- (a) A sink used for compounding or hand hygiene shall not be part of a restroom or water closet.
(b) If an SCA is used:
- (1) Except for walls, the SCA's visible perimeter shall be at least 1 meter from all sides of the PEC, or the SCA can be located in a separate room.
(2) Surfaces within the SCA 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.
(c)(1) Designated compounding area(s) shall typically be maintained at a temperature of 20° Celsius or cooler.
- (2) The temperature shall be monitored in each room of the designated compounding area each day that compounding is performed, either manually or by a continuous recording device.
- (d) Where a pass-through is installed in a secondary engineering control after October 1, 2025, the doors must be interlocking. An existing secondary engineering control that has a pass-through that is not an interlocking device may continue to be used if the SOPs document that two doors may not be opened at the same time.
- (e) No CSP shall be compounded if the compounding environment fails to meet criteria specified in law or the facility's SOPs, unless such compounding is being performed consistent with immediate use provisions.
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).