Peptides., the official text

An act to add and repeal Chapter 26 (commencing with Section 28005) of Division 20 of the Health and Safety Code, relating to public health.

LEGISLATIVE COUNSEL'S DIGEST

Existing law establishes the State Department of Public Health, which, among other things, administers various programs that prevent disease and promote health.
This bill would create the California Investigational Peptide and Novel Compound Research and Therapeutic Access Program and would require the department to convene a working group with specified members to study and make recommendations regarding the creation of a state-authorized research and investigational therapeutic framework, as specified. The bill would require the working group to study potential uses of investigational therapeutic compounds and novel peptide compounds, among other things, and to submit a report to the Legislature detailing its findings and recommendations no later than January 1, 2029. The bill would repeal these provisions on January 1, 2030.

The people of the State of California do enact as follows:

SECTION 1.
Chapter 26 (commencing with Section 28005) is added to Division 20 of the Health and Safety Code, to read:
26.
California Investigational Peptide and Novel Compound Research and Therapeutic Access Program28005.
For the purposes of this chapter, the following definitions shall apply:
(a) “Department” means the State Department of Public Health.
(b) “Investigational therapeutic compound” means a peptide or novel compound that meets all of the following:
(1) Is not currently approved for marketing by the United States Food and Drug Administration (FDA) with active patent or regulatory exclusivity protections.
(2) Is manufactured and tested under institutional standards established pursuant to this chapter.
(3) Is dispensed only under supervision of a licensed health care practitioner within a bona fide practitioner-patient relationship.
(c) “Novel compound” means a synthetically produced small-molecule compound that meets all of the following:
(1) Is not scheduled under state or federal controlled substances law.
(2) Is not approved for marketing by the FDA under Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355), unless patent and regulatory exclusivity protections have expired and a generic version is lawfully marketed in the United States.
(3) Is not currently in Phase II or Phase III clinical trials for which a manufacturer or sponsor continues to actively pursue full FDA approval.
(d) “Peptide” means a compound consisting of two or more amino acids linked by peptide bonds and includes synthetic peptides, recombinant peptides, modified peptides, conjugated peptides, and peptide analogs intended for research or investigational therapeutic use.

28006.
(a) The department shall convene a working group to study and make recommendations regarding the creation of a state-authorized research and investigational therapeutic framework that complements existing federal regulatory structures while expanding opportunities for scientific research and medically supervised investigational therapeutic access.
(b) The State Public Health Officer or their designee shall chair the working group.
(c) The working group shall include all of the following among its members, without limitation:
(1) A biomedical researcher.
(2) A licensed physician.
(3) A pharmacologist.
(4) A toxicologist.
(5) A community representative.
(d) The working group may contract with outside entities, including public or private universities for research assistance.
(e) The working group shall study all of the following, without limitation:
(1) Potential uses of investigational therapeutic compounds and novel peptide compounds.
(2) The available research on the public health implications of investigational therapeutic compounds and novel compounds.
(3) The available research on the safety and efficacy of investigational therapeutic compounds and novel compounds to support rare disease research, healthy aging and longevity science, veteran therapeutic innovation, obesity and metabolic disease treatment, and neurodegenerative disease research.
(4) The feasibility of establishing a state-authorized research and investigational therapeutic framework that complements existing federal regulatory structures while expanding opportunities for scientific research and medically supervised investigational therapeutic access.
(5) Impacts of the existing use of investigational therapeutic compounds and novel compounds.
(f) The working group shall develop policy recommendations regarding all of the following, without limitation:
(1) The content and scope of educational campaigns and accurate public health approaches regarding use, effect, and risk reduction for novel investigational therapeutic compounds and novel compounds.
(2) The authorization of various investigational therapeutic compounds and novel compounds for regulated uses.
(3) The appropriate regulation of the investigational therapeutic compounds and novel compounds for regulated uses.
(g) No later than January 1, 2029, the working group shall submit a report to the Legislature detailing its findings and recommendations. The report shall be submitted in compliance with Section 9795 of the Government Code.

28007.
This chapter shall remain in effect only until January 1, 2030, and as of that date is repealed.