1. (a) A pharmacist performing or who has direct supervision and control of compounding personnel is responsible for ensuring the integrity, quality, and labeled strength of a CSP until the beyond use date indicated on the label, provided the patient or the patient's agent follows the label instructions provided on the CSP for storage and handling after receiving the CSP.
2. (b) A pharmacist performing or who has direct supervision and control of compounding personnel is responsible for ensuring validation of an alternative method for sterility testing is done in compliance with USP Chapter 1223, Validation of Alternative Microbiological Methods and shall receive and maintain documentation of the method-suitability for each CSP formulation for which the alternate method is used.
3. (c) A pharmacist performing or who has direct supervision and control of compounding personnel is responsible for ensuring injectable CSPs made from nonsterile components, regardless of USP Category, are tested to ensure that they do not contain excessive bacterial endotoxins, as established in USP Chapter 85, Bacterial Endotoxins. Results shall be reviewed and documented in the compounding record prior to furnishing.

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, 4081, 4126.8, 4127, 4169 and 4332, Business and Professions Code.

History

1. New section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).