Chapter 37 - Gene Therapy Kits: Notice - California Business and Professions Code

Sections (2)

Added by Stats. 2019, Ch. 140, Sec. 2. (SB 180) Effective January 1, 2020.

Except as permitted by federal law, a person shall not sell a gene therapy kit in this state unless the seller includes a notice on the seller’s internet website in a conspicuous location that is displayed to the consumer prior to the point of sale, and on a label on the package containing the gene therapy kit, in plain view and readily legible, stating that the kit is not for self-administration.

§ 22949.51

Added by Stats. 2019, Ch. 140, Sec. 2. (SB 180) Effective January 1, 2020.

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.