1. (a) The facility's quality assurance program shall comply with section 1711 and the standards contained in USP Chapter 1163, Quality Assurance in Pharmaceutical Compounding. In addition, the program shall include a written procedure for action, such as a recall, in the event any compounded drug preparation is discovered to be outside the expected standards for integrity, quality, or labeled strength.
2. (b) The Board shall be notified in writing within 96 hours of the facility's receipt of a complaint of a potential quality problem involving a CNSP.
3. (c) Consistent with the facility's SOPs, a review shall be initiated of any complaints made to the facility related to a potential quality problem with a CNSP within 72 hours of receipt of the complaint. Such a review shall be documented and dated as defined in the SOPs.

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, 4126.8, 4126.9, 4169, 4301 and 4332, Business and Professions Code.

History

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