- (a) The use of technologies, techniques, material, and procedures not described in USP Chapter 825 shall be based upon published peer-reviewed literature or documents and meet FDA approved labeling requirements in accordance with sections 201.56 and 201.57 of title 21, Code of Federal Regulations, showing the technologies, techniques, material, and procedures to be equivalent or superior to those described in USP Chapter 825.
- (b) Processing with human whole blood or human whole blood derivatives shall be done in compliance with Health and Safety Code section 1602.5.
In addition to the standards contained in USP Chapter 825, the processing of radiopharmaceuticals that is performed by or through a licensee of the Board shall meet the requirements of this article.
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).