1. (a) Standard operating procedures (SOPs) for sterile compounding shall be followed and shall:

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

   2. (2) Define the following:

      1. (A) Methods by which the pharmacist compounding or supervising the compounding will ensure the quality of compounded drug preparations;
      2. (B) If applicable, procedures for handling, compounding, and disposal of infectious materials. The SOPs shall describe the facility protocols for cleanups and spills in conformity with local health jurisdictional standards;
      3. (C) The methods used to determine and approve the components and the compounding process for each preparation before compounding begins, including components referenced in section 1736.9(f); and
      4. (D) The method for complying with all other requirements specifically defined in the SOPS.
2. (b) The SOPs shall specify the steps to be taken if a classified area(s), including PEC, fails to meet the specified ISO classification, including the investigative and corrective actions, allowable activities, and retesting procedures. This subsection shall also include actions to be taken if the compounding area or equipment is rendered unusable or in downtime situations.
3. (c) The SOPs shall specify steps to be taken when the microbiological air and surface monitoring action levels are exceeded including the investigative and corrective actions, allowable activities, and resampling procedures.
4. (d) The SOPs shall specify the process and products to be used on any equipment and other items entering from an unclassified area into the clean side of the anteroom, entering a PEC, and entering the SCA. These SOPs must define at a minimum what product is to be used, the contact time required, and the method to ensure contact time is achieved.
5. (e) The SOPs shall specify the frequency and processes for cleaning, maintenance, and calibration of equipment, supplies and components, including when incubation of samples is taking place, such that samples are not compromised. All cleaning, maintenance, and calibration shall be documented and dated as defined in the SOPs.
6. (f) The SOPs shall specify which pharmacist is responsible for the review of all complaints related to a potential quality problem with a CSP and all adverse drug experiences in the event that the PIC is not available within 72 hours of the receipt of the complaint or occurrence.
7. (g) There shall be written procedures for qualification of storage, shipping containers and transportation of temperature sensitive CSPs to preserve quality standards for integrity, quality, and labeled strength.
8. (h) The PIC shall review the SOPs on an annual basis. The PIC shall document such review consistent with the SOPs. The SOPs shall be updated to reflect changes to compounding processes, facility changes, and other changes that impact the CSP. Such SOP changes shall be disseminated to the compounding personnel prior to implementation. Documentation of compliance with the subdivision shall be maintained for three years.
9. (i) Failure to follow written SOPs shall constitute a basis for enforcement action.

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, 4126.8, 4301, 4306.5 and 4332, Business and Professions Code.

History

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