Peptides.

Created the California Investigational Peptide and Novel Compound Research and Therapeutic Access Program as an actual statutory framework (new Chapter 26, Sections 28005-28013 of Division 20 of the Health and Safety Code), replacing the introduced version which only contained legislative findings and a statement of intent to enact future legislation.

Expanded coverage from peptides only to include 'novel compounds' - defined as synthetically produced small-molecule compounds that are not scheduled, not FDA-approved (or whose exclusivity has expired), and not in active Phase II/III trials pursuing full FDA approval.

Specified which entities may participate: University of California, accredited California medical schools, affiliated teaching hospitals, licensed general acute care hospitals, and physician group practices employing five or more physicians. Participation is explicitly voluntary.

Authorized licensed health care practitioners acting within their scope of practice to prescribe or dispense investigational therapeutic compounds that meet institutional certification standards, are dispensed through authorized programs, and are accompanied by written informed consent. Participation does not constitute unprofessional conduct.

Established manufacturing standards requiring compliance with federal cGMP (21 CFR Parts 210-211), USP General Chapters 797 and 800, ISO 14644 cleanroom standards, CLIA-certified testing laboratories, Drug Supply Chain Security Act compliance for sourcing, and mandatory batch testing including mass spectrometry identity confirmation, HPLC purity analysis, potency verification, sterility and endotoxin testing.

Required each participating entity to maintain an oversight committee with at minimum a biomedical researcher, licensed physician, pharmacologist, toxicologist, and patient or community representative, responsible for safety review, adverse event review, protocol review, and annual standards updates.

Provided civil liability protection for entities, practitioners, pharmacists, manufacturers, and researchers acting in good faith and in compliance with the chapter, with exceptions for gross negligence, reckless misconduct, intentional wrongdoing, fraud or misrepresentation, and failure to obtain informed consent. No private right of action is created.

Required participating entities to submit annual safety and utilization reports to CDPH, required CDPH to submit a statewide program evaluation report to the Legislature by January 1, 2032 (covering safety outcomes, research output, therapeutic outcomes, economic impact, and recommendations), and set a sunset date of January 1, 2037 for the entire chapter.

Fiscal committee review changed from 'no' to 'yes,' indicating the amendment triggers fiscal analysis requirements.