1. (a) The facility's list of HDs as required by USP Chapter 800 must be reviewed and approved by the pharmacist-in-charge (PIC), or the professional director of a clinic, or the designated representative-in-charge, as applicable. Approval shall be documented at least every 12 months.

   1. (1) In a pharmacy, the designated person(s) must be approved by the PIC to be responsible and accountable for the performance and operation of the facility and personnel as related to the handling of HDs. The designated person(s) shall not exceed the scope of their issued license. When a designated person is not a pharmacist, the PIC must review all practices related to the operations of the facility that require the judgment of a pharmacist.
2. (b) If an assessment of risk approach is taken as authorized in USP Chapter 800, it shall be approved by the designated person and the pharmacist-in-charge, professional director of a clinic, or designated representative-in-charge, as applicable.

In addition to the standards in USP Chapter 800, the following requirements apply to a facility where compounding of 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).