1. (a) The facility's standard operating procedures (SOPs) for nonsterile compounding shall be followed and shall:

   1. (1) Comply with USP Chapter 1163, Quality Assurance in Pharmaceutical Compounding.

   2. (2) Also describe the following:

      1. (A) Methods by which the supervising pharmacist will ensure the quality of compounded drug preparations.
      2. (B) If applicable, procedures for handling, compounding, and disposal of infectious materials. The SOPs shall also describe the facility's protocols for cleanups and spills in conformity with local health jurisdictional standards, if applicable.
      3. (C) The methods a pharmacist will use to determine and approve the ingredients and the compounding process for each preparation before compounding begins.
      4. (D) The validated processes for storage, for shipping containers (as applicable), and for transportation of temperature sensitive CNSPs (as applicable) to preserve quality standards for integrity, quality and labeled strength.
      5. (E) The pharmacist responsible for the review of all complaints related to a potential quality problem with a CNSP in the event the PIC is not available within 72 hours of the receipt of the complaint or occurrence.
      6. (F) Actions to be taken if the compounding area or equipment is rendered unusable or in a downtime situation.
2. (b) The SOPs shall be reviewed on an annual basis by the PIC. Such review shall be documented by the PIC consistent with the facility's SOPs. The SOPs shall be updated any time changes are made to compounding processes, the facility, or other changes occur that impact the CNSP. Such SOP changes shall be disseminated to the affected staff prior to implementation. Documentation of compliance with the subsection shall be maintained for three years.
3. (c) Failure to follow written SOPs constitutes a basis for enforcement action.

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, 4052, 4081, 4126.8, 4301 and 4332, Business and Professions Code.

History

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