- (a) All compounding of radiopharmaceuticals shall comply with all radioactive materials licensing requirements for appropriate radiation safety considerations issued by the California Department of Public Health pursuant to section 30190 of Title 17 of the California Code of Regulations, any other state licensing agency that issues specific radioactive materials licenses, or the United States Nuclear Regulatory Commission pursuant to section 32.72 of title 10 of the Code of Federal Regulations, and utilize applicable environmental controls.
- (b) All API and excipient components used to compound a radiopharmaceutical shall be manufactured by an FDA-registered facility, be accompanied by a Certificate of Analysis (COA), and suitable for use in sterile pharmaceuticals. A COA that includes the compendial name, the grade of the material, and the applicable compendial designations on the COA must be received and evaluated prior to use, unless components are commercially available drug products. API and excipient components provided without this data shall not be used in a CSP. When the COA is received from a supplier, it must provide the name and address of the manufacturer.
- (c) Except for sterile radiopharmaceuticals made for inhalation or ophthalmic administration, prior to releasing a sterile radiopharmaceutical made from one or more nonsterile component(s), results of bacterial endotoxin testing shall be reviewed and recorded. Results shall be documented in the compounding record specified in Section 9.2 of USP Chapter 825.
In addition to the standards in USP Chapter 825, the processing of radiopharmaceuticals shall meet the requirements of this section.
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 section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).