1. (a) Any person assigned to provide the training specified in this Article 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 as referenced in section 1737.17. Documentation must be maintained demonstrating compliance with training requirements and demonstrating competency must be maintained.
2. (b) All personnel responsible for compounding HDs or crushing or splitting tablets or opening capsules of antineoplastic HDs who fail any aspect of ongoing evaluation and training in compounding or crushing or splitting tablets or opening capsules of antineoplastic HDs shall not compound HDs or perform crushing or splitting tablets or opening capsules of antineoplastic HDs until after successfully passing reevaluations in the deficient area(s), as detailed in the facility's SOPs. Any failure in personnel competency shall comply with the provisions of sections 1735.2(c) or 1736.2(d), as applicable.

In addition to the standards in USP Chapter 800, the following requirements apply to a facility where compounding of HDs is performed or where crushing or splitting tablets or opening capsules of antineoplastic HDs is performed.

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).