1. (a) Training and competency procedures for all personnel who compound or have direct supervision and control of personnel performing compounding shall address the following topics:

   1. (1) Quality assurance and quality control procedures,
   2. (2) Container closure and equipment selection,
   3. (3) Component selection and handling, and
   4. (4) Sterilization techniques, when applicable.

2. (b) Initial and ongoing aseptic manipulation training and competency documentation shall include the Primary Engineering Control (PEC) type and PEC unique identifier used during the evaluation. Aseptic manipulation competency evaluation and requalification shall be performed using the same procedures, type of equipment, and materials used in aseptic compounding. Garbing and hand hygiene competencies and aseptic manipulation competencies from one premises may be used for another premises if all of the following conditions are met:

   1. (1) The Standard Operating Procedures (SOPs) required by section 1736.17 related to compounding are identical.
   2. (2) The Secondary Engineering Control (SEC) facility designs are sufficiently similar to accommodate the use of the same SOPs.
   3. (3) The PECs are of the same type and sufficiently similar to accommodate the use of the same SOPs describing use and cleaning.
3. (c) Aseptic manipulation ongoing training and competency shall occur each time and for each staff member involved in an occurrence where the quality assurance program required by the SOPs yields an unacceptable result, as defined in the SOPs, that may indicate microbial contamination of CSPs due to poor practices. Aseptic manipulation ongoing training and competency procedures shall be defined in the facility's SOPs.
4. (d) Compounding personnel or persons with direct supervision and control of compounding personnel who fail any aspect of the aseptic manipulation ongoing training and competency evaluation shall not be involved in compounding of a CSP until after successfully passing training and competency in the deficient area(s) as detailed in the facility's SOPs. A person with only direct supervision and control of personnel who fails any aspect of the aseptic manipulation ongoing training and competency evaluation may continue to provide only direct supervision and control of personnel for no more than 30 days after a failure of any aspect while applicable aseptic manipulation ongoing training and competency evaluation results are pending.
5. (e) Any person assigned to provide the training specified in this section shall have demonstrated competency in the skills in which the person will provide training or observe and measure competency described in the facility's SOPs. Documentation demonstrating compliance with training and competency must be maintained.

In addition to the standards set forth 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, 4301 and 4332, Business and Professions Code.

History

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