AB 2442: Peptides.
<p>The proposed bill establishes the California Investigational Peptide and Novel Compound Research and Therapeutic Access Program. It mandates the state department of public health to form a working group that will study and recommend guidelines for a research and investigational therapeutic framework. The working group must examine potential uses of investigational compounds, including novel peptides, and submit a report with findings and recommendations by January 1, 2029. These provisions are set to be repealed on January 1, 2030.</p>
| May. 14, 2026 | In committee: Held under submission. |
| May. 06, 2026 | In committee: Set, first hearing. Referred to APPR. suspense file. |
| Apr. 22, 2026 | From committee: Do pass and re-refer to Com. on APPR. with recommendation: To Consent Calendar. (Ayes 12. Noes 0.) (April 21). Re-referred to Com. on APPR. |
| Apr. 16, 2026 | Re-referred to Com. on JUD. |
| Apr. 15, 2026 | From committee chair, with author's amendments: Amend, and re-refer to Com. on JUD. Read second time and amended. |
| Amended IN Assembly April 15, 2026 |
| Amended IN Assembly March 19, 2026 |
| Introduced by Assembly Member Patterson |
February 20, 2026 |
LEGISLATIVE COUNSEL'S DIGEST
This bill would create the California Investigational Peptide and Novel Compound Research and Therapeutic Access Program authorizing specified entities to establish and administer peptide and novel compound research and investigational therapeutic access programs. The bill would authorize an entity participating in this program to, among other things, conduct independent batch testing of peptides and novel compounds, as defined. The bill would require the participating entities to comply with certain manufacturing standards and maintain chain-of-custody documentation regarding all compounds, as specified. The bill would require a participating entity to maintain a peptide and novel compound oversight committee to oversee, among other things, safety reviews and would specify the required composition of the committee. The bill would authorize a licensed health care practitioner acting within their scope of practice to prescribe or dispense investigational therapeutic compounds that meet certain requirements. The bill would also exclude an entity, health care practitioner, pharmacist, manufacturer, or researcher acting in good faith and in compliance with these provisions from civil liability solely for recommending, prescribing, dispensing, administering, manufacturing, or studying a compound under these provisions. The bill would require participating entities to submit annual safety and utilization reports to the department, and would require the department to submit a statewide program evaluation report to the Legislature on or before January 1, 2032, as specified. The bill would repeal these provisions on January 1, 2037.
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.
(1)
(2)
(A)
(B)
(C)
(3)“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.
(4)
(A)
(B)
(C)