AMENDED IN ASSEMBLY APRIL 15, 2026
AMENDED IN ASSEMBLY MARCH 19, 2026
CALIFORNIA LEGISLATURE— 2025–2026 REGULAR SESSION
97
Introduced by Assembly Member Patterson
February 20, 2026
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.
Vote: majority Appropriation: no Fiscal committee: yes Local program: no
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:
Chapter 26. California Investigational Peptide and Novel Compound Research and Therapeutic Access Program
(a) The Legislature finds and declares all of the following:
(1) California is a global leader in biotechnology, biomedical research, and pharmaceutical innovation.
(2) Many promising peptide-based and novel small-molecule therapeutic compounds demonstrate potential benefit in early research settings but do not progress through traditional drug development pathways due to economic, patent, or market limitations.
(3) Expanded research and investigational therapeutic access programs may accelerate scientific discovery while maintaining appropriate patient safety protections.
(4) Advancing peptide and novel compound research supports innovation in areas including, but not limited to, all of the following:
(A) Rare disease research.
(B) Healthy aging and longevity science.
(C) Veteran therapeutic innovation.
(D) Obesity and metabolic disease treatment.
(E) Neurodegenerative disease research.
(5) Federal drug approval pathways are primarily structured to support large-scale commercial drug development models and may not fully accommodate emerging peptide research, early-stage therapeutic innovation, or compounds lacking traditional commercial sponsorship.
(6) Certain peptide or novel compounds may demonstrate scientific or therapeutic potential but may not advance through traditional development pathways due to cost, market size, or lack of patent exclusivity.
(b) It is the intent of the Legislature to do both of the following:
(1) Support voluntary state-authorized research programs, investigational therapeutic access under medical supervision, institution-level safety oversight, and high-quality manufacturing and testing standards.
(2) Establish 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.
(c) It is the intent of the Legislature that participation in this chapter is voluntary. Nothing herein shall be construed to require participation by any public or private institution, health care practitioner, or research entity.
28006.28005.
(a)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.
(4)
(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.
(a) The following entities are authorized, but not required, to establish and administer peptide and novel compound research and investigational therapeutic access programs:
(1) The University of California.
(2) Any accredited California medical school.
(3) Any teaching hospital affiliated with an accredited California medical school.
(4) Any licensed general acute care hospital.
(5) Any licensed physician group practice employing five or more physicians.
(b) Participating entities may do any of the following:
(1) Contract for manufacturing.
(2) Conduct independent batch testing.
(3) Certify batches meeting institutional standards.
(4) Maintain internal compound and batch registries.
(5) Operate research dispensing or investigational therapeutic access programs.
(6) Collect and report safety and usage data to the department.
(c) Nothing in this chapter authorizes general retail sale to the public without licensed health care supervision.
28008.
(a) Participating entities shall ensure that all manufacturing conducted under this chapter complies with current Good Manufacturing Practice (cGMP) requirements as set forth in Parts 210 (commencing with Section 210.1) and 211 (commencing with Section 211.1) of Title 21 of the Code of Federal Regulations, as applicable to the type of compound produced.
(b) All sterile manufacturing or compounding activities conducted under this chapter shall comply with applicable United States Pharmacopeia (USP) standards, including, but not limited to, all of the following:
(1) USP General Chapter <797> (Pharmaceutical Compounding – Sterile Preparations).
(2) USP General Chapter <800> (Hazardous Drugs – Handling in Health care Settings), where applicable.
(3) International Organization for Standardization (ISO) 14644 cleanroom classification standards appropriate to the level of sterile production performed.
(c) All analytical testing of compounds under this chapter shall be performed exclusively by laboratories holding valid certification under the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a). Each laboratory shall maintain documented standard operating procedures for every assay performed, including validated methods for identity, purity, potency, sterility, and endotoxin testing, where applicable.
(d) All bulk active pharmaceutical ingredients and source compounds shall be obtained exclusively from licensed wholesale distributors in full compliance with the federal Drug Supply Chain Security Act (Public Law 113-54), and all applicable federal FDA importation, tracing, and distribution requirements.
(e) At minimum, each batch produced or dispensed under this chapter shall undergo all of the following:
(1) Identity confirmation using mass spectrometry or equivalent validated methodology.
(2) Purity analysis using high-performance liquid chromatography or equivalent validated methodology.
(3) Potency verification, where applicable.
(4) Sterility testing for injectable or sterile products.
(5) Endotoxin testing for injectable products.
(f) Participating entities shall maintain comprehensive chain-of-custody documentation for all compounds, including, at a minimum, all of the following:
(1) Manufacturing origin.
(2) Distributor verification.
(3) Batch numbers and certificates of analysis.
(4) Storage conditions and tracking.
(5) Full traceability from source material to final dispensation.
(g) Nothing in this section shall be interpreted to permit manufacturing practices below the standards required under federal law for comparable activities.
28009.
(a) Each participating entity shall maintain a peptide and novel compound oversight committee.
(b) The committee shall include, at minimum, all of the following:
(1) A biomedical researcher.
(2) A licensed physician.
(3) A pharmacologist.
(4) A toxicologist.
(5) A patient or community representative.
(c) The committee shall oversee all of the following:
(1) Safety review.
(2) Adverse event review.
(3) Protocol review.
(4) Annual update of institutional standards.
28010.
(a) A licensed health care practitioner acting within their scope of practice may prescribe or dispense investigational therapeutic compounds that meet all of the following:
(1) Meet institutional certification standards.
(2) Are dispensed through authorized institutional programs.
(3) Are accompanied by written informed consent.
(b) Participation under this chapter shall not, by itself, constitute unprofessional conduct.
28011.
(a) An entity, health care practitioner, pharmacist, manufacturer, or researcher acting in good faith and in compliance with this chapter shall not be subject to civil liability solely for recommending, prescribing, dispensing, administering, manufacturing, or studying a compound authorized under this chapter.
(b) This section does not apply to any of the following:
(1) Gross negligence.
(2) Reckless misconduct.
(3) Intentional wrongdoing.
(4) Fraud or misrepresentation.
(5) Failure to obtain informed consent.
(c) This chapter does not create a private right of action.
28012.
(a) Participating entities shall submit annual safety and utilization reports to the department.
(b) The department shall submit a statewide program evaluation report to the Legislature on or before January 1, 2032. The report shall be submitted in compliance with Section 9795 of the Government Code.
(c) The report required pursuant to subdivision (b) shall include, at a minimum, all of the following:
(1) Safety outcomes.
(2) Research output.
(3) Therapeutic outcomes.
(4) Economic impact.
(5) Recommendations.
(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.
28013.28007.
This chapter shall remain in effect only until January 1, 2037, 2030, and as of that date is repealed.