AB 2442

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 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.