1. (a) “Compounding personnel” means any person involved in any procedure, activity, or direct supervision and control of preparation of CSPs.
2. (b) “Designated compounding area or compounding area” means a restricted location within a facility that limits personnel access, where only activities and items related to compounding are present.
3. (c) “Designated person(s)” means one or more individuals assigned by the pharmacist-in-charge (PIC) to be responsible and accountable for the performance and operation of the facility and personnel as related to the preparation of the compounded sterile preparations. Nothing in this definition allows for the designated person to exceed the scope of their issued license. When the designated person is not a pharmacist, the PIC must review all practices related to the operations of the facility that require the professional judgment of a pharmacist. Nothing in this definition prohibits the PIC from also serving as the designated person.
4. (d) “Diluent” means a liquid with no pharmacological activity used in reconstitution, such as sterile water for injection.
5. (e) “Essentially a copy” of a commercially available drug product means a preparation that includes the same active pharmaceutical ingredient(s) (API(s)) as the commercially available drug product, except that it does not include any preparation in which there has been a change made for an identified individual patient that produces for that patient a clinically significant difference, as verified and documented by the pharmacist, between that compounded preparation and the comparable commercially available drug product.
6. (f) “Integrity” means retention of strength until the beyond use date provided on the label, when the preparation is stored and handled according to the label directions.
7. (g) “Quality” means the absence of harmful levels of contaminants, including but not limited to filth, putrid, or decomposed substances, the absence of active ingredients other than those listed on the label, or the absence of inactive ingredients other than those listed on the master formulation record as specified in USP Chapter 797.
8. (h) “Strength” means amount of active ingredient per unit of a compounded drug preparation.

The definitions in this section shall be applicable to this Article and supplement the definitions provided in United States Pharmacopeia (USP) General Chapter 797 (USP Chapter 797), titled Pharmaceutical Compounding -- Sterile Preparations for compounded sterile preparations (CSPs).

Note: Authority cited: Sections 4005, 4126.8 and 4127, Business and Professions Code. Reference: Sections 4005, 4057, 4127, 4127.1, 4301 and 4332, Business and Professions Code.

History

1. New article 4.6 (sections 1736-1736.21) and section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).