed in the same room, biannual certification shall document that the room can continuously maintain an ISO 7 classification throughout the nonsterile compounding activity. Specific standard operating procedures (SOPs) shall be written to address the maintenance of the ISO 7 classification.
2. (b) A biological-safety cabinet as defined in USP Chapter 800 Class II Type A1 shall not be used for sterile compounding of a volatile HD.
3. (c) Where there is a pass-through in a containment secondary engineering control (C-SEC), the doors must be gasketed and interlocking by January 1, 2027.
4. (d) On or after January 1, 2028, prior to installing a new pass-through, a facility shall consider the use of a HEPA purge type pass-through. Documentation shall be maintained showing compliance with this requirement if such a pass-through is not used.
5. (e) Where sterile hazardous compounding is performed, facility room pressure monitoring equipment shall be placed consistent with CETA's Certification Guide for Sterile Compounding Facilities (CAG-003, Revised October 2022), which is hereby incorporated by reference. SOPs shall address corrective and remedial actions in the event of pressure differentials excursions.
6. (f) Containment Supplemental Engineering Controls (CSTDs) shall not be used to extend the in-use time, BUD, or expiration of any manufactured product or HD CSP.

In addition to the standards in USP Chapter 800, the following requirements apply to any facility where compounding of HDs is performed.

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).