1. (a) “Added substances” means ingredients that are necessary to compound a preparation but are not intended or expected to cause a pharmacologic response if administered alone in the amount or concentration contained in a single dose of the compounded preparation. The term is used synonymously with the term's inactive ingredients, excipients, and pharmaceutical ingredients.
2. (b) “Component” means any ingredient used in the compounding of a preparation, including any active ingredient, added substance, or conventionally manufactured product.
3. (c) “Designated person” means a pharmacist identified as assigned, responsible, and accountable for the performance and operation of the radiopharmaceutical processing facility and for personnel who prepare, compound, dispense, and repackage radiopharmaceuticals. Nothing in this definition prohibits the PIC from also serving as the designated person.
4. (d) “Processing,” “processed,” or “processing activity” means the preparation, compounding, repackaging, or dispensing of a radiopharmaceutical.

In addition to the terms defined in United States Pharmacopeia (USP) General Chapter 825 (USP Chapter 825), titled Radiopharmaceuticals- Preparation, Compounding, Dispensing, and Repackaging, the following definitions apply to this article and supplement the definitions provided in USP Chapter 825 radiopharmaceutical processing activities.

Note: Authority cited: Sections 4005 and 4126.8, Business and Professions Code. Reference: Sections 4005, 4126.8, 4301 and 4306.5, Business and Professions Code.

History

1. New article 4.8 (sections 1738-1738.14) and section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).