California Codes, Business and Professions Code - BPC, Division 8 — Special Business Regulations, Chapter 37 — Gene Therapy Kits: Notice, Section 22949.51

For purposes of this chapter, the following definitions apply:

(a) “Gene therapy” refers to the administration of genetic material to modify or manipulate the expression of a gene product, or to alter the biological properties of living cells, for therapeutic use.

(b) “Gene therapy kit” refers to a product that is sold as a collection of materials for the purpose of facilitating gene therapy experiments, including, but not limited to, a system for the targeted cutting of DNA molecules, such as type II clustered regularly interspaced short palindromic repeats (CRISPR), associated proteins (CRISPR-Cas) systems, including CRISPR-Cas9, as described in Regents of University of California v. Broad Institute, Inc. (2018) 903 F.3d 1286.