(a) A CSP's beyond-use date (BUD) shall not exceed:
- (1) The chemical and physical stability data of the active pharmaceutical ingredient(s) and any added substances in the preparation;
- (2) The compatibility of the container-closure system with the finished preparation (e.g., possible leaching, interactions, and storage conditions); and
- (3) The shortest remaining expiration date or BUD of any of the starting components. Nothing in this paragraph prohibits the allowances in USP Chapter 797, Section 14.2 for pH-altering solutions.
- (b) A CSP labeled with a BUD with only a date shall expire at 11:59 p.m. (23:59) on that date.
- (c) When sterility or endotoxin testing is required, the pharmacist performing or with direct supervision and control of personnel compounding is responsible for ensuring such testing is performed. Test results shall be reviewed prior to furnishing a CSP. Results must be within acceptable USP limits. Test results shall be retained as part of the compounding record.
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, 4076 and 4126.8, Business and Professions Code.
History
1. New section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).