§ 111590 Investigational Drug Exemption

Health and Safety Code·California

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Key Takeaways

•This law says some special rules don’t apply to new drugs or medical tools that are still being tested.
•Only trained experts can test these drugs or tools to see if they are safe and work well.
•The testing must follow strict rules from the federal government.
•This law has been in place since 1996.

Example

A doctor is testing a new medicine to see if it helps people with headaches.

The doctor can test this medicine without following some usual rules because they are an expert and are doing it the right way, as per federal rules.

AI-generated — May contain errors. Not legal advice. Always verify source.

Official Source

View on CA.gov

§ 111590 Investigational Drug Exemption

Section 111550 does not apply to a drug or device intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs or devices if the investigation is conducted in accordance with the requirements of Section 505(i) of the federal act (21 U.S.C. Sec. 355(i)) or Section 520(g) thereof (21 U.S.C. Secs. 352 and 360) and the regulations adopted pursuant to the federal act. (Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)

Last verified: January 23, 2026

Key Terms

investigational use Section 505(i)Section 520(g)federal act

References

Official text at leginfo.legislature.ca.gov
California Legislature. Health and Safety Code. Section 111590.

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Related Statutes

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Key Takeaways

Example

Key Terms

Related Statutes

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