1. (a) A CSP shall not be compounded until the facility has first prepared a written master formulation record in compliance with USP Chapter 797 and that record includes the following additional elements:

   1. (1) If a source is referenced to support the assigned beyond-use date (BUD), each source referenced shall be readily retrievable at the time of compounding and shall be maintained for three years from the date each CSP is dispensed.
   2. (2) Instructions for storage and handling the compounded drug preparation.
2. (b) When a particular drug preparation is not routinely compounded at a facility, the master formulation record for that preparation may be recorded on the prescription document itself. This record shall comply with USP Chapter 797 and this section.

3. (c) A compounding record (CR) shall be maintained and, upon request, be produced as a single document. The document shall satisfy the requirements of USP Chapter 797, and also contain the following:

   1. (1) The assigned internal identification number, which shall be unique for each CR.
   2. (2) The manufacturer, lot number, and expiration date for each component for the CSP.
   3. (3) The total quantity compounded including the number of units made and either the volume or the weight of each unit.
   4. (4) The identity of personnel performing the compounding, the pharmacist who has direct supervision and control of compounding, and the pharmacist verifying the final drug preparation, if different.
   5. (5) When applicable, endotoxin level calculations and results.

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 and 4169, Business and Professions Code.

History

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