1. (a) All equipment and supplies used to compound a CSP shall be used in accordance with manufacturers' specifications and shall be surface compatible.
2. (b) Incubators used by the facility shall be cleaned, maintained, calibrated, and operated in accordance with manufacturers' specifications. For incubators without specific manufacturers' specifications, cleaning shall take place at least every 30 days and calibration shall take place at least every 12 months. Temperatures must be monitored either manually or by a continuous recording device during incubation, and the results shall be reviewed and documented as described in the facility's SOPs.
3. (c) Any component used to compound a CSP shall be used and stored in accordance with all state and federal laws and the manufacturer's specifications and requirements.
4. (d) All APIs used to compound a CSP shall be manufactured by an FDA-registered facility, be accompanied by a Certificate of Analysis (COA), and be suitable for use in sterile pharmaceuticals. A COA that includes the compendial name, the grade of the material, and the applicable compendial designations on the COA must be received and evaluated prior to use, unless components are commercially available drug products. When the COA is received from a supplier, it must provide the name and address of the manufacturer. An API provided with a COA without this data shall not be used in a CSP.
5. (e) All APIs and other components used shall be evaluated for suitability for use in sterile drug preparations, as provided in USP Chapter 797, Section 9.3 Components, and follow the USP drug monograph if one exists. Components labeled with “not for pharmaceutical use”, “not for injectable use”, “not for human use” or other equivalent statement shall not be used to compound for these purposes.
6. (f) If a component included in the published 503A Category 1 bulk drug substances list is used, it must be found suitable for sterile drug preparations as provided in USP Chapter 797, Section 9.3 Components. The facility's SOPs shall establish a process to determine the quality of the API.

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 and 4126.8, Business and Professions Code.

History

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