1. (a) A CNSP shall not be compounded until the facility has first prepared a written master formulation record in compliance with USP Chapter 795 and includes the following additional elements:

   1. (1) If a source is referenced to support the assigned beyond-use date (BUD), the source referenced shall be readily retrievable at the time of compounding and shall be maintained for three years from the date each CNSP is dispensed.
   2. (2) Instructions for storage and handling of the CNSP.
2. (b) Where a facility does not routinely compound a particular drug preparation, the master formulation record for that preparation may be recorded on the prescription document itself.

3. (c) A compounding record (CR) shall be maintained and, upon request, produced as a single document developed in compliance with USP Chapter 795, and includes the following additional elements:

   1. (1) The manufacturer, lot number, and expiration date for each component.
   2. (2) The assigned internal identification number, which shall be unique for each CR.
   3. (3) The total quantity or amount compounded, which shall include the number of units made and the volume or weight of each unit, where applicable.
   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.

In addition to the standards set forth in USP Chapter 795, the following requirements apply to nonsterile compounding.

Note: Authority cited: Sections 4005 and 4126.8, Business and Professions Code. Reference: Sections 4005, 4081, 4105, 4126.8, 4301 and 4332, Business and Professions Code.

History

1. New section filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).

2. Repealer and new subsection (a) and amendment of subsection (c) filed 9-13-2016; operative 1-1-2017 (Register 2016, No. 38).

3. Repealer and new section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).