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<ns0:ActionText>INTRODUCED</ns0:ActionText>
<ns0:ActionDate>2026-02-20</ns0:ActionDate>
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<ns0:ActionText>AMENDED_ASSEMBLY</ns0:ActionText>
<ns0:ActionDate>2026-03-19</ns0:ActionDate>
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<ns0:AuthorText authorType="LEAD_AUTHOR">Introduced by Assembly Member Patterson</ns0:AuthorText>
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<ns0:Name>Patterson</ns0:Name>
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<ns0:Title>An act to add and repeal Chapter 26 (commencing with Section 28005) of Division 20 of the Health and Safety Code, relating to public health. </ns0:Title>
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<ns0:GeneralSubject>
<ns0:Subject>Peptides.</ns0:Subject>
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<html:p>Existing law establishes the State Department of Public Health, which, among other things, administers various programs that prevent disease and promote health.</html:p>
<html:p>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.</html:p>
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<ns0:Preamble>The people of the State of California do enact as follows:</ns0:Preamble>
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<ns0:Num>SECTION 1.</ns0:Num>
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Chapter 26 (commencing with Section 28005) is added to Division 20 of the
<ns0:DocName>Health and Safety Code</ns0:DocName>
, to read:
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<ns0:Num>26.</ns0:Num>
<ns0:LawHeadingVersion id="id_22BCD8A1-F713-4CF0-9431-F1D815C1773C">
<ns0:LawHeadingText>California Investigational Peptide and Novel Compound Research and Therapeutic Access Program</ns0:LawHeadingText>
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<ns0:LawSection id="id_C0B2F94A-1C7F-4945-88A0-E72EF9A9AF9E">
<ns0:Num>28005.</ns0:Num>
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<ns0:Content>
<html:p>
(a)
<html:span class="EnSpace"/>
The Legislature finds and declares all of the following:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
California is a global leader in biotechnology, biomedical research, and pharmaceutical innovation.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
Expanded research and investigational therapeutic access programs may accelerate scientific discovery while maintaining appropriate patient safety protections.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
Advancing peptide and novel compound research supports innovation in areas including, but not limited to, all of the following:
</html:p>
<html:p>
(A)
<html:span class="EnSpace"/>
Rare disease research.
</html:p>
<html:p>
(B)
<html:span class="EnSpace"/>
Healthy aging and longevity science.
</html:p>
<html:p>
(C)
<html:span class="EnSpace"/>
Veteran therapeutic innovation.
</html:p>
<html:p>
(D)
<html:span class="EnSpace"/>
Obesity and metabolic disease treatment.
</html:p>
<html:p>
(E)
<html:span class="EnSpace"/>
Neurodegenerative disease research.
</html:p>
<html:p>
(5)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(6)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
It is the intent of the Legislature to do both of the following:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
Support voluntary state-authorized research programs, investigational therapeutic access under medical supervision, institution-level safety oversight, and high-quality manufacturing and testing standards.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
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.
</html:p>
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<ns0:LawSection id="id_F454B459-9D0F-4382-88ED-753268BCA6C8">
<ns0:Num>28006.</ns0:Num>
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<ns0:Content>
<html:p>
(a)
<html:span class="EnSpace"/>
For the purposes of this chapter, the following definitions shall apply:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
“Department” means the State Department of Public Health.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
“Investigational therapeutic compound” means a peptide or novel compound that meets all of the following:
</html:p>
<html:p>
(A)
<html:span class="EnSpace"/>
Is not currently approved for marketing by the United States Food and Drug Administration (FDA) with active patent or regulatory exclusivity protections.
</html:p>
<html:p>
(B)
<html:span class="EnSpace"/>
Is manufactured and tested under institutional standards established pursuant to this chapter.
</html:p>
<html:p>
(C)
<html:span class="EnSpace"/>
Is dispensed only under supervision of a licensed health care practitioner within a bona fide practitioner-patient relationship.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
“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.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
“Novel compound” means a synthetically produced small-molecule compound that meets all of the following:
</html:p>
<html:p>
(A)
<html:span class="EnSpace"/>
Is not scheduled under state or federal controlled substances law.
