- (a) Dry heat depyrogenation shall be done in compliance with USP Chapter 1228.1, Dry Heat Depyrogenation.
- (b) Sterilization by filtration shall be done in compliance with USP Chapter 1229.4, Sterilizing Filtration of Liquids. Filter dimensions and the CSP to be sterilized by filtration shall permit the sterilization process to be completed without the need for replacement of the filter during the process.
- (c) Steam sterilization shall be done in compliance with USP Chapter 1229.1, Steam Sterilization by Direct Contact.
- (d) Dry heat sterilization shall be done in compliance with USP Chapter 1229.8, Dry Heat Sterilization.
- (e) No compound of a CSP from nonsterile components shall be prepared when the licensed location cannot also sterilize the CSP as described in this section.
- (f) Sterilization of supplies and container -- closure systems shall be done in compliance with USP Chapter 1229, Sterilization of Compendial Articles.
In addition to the requirements in USP Chapter 797, the following requirements apply where applicable.
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).