Peptides.
Vote required
Majority
Fiscal committee
No
Appropriation
No
Current location
Appropriations
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed Assembly
- Passed Senate
- To Governor
- Became Law
Overview
This bill establishes a California program to facilitate research and access to investigational peptide and novel compound therapeutic treatments. It creates a framework for qualified entities, such as universities and hospitals, to conduct research, test compounds, and potentially offer access to these therapies under medical supervision. The program includes requirements for manufacturing standards, safety oversight committees, and reporting to ensure patient safety and track program effectiveness. The program is scheduled to expire in 2037.
Key provisions
- Creates the California Investigational Peptide and Novel Compound Research and Therapeutic Access Program.
- Authorizes qualified entities to conduct independent testing and maintain batch registries.
- Requires adherence to Good Manufacturing Practice (GMP) standards and stringent quality control measures.
- Establishes a safety oversight committee to review protocols and adverse events.
- Allows licensed healthcare practitioners to prescribe or dispense investigational compounds under specific conditions.
- Provides liability protection for entities and practitioners acting in good faith.
- Mandates annual safety and utilization reports to the Department of Public Health.
- Requires a statewide program evaluation report to the Legislature by January 1, 2032.
Who is affected
- Healthcare practitioners
- Pharmaceutical manufacturers
Bill text
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Sponsors
Official sponsors from legislative records.
1 on record
Primary sponsor
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