</html:p>
<html:p>
(B)
<html:span class="EnSpace"/>
Is not approved for marketing by the FDA under Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec.
355), unless patent and regulatory exclusivity protections have expired and a generic version is lawfully marketed in the United States.
</html:p>
<html:p>
(C)
<html:span class="EnSpace"/>
Is not currently in Phase II or Phase III clinical trials for which a manufacturer or sponsor continues to actively pursue full FDA approval.
</html:p>
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<ns0:LawSection id="id_EA52C852-D4C9-4189-9591-0BB25E654CB3">
<ns0:Num>28007.</ns0:Num>
<ns0:LawSectionVersion id="id_2DF42065-9A77-4817-BF5E-A846A4D081CE">
<ns0:Content>
<html:p>
(a)
<html:span class="EnSpace"/>
The following entities are authorized, but not required, to establish and administer peptide and novel compound research and investigational therapeutic access programs:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
The University of California.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Any accredited California medical school.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
Any teaching hospital affiliated with an accredited California medical school.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
Any licensed general acute care hospital.
</html:p>
<html:p>
(5)
<html:span class="EnSpace"/>
Any licensed physician group practice employing five or more physicians.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
Participating entities may do any of the following:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
Contract for manufacturing.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Conduct independent batch testing.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
Certify batches meeting institutional standards.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
Maintain internal compound and batch registries.
</html:p>
<html:p>
(5)
<html:span class="EnSpace"/>
Operate research dispensing or investigational therapeutic access programs.
</html:p>
<html:p>
(6)
<html:span class="EnSpace"/>
Collect and report safety and usage data to the department.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
Nothing in this chapter authorizes general retail sale to the public without licensed health care
supervision.
</html:p>
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<ns0:LawSection id="id_FAC439A1-9833-4F9C-A7D6-818753677AF6">
<ns0:Num>28008.</ns0:Num>
<ns0:LawSectionVersion id="id_0E851A38-83FC-4FF3-97E4-9CCEDA4E61F6">
<ns0:Content>
<html:p>
(a)
<html:span class="EnSpace"/>
Participating entities shall ensure that all manufacturing conducted under this chapter complies with current Good Manufacturing Practice (cGMP) requirements as set forth in Parts 210 (commencing with Section 210.1) and 211 (commencing with Section 211.1) of Title 21 of the Code of Federal Regulations, as applicable to the type of compound produced.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
All sterile manufacturing or compounding activities conducted under this chapter shall comply with applicable United States Pharmacopeia (USP) standards, including, but not limited to, all of the following:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
USP General Chapter <797> (Pharmaceutical Compounding – Sterile Preparations).
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
USP General Chapter <800> (Hazardous Drugs – Handling in Health care Settings), where applicable.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
International Organization for Standardization (ISO) 14644 cleanroom classification standards appropriate to the level of sterile production performed.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
All analytical testing of compounds under this chapter shall be performed exclusively by laboratories holding valid certification under the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a). Each laboratory shall maintain documented standard operating procedures for every assay performed, including validated methods for identity, purity, potency, sterility, and endotoxin testing, where applicable.
</html:p>
<html:p>
(d)
<html:span class="EnSpace"/>
All bulk active pharmaceutical ingredients and source compounds shall
be obtained exclusively from licensed wholesale distributors in full compliance with the federal Drug Supply Chain Security Act (Public Law 113-54), and all applicable federal FDA importation, tracing, and distribution requirements.
</html:p>
<html:p>
(e)
<html:span class="EnSpace"/>
At minimum, each batch produced or dispensed under this chapter shall undergo all of the following:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
Identity confirmation using mass spectrometry or equivalent validated methodology.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Purity analysis using high-performance liquid chromatography or equivalent validated methodology.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
Potency verification, where applicable.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
Sterility testing for injectable or sterile products.
</html:p>
<html:p>
(5)
<html:span class="EnSpace"/>
Endotoxin testing for injectable products.
