(a) The quality assurance program shall comply with section 1711 and the standards contained in USP Chapter 1163, Quality Assurance in Pharmaceutical Compounding. In addition, the facility's quality assurance program shall include the following:
- (1) 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) A written procedure for responding to out-of-range temperature variations within the medication storage areas where a furnished drug may be returned for furnishing to another patient.
- (b) Recalls and adverse drug experiences, as defined in section 310.305(b) of title 21, Code of Federal Regulations, reporting shall be completed in compliance with relevant provisions of law.
- (c) In addition to subsection (b), the pharmacist-in-charge shall initiate a review of any complaints made to the facility related to a potential quality problem with a CSP and any adverse drug experiences within 72 hours of receipt of the complaint or occurrence of the adverse drug experience. Such review shall be documented and dated as defined in the SOPs.
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, 4127.2 and 4127.8, Business and Professions Code.
History
1. New section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).