Peptides.

Plain English Breakdown

The exact composition of the oversight committees is specified in the bill but not detailed here.

Peptide Research Program

This law establishes a program in California that allows certain entities to research and test peptides and other new compounds for medical use, with rules about safety and reporting.

What This Bill Does

• Creates the California Investigational Peptide and Novel Compound Research and Therapeutic Access Program.
• Allows participating entities to conduct independent testing of peptides and novel compounds.
• Requires participating entities to follow manufacturing standards and maintain chain-of-custody documentation for all compounds used.
• Establishes oversight committees within participating entities to oversee safety reviews.
• Exempts certain groups from civil liability if they act in good faith while following the program rules.

Who It Names or Affects

• Health care practitioners who can prescribe or dispense investigational therapeutic compounds under specific conditions.
• Manufacturers and researchers involved with peptides and novel compounds.
• The State Department of Public Health which will oversee the program and submit reports to the Legislature.

Terms To Know

Peptides

Small chains of amino acids that can have various biological functions.

Chain-of-custody documentation

Records showing who has handled and stored a compound at each step, ensuring its integrity.

Limits and Unknowns

• The program will end on January 1, 2037.
• Details about the composition of oversight committees are specified in the bill but not fully detailed here.
• Specific requirements for investigational therapeutic compounds and their uses are outlined but may vary.

Official Summary Text

AB 2442, as amended, Patterson.
Peptides.
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.
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.

Current Bill Text

Download Bill PDF