</html:p>
<html:p>
(f)
<html:span class="EnSpace"/>
Participating entities shall maintain comprehensive chain-of-custody documentation for all compounds, including, at a minimum, all of the following:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
Manufacturing origin.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Distributor verification.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
Batch numbers and certificates of analysis.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
Storage conditions and tracking.
</html:p>
<html:p>
(5)
<html:span class="EnSpace"/>
Full traceability from source material to final dispensation.
</html:p>
<html:p>
(g)
<html:span class="EnSpace"/>
Nothing in this section shall be interpreted to permit manufacturing practices below the standards required under federal law for comparable
activities.
</html:p>
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<ns0:LawSection id="id_73703BEE-914E-4F5D-916C-6F09994BA316">
<ns0:Num>28009.</ns0:Num>
<ns0:LawSectionVersion id="id_7F435BC7-82B1-4D19-8035-0835E0FD1C9C">
<ns0:Content>
<html:p>
(a)
<html:span class="EnSpace"/>
Each participating entity shall maintain a peptide and novel compound oversight committee.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
The committee shall include, at minimum, all of the following:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
A biomedical researcher.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
A licensed physician.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
A pharmacologist.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
A toxicologist.
</html:p>
<html:p>
(5)
<html:span class="EnSpace"/>
A patient or community representative.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
The committee shall oversee all of the following:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
Safety review.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Adverse event review.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
Protocol review.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
Annual update of institutional standards.
</html:p>
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</ns0:LawSection>
<ns0:LawSection id="id_F7CDDA0A-841F-4774-9C2B-DC9D82FEE986">
<ns0:Num>28010.</ns0:Num>
<ns0:LawSectionVersion id="id_B3AD3F44-F194-4019-9AB4-3D738C4A5C89">
<ns0:Content>
<html:p>
(a)
<html:span class="EnSpace"/>
A licensed health care practitioner acting within their scope of practice may prescribe or dispense investigational therapeutic compounds that meet all of the following:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
Meet institutional certification standards.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Are dispensed through authorized institutional programs.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
Are accompanied by written informed consent.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
Participation under this chapter shall not, by itself, constitute unprofessional conduct.
</html:p>
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<ns0:LawSection id="id_E6B2FCA6-A729-4C0F-8A29-D287B6DFDE77">
<ns0:Num>28011.</ns0:Num>
<ns0:LawSectionVersion id="id_0BAC1580-4AAA-4EB2-AF45-DABF2E5EB515">
<ns0:Content>
<html:p>
(a)
<html:span class="EnSpace"/>
An entity, health care practitioner, pharmacist, manufacturer, or researcher acting in good faith and in compliance with this chapter shall not be subject to civil liability solely for recommending, prescribing, dispensing, administering, manufacturing, or studying a compound authorized under this chapter.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
This section does not apply to any of the following:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
Gross negligence.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Reckless misconduct.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
Intentional wrongdoing.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
Fraud or misrepresentation.
</html:p>
<html:p>
(5)
<html:span class="EnSpace"/>
Failure to obtain informed consent.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
This chapter does not create a private right of action.
</html:p>
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</ns0:LawSection>
<ns0:LawSection id="id_4940A415-FA57-41AC-9657-9EB6385E098B">
<ns0:Num>28012.</ns0:Num>
<ns0:LawSectionVersion id="id_068FF154-ECDE-4FA6-9463-9BCEC4EF7445">
<ns0:Content>
<html:p>
(a)
<html:span class="EnSpace"/>
Participating entities shall submit annual safety and utilization reports to the department.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
The department shall submit a statewide program evaluation report to the Legislature on or before January 1, 2032. The report shall be submitted in compliance with Section 9795 of the Government Code.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
The report required pursuant to subdivision (b) shall include, at a minimum, all of the following:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
Safety outcomes.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Research output.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
Therapeutic outcomes.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
Economic impact.
</html:p>
<html:p>
(5)
<html:span class="EnSpace"/>
Recommendations.
</html:p>
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<ns0:LawSection id="id_4B3C78A2-2B90-4436-BA1B-2B159BDB1053">
<ns0:Num>28013.</ns0:Num>
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<html:p>This chapter shall remain in effect only until January 1, 2037, and as of that date is repealed.</html:p>
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